FDA ‘following up’ on availability of DMAA products online

19-Oct-2015 - Last updated on 17-Jun-2016 at 14:12 GMT

The US Food and Drug Administration is following up on recent findings that almost 40 products are still using DMAA, so are more warning letters expected?

As reported by NutraIngredients-USA last week, data from the Human Performance Resource Center, a Department of Defense initiative under the Force Health Protection and Readiness Program, indicated that 39 products containing controversial ingredient DMAA are commercially available online in the US, despite the Food and Drug Administration stating that DMAA was not a lawful dietary ingredient.

In a statement sent to NutraIngredients-USA, an FDA spokesperson said: “The FDA supports DOD’s ongoing efforts to protect military personnel from being exposed to products containing DMAA, an unapproved food additive. The FDA is following up on DOD’s findings reported on October 14 that 39 supplements containing DMAA were available through online retailers.

“So far, the FDA has issued a dozen warning letters to companies selling products containing DMAA. As noted by DOD, 193 products have been discontinued, withdrawn from the market, or reformulated so that they no longer contain DMAA. The FDA continues to remind consumers to read dietary supplement product labels carefully.”

The DMAA saga

DMAA (also known as 1,3 dimethylamylamine, methyl hexaneamine (MHA), ‘geranium extract’, and many other names) has been a subject of intense debate about whether it is in fact a constituent of geranium. The ingredient was first manufactured synthetically by drug giant Eli Lily in the 1940s.

The FDA issued a Consumer Update in April 2013, which stated the agency’s position that the “information [is] insufficient to defend the use of DMAA as an ingredient in dietary supplements”.

The director of the FDA’s Division of Dietary Supplement Programs in 2013 was Dr Daniel Fabricant, now the CEO and executive director of the Natural Products Association. Dr Fabricant told us that he sees no reason as to why the Agency hasn’t taken action on products containing DMAA.

“The enforcement actions taken prior are all the precedent they need to take action, it should be no added resource drain or the like […] The precedent hasn’t been taken away so something should be done and done quickly.”