Your workout boosters may be changing. the FDA is warning makers of DMAA workout boosters, which in turn is challenging the marketing of the dietary supplement products for lack of safety evidence.
They have 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.
The following companies received warning from the FDA and 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 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.
Health Canada, the FDA equivalent in Canada, already banned DMAA in July of last year after finding it was not in fact a dietary supplement and instead was a drug that needed further approval.