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T h e S e a r c h F o r P e s t i c i d e R e s i d u e s 6The Environmental Protection Agency sets levels forpesticides used on food crops. FDA is responsible for seeing that those levels are not exceeded. This article tells howFDA does that job.

P e s t i c i d e s A n d F o o d : P u b l i c W o r r y N o . 1 1 2A nationwide survey done for a food retailer group showedthat pesticide and herbicide residues in food products wasthe top food safety concern. Cholesterol ran second.

M a k i n g B u l k F o o d s S a f e F o o d s 1 6Bulk foods sold at the retail level are coming back intostyle. The reason is not nostalgia, so don't look for anypotbellied stoves. But the fad poses some safety problems.

When Digestive Juices Corrode, You've Got An Ulcer 20For some unknown reason, the lining of the stomach orsmall intestine sometimes fails to protect against digestivejuices, and a sore, or ulcer, can result. Treatment today ismainly with drugs.

Ta l e O f T h e To m a t o : F r o m ' P o i s o n ' To P i z z a 2 4Once shunned as toxic, the tomato now finds its way intosoups, juices, sauces, pizza and condiments. In fact, theaverage American eats about five processed tomatoes aweek .

F o o d L a b e l s T o T e l l M o r e A b o u t S o d i u m 3 0Those people who watch their salt/sodium consumptionwill soon be aided by a new requirement that sodium content be listed on the labels of more than half the processedfoods.

W h a t T o D o W h e n Y o u O v e r d o S u m m e r 3 2The good ole summertime is a time to get outdoors and dothings that aren't done at other times of the year. But thereare some warm weather hazards.

U p d a t e s 2 I n v e s t i g a t o r s ' R e p o r t s 3 4The No tebook 5 Summar i es o f Cou r t Ac t i ons 37

At a California multiproduct processing plant called a "supercannery," workers give tomatoes a final once-over and sorting before a conveyor transportsthem to plant areas where they'll be used in various tomato products. Formore about tomatoes see Tale of the Tomato: From 'Poison' to Pizza staitingon page 24.

Margaret M. HecklerSecretary, U.S. Department ofHea l th and Human Serv ices

I^rank E. Young, M.D.Commissioner of Food and Drugs

Roger W. Miller/Editor

Harold C. Hopkins/Editorial Director

Jesse R . N i cho l s /A r t D i r ec to r

Cover Design: Zeb Rogerson

6

FDA Consumer / July-August 1984 / 1

Diabetic Drug Warning

A new warning that taking oral hypoglycemicdrugs to treat adult-onset diabetes can increase therisk of death from heart and blood vessel disorderswill soon be required on the labels of these drugs.

The warning, to appear in the labeling (printedmaterial that physicians and pharmacists receive),will say: "The administration of oral hypoglycemiadrugs has been reported to be associated with increased cardiovascular mortality as compared totreatment with diet alone or diet plus insulin."

The statement is based on the findings of a long-term study by the University Group Diabetes Program in 12 university medical centers. The UGDPstudy, financed by the National Institutes ofHealth, was intended to determine if reducingblood sugar by oral drugs or low doses of insulinin people with adult-onset diabetes would preventor delay blood vessel disease commonly found ind i a b e t i c s .

None of the treatments provided the hoped-forbenefit. However, the UGDP reported in 1970 thatan unexpected finding of the study had shown thatdiabetics treated by using dietary management anda typical blood-sugar-lowering drug had a highercardiovascular death rate than those treatedthrough diet alone. FDA had planned labelingchanges based on this study, but legal challengesfrom a group called the Committee on the Care ofthe Diabetic delayed those plans.

In 1975 FDA proposed to require a warning thatthe drugs "may be associated" with an increasedrisk of cardiovascular death. As a result of comments received on the proposals and an extensivedata audit and reanalysis of the UGDP study, FDAconcluded that it has not been established with certainty that there is an increased risk of cardiovascular mortality associated with oral hypoglycemics but that there is sufficient evidence of ahazard to require a label warning.

Under a guideline, announced along with thenew warning label in the April 11 Federal Register,the drug labeling will emphasize that dietarymanagement is the primary form of therapy foradult-onset diabetes.

Manufacturers have until Oct. 9 to change theirlabeling to include the warning. (For more infor

mation about diabetes, see "Diabetes Is A Controllable Disease With A Growth Factor" in theNovember 1982 issue of FDA Consumer.)

Rules For Taping Hearings

FDA's policies and procedures for videotapingand other electronic media coverage of public administrative proceedings have been set forth inguidelines that became effective May 14.

The new guidelines specify acceptable proceduresfor all forms of electronic recording and are intended to help presiding officers and chairpersonsinterpret the agency's policy of openness to thenews media. The guidelines advise that:• Requests to videotape an FDA proceeding shouldbe made 48 hours in advance if possible, althoughthe presiding officer will not deny access if suchnotice is not given.• Cameras should be set up in fixed positionsbefore proceedings begin or during a break and betaken down only during breaks or after the proceeding is over. Roving cameras will not bepermit ted.• When space is limited, the number of cameras oramount of equipment may be restricted. Underthese circumstances, pool arrangements are theresponsibility of the participating media.• "Off the record" portions of a proceeding maynot be videotaped.• Except under extraordinary circumstances,witnesses may not decline to have their testimonyr e c o r d e d .

The new guidelines were published in the April13 Federal Register.

False Lab Reports Bring PrisonThree former employees of Industrial Bio-Test

Laboratories, convicted after a seven-month jurytrial on charges of mail fraud and submitting falsestatements to FDA and the Environmental Protection Agency, have been sentenced to prison.

Dr. Moreno Keplinger, former manager of toxicology for the laboratories, was sentenced to oneyear and one day in prison and four years probation. Dr. Paul Wright, former head for rat toxicology, and James B. Plank, former assistant

2 / July-August 1984 /FDA Consumer

manager of toxicology, each received prisonsentences of six months and two years probation.

In imposing the sentences, U.S. District JudgeJohn A. Nordberg said that "a message must besent to the scientific community that no one mustfile false reports" and that persons doing so "willtruly be punished."

The now defunct Northbrook, 111., laboratorywas one of the largest private testing laboratories inthe United States. Falsified test results, discoveredat the lab in 1977, involved a pesticide; an herbicide; an antibacterial agent, trichlorocarbanilide(TCC), used in many deodorant soaps; and Naprosyn, an arthritis drug. The TCC and Naprosynstudies were submitted to FDA to evaluate the safety of the test substances. Both were further testeda n d f o u n d s a f e .

Dr. Joseph Calandra, former president of thecompany, also was indicted on the same charges,but his case was separated early in 1983 because ofan illness that required open heart surgery.

Research On Animal Drugs

About $400,000 will be available in fiscal year1984 to support research on minor use animal

drugs, according to FDA's Center for VeterinaryMedicine (formerly the Bureau of VeterinaryMedicine). It is expected that one or two awardswill be made. Support may be for a period of up tothree years.

A minor use animal drug is (I) a new animaldrug used in minor animal species or (2) a newanimal drug used in any animal species for the control of a disease that occurs infrequently or inlimited geographic areas. Minor species are thoseother than cattle, horses, swine, chickens, turkeys,dogs and cats (see "Drugs For Those Other Anim a l s " i n t h e O c t o b e r 1 9 8 3 i s s u e o f F D A C o n

sumer).FDA will consider funding research projects to

investigate the comparative physiology of majorand minor animal species, the comparative metabolism or pharmacology and toxicology of minoruse animal drugs in major and minor animalspecies, or to study the variables used to apply datafrom approved major use drugs to minor usedrugs.

Support for this program will be in the form of acooperative agreement. Such agreements can beentered into by public or private nonprofitorganizations (including state and local units of

FDA Consumer / July-A ugust 1984 / 3

government) or by for-profit organizations.For further information, contact David B. Bat-

son, HFV-500, FDA, 5600 Fishers Lane, Rockville,M d . 2 0 8 5 7 .

Treating Mood DisordersLithium and tricyclic antidepressants, drugs used

to treat certain mood disorders, are also effectivein preventing their recurrence, a pane! of expertssaid recently. The panel of participants in a consensus development conference at the National Institutes of Health, addressed the subject of thepharmacologic prevention of recurrences of moodd i s o r d e r s .

Mood disorders are common and serious conditions, the panel pointed out. It is estimated that atany one time 3 to 4 percent of the people in thiscountry will have a major depressive or manic attack. Recurrences are frequent. The frequency andintensity of subsequent attacks can be reduced withmedication, according to the panel.

For those with manic depression (known technically as bipolar disorder) who are particularly likelyto suffer recurrences, lithium is the drug of choice,the panel said. Studies have shown that patientswho were treated with lithium had half the numberof recurrences of either mania or depression compared with those who received a placebo. The recurrences were also less severe. This preventivetreatment is equally effective against both manicand depressive recurrences in male and female patients from early adulthood to old age. Littleresearch has been done on mood disorders inchildren or adolescents.

In treating patients with depression alone (unipolar disorder), the panel said both lithium andtricyclic antidepressants have been shown effectivein both men and women from early adulthood toold age. However, since the efficacy of treatmentfor depression alone is less well established, thedecision to start preventive treatment is morehighly individualized. There are no guidelines forchoosing one type of drug over another.

Repeated and candid discussions with the patient, the patient's spouse, or other relatives are a"must" to ensure full understanding of potentialadvantages and risks both when there is preventive

treatment as well as where there is no treatment,the panel pointed out. Use of lithium or tricyclicantidepressants does not appear to present appreciably different risks in preventive therapy than intherapy for acute episodes of mood disorders. Because lower doses are frequently used for prevention, side effects may, in fact, be less of a problem,although lithium taken by a mother can affect thefetus and the nursing newborn.

How long treatment should go on must be determined on an individual basis. There are no datathat establish a best length of time for preventivetherapy.

The consensus conference on "Mood Disorders:Pharmacologic Prevention of Recurrences" washeld April 24 to 26 under the joint sponsorship ofthe National Institutes of Health and the NationalInstitute of Mental Health. For more about depression, see "Using Drugs To Lift That Dark Veil OfDepression" in the October 1983 FDA Consumer.

Reprints Available

Reprints are available of the following articlesthat appeared in the April 1984 issue of FDA Consumer: "Do Yourself A Flavor," "Bee Pollen AsA Health Food," "Food Preservatives: A FreshReport," and "Questions Of Substance(s) ConcernCosmetic Users."

Single copies of these reprints can be obtainedfrom the Food and Drug Administration, HFE-88,5600 Fishers Lane, Rockville, Md. 20857. Multiplecopies are available from FDA, HFW-40, at theRockville address. Copies of reprints also areavailable from FDA's consumer affairs officers,who are located in 30 cities around the country.

In addition, the article "Sealing Teeth To Prevent Cavities" in the April issue isbeing reprinted by the NationalInstitute of Dental Research. AjjR||Copies can be obtained by /w/i IISmwriting to the National aim I ||SInstitute of Dental Research, twilll MOkiHi |)nBuilding 31, Room 2C33, HliB IjlHNational Institutes of Health, VljroiBethesda, Md. 20205.


T h e N o t e b o o k

The Notebook: a potpourri of items of interestgathered from FDA news releases, other newssources, and the Federal Register (designated PR,with date of publication). The Federal Register isavailable in many large public libraries.

■ Minimum levels for calcium and phosphorus willbe revised, and maximum levels for iron and iodinewill be set under FDA's proposed revision of infantformula nutrient requirements. The proposal isbased on recommendations of the Committee onNutrition of the American Academy of Pediatrics,international standards for infant formulas, andother sources {FR April 11).

■ Because of their low potential for toxicity, antacid and anti-flatulent products, except those containing bismuth, would be exempted from the labelwarning: "In case of accidental overdose, seek professional assistance or contact a poison controlcenter immediately," under a proposed FDA rule{FR April 13).

■ A label mix-up resulted in an April recall of onelot of isosorbide dinitrate, a prescription heart drugmanufactured by Barr Laboratories for the KrogerCo. The lot, «G17508, was marketed between Sept.1, 1983, and April 5, 1984, and was recalled becauseof the possibility that the bottles contained amitrip-tyline hydrochloride.

■ ORPHAN DRUGS: An agreement has beensigned between FDA and the U.S. Patent and Trademark Office to provide for accelerated determinationof the patentability of an orphan drug before exclusive marketing is granted {FR April 5) .... A listof the drugs and biological products granted orphandesignation is available from the Dockets Management Branch, FDA, Room 4-62, 5600 Fishers Lane,Rockville, Md. 20857 {FR April 13).

■ A Federal advisory committee has been established at the U.S. Centers for Disease Control inAtlanta, Ga., to provide advice and make recommendations for revisions of a 1978 policy statement"Preventing Lead Poisoning in Young Children"{FR April 10).

■ Effective April 4, manufacturers of soft drinks incans may emboss or print the name of the manufacturer, packer or distributor on the lid of the can.The new FDA ruling specifies type-size requirements,which parallel those in effect for soft drinks in bottles {FR April 4).

■ I n a f i n a l r u l e F D A h a s a m e n d e d t h e s t a n d a r d sfor bakery products to prohibit added color exceptthat present in butter or margarine. The agency alsohas lifted its stay of decisions that allow the use oflecithin as an optional ingredient in egg bread, thatallow unlimited use of spices, and that require aminimum content of 2.56 percent by weight of wholeegg solids in any product labeled "egg bread" {FRApril 6).

■ FDA's proposal to reclassify daily wear soft contact lenses from Class 111 (premarket approval) toClass 1 (general controls) has been withdrawn. Thereis not enough scientific evidence to provide reasonable assurance of the safety and effectiveness ofthe lenses {FR April 24).

■ FDA has "permanently" listed D&C Orange No.5 for use in externally applied drugs and cosmetics{FR April 4).

■ Among the latest medical device approvals areCibasoft, Cibathin, Torisoft and Bi-Soft contactlenses tinted blue, green, aqua or amber {FR April10).

■ Add to the GRAS (generally recognized as safe)list: Hydrochloric acid, used to control acidity infood, and propionic acid, calcium propionate andsodium propionate, used in baked goods, frostings,confections and gelatins {FR April 26, April 3).

■ FOOD STANDARDS: FDA is proposing torepeal the class standards for hard cheeses, softripened cheeses, semisoft cheeses, and semisoft part-skim cheeses and to include them in a new standardfor "certain other cheeses" {FR April 23) ... .Comments are invited on the international Codexstandards for pickled cucumbers, canned tuna andhonito, in water or oil, and edible fungi and fungusproducts (mushrooms) with a view to establishingU.S. standards {FR April 24, April 20, April 19).... For lack of interest, FDA is no longer considering amending the U.S. standards for certaincream products, including "double cream" {FRApril 6).


The Search ForPesticide Residuesby Richard C. Thompson

A steady stream of produce trucks from Mexico camerolling into the U.S. customs compound at Nogales, Ariz.,on a recent day this past spring carrying cantaloupes, watermelons, mangoes, garlic, grapes and jalapeno peppers. Onetruck was checked every two-and-a-half minutes, 300 in the12-hour day the border station was open. They were checkedby U.S. Department of Agriculture inspectors, by CustomsService officers, and by FDA inspectors taking samples tobe tested for pesticides. Then each truck was weighed andits toad transferred to American trucks or delivered towarehouses in the Nogales area. The Mexican trucks returned to the growing fields some 400 miles away for thenext day's load.

Above: Mexican trucks already cleared wait to have toadsof watermelons weighed by U.S. customs. These melonswill be reloaded onto waiting American trucks for deliveryto Oregon.

Right: Inspector Don King of FDA's Tucson office takesa sample melon at the dock at Nogales. I4-OK is the customssticker. Trucks in the distance are lined up for weighing.

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Above: FDA sample collector Richard Avenetti makes upbags of Pearlett grapes, the first of the season from Mexicoand therefore scheduled for pesticide analysis. A collectedsample is 20 pounds of any particular item.

Right: Inspector King takes mangoes from a grower forsampling; top right: he bags jalapeno peppers; bottomright: King checks truck manifests (load records) at FDA'sdesk in the customs office. Except for stipulated items, deciding whether and what to sample is a judgment based oninformation about the grower, growing region, and theproduct itself.


the pesticide on the basis of that data. After a pesticide isapproved and on the market, EPA can restrict its use orban it altogether if new data indicates the risks are higherthan they originally appeared. This happened with chlor-dimeform, once used on vegetables and fruit trees butlimited to cotton in 1978 when tests showed it causedt u m o r s i n m i c e .

