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Caffeine Conundrum: The Need for FDA Regulation

Perusing the shelves of any large grocery store reveals an abundance of caffeinated

products; ones with caffeine occurring naturally, such as coffee, tea and chocolate, as well those

as with the substance added. Within the past several years products containing added caffeine

have expanded from including not just carbonated beverages and supplements, but also water,

waffles, beef jerky, pancake syrup, cosmetics, personal hygiene products, candies, gums, and

other food and non-food items. Although caffeine is officially classified as a safe supplement,

much is still unknown about its effects both physically and psychologically. Due to the

overabundance of caffeine and recent studies linking certain disorders to its use, the Food and

Drug Administration (FDA) should update its policies regarding caffeine as a supplemental

additive. Caffeine needs to be regulated for the health and safety of the consumer.

This paper is broken into four sections, a description of caffeine and its effects, the

reasons caffeine should be regulated, ways that caffeine could be regulated, and the impact

regulation might have upon society.

1. Caffeine and its effects

According to a report by the FDA, the average American consumes approximately 150

milligrams of caffeine per day (Somogyi, 48). Considering not all Americans consume caffeine

regularly, the distribution of caffeine among adults who do consume caffeine likely indicates

individual Americans consume much higher daily levels than the national average suggests.

Recently, caffeine consumption has been linked to increased incidents of hospitalization, yet

revised regulations have not been seriously considered. The Substance Abuse and Mental Health

Administration (SAMHSA) reported in its Jan. 10, 2013 edition of the publication The DAWN

Report that from 2007 to 2011, the number of emergency visits linked to the consumption of

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energy drinks doubled from 10,000 to 20,000. Out of these emergency room visits, over half

involved energy drinks alone, with no other drug influences. The report concludes,

“Consumption of energy drinks is a rising public health problem because medical and behavioral

consequences can result from excessive caffeine intake” (Substance Abuse, 1).

A compound summary found on the website for the National Center for Biotechnology

Information, describes caffeine as a central nervous system stimulant. The substance is listed as

proven to increase alertness, produce agitation, relax smooth muscle tissue, stimulate the cardiac

muscle, encourage diuresis and treat headaches (Caffeine Compound Summary). Although

caffeine has many proven medical uses, its uses are not limited to medical purposes. In a

pamphlet Medicines in My Home, the FDA describes caffeine to be both a drug and a food

additive. As a result of being classified as a food additive, caffeine may be added to food and

beverage products, as well as non-food items, with little federal regulation.

As a recreational stimulant, adults and children consume caffeine because it functions as an

appetite suppressant, may aid in concentration and help people feel more awake, aid in athletic

performance and provide a feeling of excitement. Yet, despite its relative safety and non-

prescriptive status, Mayo Clinic lists that caffeine should never be consumed without the

supervision of a medical doctor (Micromedex Drug Information).

Caffeine was first approved as an additive for colas in the 1950s after research showed

coca, a medicinal herb previously added to cola, to be harmful upon repeated consumption.

When the FDA banned adding coca to beverages, cola companies responded by demanding

another substance be added in its place. Due to the addictive nature and enhancement qualities of

caffeine, cola companies chose it as the new additive. Since the 1950s, the FDA has done little to

reconsider its blanket approval of added caffeine and has not updated federal regulations to

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reflect the conclusions of modern scientific research (Consumer Update, 2).

2. The need for regulation

A letter written on March 19, 2013 by a group of medical professionals in Maryland to

the Honorable Margaret A. Hamburg, MD, Commissioner of the Food and Drug Administration

of Maryland, urges the FDA to look deeper into creating regulations on caffeine as a food

additive. The letter states three reasons that caffeine should be regulated as a food additive, even

though it is not regulated in coffee (Arria, O'Brian, Griffiths, and Crawford).

The letter explains how beverages with supplemented caffeine (such as energy drinks)

differ from coffee in both their intention and method. The letter first notes that the caffeine in

coffee occurs naturally, whereas the caffeine in energy drinks has been added by the

manufacturer and should therefore be regulated more closely as a food additive. Second the letter

notes that many energy drinks contain caffeine levels which exceed the caffeine concentration of

even the most highly caffeinated coffee. Third, the letter notes, “coffee is typically served hot,

tastes bitter, and is consumed slowly by sipping. By contrast, energy drinks are typically

carbonated, sweetened drinks that are served cold and consumed more rapidly.” The letter

concludes that coffee and energy drinks differ because coffee is not typically marketed in a

manner intended to appeal to adolescents (Arria, O'Brian, Griffiths, and Crawford).

