FDA Silent as Missouri Senator Acts to Strike Picamilon From Shelves


Citing frustration with the U.S. Food and Drug Administration’s (FDA) “failure to respond,” Sen. Claire McCaskill (D-MO) has taken a hands-on approach to the controversy over picamilon—that it does not fit the definition of a dietary ingredient—and directly addressed 10 major retailers to stop selling dietary supplements with the substance.

In letters sent Nov. 9 to the CEOs at Amazon, The Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC), McCaskill asked for retailers to voluntarily remove picamilon products from their shelves, given that the Dietary Supplement Health and Education Act of 1994 requires for dietary supplements to only contain “dietary ingredients.” FDA, however, has yet to issue a recall or publically address the issue of whether picamilon is approved for sale as an ingredient in dietary supplements.

The FDA’s stance on picamilon, uncovered in an affidavit by Cara Welch, acting deputy director of the FDA’s Division of Dietary Supplement Programs, is that it is not a dietary ingredient because it fails to fit any of the definition categories—as a vitamin, mineral, herb or botanical, amino acid, “dietary substance for use by man to supplement the diet by increasing the total dietary intake,” or a concentrate, metabolite, constituent, extract or combination of the above. Picamilon is a neurotransmitter, “formed by synthetically combining niacin with GABA (gamma-aminobutyric acid). Though niacin, as a vitamin, and GABA, as an amino acid, are independently recognized as dietary ingredients, the synthesized picamolin is considered a “different chemical entity.” The appropriateness of this communication has been called into question.

FDA’s declaration was made for the Oregon Attorney General’s Oct. 22 suit against GNC, alleging the company knowingly “misrepresented” products as lawful dietary supplements when they contained picamilon or BMPEA, which are unlawful for failing to meet the official definition of dietary ingredient.

Steve Mister, president and CEO of the Council for Responsible Nutrition, criticized the FDA’s move in a letter, stating “this sets a dangerous precedent regarding the cooperation between FDA and state law enforcement on matters of federal law not previously noticed to the industry.”

Several retailers, such as The Vitamin Shoppe, ceased sale of products containing picamolin prior to McCaskill’s letter. GNC stated in an Oct. 23 news release that it “stopped selling products with BMPEA and picamilon, immediately upon learning indirectly, rather than from notice directed at GNC, that FDA did not view BMPEA and picamilon as legal dietary ingredients.”


Published in WholeFoods Magazine Online, 11/13/15