EPA also regulates pesticide packaging and labeling andmonitors the presence of pesticides in the environment.EPA sets tolerances for pesticide residues in food, basedon toxicological (safety) data and on the residue level thatcan be expected to remain after proper use of the pesticide. Tolerances are the maximum legal limits for residuesin food, and they take into account safety factors that willensure the public health is adequately protected. Somepesticide uses leave no detectable residues on a food cropand can be granted an exemption from a tolerance byE P A .

Farmers and growers who apply the proper pesticide inthe proper way, as directed on the label, have few problems. But pesticides are misused when they are put oncrops for which they are not approved, or put on approved crops in excessive amounts. It is also misuse to apply them too near the time of harvest, say a week beforewhen three weeks are needed for the pesticide to disappear. In other words, pesticides are misused wheneverthey are not used in accordance with the label.

Although EPA sets residue tolerances, FDA—with itshistoric responsibility for food safety—enforces them.Meat, poultry and egg products, however, are the responsibility of the USDA Food Safety and Inspection Service.

FDA considers a food to be adulterated if a pesticideresidue exceeds the tolerance set for that pesticide in thatfood or if a residue is present for which no tolerance hasbeen set .

FDA's program to assure that foods will not containunsafe residues combines evaluation of the potentialhazard of individual pesticides, information-gathering atlocal levels, cooperation with state agencies, developmentof analytical methods, and a nationwide program to sample and analyze food and animal feed.

Some 10,000 shipments of domestic and imported foodsare sampled each year by FDA. Domestic samples aretaken as close as possible to the growing or processinglocation, and inspectors also go into the fields. They mustknow harvesting seasons for crops and the pesticides usedand the problems they present.

The types of foods frequently sampled on this routinebasis include fresh and processed fruits and vegetables,fish, milk and dairy products, grains, and animal feedsand feed ingredients.

FDA does special sampling where a problem may besuspected, when there is interest in a certain food commodity, or where more information is needed about a particular pesticide. Such surveys have been done in recentyears on residues in imported coffee beans and in variousfoods for the pesticides PCP, mirex, kepone, DBCP andbenomyl .

T h e 2 2 F D A d i s t r i c t o f fi c e s h a v e c o n s i d e r a b l e l a t i t u d ein setting up their own pesticide programs and base theirsampling on foods that are produced or consumed in their


There are at present some 300pesticides for which residue toleranceshave been established in foods andanimal feeds. The potential combinations of pesticides and foods is almostinfinite. It would be impossible, evenwith unlimited resources, to analyzecontinuously for all these combinations. Fortunately, such analysis isnot necessary because many pesticidesare not widely used, are not used inlarge amounts, have low toxicity, orhave residues that dissipate quickly.

In 1979, FDA began evaluatingpesticides for which a tolerance levelhas been set to be certain that themos t haza rdous a re i nc l uded i n t he

agency's monitoring program. Cropusage, toxicity, environmental stability, dietary exposure, and marketvolume and production are all factorsi n t h e e v a l u a t i o n .

Each pesticide has been rankedfrom one (most) to five (least) interms of hazard potential. Pesticidesnot routinely covered by FDA programs and those that EPA judgedmost risky are being looked at first.To date, about 130 have been evaluated and half of these found to below risk, with only surveillance

monitoring needed. Many of thepesticides awaiting evaluation arealready covered by FDA's multi-residue analysis.

Among those evaluated is ethylenedibromide, or EDB.

This compound has been aroundsince the 1920s as a gasoline additive.Some 300 million pounds of it areproduced annually in the UnitedStates, and 95 percent of the production still goes for that purpose. The 5percent for agriculture was almost allused as a soil fumigant to controlroot worms and soil insects, with asmall amount used for post-harvestfumigation of citrus, grains and otherfood crops.

EDB was registered as a pesticidein 1948. Tests in use at the time didnot show detectable residues, so whena tolerance was needed in 1956 an existing limit for bromide compoundswas applied. But in the 1970s newtechnology, testing now at parts perbillion, found residues where nonebefore had been detected. By thenEDB was a suspected carcinogen. TheEnvironmental Protection Agencyhad recently been established, andthat agency proposed that EDB bemore closely regulated.

Before changes could be made,E D B b e c a m e a n a t i o n a l i s s u e . T h efuror was precipitated in 1983 by afinding of EDB residues in corn, rice,wheat and other crops and in cakemixes, cereals and other foods madefrom those grains. Some scientists

pointed out that 80 percent of EDBdisappears in cooking and that the actual residues would be much lower.Nevertheless, a number of states tookindividual action, and food processors carried out massive recalls oftheir products from stores andwarehouses. Several states weredistressed to find EDB in theirground water and wells, thought tobe from soil fumigation and cropspraying runoff.

In quick succession EPA moved tocancel food crop uses for EDB and tosuspend its use as a soil fumigant,then as a grain fumigant. Final ruleswere published April 23, 1984, in theFederal Register. In them, EPArevokes earlier tolerances and exemptions and sets a new residue toleranceof 900 parts per billion for EDB as apost-harvest fumigant on grains. Itsets limits of 150 parts per billion forEDB residues in foods such as corn-meal, flour and cake mixes, and 30parts per billion for ready-to-eatfoods such as cereals .

FDA is now enforcing the newtolerances. FDA also has mounted asurvey and sampling program to provide EPA with data on residues inraw grain, finished grain products,citrus, animal feed, infant formula,and certain other foods. With its usesnow restricted and residues moreclosely controlled, EDB could largelydisappear from the nation's foodsupply.

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own areas. Analyses that can detect up to 200 differentpesticides in a single sample are used to find those mostlikely to be present.

The same laws and regulations that apply to residues inor on foods produced in the United States apply to foodsimported from other countries. Stated simply, if a tolerance has been set for a pesticide in the U.S., thattolerance applies to imported foods.

During the summer months, most of the tomatoes,cucumbers, squash, broccoli, green beans and other freshvegetables that appear on the American dinner table aregrown locally or in those several states that specialize insuch products. But as summer edges into fall and a winterchill comes down from the north, the growing season forthese foods ends in much of the United States. Then produce from Mexico begins moving across the border.

At first there are a few truckloads a day beginning inNovember, some coming to Nogales on the Arizonaborder, others to Hidalgo on the Texas line. Then thetraffic starts to build, until from January through

April—the peak growing season in Mexico—some 600trucks a day pass through Nogales and another 300 crossat Hidalgo. Almost three-quarters of the produce cominginto the United States during these months enters throughthose two c i t i es .

At the border, the trucks are guided into holding areasand checked for contraband by the U.S. Customs Service.Samples of produce are taken by FDA inspectors. Thenthe shipments are transferred to American trucks that willhaul the loads throughout the United States. The Mexicantrucks go back to their fields and terminals.

The U.S. and Mexican governments realize that controlling residues requires cooperation and that both countr ies have a stake in th is .

Strawberries, for example, are the fourth most important money crop that Mexico ships to the U.S. But in theearly 1970s, FDA was finding excessive levels of thepesticide endrin in almost every lot of fresh and frozenberries offered for import by Mexican growers. Shipmentafter shipment was turned back.


FDA sent investigators to Mexico from the Dallas officeto give technical advice and assistance to growers in thatcountry and to advise them what to do to avoid havingtheir berries rejected. The Mexican growers in turn set uptesting laboratories to monitor pesticide use and residuesbefore shipping the berries.

FDA's present system of checking Mexican produce isbased on a six-month sampling in 1978 of 1,528shipments. These shipments represented 40 kinds of freshand processed produce, including tomatoes, peppers,cucumbers, squash, peas, green beans, strawberries andeggplant. Most sampling was done as surveillance, meaning that samples were taken at random with no reason tosuspect they might contain illegal residues.

The pesticides most frequently found in the 1979 sampling were methamidophos, omethoate, chlorpyrifos,dimethoate, dieldrin, acephate, DDT, DDE (a degradedbyproduct of DDT), parathion and methyl parathion.Most of these are approved for use on certain crops in theU.S. and Mexico, but here they were being found oncrops for which they were not approved. Three of thepesticides (DDT, DDE and dieldrin) had been banned inthe 1960s but could have turned up in the samples becausethe substances disappear slowly from the environment.

FDA now samples over 2,000 shipments a year fromMexico. When illegal residues are found, investigators willdo compliance sampling, which means detaining producefrom that shipper, grower or growing region at the borderuntil it has been sampled and analyzed. Since detentioncan be costly to shippers and growers, most learn to shipproduce that does not have illegal residues. Persistentviolators must provide certified analyses that show theirproducts are within U.S. tolerances before their shipmentsare even considered for inspection at the border.

When samples are taken by inspectors from a truck atNogales, they are sent 60 miles north to the FDA residentpost at Tucson for loading on a plane to Los Angeles.They are then carried by special messenger from the airport to FDA's Los Angeles laboratory, arriving there asthe lab opens the next morning. FDA scientists doingpesticide analysis will have the results by mid-afternoon,identifying the pesticide (if any) and the levels. The findings are telephoned to Tucson, and if illegal residues arefound the offending shipment will be traced by FDA investigators to its destination and, if possible, intercepted.Future shipments from that grower or shipper will be detained by FDA at the border until the produce can beanalyzed.

FDA inspectors find a variety of residue problems.Earlier this year, for example, a shipment of cabbagefrom Mexico was found to have residues of DDT andBHC (benzene hexachloride). Both are prohibited foragricultural use in the United States. The importer wantedto recondition the cabbage by removing the outer contaminated leaves, which made up about 10 percent of eachhead. FDA turned this down, saying that the high levelsindicated the banned pesticides had been applied deliberately. Allowing the cabbage into the country would,in FDA's view, be giving "tacit approval" to use of an illegal pesticide.

Two years ago, the Dallas laboratory found the

pesticide Azodrin in 9 of 20 shipments of serrano chilipeppers from Mexico. Azodrin is permitted in the UnitedStates for some food crops but not for peppers. FDAclosed the border to this product, meaning that the peppers would have to be tested for pesticide residues andcertified by the Mexican government before entering theU.S. In 1980, the border was closed to Mexican peaswhen shipments were found to contain chlorothalonil (apesticide banned in the U.S.) and to tomatoes with illegallevels of chlorpyrifos.

Domestic produce presents similar pesticide problems.In 1981 dimethoate and methamidophos were found onspinach grown in the lower Rio Grande Valley of Texas.Methamidophos is not approved for use on spinach. Thedimethoate, though approved, was present at more thanthree times the permitted residue level. The loaded trucks,headed toward Baltimore, were intercepted, and Texas officials halted further shipments from those fields until theproblem was resolved.

In 1982 the pesticide Monitor was found on spinachgrown near Oxnard, Calif., and a shipment was alreadyon its way to Chicago. An FDA inspector had, the daybefore, picked up field samples for analysis. The LosAngeles laboratory found residues of the pesticide, notpermitted for use on spinach. FDA's Chicago districtlocated the crates in a southside market; the Minneapolislaboratory confirmed the presence of the pesticide; andthe spinach was seized by court order and destroyed. Thegrowers denied knowing how the Monitor might have gotten on the crop.

The sampling described earlier is one component ofFDA's pesticide program. The other is the agency's totaldiet or "market basket" study. (See "A Hard Look AtWhat We're Eating," FDA Consumer, April 1984.) Begunin 1962, its purpose is to determine the amounts of different residues that may be actually consumed by population groups in the United States.

FDA inspectors purchase foods in supermarketsthroughout the country, just like any other shopper.There are 234 foods in a single purchase, with identicalpurchases made in three cities in a particular region, thena month or so later in another three cities in anotherregion. The foods are shipped, region by region, to FbA'sKansas City laboratory where they are cooked, baked orotherwise made table-ready, then analyzed for pesticideresidues as well as nutrients and essential minerals. Thesestudies show, for example, that DDT and dieldrin are occurring in food at very low and diminishing levels. Endrinhas not even been detected in the American diet for thepast five years.

The surveillance of domestic and imported foods showsthat almost all samples comply with the limits forresidues. Illegal residues found are usually pesticidesregistered for use on certain food crops but not on thatparticular crop. The diet studies show that residues in thefoods Americans eat are consistently below the levelsestablished by the World Health Organization.

Richard C. Thompson is a member of FDA's publicationsstaff.

FDA Consumer / July-August 1984 /II

Pesticides And Food:PubUc Worry No. 1

For years, various surveys haved o c u m e n t e d t h e c o n t i n u e d c o nfi d e n c e o f m o s t A m e r i c a n c o n s u m e r sin the safety of the foods they buyand eat. But what happens to thepublic's trust in food safety after aseries of widely publicized incidentssuch as product tamperings, recalls offoods, controversy over chemical residues in foods, and publicity about arelationship between the foods we eatand cance r?

The Food Marketing Institute(FMI), an organization of foodretailers and wholesalers, includingmost big supermarket chains andmany independent supermarkets andregional firms, sought the answers ina telephone survey of 1,008 shopperslast January. The Washington, D.C.,organization's report, "Public Attitudes Toward Food Safety," wasissued in late March.

In the three years prior to the latestsurvey, FMI said, Americans hadbeen barraged with such issues as thetampering with Tylenol capsules in1982; a number of sizable productrecalls, including baby foods, cannedfish, mushrooms and cake mixes; therecent warnings of a possible relationship between diet and diseases such ascancer and heart conditions; and thehighly publicized controversy over theuse of ethylene dibromide (EDB) thatsurfaced in late 1983 and continuedi n t o 1 9 8 4 .

The 1,008 participants—60 percentof them women—were interviewed onbehalf of FMI by Louis Harris &Associates Inc., New York, betweenJan. 17 and Jan. 30. EDB alreadywas on the front pages, althoughmedia coverage was more extensiveafterward, FMI's report noted. EDBspecifically was not mentioned in

FMI's survey. The survey concludedthat there is a persistent public conc e r n o v e r c h e m i c a l r e s i d u e s i n f o o d sbut that there has been no generaldecline in overall "confidence" in thefood supply.

The survey focused on six subjects:residues in the food supply, cholesterol, salt, additives and preservatives, sugar, and artificial coloringagents. The participants were askedwhether they considered these products serious health hazards, somewhathazardous, or not hazardous at all.Far ahead of any other public conc e r n w a s t h a t v o i c e d a b o u t c h e m i c a lr e s i d u e s i n f o o d s .

Of those surveyed, 77 percent saidtha t chemica l res idues such aspesticides and herbicides are a serioushazard, and 18 percent describedthem as something of a hazard. Thesecond highest level of concern wasover cholesterol content of food; 45percent cited it as a serious hazardand 48 percent as something of ahazard. Salt in food was viewed as aserious hazard by 37 percent, additives and preservatives by 32 percent, sugar 31 percent, and artificialcoloring agents by 26 percent. Only 2percent did not view chemical residues as a hazard.

"The response toward residues issignificant," the FMI report said,"because it outstrips the others bysuch a wide margin." Although FMIsaid it planned to probe this issue in alater survey to see if the EDB response was caused by recent mediaattention, the pollsters said thatpublic concern over chemical residuesappeared to be deep-rooted.

The report noted that FMI'scontinuing research "has shown atendency for the public to be


Consumer Food Concerns

Q: How concerned are you about the following items being in food? Would you say that (Read Each Item) (is/are) aserious health hazard, somewhat of a hazard, or not a hazard at all?

N o t aS e r i o u s S o m e w h a t H a z a r dH a z a r d o f a H a z a r d a t A l l N o t S u r e

( % ) ( % ) ( % ) ( % )

Residues, such as pesticidesa n d h e r b i c i d e s 7 7 18 2 3

C h o l e s t e r o l 4 5 4 8 5 2S a l t i n f o o d 3 7 5 3 9 1A d d i t i v e s a n d p r e s e r v a t i v e s 3 2 5 5 8 4

S u g a r i n f o o d 3 1 5 3 15 1A r t i fi c i a l c o l o r i n g 2 6 5 3 1 7 5

(Some figures are rounded out so not all lines will add up to exactly 100%.)

Source: Food Marketing Institute survey, "Public Attitudes Toward Food Safety," by Timothy Hammonds, senior vicepresident, Washington, D.C.

