‘It’s embarrassing that it’s come to this’: FDA inactivity prompts McCaskill to ask retailers to voluntarily pull any and all picamilon supplements
Picamilon is a derivative of GABA (gamma-aminobutyric acid) and nicotinic acid that can cross the blood brain barrier. It was developed by the All-Union Vitamin Research Institute in the USSR in 1970. A search on PubMed (accessed Oct 2, 2015) for picamilon produces 49 results, with 39 of those being in Russian. A further five papers were published in Ukrainian.
No NDI has ever been submitted for picamilon, and the FDA recently confirmed that the compound is not a dietary ingredient (the Agency also does not consider it an old dietary ingredient). As such, dietary supplements containing picamilon are considered adulterated by the FDA.
“Independent scientists and the 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,” said Sen McCaskill. “So we’re at the point of relying on businesses to voluntarily take responsible steps to ensure public safety. It’s embarrassing that it’s come to this.”
The senator has written letters to 10 retailers – Amazon, CVS Health, eBay, GNC, Google, Target, Vitamin Shoppe, Vitamin World, Walgreens, Wal-Mart – asking their CEOs to “voluntarily remove any and all products containing picamilon that you may carry from your stores and from your website.
“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.”
To read the letters to the retailers, please click HERE.
Commenting on the letters, Meghan Biango, manager of corporate communications for Vitamin Shoppe, told us: “As soon as the FDA declared that picamilon was not a dietary ingredient the Vitamin Shoppe removed all products containing picamilon from its stores and website.”
Letter to FDA
Last month, Sen McCaskill, the ranking member of the US Senate Special Committee on Aging, wrote to Stephen Ostroff, FDA Acting Administrator, calling for the Agency to suspend sales of supplements containing picamilon and vinpocetine pending an investigation.
Sen McCaskill’s letters were prompted by results of a recent analysis by researchers from the National Center for Natural Products Research at the University of Mississippi and Cambridge Health Alliance / Harvard Medical School published in Drug Testing and Analysis, which found that, of the 31 picamilon supplements tested, 30 contained picamilon in quantities ranging from 2.7 to 721.5mg per recommended daily serving, with no picamilon detected in one supplement.
“These dosages range from trivial to prescription levels,” wrote the authors.
Sen McCaskill’s new letters to retailers read: “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… I request that you voluntarily remove any and all products containing picamilon that you may carry from your stores and from your website.”
McCaskill on brain health supplements
McCaskill opened an inquiry into brain health supplements this summer by sending letters to the FDA and 15 major retailers after launching an inquiry into products, regulations, and retailers in the dietary supplement industry that specifically market to seniors using claims about improving memory and treating dementia and Alzheimer’s disease.
The retailers were asked about their policies relating to the sale and/or marketing of dietary supplements, and what they had done to prevent sales of harmful or fraudulently marketed products in their stores and on their websites and shows. The 15 retailers are Amazon, QVC, Walgreens, Home Shopping Network, Walmart, Target, CVS, Vitamin Shoppe, Safeway, eBay, Kroger, Vitamin World, GNC, Google, and Yahoo.
Oregon’s Attorney General
Oregon Attorney General Ellen Rosenbaum recently filed a complaint against GNC alleging that the retailer knowingly sold products containing picamilon and other substances that were not appropriate for inclusion in dietary supplements. Attached to the OR AG’s lawsuit was an affidavit on the subject of picamilon signed by Cara Welch, PhD, FDA’s acting director of the Division of Dietary Supplement Programs.
GNC said that the OR AG’s lawsuit is “without merit”.
In a press release from GNC on October 23, the retailers stated: “With respect to the two ingredients at issue in the Oregon Attorney General's lawsuit, picamilon was included as an ingredient in dietary supplements widely sold by major retailers up to the time of the filing of Oregon's lawsuit on October 22, 2015, and products containing BMPEA were also widely available until the FDA issued a warning letter in April, 2015. There is no basis for the Oregon Attorney General's assertion that GNC or any other retailer ‘knew or should have known’ that these ingredients were not legal for use in dietary supplements. As a matter of law, this critical legal issue remains undetermined as neither FDA nor any court has issued a legally binding determination of the status of these ingredients.
“GNC 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.”
