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FDA Warning Letters May be Start of DMAA Debate

Despite the fact that the U.S. Food and Drug Administration (FDA) has recently sent warning letters to 10 manufacturers of dietary supplements containing DMAA, the debate about the safety and legality of DMAA may not be over. The violation was a failure to submit a New Dietary Ingredient (NDI) notification to the FDA. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), manufacturers of any dietary supplement ingredient introduced after 1994 must submit an NDI including safety data to the FDA. No safety data has ever been provided to the FDA regarding DMAA.

The manufacturers of DMAA dietary supplements have claimed that DMAA is a copy of a botanical constituent of the geranium plant, which has been used in the food supply for many years, and is therefore exempt from the NDI notification.

The FDA, however, concluded that “synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.” Furthermore, “There is no information demonstrating that DMAA was lawfully marketed as a dietary ingredients in the US before October 15th 1994, nor is there any information demonstrating that it has been present in the food supply as an article used in food in a form in which the food has not been chemically altered.”

The companies cited in the warning letters have 15 days to respond to the FDA. If the companies fail to immediately cease distributing the products, they could face enforcement action. Several of these companies are already facing DMAA lawsuits, brought by people who used the products and were seriously injured.

According to Council for Responsible Nutrition (CRN) chief executive Steve Mister, the debate about DMAA is far from over. He said, “The science of this has to play out, and hopefully this is now an opportunity for the companies listed to give us some more clarity on its safety.” He added that the debate is not over about whether synthetic versions of botanical ingredients could be listed as dietary ingredients.

Even if the FDA does allow synthetic botanical ingredients in dietary supplements, this does not make new ingredients exempt from the NDI requirements. It is still possible that DMAA manufacturers will submit safety data to the FDA.

DMAA has come under increasing scrutiny in the last several months, following the deaths of two U.S. soldiers who suffered deadly heart attacks, and were found to have DMAA in their bloodstream. The FDA warns that DMAA is known to increase blood pressure, which can increase the risk of deadly heart attacks. The FDA has received a total of 42 serious adverse event reports, which include cardiac disorders, central nervous system disorders, psychiatric disorders, and death.

Do I Have a DMAA Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in DMAA lawsuits. We are currently accepting new cases in all 50 states.

If you or a loved one has suffered from severe side effects after taking DMAA, you may be entitled to financial compensation. For a free case review, please click the link below or call toll free 24 hrs/day 1-800-773-0849.

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