N u t r i t i o n a l Wo r r i e s

Q: What is it about the nutritional content of what you eat that concerns you and your family the most? What else?

1983 1 9 8 4 P e r c e n t( % ) ( % ) Change

Chemical additives (e.g., flavoring, MSG, steroids) 2 7 2 5 - 2Sugar content, less sugar 2 1 2 2 + 1V i t a m i n / m i n e r a l c o n t e n t 2 4 1 9 - 5F o o d / n u t r i t i o n a l v a l u e 1 0 1 9 + 9No preservatives 2 2 1 7 - 5Salt content, less salt 18 1 7 - 1Freshness, purity, no spoilage 14 12 - 2Making sure we get a balanced diet 1 0 9 - 1

Calories, low calories 6 9 + 3Fat content, low in fat 9 8 - 1C h o l e s t e r o l l e v e l s 5 8 + 3As natural as possible, not overly processed 1 2 6 - 6No harmful ingredients, nothing that causes illness/cancer 1 0 6 - 4P r o t e i n v a l u e 5 6 + 1Quality of food 3 5 + 2Excess food coloring/dyes 6 4 - 2Empty calories, junk food 4 4 0Carbohydrate content 1 2 + 1F i b e r c o n t e n t 2 1 - 1S t a r c h c o n t e n t 1 1 0O t h e r 2 4 + 2D o n ' t k n o w / r e f u s e d 5 5 0

Source: Food Marketing Institute survey.

Sugar ranks high on the list ofn u t r i t i o n a l c o n c e r n s b u t w ewould hypothesize that mostpeople would not consider it aser ious di rect hazard. Cholesterol, on the other hand, islikely to elicit a response as aheal th hazard.

somewhat skeptical of new scientificfindings about health hazards. Thereaction to the proposed saccharinban is a case in point. The public hasbecome used to conflicting scientificopinion on health issues and positionreversals on topics ranging fromdietary recommendations to thedepletion of the ozone layer ....

"However, the findings on residuesin this study indicate that the publicis not taking a wait-and-see attitude.Residues seem to be a pervasive concern. This leads us to bel ieve thatresidues should not be thought of inthe same category as previous foodc o n t r o v e r s i e s o f s c i e n t i fi c d e b a t e w i t hlittle public constituency."

Another part of the FMI surveyc o v e r e d c o n c e r n s a b o u t t h e n u t r it i o n a l c o n t e n t o f f o o d . O f t h o s e

responding, 95 percent said they wereeither "very concerned" or "somewhat concerned," up 3 percent fromthe previous year. When asked whatconcerned them most about what theyate, one-fourth named chemical additives, and 22 percent mentionedsugar content of food. Vitamin/mineral content of food, second in1983, slipped to third and was mentioned by 19 percent of those interviewed. Although cholesterol wascons ide red the second mos t se r i ousconcern of the six subject areas, only8 percent mentioned it in terms ofn u t r i t i o n a l c o n t e n t o f f o o d .

Although pollsters and food professionals distinguish between nutritionalcontent and food safety, the publicdoesn't. Many consumers mix foodsafety and nutrition issues, the reportnoted, adding:

"Sugar ranks high on the list ofnutritional concerns (perhaps becauseof its role in weight reduction diets).

but we would hypothesize that mostpeople would not consider it a seriousdirect hazard. Cholesterol, on theother hand, is likely to elicit aresponse as a health hazard. Butb e c a u s e i t i s m u c h m o r e d i f fi c u l t t odetect from product labels, because itis present in fewer food products[than sugar], and because it seems tobe of concern primarily to specifichigh risk groups, we would hypothesize it to be less of a day-to-dayshopping concern than would sugar."

The Food and Drug Administrationat present is considering regulationsthat would provide for cholesteroland fatty acid labeling of foods.

(FMFs survey preceded issuance ofthe widely publicized study results ofthe National Heart, Lung, and BloodInstitute holding that reduction inblood cholesterol by diet or drugs canreduce the incidence of coronaryheart disease.)

The FMI report said the variousc o n c e r n s d o n o t d e t r a c t f r o m t h e

general finding that public trust in theoverall safety of food remains high:"Although we know that consumerstend to lump nutrition and food safety issues together in their minds, thebest news is that there has been no

general decline in overall confidencein the food supply. In 1984, as in1983, a stable 88 percent of thepopulation agreed with the statementthat food in the supermarket isw h o l e s o m e a n d s a f e t o e a t . . . . A l

though there have been many specificareas o f concern over the las t th reeyears, these have not shaken the basicfaith in our food system . . . ."

Other findings:• "Serious concern" over the Tylenoltampering incidents dropped to 50percent as compared to 66 percent in

the 1983 survey. Although this is asubstantial decline, "shoppers arehardly at ease over this issue." FMIsaid the quick response of manufacturers, along with stricter packagingrequirements by FDA and tough penalties enacted by Congress againstanyone convicted of tampering actions, produced a positive public reaction. Of those surveyed, 86 percentsupported the packaging changes.• Consumers "do indeed take noticeand remember when products are recalled." A "surprisingly high level"of shoppers—79 percent—said theyremembered some type of product recall. Tuna fish (though some mayhave been confusing this with salmonrecalls in recent years) was the mostfrequently mentioned (by 30 percent).This was followed by 11 percent whomentioned mushrooms and 8 percentwho singled out cake mixes.• When it comes to deciding whethera product is safe, consumers relyprincipally on their own judgment. In1979, 39 percent trusted their ownjudgment first. By 1983, the numberrose to 46 percent. Last January, itreached 48 percent. In this year'ssurvey, the federal government waslisted as a safety information source(by 22 percent). Reliance on manufacturers, on the other hand, decreasedfrom 17 percent five years ago to 11percent this year.• Consumer organizat ions sufferedmost in the public's eye. Five yearsago, 19 percent of those surveyed saidthey relied on consumer groups. In1983, the number declined to 6 percent. In 1984, it was 9 percent.

C h r i s L e c o s

FDA Consumer / July-August 1984 /15

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Making Bulk FoodsSafe Foods

by Chris Lecos

In this era of sprawling supermarkets with their glittering array ofthousands of shelf-stacked foodchoices, a growing number of Americans are getting food from barrelsand b ins .

No longer are these shopperspushing a cart past rows of colorfulboxed, canned or plastic-packagedfoods whose size, shape and weightwere set on an assembly line. Instead,they're dipping into wooden barrelsand other containers and helpingthemselves to as much or as l i t t le as

they want to buy.It could be a cupful of flour from

one container, a scoop of spices fromanother, and a bagful of ready-to-grind coffee from still another. Shoppers buy and bag only as much asthey want, not what they'd have toaccept if they chose the neatlypackaged versions of the same product e lsewhere in the same store.

This new food marketing concept—called bulk-food merchandising—was inaugurated on a large scaleby a Canadian supermarket chainabout four years ago. The idea waspicked up in California and eventually spread to other parts of the country. Competition among the supermarket chains has caused its growthto acce le ra te in recen t mon ths .Patrons of many health food stores,co-ops, and specialty food shops haveenjoyed this kind of shopping on asmaller scale for some years. Nowsome chain stores offer as many as4 0 0 i t e m s i n b u l k f o r m .

While this help-yourself-to-as-much-as-you-want-to-buy food shopping may cause some older shoppersto ask where the potbellied stove is.

more than nostalgia and choice ofquantity are involved in the growingpopularity of bulk-food shopping.Customers find it 's "fun," say supermarket officials; and, more importantperhaps, most bulk-food items arecheaper because packaging and(name-brand) promotion costs areless.

"We feel it brings in extra dollarswe wouldn't have gotten," says EricBirckner, who oversees the Safewayfood stores' bulk-food operations inVirginia, Maryland, Pennsylvania andt h e D i s t r i c t o f C o l u m b i a . " B u l k - f o o dareas are a drawing card because people can save money. A shopper canbuy as much as he or she wantswithout being penalized."

Some contend that bulk-food shopping appeals mostly to smallerhouseholds—single persons and elderly couples—who would rather notbuy in large quantities. However,Birckner says, a "very good percentage" of the total business at one ofSafeway's bulk-food operations inVirginia comes from larger, suburbanh o u s e h o l d s .

Today's bulk-food displays usuallyinclude spices, flour, coffee, sugar,cake and other mixes, snack foods,pie fillings, dried beans, rice, and avariety of pasta. Items defined as"potentially hazardous foods" arer e s t r i c t e d f r o m s a l e i n b u l k - f o o dareas. These are foods that maydevelop organisms that cause foodpoisoning and spoilage, and whichconsist wholly or in part of milk,eggs, meat, poultry, fish, shellfish,edible crustaceans (shrimp, crab,lobster), or other ingredients, including synthetic ingredients. Those

are not the kinds of foods health andsanitation officials would want tofi n d i n a b i n o r b a r r e l .

Government health officials havealso become concerned about bulk-food operations because these easilyaccessible foods may be open tohuman contact. These concerns haveprompted the Food and Drug Administration to develop guidelines forsuch operations. Drafted with thehelp of industry as well as state andlocal regulatory officials, theguidelines are designed to providemore uniformity in state and localhealth and sanitation codes, since enforcement responsibility is a local one.

The guidelines, given final approvalby the agency in April 1984, focus onsanitation procedures, supervisionand training of personnel, proper useof equipment, and tips to consumersabout the handling of bulk foods anddispensing tools.

Unlike the protection given bycommercial packaging, the agencynoted, bulk-food merchandising offers the potential for person-to-persontransfer of contaminants via foods,particularly the spread of communicable diseases, outbreaks offoodborne illness, and contaminationo f f o o d .

FDA stressed that the controls suggested in its guidelines would not insure the safety and sanitation of bulk-food operations unless managementand consumers together assume a"responsible role."

Some major recommendations setforth in the FDA guidelines:• T h e f o o d s s h o u l d b e i n c o n t a i n e r s

that are protected by close-fitting,self-closing covers. Many operations


Bulk food aisles are taking up more of the space in many supermarketsthese days. At top are rows of bins tilted toward shoppers. Only topparts of transparent covers open so food items can be removed withoutspillage from bottom. The scale is handy to weigh purchases. At lowerleft are upright bins, also with transparent covers that have hinged openings through which tongs may be used to remove larger items such asdried fruit pieces, and scoops to collect items such as beans and grains.A scoop is on a chain in a rack near the opening. At bottom right, ashopper is shoveling pecan halves into a plastic bag. Placards give pricingand other information. Customers may be asked to write product identification numbers on purchases for checkout, using pens and labels provided.

use self-closing lids that minimizeconsumer contact, product mishandling by children, and "environmental" problems (spills, items accidentally falling into a food bin, dust, andflies and other insects).• C u s t o m e r a c c e s s t o c o n t a i n e r s

s h o u l d b e l i m i t e d a n d c o n t r o l l e d . F o r

example, FDA's guidelines discouragesituating a container so low that acustomer who leans over might accidentally drop items from a shirtpocket into a container. To preventthis, the guidelines recommend thatstore operators position containers sothat there is at least 30 inches between the cover and the floor, orplace containers at an angle so that acustomer would not be bending overthem to fill a bag, etc.

FDA's guidelines also suggest thatcontainer depth be limited to 18 inches to assure rapid turnover andtherefore freshness. Many of the barrels used in bulk-food operationshave adjustable inside bottoms, andsome stores use even shal lower containers. Some containers have heavyplastic inserts that are easily removedand cleaned. Some have disposablel ine rs .• Customers should be provided withproper tools for removing foods, including mechanical dispensing devices(gravity dispensers, pumps, extruders,augers) and hand utensils such asscoops, tongs, ladles and spatulas.The guidelines suggest various waysthat hand tools provided for customers can be prevented from becomingvehicles for contaminating bulkfoods. One is to at tach a tether to the

dispensing tool so that it can't reach

the floor should a customer carelesslylet it go. Another is to provide asleeve, holster or other protectivecover near the display unit or on thecontainer for holding a utensil whennot in use. Ladles or spatulas thatcan't be tethered can be placed in thefood , con ta i ne r i f t he hand les ex tendt o t h e o u t s i d e o f t h e c o n t a i n e r.• Use of mechanical dispensers,where possible, is encouraged toeliminate customer contact with thefood. Gravity dispensers can be usedfor many foods such as candy, snackfoods and dried beans; pumps may beused for liquids such as oil, vinegarand semiliquid foods such as dressings, honey and ketchup.• Tongs, scoops, ladles, spatulas andother utensils should be cleaned andsanitized at least once each day, morefrequently if needed. Tethers alsoshould be the removable type, forcleaning. Containers, lids and otherequipment should be cleaned beforerestocking or at scheduled intervals.• Containers and utensils should bem a d e o f s a f e m a t e r i a l s t h a t a r e c o r r osion resistant, nonabsorbent, smooth,durable and easily cleaned. For example, wood that will come in directcontact with food should not be used.Unacceptable are cloth, burlap, cardboard, fiberboard and other absorbe n t m a t e r i a l s . N o n - f o o d - c o n t a c t s u rfaces should be smooth and easy toclean, without unnecessary ledges,cracks or crevices where spilled food(such as flour) can collect.• A supply of bags, cups, lids andother containers should be providedf o r c u s t o m e r s t o t a k e f o o d i t e m shome. Marking pens or labels should

be handy so shoppers can identifytheir packages and avoid confusionbetween products that look alike,such as grits and soap flakes. Mostbulk-food operations have scales nearthe food containers for shoppers toweigh the food. Some stores havecentrally located points where shoppers can take their items to beweighed and priced.

FDA's guidelines also suggest thatconsumers be given labeling informat i o n t h a t i n c l u d e s t h e c o m m o n n a m eof the product, a list of the ingredients (with the predominant oneslisted first), and identification of anyartificial colors, flavors and/orpreservatives. The labeling information can be placed on the containerby cards, signs or other easily seendisplays. Bakery products and otherunpackaged foods made on the premises or manufactured by the seller at adifferent location are exempted fromthe labeling requirements. Some stateand local authorities may choose tooverride this exception. Products notintended for human consumption—such as pet foods and soappowders—may be sold in bulk, too,but FDA's guidelines stress that "abarrier or open space" shouldseparate these from containers thathold products for human consumption. Under the guidelines, bulk foodsreturned to a store by a customershould not be offered for resale, andcustomers should not use their owncontainers but only those provided byt h e s t o r e .

Chris Lecos is a member of FDA'spublications staff.


When Digestive Juices Corrode,\bu've Got An Ulcer

by Louise Fenner

The image sticks in the mind: A middle-aged executive grimacing over a pain in his stomach, gulpingdown a chalky tasting antacid and mournfully wavingaway pizza or chili because his doctor won't "let" him eatspicy food. The portrait of a man with an ulcer.

In truth, more than a third of ulcer sufferers arewomen, and they appear to be gaining on men. Childrenand teen-agers also develop ulcers. Antacids are still apopular treatment, but three new prescription drugs arenow available. And, instead of giving up broad categoriesof food, ulcer sufferers need only avoid foods that bothert h e m .

Peptic ulcers are small sores or lesions in the lining ofthe stomach or small intestine. The term "peptic" comesfrom pepsin, a digestive enzyme that acts in concert withhydrochloric acid to digest food in the stomach. Thethought, sight, smell and taste of food can cause even anempty stomach to secrete acid and pepsin. Normally thelining of the stomach and small intestine can resist corrosion from these digestive juices, but sometimes resistancebreaks down and an ulcer develops. Why this happens isnot completely understood.

An estimated 4 million Americans suffer from pepticulcer disease at any given time. About 12 percent of U.S.males and 4 to 8 percent of females will develop one ormore ulcers during their lifetimes.

Peptic ulcer disease can be painful and debilitating, butit is usually not life-threatening unless there are complications. In 1982, 176,000 men and 175,000 women werehospitalized with peptic ulcer, according to the most recent survey by the National Center for Health Statistics.About 6,000 people die each year from complications ofpeptic ulcer. The death rate increases with age, and inmany cases the ulcer combines with another disease tocause death. The Stanford Research Institute has estimated that in the United States peptic ulcer disease costsnearly $3 billion annually in medical expenses and lostearnings (including earning losses due to death).

