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GNC (GNC), Vitamin Shoppe (VSI) Shares Hit on FDA Warning Letters to DMAA Makers

April 30, 2012 11:49 AM EDT
Shares of GNC Holdings (NYSE: GNC) and Vitamin Shoppe (NYSE: VSI) are taking one on the chin Monday following a late Friday warning from the U.S. FDA to "ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA."

Key points in the warning letters:
  • notifications were not submitted to the FDA for the use of DMAA as a New Dietary Ingredient;
  • The FDA said it is not aware of evidence or history of use to indicate that DMAA is safe; and
  • The FDA letters noted that 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.
Further: "The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death."

Shares of GNC are off 6.4 percent while Vitamin Shoppe shares are down 4 percent Monday.


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