Regulatory Focus™ > News Articles > Legislators Fire off Letters to FDA, Industry Seeking Information about 'Illegal' Supplement

Legislators Fire off Letters to FDA, Industry Seeking Information about 'Illegal' Supplement

Posted 09 May 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) often finds itself in the firing line of US legislators. The reasons vary-unsafe drugs, a deficient supply chain, too much regulatory activity, too little regulatory activity, and seemingly everything in between. But one area has been relatively free from congressional interference in recent years: Dietary supplements.

That is, until now. In a series of letters sent to FDA regulators and several companies on 8 May 2013, Republican Reps. Tim Murphy (R-PA), Michael Burgess (R-TX) and Joe Barton (R-TX) wrote that they are opening an investigation into the safety of dimethylamylamine (DMAA), a dietary supplement used in several workout supplements.

Background of DMAA

DMAA has been the subject of intense scrutiny by public health officials and FDA in particular. In warnings sent out in April 2013, FDA said the supplement could be associated with heart attacks, and its presence in dietary supplements was "illegal."

"Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems ranging from shortness of breath and tightening in the chest to heart attack," FDA wrote in its warning. "Dietary supplements containing DMAA are illegal and FDA is doing everything within its authority to remove these products from the market. FDA has issued warning letters to companies notifying them products with DMAA need to be taken off the market or reformulated to remove this substance."

Agency regulators said DMAA was and remains indicative of a larger "challenge" facing the agency: Consumers are using more and more supplements, even as the agency is recalling more of them for being tainted with unapproved drugs.

"With dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe," the agency explained. That stands in opposition to pharmaceutical products, which must undergo an extensive testing process meant to ensure that a product is safe and effective for its intended use.

In April 2013, FDA sent ten warning letters to companies citing them for the inclusion of DMAA in their products. Among the most prominent of those companies is USP Labs, whose workout supplement Jack3D contained DMAA. In its warning letter to the company, FDA said that all available evidence pointed against DMAA being a supplement or herbal or botanical product.

Legislators: Show us the Paper Trail

Legislators, however, seem more focused not on the drug's regulatory classification, but on its real-world effects, particularly after an April 2013 report by NBC associated the drug with the death of a soldier. At the time, FDA's director of the Division of Dietary Supplement Programs, Daniel Fabricant, told the news agency that he believed the supplement was "illegal" and that FDA was "very concerned."

Murphy, Burgess and Barton all seemed to indicate that they wanted to get to the root cause of why DMAA was ever allowed on the market, and why FDA did not take significant regulatory action until April 2013.

"FDA … asserted that it could ban an unsafe ingredient in a dietary supplement, though the agency is required to 'undertake a series of lengthy scientific and legal steps' in doing so," the legislators observed in their letter to FDA Commissioner Margaret Hamburg. "In addition to banning certain ingredients, the agency said that 'FDA can also take a seizure action to remove the products from the market or obtain an injunction against a company to prevent it from manufacturing and distributing illegal products."

The letter goes on to request all FDA documents and communications related or referring to DMAA. Similar communications have often times preceded committee hearings, such as the pharmaceutical compounding hearings that have taken place in recent months.

What remains to be seen, however, is if FDA in any way acted improperly (the letter made no indication that it did) and who, if anyone, might face blame if legislators do decide to hold a hearing. Similar letters were sent to GNC, a vitamin distributor that profited from the sale of DMAA, and USP Labs. Both letters requested access to documentation similar to that requested of FDA.

Read the legislators' letters here.


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