There are two main types of peptic ulcer: Duodenalulcer occurs in the duodenum, the first few inches of thesmall intestine after it exits from the stomach. More thantwice as many men as women have duodenal ulcers. Theyusually strike people during their most productive yearsand are four to eight times more common than gastriculcers. Gastric ulcer occurs in the stomach, most commonly in older patients. It rarely develops before age 40,and the peak incidence is from 55 to 65. Incidence is thes a m e f o r m e n a n d w o m e n .

Who is most likely to develop an ulcer? Smokers are,and their ulcers take longer to heal. They have more ulcerrecurrences, more complications, and a higher ulcer-related death rate. The same does not appear to be truefor alcohol users, except those with cirrhosis of the liver.

The tendency to have ulcers can run in families. The

risk of developing a duodenal or gastric ulcer is threetimes greater in people who have close relatives with theseailments. Persons with group O blood are at greater riskof having duodenal ulcer disease. Blacks appear to have ahigher ulcer rate than whites, including deaths from complications.

Several studies have shown more gastric ulcer diseaseamong patients who take large quantities of aspirin thanthose who don't. Aspirin is known to cause lesions in thelining of the stomach. The same ulcer rate is shown forbuffered aspirin as for plain aspirin, but the risk is muchsmaller with enteric-coated aspirin (which dissolves in thesmall intestine instead of the stomach). Other drugs forarthritis, the steroids and the non-steroidal anti- finflammatory drugs, also are suspected of contributing tos t o m a c h u l c e r s .

Stress may help cause some people's ulcers, but its importance has not been conclusively shown. Emotionalstress is difficult to measure, and people do not react tostressful situations in the same manner. A pressured executive, for instance, may be less anxious than anassembly line worker or a 2-year-old's mother. There is nooccupation or personality type that characterizes ulcers u f f e r e r s .

Some studies indicate that stressful events frequentlyprecede the development of an ulcer, but other studies failto implicate such events in ulcer cases. Air traffic controllers as a group experience tremendous occupationalstress, but they develop no more ulcers than the generalpopulation. However, during the bombing of London inWorld War II there was a notable increase in the incidence of certain ulcer complications. Apparently, somepeople are more susceptible than others to the effects ofstress on their gastrointestinal tracts.

Certain foods, beverages and spices may bring on indigestion, but there is no convincing evidence that theycause or reactivate ulcers. Food buffers stomach acid andcan temporarily relieve ulcer pain. However, some foodsare particularly potent stimulators of stomach acid secretion. A few of the most common offenders are certainbeverages, such as carbonated drinks, beer, tea and coffee(regular, decaffeinated and acid-neutralized). To makematters worse, these buffer little acid, particularly if theytravel rapidly through an empty stomach. Many ulcer sufferers drink milk because it neutralizes stomach acid, butunfortunately it has a "rebound" effect. That is, after acertain amount of acid has been buffered, the calcium andprotein in milk stimulate the production of even more acid.

Several studies have shown that a bland "peptic ulcer"diet does not produce healing or relieve ulcer symptomsany better than regular or slightly modified diets. Currentadvice to ulcer sufferers is to eat several meals a day (tokeep the stomach from being empty too long) and avoidfoods that cause stomach distress. Coffee and other acid


food particles

hydrochloric acid and pepsin

gastric ulcer

duodena l u l ce r

An ulcer occurs when the lining of the stomach or ojthe duodenum can no longer resist the corrosive effectsof digestive juices, chiefly hydrochloric acid and pepsin.Food causes the stomach to secrete these juices—hutstress or alcohol may get them started. Even the thoughtor smell of food can get those juices flowing.

About 12 percent of U.S. males and 4 to8 percent of females will develop one ormore ulcers during their lifetimes.

stimulators should be used in moderation, especially on anempty stomach. Milk should not be used as an antacid.Many ulcer patients take antacids or other medications atbedtime to control excess acidity; therefore, bedtimesnacks, which stimulate acid secretion, are not recommended. If symptoms occur in the middle of the night, anantacid can provide relief.

Gastric ulcer patients are often advised to avoid ordecrease alcohol use because alcohol in high concentrations can damage the lining of the stomach. The situationis different for duodenal ulcers because alcohol is partiallyabsorbed or diluted in the stomach before it reaches theduodenum. The question of alcohol's impact on a duodenal ulcer remains to be answered.

"I don't diet, but through trial and error I've learnedwhat food has an effect on me," says a 54-year-oldformer duodenal ulcer patient. "Some brands of beer,wine and scotch really upset my stomach, but not others.Most foods are OK except cabbage or sometimes highlyacidic things like tomato sauce and pizza. And I'vestopped skipping breakfast. The worst thing you can dofor an ulcer is leave the stomach empty."

His ulcer experience was fairly typical. He learned hehad an ulcer the way many people do. It told him.

"I was a guy who always took pride in having a cast-iron stomach. I had a job on a newspaper, and the greaterthe pressure the more I loved it. I started feeling thisburning sensation in my gut, but I ignored it until Icouldn't anymore and it was affecting my job. The soreness would persist for hours. It was never severe pain, justconstant soreness, and it debilitated me. I couldn't thinkstraight, couldn't concentrate. It drained me. I'd try different things—antacids, ice cream. Any relief would bet e m p o r a r y. "

Following treatment with antacids his ulcer healed, andhe is currently on medication to prevent a recurrence."I've been lucky," he says.

Some people with an ulcer do not experience distinctsymptoms and, ironically, many patients with symptomsdo not have a detectable ulcer crater. Nevertheless, themost common sign of an ulcer is a steady gnawing orburning pain between the navel and the lower end of thebreastbone. It usually starts when the stomach has emptied, and it can often be relieved by eating more food orby taking antacids. Pain may awaken the patient at night.

It is often difficult to distinguish between a gastrie andduodenal ulcer from symptoms alone. However, with aduodenal ulcer it is not uncommon for symptoms todisappear and return repeatedly over several years, withintervening pain-free periods lasting a few months to afew years. One textbook noted that over half of duodenalulcer patients have had symptoms for more than twoyears before seeking medical advice. Complications of

gastric and duodenal ulcers may produce symptoms suchas dark stool (a possible sign of internal bleeding), severepain, nausea, vomiting and weight loss.

The traditional method of diagnosing an ulcer is a seriesof X-rays commonly known as an "upper GI (gastrointestinal) series." On an empty stomach, the patient swallowsa chalky liquid containing barium, a metal that shows inX-rays. The stomach and duodenum are outlined on thefilm, and an ulcer crater may be seen filled with theb a r i u m .

In a newer technique called endoscopy, a long flexibletube (endoscope) made of optical fibers that transmit lightis snaked down the sedated patient's throat and into thestomach and duodenum. This allows the physician to seethe ulcer directly and to collect tissue for a biopsy ifnecessary. Endoscopy is more expensive, but it avoids exposing the patient to X-rays and offers somewhat greateraccuracy in detecting ulcers. (See "A Physician's SpyglassFor Looking Inward," FDA Consumer, December 1982-January 1983.)

The basic aim of ulcer treatment is to relieve pain andgive the ulcer a chance to heal itself—either by reducingthe amount of acid and irritants in the stomach or bycoating and protecting the ulcerated area.

Antacids have been used for decades to neutralize hydrochloric acid in the stomach. They are still prescribed orrecommended by many physicians for use alone or withother ulcer medications. (Antacids should not be taken atthe same time as certain other ulcer drugs, since they caninterfere with absorption.) Studies show that antacidscompare favorably with newer drugs in ulcer healing, butthe periods of relief are shorter, necessitating more frequent doses. Patients often become frustrated with thedosage schedule, the taste, and the side effects, and theyneglect to follow the schedule.

The most common side effects are diarrhea frommagnesium-based antacids, constipation from aluminum-based products, and acid rebound from calcium-type antacids. Some newer combination aluminum-magnesiumpreparations may reduce these bowel disturbances.Because of potential drug interactions, patients using antacids for prolonged periods should ask a doctor beforetaking other medications.

Since 1977 three new prescription drugs have been approved by the Food and Drug Administration for treatment of specific types of ulcers. Cimetidine (brand nameTagamet) entered the U.S. market in 1977 and is used totreat duodenal and gastric ulcers and to prevent recurrence of duodenal ulcers. Two other drugs—sucralfate(Carafate) and ranitidine (Zantac)—were approved in 1981and 1983, respectively, for use in treating duodenal ulcers.

These drugs work in two very different ways.Cimetidine and ranitidine are powerful inhibitors of


After healing—with or without drugs—60to 80 percent of duodenal nicer patientswill have an ulcer again.

stomach acid and pepsin secretion, while sucralfate formsa protective coating over the ulcer to shield it from irritation as it heals. Various clinical studies do not show greatdifferences between the three drugs in rates of duodenalulcer healing. All three drugs have low incidences of sideeffects, but since some potential effects are serious, patients should be carefully monitored by a physician.

Several anticholinergic drugs are also occasionally usedas adjuncts to other ulcer medications. They inhibit theaction of a chemical called acetylcholine, which stimulatesacid-producing cells in the stomach. Because anticholinergics are not as effective as the new acid blockersand often have unpleasant side effects, they are rarelyprescribed by themselves. Several other drugs currentlyunder study for treatment and prevention of ulcers includecolloidal bismuth, pirenzepine, tricyclic antidepressants,and prostaglandins.

Many ulcers clear up without drug therapy or with onlyoccasional use of antacids. Studies show, however, that astrict regimen of antacids or prescription drugs usuallyproduces somewhat faster symptomatic relief and higherhealing rates than placebos (inert substances). In duodenalulcer studies, healing took place in about 70 to 85 percentof patients taking drugs, compared with 30 to 60 percentof those given a placebo.

After healing—with or without drugs—60 to 80 percentof duodenal ulcer patients will have an ulcer again. Inabout two-thirds of all cases, the disease seems to subsidefor good after about 10 or 15 years. One drug, cimetidine,is currently approved for use in preventing duodenal ulcerrecurrence. It reduces the recurrence rate to less than 20percent, but this protection disappears as soon as the drugis stopped. The consequences of long-term use ofcimetidine—that is, beyond one year—are not known.

The pattern for gastric ulcer disease is different. Symptoms of a gastric ulcer are similar to those of stomachcancer, and it is therefore imperative to make sure theulcer has healed (an indication it is benign). This findingmay be made with an endoscope, which also can be usedto remove tissue for biopsy. A patient with a persistent orrecurrent gastric ulcer probably will have to undergosurgery to determine if the lesion is benign, as well as torelieve symptoms. In contrast, duodenal ulcers are rarelycancerous, and surgery is less often needed in recurrences.

Simple ulcers sometimes develop into more serious conditions that require hospitalization, and even surgery. Thethree main complications of peptic ulcers are hemorrhage,perforation and obstruction.

Internal bleeding or hemorrhage affects 10 to 20 percentof ulcer patients. As an ulcer burrows into a muscularportion of the intestinal wall, it can damage blood vesselsand cause bleeding into the intestinal tract. One sign ofslow internal bleeding is a dark, tarry stool. Eventually

the patient may become anemic. If the ulcer damages alarge blood vessel, there may be rapid hemorrhaging,vomiting of blood, faintness and sudden collapse.Without prompt medical action, the patient may bleed tod e a t h .

Perforation—erosion by an ulcer all the way throughthe stomach or duodenal wall—occurs in about 5 percentof patients. It is often heralded by sudden, severe painthroughout the abdomen. Perforation may allow digestedfood and bacteria to spill into the abdominal cavity andcause infection, and it can be fatal if untreated.

Obstruction occurs when the narrow opening betweenthe stomach and duodenum becomes blocked by swellingor scarring. This keeps food from passing out of thestomach, and the patient may vomit or constantlyregurgitate stomach secretions. It affects about 2 percentof ulcer patients and often must be corrected surgically.

Each year about 50,000 Americans undergo surgery forpeptic ulcers. Some surgery is to treat complications, butmost often it is done to alleviate severe, incapacitatingulcers that won't heal or stay healed.

At one time the most common ulcer operation consistedof cutting out two-thirds of the patient's stomach toreduce the amount of acid-secreting tissue. Now, there areless drastic techniques that produce fewer side effects.

One common operation involves severing the nerve thatstimulates the stomach to secrete acid and empty food into the intestine (the vagus nerve). This is accompanied bya procedure that allows the stomach to empty its contentsmore rapidly into the intestine, or by removal of the smallpart of the stomach where a hormone is produced thatstimulates acid secretion. These techniques drastically ,reduce ulcer recurrence, but some patients suffer severedigestive side effects and may need additional surgery.

The newest type of operation involves cutting selectedbranches of the vagus nerve instead of severing it entirely.This produces fewer side effects but is somewhat less effective in preventing ulcer recurrence.

Elective surgery for peptic ulcers is declining. Doctorsare putting more patients on maintenance drug therapyand trying non-surgical methods for non-emergency complications. Lasers, electric probes and balloon dilatorsnow can be sent down to the stomach or duodenumthrough an endoscope. The first two "sizzle" tissue andstop an ulcer from bleeding, while the balloon helps openup obstructed passages.

For more information on peptic ulcer disease, write:National Digestive Diseases Clearinghouse1555 Wilson BoulevardSuite 600 (FD)Rosslyn, Va. 22209

Louise Fenner is a member of FDA's publications staff.

FDA Consumer / July-A ugusl 1984 / 23

Tale Of The Tomato:From 'Poison' To Pizza

by Evelyn Zamula

Although you probably didn't know it, you ate fivetomatoes last week. If you're an average American,you eat that many every week. That's not counting fresh.

They got into your diet in a number of ways: in pizza,in sandwiches, mixed with soup, maybe even in a before-d i n n e r d r i n k .

It's presumed that you eat five tomatoes a week because7 million tons of tomatoes were grown and processedcommercially for consumption in the United States lastyear. At four tomatoes to a pound, that comes to around233 tomatoes per person for the year, roughly five a week.

Tomatoes go into juices, soups, ketchup and anynumber of sauces. Most tomatoes—about six out ofseven—were grown in California, where the crop wasworth $350 million in 1983, making the tomato theleading processing vegetable grown in the No. 1agriculture state. Most other processing tomatoes comefrom the Midwest.

These are pretty good figures for a fruit (now legallyconsidered a vegetable) that once grew as a weed in thebean fields of Central America, and in the United Stateswas shunned by some people as late as 1900.

For centuries the tomato had a bad name. ColonialAmericans thought tomatoes were poisonous. Like thepotato (see "Potatoes: Delicious, Nutritious, And AlmostFat-Free," March 1984 FDA Consumer), the tomato,Lycopersicum esculentum, is a member of the nightshadefamily. Native to the Peru-Bolivia-Ecuador region inSouth America, tomatoes were carried to Mexico andCentral America by about the first century A.D. It wasthere that they were discovered by the Spanish conquistadors and introduced to Europe. Botanical referenceswere made to the tomato in Italy as early as 1554. Thetomato the Italians first encountered may have beenyellow, because their word for it was "pomo d'oro," orapple of gold.

The Italians recognized a good thing when they saw it,and before long they learned to concoct the tomato saucesthat are so much a part of southern Italian cuisine. TheItalians also developed new varieties and by the latter partof the 18th century were growing tomatoes as a field crop.

Prejudice against the tomato persisted for a long timein the United States. Although Thomas Jefferson plantedthem in his garden in 1781 and the French inhabitants ofNew Orleans were raising tomatoes in the late 18th century, the rest of the country waited until, it is said, oneday in 1820. On that day a Col. Robert Gibbon Johnsonstood on the steps of the Salem County (N.J.) courthouse,ate a tomato in full view of an incredulous crowd of spectators, and didn't drop dead. For the tomato, it's beenthe highroad ever since.

Today the tomato is the most frequently used processedvegetable in the United States. (It is second in economicvalue only to the potato.) We consume almost all ourprocessed tomatoes and export most of the rest toCanada. Imports of processed tomato products in 1981-83accounted for 529,000 tons of the raw product. Thisamounted to 8 percent of U.S. consumption, causingdomestic growers increasing concern at the competition.The leading producing states behind California are Ohio,Michigan and Indiana.

In California, tomato production really took off in theearly 1970s. Before World War II, the state producedabout 20 percent of the nation's processed tomatoes andtomato products. In 1983 the figure had climbed to 85p e r c e n t .

