FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly

Regulatory News

Sen. Claire McCaskill (D-MO) is calling on ten major retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA).

The letters sent Monday to Amazon, the Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC) call on them to pull from their shelves any dietary supplements containing picamilon as FDA has declared it’s not a dietary ingredient.

Picamilon, a derivative of GAMA (gamma-aminobutyric acid) and nicotinic acid, was developed in 1969 by the All-Union Vitamin Research Institute in the Soviet Union and is used in Russia as a pharmaceutical.

FDA Inaction

But the letters to the 10 retailers also outline a number of issues that McCaskill is having with FDA and its inaction.

“In October, I requested that the FDA take appropriate steps to determine whether picamilon is appropriate for sale, and to remove it from store shelves if it is not. Despite my repeated requests, the FDA has failed to produce any response to my inquiry and remains silent on whether products containing picamilon should be recalled or removed from sale in dietary supplements,” McCaskill writes.

Last month, McCaskill twice wrote FDA Acting Administrator Stephen Ostroff to request that the agency take action to suspend sales of any supplement containing picamilon. She also asked for any documents submitted to the FDA as a part of the new dietary ingredient notification process that confirm the ingredient’s safety, and for any cases in which picamilon had caused adverse events in consumers.   

She also says in the letters that she understands some retailers have curtailed picamilon sales, but “in the absence of FDA action with regard to this ingredient,” she felt it was necessary to reach out to the retailers directly.

In addition, the Oregon Attorney General recently filed a complaint against GNC alleging that the company knowingly sold products containing picamilon and other substances that were not appropriate for inclusion in dietary supplements.

In connection with the Oregon investigation, FDA submitted an affidavit stating that picamilon is not a dietary ingredient.

Letters from McCaskill