FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence - Pharmaceutical Technology

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FDA Issues Warning Letters to Ten Companies for Lack of Safety Evidence


ePT--the Electronic Newsletter of Pharmaceutical Technology

On Apr. 27, 2012, FDA issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine (DMAA). FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

Under the law, manufacturers of dietary ingredients are responsible for notifying FDA within 75 days of marketing their products with evidence that supplements containing new dietary ingredients are safe. "Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, PhD, Director of FDA’s Dietary Supplement Program, in an FDA press release.

FDA warned the companies in the letters that because synthetically produced DMAA is not a dietary ingredient it is “not eligible to be used as an active ingredient in dietary supplements.”

According to FDA, DMAA “is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.” Forty-two adverse event reports regarding products containing DMAA have been submitted to FDA.

The companies have 15 business days to provide FDA with the steps they plan to take in response to the Warning Letters. The companies cited in the FDA press release are listed below:

Exclusive Supplements
Fahrenheit Nutrition
Gaspari Nutrition
iSatori Global Technologies, LLC
Muscle Warfare, Inc.
MuscleMeds Performance Technologies
Nutrex Research
SEI Pharmaceuticals
SNI LLC
USP Labs, LLC

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Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
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