What spurred this growth was the drying up of a sourceof manual labor. In 1964 a change in federal policy endedthe importation of agricultural workers from Mexico. Thisforced the California tomato industry into developing newmachines to replace so-called stoop labor and breeding

(Continued on page 28)


Marching AlongWith Canned Food

To Napoleon Bonaparte, who realized tha t a i l a rm ies march on the i r

stomachs, goes the credit for encouraging the invention of canning.

In 1795 Napoleon's military campaigns were sending French soldiersfarther and farther afield, away fromnormal sources of supply. Exceptwhen foraging, their rations consistedmostly of salt meat, salt fish andhardtack. The diet was not onlym o n o t o n o u s b u t a l s o t o o k i t s t o l l :French soldiers and sailors were dyingfrom scurvy and other diseases causedby dietary deficiencies.

In response to Napoleon's plea forbetter rations for his troops, theDirectory, that group of five menwho ran France before Napoleoneventually took over, offered a prizeto anyone who could devise a methodof preserving food for transport onmilitary campaigns.

Stimulated by the 12,000-francprize, Nicholas Appert, a Parisianconfectioner and former pickler,brewer and winemaker, gave up hisbusiness and set out to win the fortune. Appert was familiar with theexperiments of an Italian priest, Laz-zaro Spallanzani, who in 1762 showedthat meat extracts thoroughly heatedin sealed flasks did not spoil. Usingthe same principle, Appert methodically tried canning other kinds off o o d s .

After 14 years of experimentation,Appert perfected a method thatworked. He put food in large glassjars, leaving some room for expansion. He stoppered them with hand-cut corks, then bound wire over andaround the corks to prevent themfrom blowing out. Each jar waswrapped in a sack and lowered intoboiling water "for more or less timeaccording to their nature," says his1810 book. The Book for AllHouseholds or The Art of PreservingAnimal and Vegetable Substances forMany Years.

Appert succeeded in preservingfresh eggs, milk, cream, manyvegetables and fruits, mushrooms,and meat, poultry and other low-acidfoods. The French government sent

samples of his preserved foodsaround the world on sailing ships.They retained their wholesomeness,and in January 1810, Napoleon'sMinister of the Interior awarded the12,000-franc prize to Appert. He waslauded as the man who had discovered "the art of making the seasonss t a n d s t i l l . "

Because of Appert's success, othersturned their attention to perfectingthe canning process. From here on in,history records the steady development of better containers, techniquesand equipment. But it took over 50years and the genius of Louis Pasteurto discover why food spoils to beginwith. Pasteur proved that spoilage occurs from the action of certainmicroorganisms ever present in foods.He confirmed the soundness of Appert's method of food preservation,explaining that it was based on thescientific principle that heat destroysthe microorganisms that causespoilage.

Just two years before Appert wonthe prize. Sir Humphrey Davy, anEnglish chemist, discovered that hecould raise the boiling point of waterfrom 212 degrees Fahrenheit to.240degrees Fahrenheit or higher by adding calcium chloride to the water. Noone understood the importance ofthis discovery at the time, but it wasto prove significant later on.

Canning made further strides whenthe tin can was patented by PeterDurand of England in 1810. Thosefirst tin canisters, or cans, as theycame to be called, were laboriouslycut from sheets of tin plate andsoldered by hand. A good workmancould make 60 a day. A cap hole wasleft in the top end through whichfood could be forced into the can.After filling, a tin disc was solderedover the cap hole, and the food wasthen processed with heat.

Tinned foods were taken to theArctic by the English explorer Sir

(Continued next page)


William Edward Parry during the1820s. A tin of pea soup and a tin ofbeef left in the Arctic by a Parry expedition were recovered and the contents eaten with no ill effects inEngland in 1911.

A transplanted Englishman,Thomas Kensett of New York City, iso f t en ca l l ed t he f a the r o f t heAmerican canning industry. Kensettand his partner, Ezra Daggett, applied for a patent on a method ofpreserving foods in cans in 1825. Itwas 10 years before it was granted.

Two important innovations camealong just in time to help feedfighting men in the Civil War. In1856 Gail Borden patented his condensed milk process; and in 1860I s a a c S o l o m o n o f B a l t i m o r e m a d e u s eof Sir Humphrey Davy's 1808 discovery. He raised the temperature ofthe water bath by adding calciumchloride, thus shortening the process

ing time of five to six hours to 25 to45 minutes. This permitted an increase in production from 2,500 to20,000 cans a day.

As demand for canned products increased, another breakthrough occu r red . I t was t he i nven t i on i n 1874of the retort, or high-temperaturepressure cooker, by another Baltimore native, A.K. Shriver. The retortmade it possible for canners to increase temperatures (to 240 degreesFahrenheit and above) to sterilize thecontents o f the sea led cans.

A new type of container, inventedaround the turn of the century, wasan important technological advance.This was the open-top cylindrical can,called the sanitary can. It could befilled with larger pieces of food thanwas possible with the old hole-and-cap can. After the can was filled, itstop lid was crimped on by machine.Not only was this method faster, but

it decreased the amount of lead solderthat came in contact with food.Within two decades, the sanitary canhad replaced all other types of cans.The most recent figures, for 1982,show tha t ove r 27 b i l l i on cans we remanufactured for food industry use,according to the National Food Proce s s o r s A s s o c i a t i o n .

The invention of high-speed sealingequipment in the 1930s made it possible for packers to increase productionand lower prices of foods packed inglass containers—ideal for baby foodsand colorful fruits and vegetables.Ketchup, pickles, jellies and jamshave always been packed in glass, andconsumers like them that way.

(For a discussion on lead levels incanned foods, see "On Getting TheL e a d O u t O f F o o d " i n t h e M a r c h1982 FDA Consumer.)

This specially designed mechanical harvester for tomatoes, which costs about$150,000, pulls the vine out of theground and shakes the fruit hose fromit. A crew of workers rides the harvester and does the preliminary sorting.The gondola into which the tomatoesare deposited holds 12 tons of thes t u f f

26 / July-A ugust 1984 / FDA Consumer

L

Sorters on the line at a California plantsort tomatoes mainly for ripeness anduniform size. The well-shaped tomatoesare used for canning whole.

The Evolution OfKetchup

Ketchup, that bane of gourmets,has an Oriental history. According tothe H.J. Heinz Company, its ancestoris one o f the fermented fish saucesthat have been popular in the FarEast for centuries. How ketchup (alsocorrectly spelled catsup or catchup)evolved from a smelly fish sauce to atomato condiment is entwined withthe rise of England as a colonialpower and our own trade with theO r i e n t .

In the late 17th century, whenBritish seamen were sailing to allparts of the globe and establishing theempire on which the sun never set,they found the natives of Singaporeand Malaysia using "kechap" (Dutchspelling ketjap), a tangy blend of fishbrine, herbs and spices. When theyreturned to England they tried toduplicate the sauce but, lacking manyof the exotic ingredients, had to makedo with a sauce of mushrooms, walnu ts and cucumbers .

Ketchup became popular in England, and recipes for it appeared in a1748 cookbook and later in Mrs.Beeton's Book of Household Management in 1861. She offered a

number of recipes, some includingoysters, and said, "This flavoring ingredient, if genuine and well prepared, is one of the most usefulsauces to the experienced cook, andno trouble should be spared in its

preparation."A m e r i c a n h o u s e w i v e s w e r e a l s o

cooking up batches of ketchup, usingmore or less the same ingredients,and adding grapes, berries or lobsters, always with spices and avinegar base, but usually withoutsugar. Since the solids were oftendiscarded and only the juice retained,those early English and American ketchups resembled today's Worcestershire sauce more than ketchup.

On their trips around the world inclipper ships, Maine sea captainsdiscovered the same fish sauces of theOrient and the succulent tomatoes ofMexico. Somewhere along the Ifnesomeone put the fish sauce, minus thefish, and the tomato together to makethe forerunner of the ketchup weknow today. But by the 1870s ketchup wasn't ketchup to many peopleunless it had both tomatoes and added sugar.

Until H.J. Heinz came along withbottled ketchup in 1876, Americanhousewives continued to make theirown. Stirring the tomatoes and spicesall day long until the mixture reachedthe proper consistency, and keeping itfrom sticking to the pot, was oftenthe job of the small fry of thehousehold. Mr. Heinz freed them andtheir descendants from this choref o r e v e r .


Tomato paste is transferred by the tankcar. In the background are rows of55-gallon drums of tomato paste, and40,000 gallon tank silos from whichpaste is pumped into the tank car.

(continued from page 24)types of tomatoes sturdy enough to withstand handling bym a c h i n e s . T h e e f f o r t s s u c c e e d e d .

When the first mechanical harvester was introduced toCalifornia tomato fields in 1960, it delivered less than 1percent of the harvest. As machines improved, farmerswere gradually freed from their dependence on field laborand were able to expand acreage and production. By 1970the state's processing crop was totally converted tomachines. Farmers were also aided by plant geneticistswho developed firm-fruited varieties with good "machine-ability," good yield, and the ability to set fruit during ashort span of time and under a wide range of climaticconditions, so that a high proportion of them could ripen(and therefore be harvested) at the same time.

Contributing to the growth of the industry was the increasing interest in ethnic foods. The GIs who returnedfrom World War II had been exposed to different cuisines, such as those of Mediterranean countries, that usedthe tomato with imagination. The post-war travel boomalso widened Americans' gastronomical horizons.

The strongest impetus, however, came from the expansion of fast-food chains, with their demands for ketchupand other tomato products. Although Americans had beeneating ketchup for years, the fast-food hamburger andfrench fries put ketchup on the map, according to industry sources. And those same returning GIs and travelers who had discovered the joys of Italian cooking contributed to the popularity of pizza huts and spaghettimills, all using immense quantities of processed tomatoes.

Botanically the tomato is a fruit, but commercially it'sa vegetable. The U.S. Supreme Court supported this viewin 1893, ruling against a merchant who had sought toevade the import duty then imposed on vegetables bymaintaining it was a fruit. Holding that tomatoes wereused mostly for a meal's main course, the court decidedthis made it a vegetable.

Whatever it's called, it's a natural for processing. The

flavor, both sweet and acidic, and pulpy flesh and juicelend themselves to sauces, soups and scores of otherdishes. A fresh, quarter-pound tomato contains about 25calories and offers significant amounts of vitamins A andC and potassium. Niacin, thiamine, riboflavin, sodiumand calcium also are present in smaller amounts (under 10percent of the U.S. recommended daily allowance—RDA—per serving). All these nutrients are packed into afruit that is about 95 percent water.

Its versatility is amazing. Tomatoes are peeled andcanned whole, in chunks, and in slices. They're crushedand strained to form juice for canning and freezing.Tomatoes can be dehydrated to a powder and reconstituted as tomato juice, or as an ingredient of packagedsoups, salad dressing, baby foods or condiments. Withskins and seeds removed, they're crushed for processingof soups, ketchup, or tomato juice cocktails. They can becrushed, strained and concentrated to a puree or paste,starting materials for a whole range of other products.

Tomato paste uses up more tomatoes than any othertomato product. In 1983 California produced 16.7 millioncases (based on 24 one-pound cans to the case). Manyyears ago southern Italian peasants found that if crushedtomatoes were spread out on stone slabs in the sun, theheat evaporated the water in the tomatoes and concentrated them to a paste. Mixed with salt, the paste wouldkeep the whole winter in jars or crocks. This method ofmaking tomato paste is still used in southern Europe.

FDA's standard of identity for tomato paste is alsobased on reduction of the moisture content. Strainedtomatoes are evaporated to 24 percent soluble materials.Basil leaf, salt and other flavoring agents may be added.(Standards of identity were established by FDA to assureconsumers that a particular product contained at leastminimum quantities of specific ingredients.)

There's not a hot stone to be found in today's tomatopaste-making factories. In modern processing plants, thetomatoes are washed in a preliminary water bath, in-

28 / Juty-August 1984 /FDA Consumer

spected for defects and sorted, then washed again andchopped for scalding or precooking in stainless steel vats.They are then pumped into pulping machines which remove seeds, stems and skins. The pulp is pumped into alarge evaporator and concentrated by heat to remove thewater. The paste is ready for canning after a cool-downperiod in a vacuum cooler.

California processors ship the pulp concentrate to foodprocessors in other parts of the country in 20,000-gallontank cars for use in manufacturing ketchup, pork and beans,spaghetti and pizza sauces, and dozens of other products.

Besides the standard of identity for tomato paste, FDAhas standards for ketchup, tomato juice and cannedtomatoes. The standard for ketchup follows the originalcommercial recipe and includes ripe tomatoes, vinegar,sugar or other nutritive sweeteners such as corn syrup,salt, onions, spices and natural flavorings. Ketchup mustmeet an FDA "pour-ability" or consistency standard(neither too thick nor too thin) and may contain otherflavoring ingredients such as garlic and hot peppers.

At processing plants, ketchup starts out with strainedtomatoes evaporated to a consistency of 8 percent or moresoluble tomato salt-free solids. After the pureed tomatoesare brought to a boil, sweeteners, white vinegar, salt,spices and flavorings are added. The blend is then cookedto the desired consistency and de-aerated. Removing theair keeps the ketchup from darkening. The ketchup isthen hermetically sealed in hot bottles, capped and cooled.With labeling and coding, and a final inspection, theproduct is ready to be shipped. The entire process—fromtomato to finished product—takes about three hours.

Tomato juice gave processors trouble for a long time.In the 19th century, canned tomatoes were "packed dry,"that is, without tomato liquid added by modern packers.Tomato juice was a waste product of processing and anuisance to dispose of. One Syracuse (N.Y.) canner solvedthe problem by dumping it into the Erie Canal.

Tomato processors began to change their minds aboutits value when scientists deplored the loss of valuablenutrients. Then, too, some Americans were getting a tastefor tomato juice. Supposedly, World War I doughboyshad cut open cans of tomatoes with their bayonets anddrunk the juice off the top. At about the same time, hotelsand restaurants began serving fresh tomato juice, with orwithout the addition of something stronger, to guests.

Realizing there was a market for the product, processors tried many times to can tomato juice commercially,but they just couldn't come up with a manufacturingmethod that provided acceptable flavor or appearance.

A pediatrician persuaded Ralph Kemp of Frankfort,Ind., one of three brothers who had recently entered intotheir father's canning business, to try his hand at canningthe juice. Because of the high vitamin content, the doctorliked to prescribe it for his little patients but had no conv e n i e n t s o u r c e .

Kemp and his brothers were interested in the idea,especially since their area of north central Indiana produced bumper tomato crops. There were two problems:One was to break the tomato solids into such minute particles that they would float in the juice and not settle tothe bottom; the other was to preserve as much of thevitamin content as possible by excluding air from theprocessing. Vitamin C, especially, tends to lose potencywith exposure to air. (Retaining vitamin C content is important: A six-ounce glass of tomato juice provides 29milligrams of that vitamin, almost half of the U.S. RDA.)

After four years of experimentation, they borrowed atechnique from the ice cream industry to homogenize thejuice. From applesauce makers, they adapted a method ofpressing the tomatoes through a sievelike machine, insteadof using the traditional pulper, or "cyclone," which admitted lots of air during processing. After pasteurizing thejuice in a vacuum, without cooking, the Kemp brotherssucceeded in turning out a wholesome, appetizing productthat had a good appearance and retained the nutrients andflavor of fresh, ripe tomatoes. The process was patentedin 1928.

Tomato juice, according to FDA's standard of identity,is simply juice extracted from red, ripe tomatoes, freefrom seeds, skin and other hard materials, and with noadded water. It may be homogenized, contain salt, and beslightly acidified. Any additional ingredients must bedeclared on the label.

Canned tomatoes must be prepared from mature redtomatoes, may be peeled or unpeeled, must have the stemsremoved, and must be cored unless the tomatoes are ofthe coreless type.

And how did you eat your five tomatoes this week?

Evelyn Zamula is a member of FDA's publications staff.


