Federal health regulators have issued warnings to ten companies that manufacture sports performance drinks, indicating that they are failing to make sure the drinks are safe before marketing them and that they should be removed from the market.
The FDA sent the warning letters on April 27, to manufacturers of drinks using dimethylamylamine, also known as DMAA.
Companies that received the letters include Exclusive Supplements, Fahrenheit Nutrition, Gaspari Nutrition, iSatori Global Technologies, LLC, Muscle Warfare, Inc., MuscleMeds Performance Technologies, Nutrex Research, SEI Pharmaceuticals, SNI LLC and USP Labs, LLC.
According to the FDA, DMAA constitutes a new dietary ingredient not marketed in dietary supplements prior to 1994. That means that the companies have to legally notify the FDA of evidence that supports the claims that the ingredient is safe.
The drinks that contain DMAA include:
- Biorhythm SSIN Juice
- Lean Efx
- Code Red
- Hemo Rage Black
- Lipo-6 Black
- MethylHex 4,2
- Nitric Blast
- Oxy Elite Pro
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products,” Dr. Daniel Fabricant, director of the FDA’s Dietary Supplement Program said in a press release. “They haven’t done that and that makes the products adulterated.”
According to the FDA, DMAA side effects can include a narrowing of the blood vessels and arteries, and can cause heart attacks, high blood pressure and shortness of breath. The FDA reports that it has received 42 adverse event reports tied to drinks containing DMAA, ranging from heart problems, psychiatric problems and death.
The companies have been ordered to cease sales of the drink immediately and are warned that they could be subject to further enforcement action without warning. They have 15 days to respond to the letters to show that they are addressing the violations.