As mentioned briefly in the letter to the commissioner, a major reason caffeine should be

regulated is that caffeinated products are most often marketed to minors. Products such as energy

drinks, candies and gums are marked to youth by being given trendy names, attractive bottles

and sugary flavors. According to a market research study published in Comprehensive Reviews

in Food Science and Safety, energy drinks were initially marketed to athletes, but when the drink

market found its niche, the majority of energy drinks became marketed to teenagers and young

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adults because that demographic has an active life-style and is intrigued by the creative names

and youthful marketing campaigns of the beverages (Heckman, Sherry, and Gonzalez De Mejia).

Energy drinks appeal to adolescents because many young adults look for ways to compensate for

a lack of sleep or enjoy using the drinks as a mixer for alcohol.

The fact these drinks are marketed to adolescents predisposes caffeine to greater levels of

abuse than if energy drinks were marketed to adults, who typically have developed stronger

systems for measuring cause and effect. Adults have a greater ability to foresee long-term side

effects of using the drinks as a replacement for healthy meals or regular sleep. Adults also have a

larger body mass and a greater capacity to physiologically process caffeine. According to Mayo

Clinic’s online page on caffeine, “[Caffeine] is used to help restore mental alertness when

unusual tiredness or weakness or drowsiness occurs. Caffeine's use as an alertness aid should be

only occasional. It is not intended to replace sleep and should not be used regularly for this

purpose” (Micromedex Drug Information).

Data on the influence of caffeine in youth is not conclusive enough to label the substance

as completely safe for consumption by young people. According to KidsHealth website’s article

Caffeine and Your Child, children are recommended to consume no more than 44 milligrams of

caffeine daily, about the average amount in one can of soda (KidsHealth). Not only may children

experience the same negative effects of caffeine as adults (nervousness, trouble sleeping,

headache, increased blood pressure, etc.), the website also suggests children are more susceptible

than adults to experiencing life-threatening heart disorders because children often have not had

heart screenings and do not know they are at risk, whereas at-risk adults are typically aware of

their sensitivity (KidsHealth).

Not only can caffeine lead to physical problems in children, it can also affect them

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psychologically. A study on school behavior published in the Journal of School Health indicates

that with increased levels of caffeine consumption in students between fifth and tenth grade

comes higher levels of depressive behavior. The study also indicates that caffeine can interfere

with students’ ability to concentrate in school by causing an inability to sleep at night therefore

resulting in daytime tiredness (Luebbe, 380-87). Children also typically have a smaller body

mass than do adults, therefore, levels of caffeine that may be inconsequential for adults may

produce undesirable results in children.

Another reason caffeine needs to be regulated is that an abundance of caffeinated products

leads to unintentional over-consumption. In the United States, companies are not currently

required to disclose the amounts of added caffeine contained in their products. Because of this,

consumers may not be aware how much caffeine they have consumed during the course of a day.

This problem is becoming even more common with items not intended for consumption being

added to the market, due to the difficulty of measuring the amount of caffeine absorbed into the

body from nonfood sources.

For example, with the advent of more diverse caffeine sources, a person is now able to

integrate caffeine into nearly every step of getting ready for work in the morning. A person could

wake up and then shower with caffeinated shampoo and body wash, drink coffee, eat caffeinated

waffles with caffeinated syrup, apply caffeinated eye cream to their under eye circles and then

take a caffeinated pain killer to ease the headache that comes after the first caffeine begins to

wear off. Then if that person consumes a mid-afternoon energy drink and a second cup of coffee

with dinner, the FDA’s guidelines for a safe and moderate level of caffeine consumption,

approximately 100-200 milligrams (Medicines in My Home) will be more than surpassed. Yet, if

this person were surveyed on the amount of coffee that is consumed the answer would be two

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cups, which is well within the safety limits.

The problem with caffeine consumption is that the number of products containing caffeine

allows over-consumption to be a nearly thoughtless process. Without intervention on which

products may contain added caffeine, people are unlikely to be fully aware of their total daily

consumption.

