Senator McCaskill Frustrated by FDA Inaction, Calls on Retailers to Pull Picamilon Supplements

Coming a few weeks after the Oregon Attorney General filed a lawsuit against GNC over dietary supplements containing picamilon, Senator Claire McCaskill (D-MO) is now calling on 10 retailers to voluntarily pull picamilon supplements from their shelves. McCaskill says she was compelled to take action because FDA “hasn’t lifted a finger to inform the public or taken any action to remove it from shelves.”

Picamilon, an ingredient created through the synthetic combination of niacin and gamma-aminobutyric acid (GABA), is not considered a dietary ingredient by FDA and is classified as a prescription drug in many other countries. On October 22, Oregon Attorney General Ellen Rosenblum acted on FDA’s confirmation that picamilon was not a dietary ingredient and filed a lawsuit against supplements retailer GNC. But FDA’s inaction in recent weeks frustrated Senator McCaskill and prompted her to reach out to retailers.

“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,” wrote McCaskill, in her letters to retailers. “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.”

Although McCaskill acknowledged that some retailers have already taken “reasonable steps to remove these products,” she felt her actions were necessary to “ensure that these products are entirely removed from shelves.”

“Given FDA’s failure to respond, I request that you voluntarily remove any and all products containing picamilon that you may carry from your stores and from your website,” wrote McCaskill, in her letter to retailers.

McCaskill, the ranking member on the Special Committee on Aging, sent letters to Amazon, GNC, Vitamin Shoppe, CVS Health, Wal-Mart, eBay, Google, Target, Vitamin World, and Walgreens.

“We’re at the point of relying on businesses to voluntarily take responsible steps to ensure public safety,” says McCaskill. “It’s embarrassing that it’s come to this.”

The Council for Responsible Nutrition (CRN; Washington D.C.) and the Natural Products Association (NPA; Washington D.C.) have also criticized FDA for abdicating its authority in this case, and for failing to adequately publicize its opinion that picamilon is not a dietary ingredient.

Copies of McCaskill’s letters to retailers are available here.

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Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com