FDA Issues Warning Letters to Makers of DMAA Workout Boosters

FDA Issues Warning Letters to Makers of DMAA Workout BoostersThe U.S. Food & Drug Administration (FDA) just issued warning letters to the makers of DMAA workout boosters, challenging the marketing of DMAA dietary supplement products for lack of safety evidence.

The FDA cited 10 companies that manufacture and distribute dietary supplements containing dimethylamylamine, known as DMAA, for marketing products for which evidence of the products’ safety was not submitted to the agency. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. The ingredient is often marketed as a “natural stimulant” in dietary supplements.

“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.

The warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible to advise the FDA of evidence to support their conclusion that their NDI-containing dietary supplements are safe. Manufacturers or distributors must submit notification at least 75 days prior to marketing their products.

The following companies were warned that they were marketing products for which this requirement had not been met:

• Exclusive Supplements: Biorhythm SSIN Juice
• Fahrenheit Nutrition: Lean Efx
• Gaspari Nutrition: Spirodex
• iSatori Global Technologies, LLC: PWR
• Muscle Warfare, Inc.: Napalm
• MuscleMeds Performance Technologies: Code Red
• Nutrex Research: Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
• SEI Pharmaceuticals: MethylHex 4,2
• SNI LLC: Nitric Blast
• USP Labs, LLC: Oxy Elite Pro and Jack3D

The agency’s letters advised the companies that it is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible to ensure that they are marketing a safe product.

The letters stated that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events that can include anything from shortness of breath and tightening in the chest to heart attack. To date, the FDA has received 42 adverse event reports on products containing DMAA. The complaints do not establish that DMAA was the cause of the incidents; however, some reports include complaint of cardiac disorders, nervous system disorders, psychiatric disorders, and death. The companies have 15 business days to respond to the FDA with the specific steps they will take to address the issues outlined in the warning letters.

The FDA also warned the companies that synthetically produced DMAA is not a “dietary ingredient” and is ineligible as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.

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