A fourth reason caffeine should be regulated is that it is not safe for all people. Those with

predisposed medical conditions, such as high blood pressure, heart defects, mental conditions

and those who take certain prescription medications are advised to stay away from caffeine. Yet,

without strict regulation, it is becoming more difficult for consumers with these conditions to

know what to avoid. For example, previously if a person with a sensitivity to caffeine were

advised to avoid it, that person would know exactly what to stay away from: coffee, tea,

chocolate and sodas (except for those which are clear). Now with more items containing the

substance, it is becoming more difficult for individuals to avoid caffeine. Suppose a person who

is to avoid caffeine is also elderly, with less than perfect eyesight; this person may not

understand the buzzword “energizing” on a package of a new orange flavored low calorie

beverages equals caffeinated and may not check the ingredient list to be sure it is safe. Caffeine

should not be added to products people do not traditionally expect to be caffeinated because it

poses a health risk to the caffeine sensitive.

The final reason caffeine should be regulated is that companies use caffeine as part of an

ethically questionable marketing strategy. A research study conducted by Buffalo University and

published in the Journal of Psychopharmacology indicates that although soda companies claim

to add caffeine as a flavor enhancer, the true purpose of the substance is to increase dependency

on the product (Temple, 176-201). The research study introduced fifth and tenth graders who

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were not accustomed to consuming caffeine to sodas of novel flavors and cited which flavors

each subject liked best. Then subjects in the test group were given those same sodas for a period

of six days, except caffeine had been added to some of the sodas. Each subject noted on the first

day consuming the soda with the added caffeine that those sodas tasted more bitter and his or her

liking of them decreased. Then each day following, the subjects noted that they liked the

caffeinated products more than each previous day. The study concluded that since the subject

noted an initial decrease in liking the caffeinated products, as well as an unsavory bitter taste,

that caffeine is not likely added to the products as a flavor enhancement. Yet, because the

subjects noted their favorite flavors by the end of the study were the most highly caffeinated

ones, the scientists concluded that the mental and physiological effects of caffeine caused the

subjects to crave the caffeinated flavors over the non-caffeinated flavors. The subjects in the

control group did not change their opinions of which flavors they most favored from the

beginning to the end of the study (Temple, 176-201). Even if the intent of using the addictive

qualities of caffeine as a marketing ploy to exploit consumers into purchasing a product is

difficult to prove, the fact that companies could possibly practice this method without notifying

the consumer warrants a greater level of federal regulation.

3. Methods of regulation

Caffeine could be regulated in several ways that would address the issues presented in the

previous section.

To combat the concern that caffeine is marketed to adolescents, age restrictions could be

placed on the purchase of highly caffeinated products. These age regulations could either be on

all caffeinated products or just on certain products containing over a set amount of caffeine. If

this method of regulation were chosen, adults could still have access to the caffeinated products

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to which they are accustomed and children would not have access to those products unless an

adult purchased them. This type of regulation would help increase the level of supervision under

which children consume caffeine. An adult would better be able to monitor the effects of caffeine

on an individual child and parental precautions could be taken to prevent each child from

consuming beyond the level which his or her body is able to handle effectively.

A reason age regulations may not be the ideal method of regulation would be that similar

regulations are already ineffective at preventing children from consuming other substances, such

as alcohol and tobacco, which present a much greater health risk than caffeine. The

ineffectiveness of age regulations could partly be due to adults thinking it is unimportant to

monitor their child’s caffeine intake. These adults will continue to purchase caffeinated products

for their child to consume potentially unsupervised. Children would still be able to consume

products that adults have purchased for their own consumption. Because an age restriction could

be easily ignored and does not fully address all the aspects of the caffeine issue, on its own it

would not be the best method of regulation.