Food Labels To TellMore About Sodium

by Roger W. Miller

NUTRITION INFORMATION(Per Serving)

Serving Size 1 OunceNumber ot Senrings 8C a l o r i e s 1 5 0P r o t e i n 2 g r a m sC a r b o h y d r a t e 1 4 g r a m sF a t 1 0 g r a m sCho les te ro l t ( 0mg /100g ) 0 m i l t i g ramsS o d i u m 2 5 m i l l i g r a m sP o t a s s i u m 4 0 0 m i l l i g r a m s

Percentage of U.S. RecommendedDally Allowances (U S RDA)P r o t e i n 2V i t a m i n A •V i t a m i n C 1 0T h i a m i n e 4R i b o l l a v i n •N i a c i n 6C a l c i u m •I r o n 2V i t a m i n B e 1 0P h o s p h o r u s 4M a g n e s i u m 4C o p p e r 6

tlntormation on cholesterol content is provided forIndividuals who, on the advice of a physician, are modifyingtheir total dietary intake of cholesterol.

•Contains less than 2% of U.S. RDA for this nutrienb

Those people who want to limittheir salt and sodium consumpt ion a re in fo r a b reak .

Within a year, sodium content willbe listed on all processed foodsregulated by FDA that carry nutritionlabeling. A new Food and Drug Administration regulation will requirethe listing beginning July 1, 1985.

This may seem like a minor publichealth matter, but the fact is that today, on a dollar volume basis, morethan half of the processed foodsregulated by FDA carry nutritionlabeling. (This excludes meat andpoultry products, regulated by theU.S. Department of Agriculture.) Theaddit ional sodium content information will be welcome to many of thenation's estimated 60 million personswith high blood pressure, as well asothers who are trying to control ormoderate their salt/sodium intake.

The regulation, printed in theFederal Register in mid-April, requires the amounts of sodium perserving be included on nutrition-labeled foods. Information is alreadyincluded for calories, protein, carbohydrate, fat and some minerals andvitamins. The sodium informationwill be given in milligrams. (Amilligram is one-thousandth of agram, and there are 28.5 grams to anounce.) Food processors are given until 1985 to comply so that necessaryprinting and application changes canbe made on their products.

An early 1983 FDA survey showedthat some 55 percent of processedfoods under FDA jurisdiction carriednutrition labeling. Such labeling has

been used on a steadily increasingnumber of processed foods over theyears; in 1980 only 40 percent was solabeled. Under FDA regulations, nutrition labeling is required on fortifiedfoods and when nutrition claims aremade for a product. It is also voluntarily added to many other foods bym a n u f a c t u r e r s .

The issuance of the regulation supports one of the more successfulpublic education campaigns in recentyears as well as one of the moreoutstanding examples of industry-government cooperation. The effortsbegan almost three years to the daythat the regulation was issued. OnApril 14, 1981, FDA Deputy Commissioner Mark Novitch told a Congressional committee about the program plans. The program includedthe nutrition labeling, a public education program, research, regulation,and a cooperative effort with industry.

Industry responded not only byvoluntarily adding sodium to nutrition labeling on many products butalso by offering a variety of low- andreduced-sodium products. (For a listing of such products, see "The PublicKnows And Cares About Sodium" inthe April 1983 FDA Consumer.)

The publicity generated by thegovernment sodium program and byindustry and other efforts has produced some startling results. For example, in a late 1982 FDA survey, 40percent of the people interviewed saidthey were trying to avoid salt/sodiumfor their health. This was up from 14percent who made such statements in

m m m r n r n m

a 1978 FDA survey. The public'sreaction to the campaign to reducesodium intake showed up in othersurveys and in the marketplace. Insurvey after survey, industry foundthat the public wanted low- orreduced-sodium products. FDA's1982 survey found that about one outof six shoppers considered themselvesregular purchasers of sodium-modified products.

The health premise for the sodiumcampaign was based on studies show-


ing a possible association betweensodium intake and hypertension, orhigh blood pressure. Some 60 millionAmericans are believed to have highblood pressure to some degree. Nota l l o f t hese a re sod ium-sens i t i ve . Tha tis to say, not all will benefit fromreducing sodium intake, as hypertensives may also need to reduce weightand get more exercise, and some require drug therapy. But the sodiumrestriction message is not limited tohypertensives. A 1978 study by theFederation of American Societies forExperimental Biology concluded thatAmericans in general should lowertheir salt intake. Many health officials also point out that modifyingsalt use is a good idea for everyonebecause it is never known who willbecome a hypertension victim, theelderly being particularly susceptible.

The National Research Councilbelieves that 1,100 to 3,300milligrams of sodium daily is a safeand adequate amount for adults. Onthe average, Americans consume5,000 to 7,000 milligrams per day.Salt, which is 40 percent sodium, isthe major source of sodium in thediet. A teaspoon of salt containsnearly 2,000 milligrams of sodium.

The new regulation spells outdescriptors that food processors mayuse when making sodium claims fortheir products. They are:• "Sodium free"—less than 5

milligrams per serving.• "Very low sodium"—35 milligramsor less per serving.• "Low sodium"—140 milligrams orless per serving.• "Reduced sodium"—processed toreduce the usual level of sodium by75 percent.• "Unsalted"—processed without thenormally used salt.

Roger W. Miller is editor of FDAC o n s u m e r .

All foods that have labels with nutrition information will soon be including sodium contentamong the ingredients listed. The sodium listinghad not been required previously. Shown beloware two examples of products on which the sodium content is included in the labeling. The topexample is from regular chicken noodle soup;the bottom label is from "no salt added chickenwith noodles soup" by the same manufacturer.

NUTRITION INFORMATION PER SERVINGS E R V I N G S I Z E 4 O Z . - C O N D E N S E D

(8 OZ, AS PREPARED - 2Z6 g)S E R V I N G S P E R C O N T A I N E R Z V .C A L O R I E S 7 0P R O T E I N ( G R A M S ) 3TOTAL CARBOHYDRATES (GRAMS) 8

S I M P L E S U G A R S ( G R A M S ) 1COMPLEX CARBOHYDRATES (GRAMS) 7

F A T ( G R A M S ) 2S O D I U M 9 6 0 m g / s e r v i n g

PERCENTAGE OF U S RECOMMENDEDDAILY ALLOWANCES (U.S. RDA)

P R O T E I N 4 R I B O F L A V I N 2V I T A M I N A 4 N I A C I N 4V I T A M I N C * C A L C I U MT H I A M I N E 4 I R O N 2•CONTAINS LESS THAN 2% OF THE U.S. RDA OFTHESE " "TP-cutc

NUTRITIONAL INFORMATION PER SERVINGS E R V I N G S I Z E l O ^ ^ O Z O O b g )S E R V I N G S P E R C O N T A I N E R 1C A L O R I E S 1 8 0P R O T E I N i G R A M S l 1 2T O TA L C A R B O H Y D R AT E ( G R A M S ' 1 9

S I M P L E . S U G A R S I G R A M S l 3COMPLEX CARBOHYDRATES iGRAMSl 16

F A T ( G R A M S ) 5SODIUM i35mg'100 GRAMS) 100 mg

PERCENTAGE OF U S RECOMMENDEDDAILY ALLOWANCES (US RDA)

P R O T E I N 1 5 R I B O F L A V I N 2 5V I T A M I N A 2 5 N I A C I N 3 0V I T A M I N C * C A L C I U M 2T H I A M I N E 1 0 I R O N 1 0•CONTAINS LESS THAN 2% OF THE US RDA OF

THIS NUTRIENT

What To DoW h e n T b uO v e r d oS u m m e rby Harold Hopkins

When the good old summertimecomes each year many of usmove outdoors to enjoy it. Andalmost invariably we encounter a fewbad moments that make us thinktwice about the so-called joys of summer. A big part of how we enjoywarm weather is in how well we cansidestep or otherwise deal with thoseproblems.

Almost everybody who venturesoutdoors to be smiled upon byMother Nature's pleasanter face will,at one time or another, be forced tocope with some of the little un-pleasantries devised by the samedame. Sunburn, sunstroke, heat prostration, drug-sun interactions, orprickly heat may result from communing too long with the sun,especially during the hotter part ofthe day.

Getting closer to nature may alsomean getting troublesome skin problems caused by poison ivy, poisonoak, poison sumac and nettles, or being chewed or stung by ants, mosquitoes, yellow jackets, hornets,wasps, spiders, ticks, ants, bees, chig-gers or even snakes.

Other ailments are swimmer's itch,infected ears, and eye problems frombacterial or fungal contaminationfound in or around swimming pools,showers and such. Food spoilage canspoil the fun of a picnic for manypeople in a more serious way thanants can. Travelers to certain vacationregions can suffer from diarrhea orother illness caused by drinking contaminated water or eating food notthoroughly cooked.

Many of the problems of summer

can be avoided through caution,foresight and common sense, andsome of those that can't be avoidedcan be minimized. Here's a guide onhow to cope with some of summer'sse tbacks :

SrmiiM/-/?—Those venturing into thebright summer sun to obtain thatbadge of the indolent and the chic, asuntan, should understand thatoverexposure to the sun's rays notonly can produce an unwanted sunburn but can also, from repeated exposure, cause the skin to become irreversibly leathery, lined andwrinkled—and the sun's ultravioletrays can eventually cause skin cancer.Avoidance of exposure of the skinand eyes to strong sunlight, especiallyaround midday—from 10 a.m. to 2p.m.—is the safest measure. Thosewho insist on staying in the sunshould expose themselves initially forshort break-in periods.

Tanning can't be rushed. Figure onabout two weeks of careful sunbathing, 10 to 15 minutes the firstday, and perhaps a little longer thenext day and the next, until you'resure you're not getting too much sunfor your complexion and condition.Sunscreens rated from 1 to 15 forSPF (sun protection factor) are soldat drug counters and elsewhere andshould be used to protect against sunburn. A good pair of sunglasses canhelp protect the eyes, but they cannotgive total protection.

Photosensitivity—Photosensitivityreactions may also occur from exposure to strong sunlight in the caseof persons with certain diseases suchas herpes simplex (cold sores), people

taking some drugs (for example, sulfonamides, tetracyclines, thiazides,griseofulvin), and those who wearcertain types of cosmetics. Elderly orobese people and those who have diabetes or heart d isease need to take

special precautions against overexposure to the sun.

H e a t s t r o k e — H e a t s t r o k e a n d h e a te x h a u s t i o n c a n r e s u l t f r o m o v e r e x

posure to heat; sunstroke results fromexcessive exposure to the heat of thesun. The symptoms vary somewhatfo r each . A l l a re se r ious and need adoctor's attention. Sunstroke may bemarked by convulsions, coma andhigh skin temperature. Heatstrokemay be marked by dry skin, vertigo,headache, thirst, nausea, muscularcramps, and possible high body temperature. Heat exhaustion is markedby subnormal body temperature,nausea, dizziness and delirium or collapse.

Prickly /zent—Prickly heat is an uncomfortable itching or burning nearthe skin surface caused by malfunctioning of the sweating process and isbest treated by cooling and drying;air conditioning is ideal therapy if it'savailable. If you have a case of prickly heat, avoid conditions that causesweating.

Skin reactions—Handling or contacting poison ivy, poison oak,poison sumac, nettles and other irritant plants causes woes that arefamiliar to most of us. Anyone whospends time in the woods, or even thebackyard, should learn to recognizethese plants, especially the more common poison ivy, and avoid them.Treatment varies, but discomfort isgoing to stay awhile, so caution is thebetter part of valor when among thatstrange vegetation.

Insect bites—Biting or stinging insects, or even snakes, do so to defendthemselves or their nests or territoriesagainst human or other invaders. It'sbest to assume a live and let livepolicy, giving them all a wide berth.Most are harmless, though there aresome poisonous snakes and spiders.Some people have severe reactions tostings from bees, hornets and yellowjackets and require prompt medicalattention. Persons with known hypersensitivity should carry a kit containing an antihistamine and epinephrinewhen in areas where a sting is likely.


For non-emergency bites, an ice cubeheld on most bites will reduce thepain. Stingers of some bees left in theskin should be removed by rubbing orteasing.

Ticks—Ticks are arthropods thatare potential carriers of such diseasesas the dreaded Rocky Mountain Spotted Fever. They are parasites, andwhen they jump aboard a human theyare looking for a free meal. Theymay attach themselves to the skinwithout the victim knowing it at first.Anybody who has spent a period inthe woods, the garden, or other outdoor places should, upon coming inside, disrobe and inspect the body allover and remove ticks. A partner canlook for ticks on the parts of yourbody you can't see yourself.

A tick is best removed by graspingit with tweezers, or the fingers, as fartoward the front of its body as possible and pulling gently and repeatedlyuntil it is freed. Ticks and other arthropods also can be removed by applying an irritant such as a petroleumproduct to the creature. The biteshould be cleansed and a corticosteroid lotion applied. Care should betaken to avoid crushing the tick orpulling its body loose from its headbecause any bacterial contaminationit carries may enter through brokenskin. If, within two weeks after a tickis removed, any symptoms occur,such as fever, headache, rash on thebody, or rash on palms of the handsor soles of the feet, a doctor shouldbe consulted immediately.

Swimmer's maladies—Swimmer'sear, or external otitis, consists ofbacterial or fungal infection of theear canal and may be localized(furuncle) or involve the entire canal(generalized or diffuse). Furunclescause pain and are not helped bytopical antibiotics. They should beallowed to drain normally. Generalized external otitis causes itching,pain, a foul-smelling discharge, andsometimes loss of hearing. It may betreated with topical antibiotics or corticosteroids. Water and irritants suchas hair spray or dyes are predisposingfactors to development of externalotitis. Some allergic persons are moresusceptible to external otitis. Personswith external otitis should not try tocleanse their ears because this interrupts the natural healing process.

Other troubles for swimmers include stings or bites from stingrays(about 750 stings per year on bothAmerican coasts); coelenterates (orjellyfish); mollusks, including cones,octopuses and bivalves; and sea urc h i n s .

Stingray wounds should be washedwith the sea water at hand, the stingershould be removed if possible, andthe affected arm or leg submerged inwater as hot as the patient can standf o r a n h o u r o r s o . T h e w o u n d s h o u l dbe sutured if necessary and an analgesic (preferably meperidine) administered to reduce pain.

No preferred treatment has beenr e c o m m e n d e d f o r t r e a t m e n t o f o c

topus bites or those of Conus califor-nicus (the only biting cone in NorthAmerica), though mechanical ventilation and treatment for shock may benecessary after a cone's bite. Sea urchin stings are treated by washing thearea and applying an analgesic-corti-costeroid cream. The spines should beremoved as quickly as possible.

For jellyfish stings, application ofammonia, vinegar and papain (meattenderizer) is practiced. Baking soda,boric acid, lemon juice, gasoline andalcohol are also recommended. Thetentacles should be removed, preferably with a gloved hand, and oceanwater poured over the area. Alcoholis then poured over the wound andthen flour, baking powder, or shavingsoap applied. This material is thenscraped from the wound with a sharpknife or instrument, not a razor, andthe area again washed with saltwater.Finally, a topical analgesic-cortico-steroid is applied, preferably byspraying.

For travelers—When traveling andyou don't trust the local water supply, you don't have to drink beer instead—just boil the water or drinkbottled water. Eat food that's wellcooked, and when you eat raw fruit,peel it carefully or give it a goodscrubbing first with boiled or bottledwater. Water purifying tablets containing chlorine, such as Halazone(Abbott), can be purchased at camping supply stores by persons who planto go backpacking or hunting in areaswhere it's unhandy to boil the water.

Some people traveling in thewarmer countries or in regions wheresanitation standards are not as high

as our own may want to carry prescription or other drugs that offersome protection or relief from the incompletely categorized gastroenteritissyndromes—often caused by Escheri c h i a c o l i — e n c o u n t e r e d i n t h e s e c o u nt r i es . Some s tud ies show tha t a non

prescription drug containing bismuthsubsalicylate, such as Pepto Bismol,is helpful with traveler's diarrhea, butconsiderable quantities are neededboth as preventive and as treatmentin acute phases. Because of PeptoBismol's salicylate content, personstaking aspirin, those sensitive toaspirin, and those taking drugs withwhich aspirin interacts unfavorablyshould be extremely careful with Pepto Bismol or avoid using it altogether.

For picnickers—Summer is thattime when we're most likely to comedown with food poisoning, simplybecause the food may be unrefriger-ated for a time when carried on orprepared for picnics, or left to set atroom temperature during normalhome meal preparation. Summer conditions can facilitate the rapid growthof and production of toxins by avariety of bacteria, most commonlyStaphylococcus aureus and its toxicproducts. Food poisoning may require a trip to the hospital.

