On November 30, 2015, the Agency sent warning letters to DBM Nutrition, ICF International, Top Secret Nutirition, LLC, Applied Nutriceuticals, Inc., and SDC Nutrition, Inc stating that picamilon is a substance that does not meet the statutory definition of a dietary ingredient. Links to the warning letters can be found at the end of this article.
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.
“Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading),” stated the FDA in a Q & A on Dietary Supplements on its website.
The agency noted that the companies have 15 business days from the date of receipt of the letter to reply to the FDA on the specific steps they will take to bring their products into compliance.
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.
The ingredients is also known as pikatropin; pikamilon; nicotinyl-gamma-aminobutyric acid; nicotinyl-GAB.
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.
From Oregon to Missouri and beyond
Picamilon was one of the substances listed by Oregon Attorney General Ellen Rosenbaum in a complaint against GNC, which alleged that the retailer knowingly sold products containing picamilon and other substances that were not appropriate for inclusion in dietary supplements. Cara Welch, PhD, FDA’s acting director of the Division of Dietary Supplement Programs provided expert testimony to the OR AG’s office stating that picamilon.
Sen Claire McCaskill (D-MO), the ranking member of the US Senate Special Committee on Aging, then waded into the situation, writing to Stephen Ostroff, FDA Acting Administrator, calling for the Agency to suspend sales of supplements containing picamilon and vinpocetine pending an investigation.
Citing FDA inactivity, Sen McCaskill subsequently wrote 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”.
Commenting on the new development, Sen McCaskill said: “I am glad that the FDA is finally taking steps to remove this substance from virtual and online shelves—but the old saying ‘better late than never’ certainly applies here.
“It’s hard to understand how it took this long to send a handful of letters to prevent the sale of an ingredient that the FDA determined months ago was not a dietary ingredient. This entire episode is an illustration of how regulatory safeguards that are in place to protect American consumers are falling dramatically short.”
The warning letters, which can be accessed via the links below, represent action by the FDA: