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Regulatory Focus™ > News Articles > FDA Continues Crackdown on DMAA-Containing Supplements, Seizes $2 Million in Product

FDA Continues Crackdown on DMAA-Containing Supplements, Seizes $2 Million in Product

Posted 19 November 2013 | By Alexander Gaffney, RAC

More than $2 million in dietary supplements adulterated with 1, 3-Dimethylamylamine HCl-more commonly known as DMAA-were seized by federal officials on 12 November 2013, the latest move by the US Food and Drug Administration (FDA) to crack down on products containing the ingredient.


DMAA has been the subject of intense scrutiny by public health officials and by 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.

While most companies have removed DMAA from their products, some have replaced the ingredient with new ones that appear to be just as-if not more-dangerous.

New Seizures

FDA's 19 November 2013 statement regarding the seizure of $2 million in DMAA-adulterated supplements is thus the latest in a long string of regulatory actions taken by the agency.

FDA said US Marshals had seized control of 1,500 cases of drug product from Georgia-based Hi-Tech Pharmaceuticals on 12 November 2013. The products included Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION, FDA said.

"This company has a responsibility to ensure its products are safe for distribution and human consumption," said Melinda Plaisier, associate commissioner for regulatory affairs at FDA. "We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system."

As of the time of this article's posting, Hi-Tech's website featured many of the products seized by FDA last week, though attempts to purchase the product elicited an error message that the company was "closed for maintenance" and would "re-open soon." A phone number was made available to order products directly from the company.

FDA Statement

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