Among foods affected are thosefrom the sea, as summer's warm conditions are more conducive to growthof contaminating bacteria such ascholera-like bacteria, the virus inseafoods that causes hepatitis, andthe protozoa that causes paralyticshellfish poisoning. Since thesediseases arise from contaminated environments, state agencies usuallyprohibit the harvesting of shellfishfrom areas known to be contaminated. Harvesting your own clams oroysters is a no-no unless you knowthe growing area has been approvedfor growing shellfish.

Summer is our chance to renew ouracquaintance with the outdoors andthere are really no more perils outthere than there are inside. We justhave to relearn some of the lorewe've forgotten since last summer.

Harold Hopkins is editorial directorof FDA Consumer. Some say he wasan ardent fisherman who kept hooking himself His treatment was totake up golf.


Investigators'Reports

Hamel in Rev is i t ed

The Pied Piper would have had hiswork cu t ou t f o r h im a t Sc ia lesWholesale Grocer Co., St. Louis.During a November 1983 visit, investigators from FDA's St. Louis office found widespread and active roden t and i nsec t i n f es ta t i on bo th i n t he

facility and in a number of foodproducts .

Th i s wasn ' t t he fi r s t t ime Sc ia l eshad such problems. In the past, thefacility had needed repairs to preventrodents from getting in. Openings inwalls and ill-fitting doors gave easyaccess to rats, mice and other vermin.Outside, rodents could find snug har-'borage in trash, pallets and weedsthat had grown near the building. Inside, the storage areas were crampeda n d c l u t t e r e d .

During the November inspection,live and dead rodents were observedunder stored food stocked on pallets,behind floor moldings, along thewalls and in shipping cases of foodstored in the main storage room. Liveand dead insects and insect larvaewere also found on and in cases ofstored food. Even as the FDA inspection was going on, the manager waschasing and attempting to kill mice int h e w a r e h o u s e .

Seventeen lots of food productswere sampled during the inspection.Laboratory examination of samplestaken from the firm's cooler confirmed rodent infestation: urine andexcreta on bagging and product wrappers, rodent hair and excreta adheringto food, and rodent-gnawed products.Samples of food collected from otherareas of the warehouse showed simila r ev idence .

Several contaminated lots of foodthat had been examined or sampled

FDA personnel were destroyedby the firm.

The investigators pointed outdeficiencies in the warehouse,but reinspection a month later

revealed these conditions were substantially unchanged. The firm continued to

ship infested lots of food and storednew products next to obviously inf e s t e d o r d e fi l e d l o t s o f f o o d .

A s a r e s u l t o f a n F D A r e c o m m e n

dation, all foods stored at Scialeswarehouse were seized by U.S. marshals. An inventory taken at the timeshowed approximately 133,000pounds of food valued at almost$310,000.

The firm began cleaning up the environment and correcting buildingdefects that allowed rodent entry.Stocks of food products were reconditioned under FDA supervision.

Tip Of The Iceberg

Consumers frequently report foodand drug problems to FDA. On occasion, these reports result in dramaticfindings.

Such was the case with a consumercomplaint to FDA's Brooklyn districtoffice against the Kadouri ImportCorp., a New York City importer,wholesaler and retailer of Middle Eastf o o d i t e m s .

The consumer reported seeing a liveinsect in a bin of dried apricots in thefirm's retail store. FDA inspection ofthe premises disclosed that this wasonly the tip of the iceberg.

On each floor of the five-floorbuilding insect and rodent contamination was found in products, and inthe basement there were numerousavenues for rodent access and harborage. In general, the building provided a haven for rodents, several ofwhich were seen scurrying about. Theinspection also revealed moldy figs,as well as improper storage of otherfoods requiring refrigeration.

FDA asked the New York StateDepartment of Agriculture andMarkets to place the firm's productsunder embargo to prevent removal orsale while seizure action was beingconsidered. Based on the FDA findings, the state embargoed all food insoft packages vulnerable to contamination—about 80 percent of thefirm's inventory.

After this action, the firm decidedto enter into an agreement with FDAto recondition. This process tookabout three weeks and resulted in thedestruction of goods valued at approximately $20,000. Contaminatedgoods were segregated from thosethat were not and were either reconditioned or destroyed in the presence ofFDA investigators. The firm beganstructural repairs to prevent furtherc o n t a m i n a t i o n .

Pop Goes The Can

A nurse who was preparing to feeda patient at University Hospital inNewark, N.J., pulled the tab on acan of Magnacal high-calorie formula, and the contents exploded ontoher c lo thes and the wal ls o f the room.The liquid was foaming and foulsmelling.

Another can of the same productexploded at Misericordia Hospital inthe Bronx, N.Y. FDA sent some investigators to check out the trouble.

Magnacal is a nutritionally complete meal supplement for use in oraland tube feedings of patients whosemedical conditions require calorie andnutrient intakes higher than standardmeals provide. Manufactured by Or-ganon Inc., Buena Park, Calif., theproduct is a low-acid canned medicalfood, thus subject to FDA's goodmanufacturing practice regulations.

Inspections by FDA's Newarkdistrict at the firm's headquarters inWest Orange, N.J., and by the LosAngeles district at its manufacturingsite turned up a history of problemsin production of Magnacal from thebeginning.

Organon began producing Magnacal in October 1982. The first day'sproduction of 5,500 cans was embargoed by California stateauthorities because of cracks on thecan flanges (the projecting rim ateach end).

Several months later, the firmnoticed that the lids of some of thefilled cans were beginning to rust.

The rust on some was removed withliquid petrolatum, but 6,500 cans hadto be destroyed. During the reconditioning, six swollen cans were found.The company told FDA it did notfind the cause of the swelling and hadcontinued to distribute the product.

FDA analyzed the contents of theproduct and found no harmful organisms. Analysis of the cans foundmicro leaks in some can seams. Thiscould allow microorganisms to enterthe can, reproduce and result in thebuildup of gases and cause the subsequent explosions.

Newark district staff met withOrganon Inc. representatives, whoagreed to withdraw all questionablelots of Magnacal from the market.

The company notified its consignees,and 21,369 cans of Magnacal werereturned to the firm and destroyed.

500 Mg Is Not 325 Mg

Drug products that have beenmanufactured by the rules can stillpose a problem if they end up in thewrong bott les. Newtron Pharmaceuticals Inc. learned of such a probleminvolving its acetaminophen, a nonprescription painkiller.

The Bohemia, N.Y. , firm manufactures the drug in two strengths:325-miIligram tablets, sold in bottlesof 100, and 500-milligram tablets,so ld i n bo t t l es o f 60 tab le t s .

Recently, a hospital pharmacy inMissouri found 500-milligram tabletsin bottles identified as containing325-milligram tablets. Since the pharmacy employees were familiar withNewtron's products, they recognizedthe difference and immediately filed areport through the Drug ProductProblem Reporting Program. TheProgram, jointly sponsored by FDA,The United States PharmacopeialConvention (USPC), the AmericanSociety of Hospital Pharmacists, andstate pharmacy associations, is coordinated by USPC. Problems withdrug products can be reported toUSPC, which then sends copies of thereport to FDA and the drug manufact u r e r .

The firm's own investigation foundthe trouble soon enough. Labels areput on after the bottles are filled.During the manufacture of this particular lot of acetaminophen, 3,442bottles received labels for the325-milligram strength product.However, as a result of inadequatelabel separation and inventory controls, the lot included 195 bottles containing 500-milligram tablets from aprevious run.

Because of the mix-up, the firmr e c a l l e d t h e e n t i r e l o t .

Following an inspection by FDA'sBrooklyn district office, the firmagreed to substantially improve its


control over storage of bottles andlabels. New inventory systems wereinstituted that should improve thefirm's capability to account for labelsused and make it easier to identifybottles from previous runs.

Preventing A Repeat Of HistoryP r o m o t i o n a l m a t e r i a l s f o r P l e x a l l

Family Remedy, manufactured byPlexico Products Co., Charlotte,N.C., stated that it would provide" i m m e d i a t e r e l i e f " f o r s u f f e r e r s o farthrit is, rheumatism, neuralgia,swollen joints, muscular pains,sprains, bruises, insect bites, tiredfeet, boils, athlete's foot, feverblisters, ringworm, pimples, shingles,eczema, bronchitis, emphysema,mumps, nettle rash, barber's itch andlumbago. The remedy was also toutedfor the treatment of sore gums, coldsores, and as a mouthwash.

The plethora of claims, however,was no t wha t mos t conce rned t he i nvestigator from FDA's Charlotte,N.C., office. The product contained a

disturbing—and highly toxic—ingredient: ethylene glycol. This chemicalshould have a familiar ring to thosewho know FDA history, for it has thesame toxic effects as diethyleneglycol, the ingredient in the "ElixirSulfanilamide" that was responsiblefor the deaths of over 100 people inthe late 1930s. The Plexall productalso contained 2-ethoxy ethanol, aderivative of ethylene glycol that isa l so a t ox i c i ndus t r i a l chem ica l .

While at the firm, the investigatoruncovered other problems. The firmwas not registered with FDA, as required by law. The firm was notfollowing Good Manufacturing Practices (GMPs), the regulations thatoutline the minimum requirements formethods of manufacturing, processing, packing or holding a drug toassure the drug's identity, safety,quality, purity and potency. Failureof a manufacturer to comply withGMP regulations makes any drugproduced by that firm adulterated,and therefore subject to furtherregulatory action. Specifically, thefirm did not maintain productionrecords, nor perform stability tests toestablish expiration dates for theproduct. Some raw materials on handwere unlabeled, and the firm had notestablished specifications for rawmaterials or finished products. Finally, there was no system of codingproduct batches to distinguish one lotf r o m a n o t h e r .

After being informed that the product contained two toxic ingredients,the owner agreed to recall all lots ofthe "remedy" remaining on themarket. The drug was distributed inSouth Carolina, Virginia, North Carolina and Georgia.

The firm has since gone out ofbus iness.

Aspartame Mislabeling

Over 200,000 cans of diet colarecently were recalled by an Ohiomanufacturer because of a criticalomission in the labeling. The labelsfailed to list an important ingredient—aspartame; and they failed tobear a warning to people with thedisease phenylketonuria who are susceptible to one of aspartame's constituents—phenylalanine.

Phenylketonuria (PKU) is a birthdefect characterized by faultymetabolism of phenylalanine, anessential amino acid found in proteinf o o d s . I n t h e U n i t e d S t a t e s t h i s c o ndition occurs in approximately 1 in16,000 live births and, if not treated,c a n c a u s e m e n t a l r e t a r d a t i o n a n d

neurological effects such as seizures,hyperactivity, and abnormal reflexes.Preventive therapy includes limitingintake of phenylalanine.

Because aspartame contains thisamino acid, FDA requires that allproducts containing the artificialsweetener bear the warning:"Phenylketonurics: Containsphenylalanine."

An investigator from FDA's Cincinnati district found the recall hadoccurred during a routine inspectionof Great Lakes Canning Inc., Twins-burg, Ohio. He was told that fourdays' production of the firm'sCaffeine-Free Diet Coca-Cola hadbeen put inadvertently into cans thatlisted saccharin as the only sweetenerwhen, in fact, the colas containedboth saccharin and aspartame. Themix-up occurred when the companyswitched manufacture of the cansfrom a New York plant to a nearerOhio plant. The first shipment fromthe Ohio plant was labeled incorrect ly.

Great Lakes Canning reported ithad notified 12 consignees in Ohio,Pennsylvania and Michigan where thefour lots had been distributed andhad asked that the mislabeled stockb e r e t u r n e d .

—This small sample of reports fromthe field was compiled and edited byAnnabel Hecht, Carol Ballentine, Michael Herndon and Carolyn Hommel.


Summaries of Court Actions are given pursuant to section705 of the Federal Food, Drug, and Cosmetic Act. Summariesof Court Actions report cases involving seizure proceedings,criminal proceedings, and injunction proceedings. Seizureproceedings are civil actions taken against goods alleged tobe in violation, and criminal and injunction proceedings areagainst firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, orcosmetics which were alleged to be adulterated or misbrand-ed or otherwise violative of the law when introduced into andwhile in interstate commerce, or while held for sale after shipment in interstate commerce. Full court opinions for thesecases are published by either the West Publishing Companyor the Commerce Clearing House Inc. Texts can be obtainedfrom Commerce Clearing House at 1301 Pennsylvania Ave.,N.W., Washington, D.C. 20004.

Summaries of Court Actions are prepared by the Food andDrug Division, Office of the General Counsel, HHS.

Published by direction of the Secretary of Health andH u m a n S e r v i c e s .

S E I Z U R E A C T I O N S

Foods/Poisonous and Deleterious Substances

PRODUCT: Fish fillets, "Red Snapper," frozen (two lots),at Port Newark, Dist. N.J.; Civil No. 82-1255 HLS.CHARGED 4-22-82: While held for sale, the articles, labeled "Aldea Brand Fresh Red Snapper . . . Packed byCIA . . . Panama Rep. De PMA," contained the deleterious substance histamine in such quantity as ordinarilyrendered the articles injurious to health; the articles contained decomposed fish; and the articles' labeling was falseand misleading as to the identity of the fish, since the articleswere not red snapper—402(a)(1), 402(a)(3), 403(a)(1).DISPOSITION: Waldco Enterprises, Inc., New York,N.Y., claimed 106 cartons of the 276-carton lot and 532 cartons of the 717-carton lot, and denied the charges. Subsequently, a consent decree ordered destruction of the claimedcartons; and a default decree ordered destruction of the remaining cartons. (F.D.C. No. 63706; S. Nos. 82-286-669/70; S.J. No. 1)

Foods/Contamination, Spoilage, Insanitary HandlingPRODUCT: Drink-base mix for limeade, ice-tea mix, coughdrops, and other food and drug warehouse stocks, at Cin-naminson, Dist. N.J.; Civil No. 83-503.CHARGED 2-10-83: While held by Corradetti Enterprises,t/a Anthony Sales, Cinnaminson, N.J., some of the foodscontained rodent filth, and all of the foods and drugs hadbeen held under insanitary conditions—402(a)(3), 402(a)(4),501(a)(2)(A).DISPOSITION: Consent—authorized release to the dealerfor salvaging. (F.D.C. No. 63973; S. No. 83-311-862 et al.;

S.J. No. 2)

PRODUCT: Flour, at West Liberty, E. Dist. Ky.; Civil No.8 3 - 1 9 .CHARGED 1-24-83: While held by The May Grocery Co.,West Liberty, Ky., the article contained rodent filth and hadbeen held under insanitary conditions—402(a)(3), 402(a)(4).DISPOSITION: Default—ordered destruction. (F.D.C.No. 63945; S. No. 83-229-416; S.J. No. 3)

PRODUCT: Mung beans, and other food stocks, at LosAngeles, C. Dist. Calif.; Civil No. CV 83-0516-AWT (Px).CHARGED 1-27-83: While held by Black Bros. & Son, LosAngeles, Calif., all of the articles had been held under insanitary conditions, and some of the articles contained insect and/or rodent filth—402(a)(3), 402(a)(4).DISPOSITION: Default—ordered destroyed. (F.D.C. No.63962; S. No. 83-296-528; S.J. No. 4)

PRODUCT: Peanuts, at Suffolk, E. Dist. Va.; Civil No.8 3 - 1 4 1 - N .CHARGED 2-22-83: While held by Parker Peanut Co.,Inc., Suffolk, Va., who was warehousing a number of lotsof peanuts in a rodent-infested warehouse, some lots ofpeanuts contained rodent filth, and all lots of peanuts hadbeen held under insanitary conditions—402(a)(3), 402(a)(4).DISPOSITION: Consent—authorized release to the dealerfor salvaging. (F.D.C. No. 63955; S. No. 83-339-086 et al.;S.J. No. 5)

PRODUCT: Snapper fillets, frozen, at Houston, S. Dist.Texas; Civil No. H-82-3807.CHARGED 12-15-82: While held for sale, the article contained decomposed fish—402(a)(3).DISPOSITION: Default—ordered destroyed. (F.D.C. No.63916; S. No. 82-261-106; S.J. No. 6)

