FDA Acts against Adulterant DMBA

April 30, 2015

The move comes less than a week after FDA enforced against a different stimulant adulterant.

Less than a week after acting against BMPEA adulteration in dietary supplements, FDA is now working to remove a different stimulant from supplements. DMBA (1,3-dimethylbutylamine) is the latest adulterant that FDA is targeting for being falsely labeled as a dietary ingredient.

On April 28, FDA sent warning letters to 14 companies regarding a total of 17 products that list DMBA as a dietary ingredient on the label. The move comes after researchers published an article last October that found 12 dietary supplements adulterated with DMBA.

DMBA has not been tested for safety in humans and is chemically similar to other harmful stimulants like DMAA (1,3-dimethlamylamine), said researchers from NSF International (Ann Arbor, MI), Harvard Medical School (Boston, MA), and the National Institute for Public Health and the Environment in the Netherlands (RIVM; Bilthoven, The Netherlands). FDA banned DMAA from the market in April 2013 following reports of adverse events, and researchers called for FDA to take the same action against DMBA. This week it looks like they are getting their wish.

“We applaud FDA efforts to remove harmful ingredients such as DMBA from dietary supplements,” says John Travis, senior research scientist, NSF International.  He adds that “DMBA has been attributed to negative health events such as strokes, heart failure, and sudden death.”

In its announcement, FDA also listed some of the other names DMBA is known as, including “2-amino-4-methylpentane citrate,” “amperall,” “AMP,” and “4-methyl-2-pentanamine.”

Companies will have 15 business days from the receipt of the letter to explain to FDA what steps they will take to bring products into compliance with the law. Many of the products that FDA addressed in the letters are designed for weight loss or sports nutrition.

FDA drew criticism earlier this month for not doing enough against known adulteration in dietary supplements, but the agency’s recent actions against BMPEA and now DMBA suggest the issue may be getting more attention.

 

Michael Crane
Associate Editor
Nutritional Outlook magazine
michael.crane@ubm.com

 

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