To deal with the issue of accidental over-consumption, regulations could focus on

designating which products may contain caffeine. With this type of regulation soda might be

allowed to continue to contain the same levels of caffeine which it contains now, yet energy

drinks would have their caffeine levels lowered to establish a consistent measure of caffeine

allowance per fluid ounce. Other products, such as food, candies and non-consumables, might

not be allowed to contain caffeine at all. This type of regulation would allow for products which

people are accustomed to containing caffeine to continue to have it, while preventing additional

products from being introduced to the market and reducing levels of caffeine found in certain

products. This regulation would also remove or alter the components of some products already

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being marketed. The benefit to this method of regulation would be that people could still access

many of the forms of caffeine that they are accustomed to consuming, but consumption levels

would not likely increase at the same rate they would if additional caffeinated products were to

be added to the market. Regulating which products could contain caffeine could stimulate

caffeine awareness in consumers, since they would be receiving caffeine from a limited number

of items and could more easily self-regulate their own consumption. The drawback of regulating

what types of items may contain caffeine would be that children would still have access to

caffeinated sodas.

Regulations could focus on setting a maximum legal amount for added caffeine.

Currently the only product that has a maximum allowance for caffeine levels is soda, because it

is classified as a beverage. Energy drinks and foods do not need to adhere to the caffeine cap

level because they are classified as supplements. Other products, such as non-consumables, do

not need to adhere to the caffeine level cap because they are not intended for internal use and the

amount of caffeine absorbed into the body from these products is difficult to measure. A benefit

to regulating caffeine in this manner would be that it is the most fair to the companies that

produce items containing added caffeine. Every product would be subject to the same guidelines

and certain products would not need to be pulled from the market or have all the caffeine

removed from them; companies would simply need to ensure each product adheres to the new

regulations.

A problem with regulating caffeine in this manner would be that consumers could still

easily overdose on caffeine by consuming multiple caffeinated products and might be unaware of

the total amount of caffeine they are consuming through those multiple products.

All three forms of caffeine restriction mentioned allow for a greater amount of caffeine to

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be accessible to the consumer than is ideal. Therefore, the best method of caffeine restriction

would be to administer a combination of all three methods. The amount of caffeine available in

certain products, such as soda, energy drinks and non-prescription medications could be limited,

while also restricting the type of products to which caffeine may be added. Products such as

candies, mints, gums, foods and certain cosmetic items would not have caffeine added to them

because many consumers are unaware of the amount of caffeine they are exposed to when using

these products in combination with other sources of caffeine. Enforcing an age restriction would

be difficult; therefore, the best way to reduce the amount of caffeine consumed by children

would be to regulate marketing these items to children. Highly caffeinated items could be

removed from vending machines and concessions stands where children are the main customers.

Energy drinks could be repositioned in stores so that they are not sold next to juice or lower-

caffeine content sodas. Marketing agencies for energy drinks could remove youth oriented

activities, such as extreme sports from their advertisements, as well as display their ads in places

where and during television times when children are not the main audience. By implementing

these methods of restriction, caffeine could be both accessible by responsible adults while also

being downplayed for consumption by children.

4. Possible impact of regulation

Those who oppose caffeine regulation could argue that regulating products with added

caffeine would be detrimental to companies producing those products. While initially products

impacted by the change may experience decline in sales, companies who are proactive in their

marketing strategies would not have long-term difficulty re-marketing healthier versions of their

products. According to the Journal of William & Mary Business Law Review, regulating amounts

of caffeine or types of products containing added caffeine would not impact long-term sales

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because even without that type of regulation, the market is always changing therefore only

progressive marketing companies will be able to continue or increase sales. The article stated

that companies are always in need of reworking marketing ideas, hence a change such as the

regulation of caffeine will have no effect on companies that possess an understanding of their

market and how it is constantly changing. Any company which is unable to keep up with that

type of regulation would not likely have been able to keep up with the ever-changing market and

would have been in the same failing position regardless of the caffeine restrictions (Parikh, 644-

66).

Society would benefit by regulation of caffeine because it would spur a return to receiving

energy from healthier sources, such as sleep, food and exercise. When Americans have access to

unlimited amounts of caffeine in an array of products, they may not take seriously the

importance of maintaining a healthy body through sustainable energy sources, such as a healthy

lifestyle, rather than through artificial energy supplements. Without being addicted to caffeine or

with a reduced level of caffeine addiction, adults may be able to function more clearly at work,

focus better when driving and sleep better at night. Certain health problems, which may be

linked to caffeine, could show a reduction of diagnoses, as well as improvement in those with

those problems.

