Sen. McCaskill Reaches Out To Retailers On Picamilon ‘In The Absence Of FDA Action’
This article was originally published in The Tan Sheet
Executive Summary
The Missouri Democrat tells retailers that FDA “hasn’t lifted a finger to inform the public or taken any action to remove” picamilon. Although an FDA official said in an affidavit to the Oregon AG that picamilon is not a dietary ingredient, the agency has not warned firms or consumers that it is unsafe.
Sen. Claire McCaskill stops waiting for FDA and directly asks retailers to stop selling dietary supplements containing picamilon, an ingredient an agency official recently said is not appropriate for use in supplements but about which FDA has not warned firms or consumers.
The Missouri Democrat on Nov. 10 said scientists and FDA “agree that picamilon is not a dietary ingredient, but the FDA – the agency tasked with ensuring the safety of the things we consume – hasn’t lifted a finger to inform the public or taken any action to remove it from shelves.”
McCaskill, ranking member on the Special Committee on Aging, submitted letters Nov. 9 to online retailers Amazon, eBay and Google and mass-merchandizers Target, Walgreens and Walmart in addition to supplement chains GNC, Vitamin Shoppe and Vitamin World.
“While I understand that some retailers have taken reasonable steps to remove these products, in the absence of FDA action with regard to this ingredient, I feel it necessary to reach out and make this request to ensure that these products are entirely removed from shelves,” the senator said in each of the letters.
McCaskill contacted FDA after the publication of research showing that some supplements labeled as containing picamilon or another ingredient promoted for cognitive benefit, vinpocetine, did not contain either. The researchers also said neither ingredient is derived from natural sources but both are synthetics used as drugs in other countries (Also see "New Wrinkle In NDI Debate: Supplement Ingredients Used As Drugs Outside US" - Pink Sheet, 12 Oct, 2015.).
The letters do not mention vinpocetine, but point out that the Oregon attorney general filed a complaint alleging [GNC Holdings Inc.] sold products containing picamilon in the state even though an FDA official submitted an affidavit in September to the AG stating that picamilon does not meet regulatory criteria as a dietary ingredient.
However, GNC has said it removed picamilon-containing products from its stores when it learned from FDA that the ingredient was noncompliant. [Vitamin Shoppe Inc.], which is not targeted in litigation by the state, also has said it pulled picamilon products from its shelves (Also see "Industry Roundup: GNC, Sanofi And Bayer Earnings, 'Miracle Supplement' Fraud Conviction" - Pink Sheet, 2 Nov, 2015.).
McCaskill contacted these and other retailers earlier in 2015 inquiring about their sales of supplements making claims enhance memory and treat dementia. She and Special Committee on Aging Chairwoman Susan Collins, R-ME, asked FDA for information on its enforcement against noncompliant supplement manufacturers and distributors and for a “detailed description” of the agency’s evaluation of medical and nutritional claims for supplements on the market (Also see "Cognitive Claims Stir Senators To Question FDA Supplement Regulation" - Pink Sheet, 19 Jun, 2015.).
GNC Learns ‘Indirectly’
Oregon and McCaskill appear to be targeting the supplement industry and retailers about an ingredient commonly used, and known to FDA, in products available in the US. GNC and other stakeholders point out they learned of FDA’s objection to picamilon in the Oregon AG’s complaint, and not previously.
In a Sept. 28 declaration submitted to the Oregon AG, the acting deputy director of FDA’s Division of Dietary Supplement Programs, Cara Welch, said picamilon does not meet any criteria as a dietary ingredient under the agency’s regulations.
Picamilon is gamma-aminobutyric acid, a neurotransmitter, synthetically modified by combining it with niacin “to facilitate its translocation across the blood-brain barrier,” Welch stated. “There is no indication in the literature that this compound is found in nature.”
The Oregon complaint filed in state court also alleges that the Pittsburgh-based firm sold products labeled as containing botanical acacia rigidula that had been spiked with unlabeled” ‘beta-methylphenethylamine. The state seeks fines of $25,000 for each violation, disgorgement of GNC’s revenues from sales of the products and other penalties.
In an Oct 23 statement, GNC said it stopped selling products containing 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.”
The firm says neither picamilon nor BMPEA were included in a previous FDA warning letter or other notification from the agency, and it took action to remove the products “even though the FDA did not raise any safety concerns with respect to these ingredients.”
GNC, which has asked to move the complaint to federal court, said it attempted to reach an agreement with the Oregon AG before the complaint was filed.
Council for Responsible Nutrition President and CEO Steve Mister questioned why picamilon has become an ingredient of concern despite other, more serious problems in the supplement market.
“I am baffled as to why FDA would issue a declaration on picamilon, which does not have a history of safety problems, and yet continue to allows companies to operate that don’t observe” supplement good manufacturing practices, Mister said.