27 April 2015

US FDA issues warnings to supplement manufacturers

The US Food & Drug Administration (FDA) has issued warnings to five supplement manufacturers, after it found that their products contained Beta-methylphenethylamine (BMPEA). ‘BMPEA is not approved as a food additive or prior sanctioned for use in dietary supplements’, warn the letters. ‘Declaring BMPEA in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.’ The warning letters and the companies concerned can be viewed here.

‘Phenethylamine and its derivatives’ feature under section S6.(b), Specified Stimulants under the 2015 World Anti-Doping Agency’s (WADA) Prohibited List. However, an athlete searching for ‘Beta-methylphenethylamine’ or ‘BMPEA’ using the online search function within the Prohibited List would not find either substance listed. This highlights the danger athletes face when taking supplements – to understand that ‘Beta-methylphenethylamine’ or ‘BMPEA’ are prohibited, an athlete or their support staff must understand that they are a substituted derivative of phenethylamine.

On 13 April, the FDA issued a warning over use of a dietary supplement sold over the internet, as it was found to contain anabolic steroids. ‘Tri-Methyl Xtreme, distributed by Las Vegas-based Extreme Products Group, claims to contain anabolic steroids and is sold on the internet and in some retail stores and gyms’, read a 13 April FDA statement. ‘An investigation is underway by the FDA to identify the product’s manufacturer after the agency received adverse event reports from consumers – one each from California, New Jersey and Utah. The agency has not received reports of death from use of the product’.

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