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FDA closing in on DMAA

Following up its series of letters warning marketers their DMAA products are marketed illegally as supplements, FDA has issued a warning to the public that DMAA is dangerous and has signaled its goal to remove the ingredient from the marketplace.

If there was any question what regulators hope to do with DMAA (1,3 dimethylamylamine), an ingredient in some sports nutrition products, the newly issued public warning to consumers on the dangers of DMAA includes comments showing the agency is pushing to remove the ingredient from the market. This follows a series of warning letters the agency sent to DMAA marketers in April 2012 that called the ingredient synthetic and illegal for use in dietary supplements.

" The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace," the agency wrote.

FDA's problem, from a health perspective, with DMAA is it can raise blood pressure and cause cardiovascular problems, the warning noted. From a regulatory perspective, the agency's problem with DMAA focuses on lack of safety record and its legality as a dietary ingredientmarketers contend the ingredient is found in a geranium specific to one geographic region, while the agency argues the ingredient is synthetic, whether or not marketers can produce evidence DMAA can be found in a plant. In fact, FDA has reviewed studies supplied by USPLabs, one of the few warning letter recipients to still use DMAA, and found the study data insufficient to defend DMAA's use in dietary supplements.

In its warning to consumers, the agency referenced 60 adverse event reports (AERs) it has received detailing illnesses (heart, nervous system and psychiatric problems) and death in combination with DMAA use. FDA advised consumers to check labels closely and look for the many alternate names used for DMAA; it directed consumers to the FDA website's Q&A on DMAA in Dietary Supplements for more information on alternate names. It further urged consumers to report any problems associated with use of DMAA to the company or to FDA via MedWatch.

For the supplement industry beyond DMAA, FDA's warning to consumers included an explanation from Dan Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Program, on how difficult the process is for removing potentially dangerous dietary supplements from the marketplace.

Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products," Fabricant said. In contrast, with dietary supplements, there is no premarket approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe."

The agency noted among its enforcement tools, warning letters seek voluntary cooperation, which is the quickest way to remove an ingredient or product. However, the agency has also banned products (ephedra), secured injunctions, conducted seizures, signed consent decrees and pressed criminal charges.

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