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FDA Sends Warning Letters to 10 DMAA Manufacturers

FDA Sends Warning Letters to 10 DMAA Manufacturers

On April 17, 2012, the FDA sent warning letters to ten manufacturers of DMAA dietary supplements, challenging the marketing of these products. Manufacturers claim that DMAA is a natural substance derived from the geranium plant that has been used in food for many years, and therefore exempt from FDA oversight. The FDA contends that “synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.”

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). By law, all ingredients introduced in dietary supplements after 1994 must submit an NDI to the FDA at least 75 days before marketing their products. In the warning letters, the FDA stated: “There is no information demonstrating that DMAA was lawfully marketed as a dietary ingredient in the U.S. before October 15th 1994, nor is there any information demonstrating that it has been present in the food supply as an article used in food in a form in which the food has not been chemically altered.”

The warning letters specifically cite the manufacturers for failing to provide the FDA with New Dietary Ingredient (NDI) notification before DMAA was used in dietary supplements. An NDI must contain evidence of the safety of the new ingredient. Supplement manufacturers have never submitted an NDI for DMAA, and therefore, the products are illegally adulterated.

The following manufacturers received warning letters:

  • USP Labs, LLC (Oxy Elite Pro, Jack3D)
  • 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, and Lipo-6 Black Hers)
  • SEI Pharmaceuticals (MethylHex 4,2)
  • SNI LLC (Nitric Blast)

The manufacturers have 15 days to respond to the FDA warning letters, or they may face enforcement action with no further warning.

The FDA also issued the following notice regarding DMAA side effects: “DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.”

DMAA was found in the bloodstream of two U.S. soldiers who died of heart attacks during physical training. Upon review of the incidents, the Department of Defense banned the sales of all products containing DMAA on military bases.

Dietary supplements containing DMAA remain legal in the rest of the U.S. They are mostly used by bodybuilding enthusiasts who enjoy taking supplements as pre-workout energy boosters. Other DMAA products are also marketed as weight-loss aids or party pills.

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