Adults who wish to consume caffeine would be encouraged to receive that caffeine from

sources such as coffee or tea, which are linked to having health benefits such as antioxidants,

according to Harvard Health newsletter’s article on “Coffee Health Benefits,” as wells as the

University of Maryland Medical Center’s complementary and alternative medicine guide. Often

coffee and tea are consumed with less sugar than other caffeinated beverages, therefore it is

possible that those who switch their consumption could benefit from a reduced risk diabetes and

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obesity (“Coffee Health”). Children also would be unlikely to want to consume coffee and tea in

the amounts they wish to consume soda and energy drinks; therefore, they would naturally

consume less caffeine. They may still consume the same amount of carbonated beverages, but at

least the caffeine question would have been removed from the equation.

Caffeine needs to be regulated to ensure that Americans can make conscious and

educated decisions about the amount of caffeine they wish to consume. Regulation is important

because caffeine is used as a marketing ploy to draw children to purchasing their products.

People with certain medical conditions must be vigilant in avoiding all amounts of caffeine,

which without strict regulation and clear rules on packaging information can be difficult. Adults

who are not careful about caffeine intake may consume well above the recommended daily

amount due to so many sources containing the substance. Children often consume caffeinated

products, which is scientifically questionable.

The best methods for caffeine regulation would be to restrict how much caffeine is

allowed in certain products, ban other products from containing any caffeine and place

restrictions on marketing strategies for caffeinated items.

Once caffeine regulations come into effect public awareness would increase regarding

caffeine use and potential concerns thereof. Regulating caffeine would give Americans the

opportunity to make more informed choices regarding the inclusion of caffeine in their regular

diets.

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Works Cited

Arria, Amelia M., O'Brian, Mary Claire, Griffiths, Roland R., and Crawford, Patricia B."Re: The

Use of Caffeine in Energy Drinks." Letter to Margaret A. Hamburg. 19 Mar. 2013. MS.

Silver Spring, Maryland.

"Benefits of Tea." Complementary and Alternative Medicine Guide. University of Maryland

Medical Center, 21 July 2013. Web. 14 Nov. 2013.

"Caffeine Compound Summary." PubChem. National Center for Biotechnology Information.

Web. 12 Nov. 2013.

“Coffee Health Benefits: Coffee May Protect against Disease.” Harvard Health, Feb. 2006.

Web. 14 Nov. 2013.

Consumer Update: FDA to Investigate Added Caffeine. By Michael R. Taylor. Food and Drug

Administration, May 2013. Web. 12 Nov. 2013.

Heckman, M. A., Sherry, K., and Gonzalez De Mejia, E. "Energy Drinks: An Assessment of

Their Market Size, Consumer Demographics, Ingredient Profile, Functionality, and

Regulations in the United States." Comprehensive Reviews in Food Science and Food

Safety 9.3 (2010): 303-17. Print.

"KidsHealth." Caffeine and Your Child. N.p., n.d. Web. 13 Nov. 2013.

Luebbe, Aaron M., and Bell, Deborah J. "Mountain Dew® or Mountain Don’t: A Pilot

Investigation of Caffeine Use Parameters and Relations to Depression and Anxiety

Symptoms in 5th- and 10th-Grade Students." Journal of School Health 79.8 (2009): 380-

87. Print.

Medicines in My Home: Caffeine and Your Body. N.p.: Food and Drug Administration, 2007.

Print.

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Micromedex Drug Information Provided By: Mayo Clinic. Mayo Foundation for Medical

Education and Research, 01 Nov. 2011. Web. 12 Nov. 2013.

Parikh, Rakesh J. "America's Energy Dependency: Will Government Regulations of Caffeine

Bring the Caffeine Companies to a Crash?" William & Mary Business Law Review 7th

ser. 3.2 (2012): 644-66. William & Mary Law School Scholarship Repository, 2012.

Web. 13 Nov. 2013.

Somogyi, Laszlo P. Caffeine Intake by the U.S. Population. Rep. no. 70000073494. The Food

and Drug Administration, Sept. 2009. Web. 12 Nov. 2013.

Substance Abuse and Mental Health Services Administration, Center for Behavioral Health

Statistics and Quality. (January 10, 2013). The DAWN Report: Update on Emergency

Department Visits Involving Energy Drinks: A Continuing Public Health Concern.

Rockville, MD.

Temple, Jonathan D. “Influence of Caffeine.” Journal of Psychopharmacology. 102.4 (2010):

176-201. Print.