Foods/Economic and Labeling Violations

PRODUCT: "Apple juice" and "apple concentrate," atMiddletown, S. Dist. N.Y.; Civil No. 82-285-988.CHARGED 10-7-82: When returned from New Jersey, toPerry Products, Inc., Middletown, N.Y., who had manufactured the articles using water and other ingredients, thenames of the articles (which were labeled "PURE AppleJuice . . . Packed for Foodtown, Edison, N.J." and "Apple Cone. . . . Dist. By Universal Juice Riverdale, N.Y.")were false and misleading for articles containing no applejuice; and the valuable constituent apple juice had beenomitted from the articles—403(a), 402(b)(1).DISPOSITION: Consent—authorized release to the manufacturer for reconditioning and/or relabeling. However, themanufacturer was unable to get its supplier to fully identifysome of the articles' ingredients; and therefore the manufacturer relinquished its claim to the article, so as to permit its


donation to a charitable institution. (F.D.C. No. 53814; S.No. 82-285-988; S.J. No. 7)

Drugs/Human UsePRODUCT: Decongestant capsules (caffeine, phenylpropanolamine HCI, and theophylline), at Linden, S. Dist.Ala.; Civil No. 82-1356-C.CHARGED 12-10-82: When shipped by B.T. Products, St.Petersburg, Fla., the article was a new drug without an effective approved New Drug Application; and the article'slabeling lacked adequate directions for use due to its newdrug status—505(a), 502(f)(1).DISPOSITION: Default—ordered destruction. (F.D.C.No. 63873; S. No. 82-401-483; S.J. No. 8)

PRODUCT: Ephedrine sulfate capsules, ephedrine sulfatetablets, caffeine and ephedrine sulfate capsules, and othersimilar drugs, at Charles Town, N. Dist. W.Va.; Civil No.8 2 - 2 9 - M .CHARGED 10-14-82: While held by Z&J's Distributors,Charles Town, W.Va., the articles (which bore labels suchas "Ephedrine Sulfate for Asthma . . . CapsulesDistributed by Z&J's Distributors . . . Oxford,Pa. . . . Expiration Date: Jun '82", "CapsulesCaffeine . . . Ephedrine Sulfate . . . Distributed by Z&J'sDistributors . . .Oxford, Pa. . . . Exp. Date: 11-'81", and"Ephedrine Sulfate Tablets . . . Distributed by CharlesPharmacal, Havre De Grace, Md. . . . EXP 11-81") wereheld under circumstances that failed to conform with current good manufacturing practices, since the articles werebeing held for sale beyond their labeled expirationdates—501(a)(2)(B); and two of the articles were counterfeitdrugs since, without authorization, the articles bore theidentifying mark, imprint, or likeness of another drugmanufacturer, processor, packer or distributor—201(g)(2).DISPOSITION: Consent—ordered destroyed. (F.D.C. No.63869; S. No. 82-310-187 et al.; S.J. No. 9)

PRODUCT: Furosemide tablets, at Brooklyn, E. Dist.N.Y.; Civi l No. CV-80-1586.CHARGED 6-11-80: While held for sale, the article, whichhad been manufactured by Superpharm Corp., West Islip,N.Y., using interstate furosemide, was a new drug withoutan effective approved New Drug Application; and the article's labeling lacked adequate directions for use and was notexempted due to the article's new drug status—505(a),502(f)(1).DISPOSITION: Consent—ordered destruction. (F.D.C.No. 63040; S. No. 80-200-391; S.J. No. 10)

PRODUCT: Furosemide tablets, at Inglewood, C. Dist.Calif.; Civil Nos. 80-5257-R, and (on transfer) CV-81-0458.

CHARGED 12-10-80: When shipped by Superpharm Corp.,Central Islip, N.Y., the article (labeled "FurosemideTablets . . . Manufactured by Superpharm Corporation,Central Islip, New York") was a new drug without an effective approved New Drug Application—505(a).DISPOSITION: The article was claimed by the shipper whodenied the charge and demanded a jury trial. Pursuant tostipulation, the action was ordered transferred to theEastern District of New York for possible consolidation andtrial with a similar action. Ultimately, a consent decree ofcondemnation ordered the article destroyed. (F.D.C. No.63228; S. No. 80-213-794; S.J. No. 11)

PRODUCT: Furosemide tablets, at Valley Stream, E. Dist.N.Y.; Civil No. CV 80-1656.CHARGED 6-17-80: While held for sale, the article, whichhad been manufactured by Superpharm Corp., CentralIslip, N.Y., using interstate furosemide (and which had beenlabeled "Furosemide Tablets . . . Manufactured by Superpharm Corp. . . . Central Islip, N.Y. . . . ManufacturedFor Spencer-Meade, Inc., Valley Stream, N.Y."), was a newdrug without an effective approved New Drug Applicationand the article's labeling lacked adequate directions for use,because of the article's new drug status—505(a), 502(0(1).DISPOSITION: Consent—ordered destruction. (F.D.C.No. 63039; S. No. 80-139-345; S.J. No. 12)

PRODUCT: Geravite pentylenetetrazole elixir, at Alpharet-ta, N. Dist. Ga.; Civil No. C-82-1710A.CHARGED 8-16-82: While held for sale after manufactureby Mikart, Inc., who used interstate pentylenetetrazole, thearticle was a new drug without an effective approved NewDrug Application; and the article's labeling lacked adequatedirections for use and was not exempted due to the article'snew drug status—505(a), 502(0(1).DISPOSITION: Default—ordered destruction. (F.D.C.No. 63783; S. No. 82-288-990; S.J. No. 13)

PRODUCT: Gerovital H3 tablets, and Zeil H3 tablets, atFlagstaff, Dist. Ariz.; Civil No. 82-2015-PHX-EHC.CHARGED 12-1-82: When shipped from outside Arizona,the articles (labeled "Tablets Gerovital H3 . . . A vitaminproduct Manufactured By World Institute of Health, Inc.,Grand Cayman, British West Indies . . . Procainehydrochloride" and "Zell H3, a vitamin product manufactured by: World Institute of Health, Inc., Grand Cayman,British West Indies . . . tablet contains . . . procaine-hydrochloride") were accompanied by promotional labelingtitled "The Promise of Gerovital" and "Dr. Asian ClaimsAging Reversed"; and the articles were new drugs withouteffective approved New Drug Applications for the usesstated in the accompanying labeling—505(a).DISPOSITION: Default—ordered destruction. (F.D.C.


No. 63884; S. No. 82-306-255; S.J. No. 14)

PRODUCT: N iazo le pen ty lene te t razo l tab le ts , a tPhiladelphia, E. Dist. Pa.; Civil No. 82-4567.CHARGED 10-18-82: While held by Wesley PharmacalCo., Inc., Philadelphia, Pa., who had manufactured the article using interstate pentylenetetrazol, the article was a newdrug without an effective approved New Drug Application;and the article's labeling lacked adequate directions for useand was not exempted due to its new drug status—502(a),502(f)(1).DISPOSITION: Default—ordered destruction. (F.D.C.No. 63845; S. No. 82-343-495; S.J. No. 15)

Drugs/ Veterinary

PRODUCT: Phenylbutazone injectable, dipyrone, andother veterinary prescription drugs, at Abilene, N. Dist.Texas; Civil No. 1-79-19.CHARGED 4-26-79: While held by West Texas VeterinarySupply Co. (a partnership), Abilene, Texas, the labeling ofthe articles lacked adequate directions for use and were notexempted as prescription veterinary drugs, since they werenot held for sale to or on the order of a veterinarian (thedrugs were stored on the dealer's shelves with OTC drugsand were sold without the required prescriptions)—502(f)(1).DISPOSITION: The dealer claimed the articles. Subsequently, a consent decree authorized release of the articlesfor bringing into compliance. In addition, the consentdecree enjoined the claimant partnership and its partners(Philip Smith, D.V.M., and Jack Stricklin) from offeringfor sale any prescription drugs, unless and until a number ofspecific conditions were met to assure that the sale of suchdrugs occurred only in conformance with FDA policy.(F.D.C. No. 62235; S. No. 79-181-236; S.J. No. 16)

Medical Devices

PRODUCT: Metal balls on surgical tape, acupunctureneedles, neurometer electrical devices, and other acupuncture devices for the treatment of humans and animals, atDearborn, E. Dist. Mich.; Civil No. 7-70077.CHARGED 1-12-77: The articles, which were held by GraceH. Dohring, D.C., t/a Doctor's Supply, Dearborn, Mich.,were accompanied by labeling (i.e., pamphlets, charts,booklets, books, and other written or graphic matter) whichcontained false and misleading claims for treatment anddiagnosis through use of electric meters, pressure therapy,rveedles, and needle-less therapy; for balancing oppositeforces in the body; for aiding almost all types of pain conditions; for being of benefit where other therapy cannot haveany effectiveness; for relief of pain from neuralgia and otherconditions; for aiding chronic conditions of deafness; for

muscle spasms; for normalizing high or low blood pressureor sugar; for curing "incurable or hopeless" conditions; andfor aiding vision and hearing problems, lumbago, glaucoma, laryngitis, obesity, smoking problems, drug addictionand others—502(a); the articles' labeling lacked adequatedirections for use for their intended purposes, since neitheradequate directions for lay use nor adequate informationfor use by licensed practitioners could be furnished for suchpurposes—502(f)(1); the labeling of the metal balls onsurgical tape, the acupuncture needles, and certain devices(Acu-Audio Meters) lacked adequate direct ions forveterinary use as an analgesic and anesthetic, for lame legs,breeding problems, obesity, kennel cough, deafness andother specified diseases, and was not exempted—502(f)(1).DISPOSITION: The articles were claimed by the dealer. Sixbooks, two journals, and some teaching and personal itemshad been mistakenly seized; they were returned, leaving 194articles still under seizure. The government served writteninterrogatories on the claimant. When the claimant, afterseveral months, had failed to answer the government's interrogatories, the government moved to compel answers.

The claimant moved for summary judgment. The courtdenied such motion on the ground that genuine issues ofmaterial fact existed. Meanwhile, the motion to compelanswers to interrogatories had been postponed, and theclaimant obtained an order authorizing accesses to theseized articles for the purposes of inspecting, inventoryingand photographing the articles. The court also authorizedthe government to obtain representative samples of the literature seized in the action.

Ultimately, a consent decree of condemnation authorizedrelease of the articles for bringing into compliance (including not only the statute and regulations but the provisions of the Federal Register notice "Acupuncture DevicesLabeling," 38 FR 6419 (March 9, 1973)), and for release,revision or destruction, in a specified manner, of the seizedliterature. (F.D.C. No. 60930; S. No. 77-66-767 et al.; S.J.No. 17)

PRODUCT: Thermometers, mercury, clinical, at Chicago,N. Dist. 111.; Civil No. 83 C 198.CHARGED I-12-83: The quality of the articles (which hadbeen imported from India and which were labeled (carton)"Milex Pro-Ception Basal Temperature Thermometer ForDetermining Time of Ovulation . . . Graphs Included. . . Milex Products, Chicago, Illinois") fell below their

purported quality, since the articles failed to meet the standard for clinical thermometers (27 of 36 tested thermometers failed to meet the standard, and 16 of the 27nonstandard thermometers failed to register at anytemperature)—501 (c).DISPOSITION: Default—ordered destruction. (F.D.C.No. 63951; S. No. 83-317-924; S.J. No. 18)


C I V I L P E N A LT Y A C T I O N S

DEFENDANT: Rubinstein Dental Equipment Corp., andGeorge H, Rubinstein, president, New York, S. Dist. N.Y.;Civil No. 82 Civ. 6770 (EW).C I V I L P E N A L T I E S & I N J U N C T I O N C H A R G E D10-12-82: That the defendants were in the business of installing and assembling diagnostic X-ray systems; that the defendants had installed a number of designated diagnostic X-raysystems and/or major components for various doctors inNew York and New Jersey and had failed to. issue to suchpurchasers the required certifications, and had failed to submit to FDA the required assembler's reports; and that thedefendants were well aware that they were violating thelaw—42 U.S.C. 263j (a) (5) (A) , 263f(h) , 42 U.S.C.263j(a)(4), 263i(b).DISPOSITION: A consent decree ordered the payment of$15,000 in civil penalties, as well as permanently enjoiningthe complained of violations. (Inj. No. 1008; S. No. 902989et al.; S.J. No. 19)

C R I M I N A L C O N T E M P T A C T I O N S

DEFENDANT: Bill R. Frye (president of Frye Pharmaceuticals, Inc.), Birmingham, N. Dist. Ala.; Civil No.8 1 - L - I 5 3 I - S .CHARGED 2-24-82 in a motion for an order to show causein criminal contempt: That the defendant had distributed5,OCX) black capsules labeled RJS, which were counterfeitdrugs, in violation of a consent decree of permanent injunction (see N.J. No. 12 of the December 1983-January 1984issue of FDA Consumer)', and that the drug manufacturingequipment released to him should be seized and disposed ofby sale or destruction.DISPOSITION: The court issued an order to show cause incriminal contempt. Without admitting to violating the provisions of the consent decree in the seizure action, the defendant entered into an amendment to the consent decree ofpermanent injunction in that case. The original provisionsfor release to the claimant of the condemned equipmentwere withdrawn; all of the equipment, except a scale, wasordered sold for the benefit of the government; and the scalewas ordered delivered to the Drug Enforcement Administration. (F.D.C. No. 63571; S. No. 81-163-465 et al.; S.J.No. 20)

I N J U N C T I O N A C T I O N S

DEFENDANT: The Harthill Co., and Alexander Harthill,president, and Edward F. Reiss, secretary-treasurer,Louisville, W. Dist. Ky.; Civil No. C 77-0308-L(A).CHARGED 8-6-77 in a complaint for injunction: That thedefendants, at their plant at Louisville, Ky., had been

A

manufacturing, processing, packing, labeling, holding anddistributing in intrastate and interstate commerce, variousdrugs for animal use; that the circumstances used for themanufacture, processing, packing and holding of such drugsfailed to conform with current good manufacturing practice—502(a)(2)(B); that a number of the defendants' drugs{No. 10 Nasal Balm, No. 38 EZ Wind, Wind Aid, PARNasal Remedy, RX 56 Kidney Medicine, Hold AnalgesicBalm, and Tansy) were new animal drugs and no approvalof a New Animal Drug Application was in effect withrespect to their use or intended use—501(a)(5); the strengthsof one lot of the defendants' No. 32 Red Mercury and PineTar and one lot of the defendants' No. 11 Ichthammol 20%Improved differed from their purported strengths, since theformer contained more than the declared amount of mercuric iodide and the latter contained less than the declaredamount of ichthammol—501(c); and the labeling of thedefendants' M-R Blister lacked adequate directions for useand was not exempted, since it lacked the requiredveterinary prescription legend—502(f)(1); that FDA inspections disclosed a number of specified deviations from current good manufacturing practice; and that the defendantswere well aware that their activities were in violation of thel a w .DISPOSITION: The court issued a temporary restrainingorder restraining the defendants. Subsequently, a consentdecree of permanent injunction was filed which enjoined thecomplained of violations and enjoined continued operationsinvolving interstate drugs or components, unless and until anumber of specified conditions had been met. Ultimately,the firm resumed manufacturing and FDA inspectiondisclosed no problems. (Inj. No. 787; S. No. 77-33-796 etal.; S.J. No. 21)

DEFENDANT: Performance Products, Inc., and James A.Warnhoff, president, St. Louis, E. Dist. Mo.; Civil No82-I257-C-(A).CHARGED 8-5-82: That the defendants, at their plant atSt. Louis, Mo., manufactured, processed, packed, labeled,held and distributed in interstate commerce the drugEquidantin, which was a new animal drug, and no approvalof a New Animal Drug Application was in effect withrespect to its use and intended use; and that the defendantshad received ample notice that FDA considered Equidantinto be violative {i.e., a seizure action had been initiated, adjudicated and affirmed upon appeal, although the manufacturer was appealing to the Supreme Court)—501(a)(5).DISPOSITION: A consent decree of injunction enjoinedthe defendants (pending final adjudication by the SupremeCourt) from the continued production and distribution ofEquidantin. Ultimately, the Supreme Court denied the petition for certiorari, and the injunction was made a permanent decree of injunction. (Inj. No. 1004; S. No. 82-257-221et al.; S.J. No. 22)

40 / July-August 1984 / FDA Consumer U.S. GOVERNMENT PRINTING OFFICE 1984-421-174/143

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