Sports Nutrition Products Mark Start Of FDA’s Picamilon Enforcement
This article was originally published in The Tan Sheet
Executive Summary
Five warnings likely mark the start of a sweep to rid the US market of products containing the ingredient that the agency initially identified as violative in a recent declaration submitted for the Oregon attorney general’s complaint against GNC and that Senator McCaskill says FDA should prevent firms from using.
FDA affirms its position against using picamilon in dietary supplements by following up testimony an agency official made in state enforcement litigation with warnings to five firms marketing supplements containing the ingredient.
The Nov. 30 letters could mark the start of a sweep to rid the US market of products containing the ingredient that the agency initially identified as violative in a Sept. 28 declaration submitted for a civil complaint the Oregon attorney general filed against [GNC Holdings Inc.] and that Sen. Claire McCaskill on Nov. 10 said FDA should prevent firms from using in supplements.
McCaskill, D-MO, in letters highly critical of FDA, questioned supplement firms and marketers about picamilon’s use in supplements marketed to elderly consumers as providing cognitive benefits (Also see "Sen. McCaskill Reaches Out To Retailers On Picamilon ‘In The Absence Of FDA Action’" - Pink Sheet, 16 Nov, 2015.).
However, FDA warned firms that use the ingredient in powder supplements intended to be mixed with water and marketed for sports training, with picamilon included for mental focus benefit.
According to the letters released Dec. 2, the firms advised to immediately cease marketing supplements with picamilion, and their noncompliant products are:
- DBM Nutrition , Cortland, Ill., DBM Endurance World Championship Countess
- ICF International LLC , Fayetteville, Ga., Myokem Nitramine
- Top Secret Nutrition LLC , Miramar, Fla., Pump Igniter
- Applied Nutriceuticals Inc. , Poway, Calif., HG4UP
- SDC Nutrition Inc. , d/b/a NVIE Nutrition, Pittsburgh, NVIE Edge Pro.
FDA’s Center for Food Safety and Applied Nutrition said picamilon is used as a prescription drug in Russia for neurological conditions but is not approved as a drug in the US.
According to CFSAN, picamilon is a chemical synthesized from the dietary ingredients niacin and gamma-aminobutyric acid that is absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity.
However, unlike most substances that FDA identifies as violative for use as a dietary ingredient in supplements, the agency does not warn about picamilon being unsafe. Instead, CFSAN warns that picamilon-containing products are misbranded because it does not fit any category of ingredient allowed for use in dietary supplements.
Top Secret Nutrition markets Pump Igniter, one of the sports supplements products FDA identified in warning letters on the use of picamilon.
The ingredient also is known as pikatropin; pikamilon; nicotinyl-gamma-aminobutyric acid; and nicotinyl-GAB.
In addition to Sen. McCaskill, researchers including officials from the FDA-funded National Center for Natural Products Research at the University of Mississippi question picamilon’s use in supplements. Their study published in the journal Drug Testing and Analysis also stated picamilon is only produced synthetically and has no known natural source (Also see "Researchers Match Supplement Ingredients With Foreign Prescriptions" - Pink Sheet, 12 Oct, 2015.).
Of the 31 supplements tested in the study, 30 contained picamilon at levels from 2.7 mg to 721.5 mg per recommended daily serving. In the supplements labeled with a specific quantity of picamilon, the actual quantities were from 99.6% to 157.9% of the labeled amounts.
However, the ingredient has proponents, including supplement industry trade groups, who laud its safety, and numerous picamlion products remain available.
A website focused entirely on the ingredient’s use in supplements says, “As far as safe and legal supplements go, picamilon is in a class of its own. Its laundry list of positive benefits and reasonable cost make it a supplement that many would be interested in … if only they knew about it.”
However, the source of the information on the site displays some lack of familiarity with US supplement product regulation in a reference to picamilion’s use as a drug in Russia.
“To me, the fact that picamilon is classified as a prescription drug in Russia, validates it as an effective supplement. Picamilon achieving this status indicates that it is safe and can result in the benefits for which it was developed. The mechanism of action for picamilon … that results in its many positive effects is also what enables it to be used by Russian physicians as a successful medical treatment,” according to the website, which does not identify the author of the information.
FDA’s initial statement on picamilon, in the testimony for the Oregon AG’s complaint against GNC, was the first information that GNC said it received about the agency’s position on the ingredient.
GNC, which has asked to move the complaint to federal court, has said it removed picamilon-containing products from its stores when it learned that FDA considered it noncompliant and it attempted to reach an agreement with the Oregon AG before the complaint was filed.