Regulatory Focus™ > News Articles > FDA Sends out Warning Letters to Supplement Manufacturers

FDA Sends out Warning Letters to Supplement Manufacturers

Posted 30 April 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) sent out ten warning letters on 24 April to manufacturers and distributers of products containing the dietary supplement dimethylamylamine (DMAA), warning them that the products are adulterated because the safety of the ingredient has not been established with the agency.

"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products," said Daniel Fabricant, director of FDA's Dietary Supplement Program (DSP). "They haven't done that and that makes the products adulterated."

DMAA is also being marketed as a dietary ingredient without meeting that definition, said FDA.

"The agency additionally warned the companies 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," explained FDA. "[Federal law] defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances."

The 24 April warning letters-released to the public 27 April-cite the companies for failing to register with FDA as a New Dietary Ingredient (NDI), which is required under federal law, and for failing to establish the safety of DMAA for human consumption.

FDA noted it had received 42 adverse event reports associated with DMAA, including the narrowing of blood vessels and arteries, elevated blood pressure, shortness of breath and heart attack, and at least one person has died after taking the supplement.

The ten companies cited in the warning letter reportedly have 15 days to respond to FDA before the agency takes more serious action.

The New York Times reports the companies and their legal representation intend to fight the agency and are "unaware of any scientific or medical evidence which calls the safety of DMAA into question."

Fabricant's public comments come just days after he said FDA is "aghast at the degree of non-compliance" the industry is exhibiting when it comes to complying with current Good Manufacturing Practices (cGMPs) and FDA warning letters.

"We're seeing some of the same mistakes from warning letter to warning letter, and that's concerning," said Fabricant. "Whether it's failure to prepare  batch records, problems with specifications-there are failures of adequate quality control," said Fabricant on 25 April.

Read more:

FDA - FDA challenges marketing of DMAA products for lack of safety evidence 

Regulatory Focus - FDA 'Aghast' at Lack of cGMP, AER Compliance by Supplement Manufacturers

The New York Times - F.D.A. Sends Warning Letters to 10 Marketers of 'Workout Boosters'

Nutra Ingredients USA - Updated: FDA cracks down on DMAA - but this is just the start, not the end, of the debate, predicts CRN

Eye on FDA - FDA Sends Out 10 Warning Letters to Dietary Supplement Manufacturers

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