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Warning Letters Sent to Five Supplement Makers Regarding the Synthetic Drug Picamilon

Published on Jan 4, 2016 at 10:35 pm in Supplements.

The U.S. Food and Drug Administration has sent letters to five nutritional supplement manufacturers warning them to remove products labeled with the synthetic ingredient picamilon.  Letters were sent to DBM Nutrition, ICF International LLC, Top Secret Nutrition LLC, Applied Nutriceuticals Inc., and SDC Nutrition Inc., giving each company fifteen business days to respond to requests to take away products labeled with picamilon as an ingredient or be subject to further enforcement by the FDA.  Picamilon is a synthetic chemical developed in the former Soviet Union and still used in Russia as a drug to treat neurological conditions.  According to the FDA, the substance does not meet its definition of a dietary ingredient, therefore any supplements sold listing picamilon as a dietary ingredient are misbranded.

The letters are an action following a lawsuit filed in October by the Oregon Attorney General against the large supplement retailer GNC Holdings Inc., accusing the company of selling drug-spiked dietary supplements.  GNC is one of the world’s largest retailers of dietary supplements.  According to internal company records, the retailer has knowingly sold products containing the two synthetic drugs, picamilon and beta-methylphenethylamine (BMPEA).  The retailer claims to sell products made only from all-natural ingredients, yet their internal records indicate knowledge of picamilon as a synthetic drug as far back as 2007.  GNC stopped selling products with BMPEA in April and products with picamilon in September.

GNC has released a short statement regarding the pending litigation, stating “The claims made by the Oregon Attorney General are without merit and GNC intends to vigorously defend against these allegations.  In response to FDA statements regarding the regulatory status of BMPEA and picamilon, GNC promptly took action to remove from sale all products containing those ingredients.”  The Oregon lawsuit raises questions about the effectiveness of the FDA in regulating the dietary supplement industry, who’s supplements have increasingly been found to contain hidden and risky pharmaceuticals.

Under existing law, the FDA says it must show a product is unsafe, that its labeling is false or misleading, or that it was not made using good manufacturing practices before it can take any action to remove it from the market.  GNC argues that any issue involving use of the ingredients picamilon and BMPEA should have been addressed by a warning letter from the FDA, not a lawsuit at the state level.  Oregon’s Assistant Attorney General said in a statement, “Regardless of whether regulation of dietary supplements requires reform, more aggressive enforcement of existing laws will better protect consumers.”

 

If you wish to learn more about the FDA and the regulation of dietary supplements, contact Thomas Law Offices for more information.