1 / FDA Consumer Hea l th In o rmat ion / U . S . Food and D rug Admin i s t r a t i on APR IL 2013

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 The ingredient, DMAA, is most com-monly used in supplements promis-ing weight loss, muscle building andperormance enhancement; it canelevate blood pressure and could leadto cardiovascular problems, includ-ing heart attack, shortness o breathand tightening o the chest. Given theknown biological activity o DMAA,the ingredient may be particularly dangerous when used with caeine.

FDA has received 60 reports o ill-nesses and death associated withsupplements containing DMAA. Themajority are voluntary reports romconsumers and healthcare practitio-ners. The illnesses reported includeheart problems and nervous systemor psychiatric disorders. Note, how-ever, that a report is not proo that theproduct actually caused the problem.

FDA has warned companies knownto be using DMAA in dietar y supple-ments that those products containing this ingredient are illegal. Such warn-ings oer the quickest way at FDA’s

The Food and Drug

Administration (FDA)

is using all available

tools at its disposal to ensure

that dietary supplements

containing a st imulant called

dimethylamylamine (DMAA)

are no longer distributed and

available for sale to consumers

in the marketplace.

Stimulant PotentiallyDangerous to Health,FDA Warns

FDA’s eorts to get dietary supplements containing the stimulant DMAA o the

market illustrates the agency’s role in regulating dietary supplements and serves

as a warning to consumers.

 

2 / FDA Consumer Hea l th In o rmat ion / U . S . Food and D rug Admin i s t r a t i on APR IL 2013

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disposal to halt the urther distribu-tion o dietary supplements contain-ing DMAA in the marketplace. Inact, all but one o the companiessent a Warning Letter have agreed tostop using DMAA as an ingredient in their dietary supplements. Theone company that has yet to agree tosuch action, USPLabs, has respondedto FDA’s warning by submitting pub-lished studies that purport to chal-lenge FDA’s conclusions.

However, ater reviewing the stud-ies provided by USPLabs, FDA hasound the inormation insucient todeend the use o DMAA as an ingre-dient in dietary supplements. FDA isnalizing a ormal response to therm to refect its ndings, according to Daniel Fabricant, Ph.D., director o FDA’s Division o Dietary Supple-ment Program.

FDA’s authority over dietary sup-plements is very dierent rom itsauthority over drugs and other med-ical products. FDA is required toundertake what are usually lengthy scientic and legal steps in order toorce the removal o dietary supple-ments that may be unsae or are oth-erwise illegal i companies don’t vol-untarily comply. As FDA continues the process needed

to get DMAA o the market, the agency is urging consumers to check labelsand avoid any dietary supplementscontaining DMAA, which is reerredto on dierent product labels by 10possible names. The alternatives arelisted at FDA’s DMAA web page (http:// www.fda.gov/Food/DietarySupplements/ QADietarySupplements/ucm346576.htm).

The ChallengeFDA’s response to the use o DMAA illustrates the challenges that the

agency aces in addressing incidentsinvolving potentially dangerousdietary supplements. The eort isincreasingly important as the useo dietary supplements increases worldwide. A 2011 study (http://www.cdc.gov/nchs/data/databriefs/db61.htm )ound that more than hal o U.S.adults used a dietary supplement between 2003 and 2006, comparedto 40% between 1988 and 1994.

In recent years, FDA has alertedconsumers to hundreds o taintedproducts marketed as dietary supple-ments. Consumers should be awarethat dietary supplements are subject to dierent oversight than drugs andother medical products.

“Consumers may mistakenly look at a capsule and think that FDA hassigned o on that product as sae andeective prior to that product appear-ing on the market, as we do withdrugs and other medical products,”says Fabricant. “In contrast, withdietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on theFDA to prove that a product is unsae.”

FDA’s role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments. FDA’senorcement capabilities range romissuing warning letters seeking volun-tary cooperation—the quickest way to get a product o the market—tobringing criminal charges. In recent  years , FDA en orcement ac tionsinvolving dietary supplements haveincluded banning products, executing injunctions, working with U.S. mar-shals to seize products, and issuing saety alerts and consent decrees— which are agreements approved andenorced by a ederal court.

In many cases, FDA has acted when

dietary supplements were ound tocontain ingredients approved or usein prescription drugs. DMAA wasapproved in 1948 or use as a nasaldecongestant, but the approval was withdrawn in 1983.

 The products cited in the warning letter to USPLabs are Oxy Elite Proand Jack3D. These products claim,among other things, to be at-burning and per ormance-enhancing supple-ments, respectively. While action inthat case in pending, FDA is ollow-ing up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary sup-plements are actually doing so. FDA is also looking to see i there are other dietary supplement products contain-ing DMAA in the marketplace, and will continue to act to ensure that such products, when identied, areno longer distributed and availableor sale to consumers.

Consumers are urged to report any problems associated with supplement use to the company or the agency (http://www.fda.gov/Safety/MedWatch/ default.htm), and to always consult  with their health care proessionalbeore using a supplement.

“Consumers may mistakenly look at a capsule and think that 

FDA has signed off on that product as safe and effective prior 

to that product appearing on the market …”