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FDA warning re: dietary supplements
FDA Goes After Products with DMAA
Published: May 01, 2012
WASHINGTON -- The FDA has issued warning letters to 10 manufacturers of dietary supplements that contain dimethylamylamine (DMAA) for failing to verify the safety of their products.
DMAA is marketed in these products as a "natural" stimulant and is included on labeling as 1,3-dimethylamylamine, methylhexanamine, and geranium extract, the FDA said in a statement.
"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 statement said.
No adverse events related to DMAA have yet been reported, the agency said in the latest release. But in March, two Army soldiers died suddenly during fitness exercises after both reportedly took DMAA products.
The FDA noted in its warning that, under current law, companies selling products with certain dietary ingredients, which were not marketed in a dietary supplement before Oct. 15, 1994, must notify the FDA that the new dietary ingredient in the product is safe.
The agency added that no current evidence exists showing DMAA is a safe ingredient and the companies who were sent warning letters had not met this requirement.
The agency warned that synthetically-produced DMAA is not considered a dietary ingredient, as defined by the Dietary Supplement and Health and Education Act (DSHEA) of 1994, and is not eligible for use as an active ingredient in a dietary supplement.
The act lists vitamins, minerals, amino acids, herbs, and other botanicals, "a dietary substance for use by man to supplement the diet," or a concentrate, metabolite, constituent, extract, or combination of those substances as dietary ingredients.
The companies issued letters by the agency are:
- Exclusive Supplements
- Fahrenheit Nutrition
- Gaspari Nutrition
- iSatori Global Technologies
- Muscle Warfare
- MuscleMeds Performance Technologies
- Nutrex Research
- SEI Pharmaceuticals
- SNI
- USP Labs (Jack3D)
A full list of DMAA-containing products from those companies is available on the FDA website.