FDA Picamilon Status

In the FDA’s most recent set of warning letters Picamilon noticeably stood out with five (5) firms receiving a FDA Warning Letter on the same day. The FDA Picamilon status is now clear – it is not an approved dietary ingredient.

In each FDA Warning Letter the ingredient is described as:

This ingredient is also called, among other names, pikatropin, pikamilon, nicotinyl-gamma-aminobutyric acid, and nicotinoyl-GABA (hereinafter referred to as picamilon).

Each Warning Letter then turns to the question of whether Picamilon qualifies as a dietary ingredient. Perhaps one of the most important steps in a label review is a review of definitions in the regulations. In particular how a dietary ingredient is defined. This narrow definition must be reviewed and applied to determine the FDA status of an ingredient, like Picamilon.

The FDA concludes on the status of Picamilon:

Under section 201(ff)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(ff)(1)], a dietary ingredient is a vitamin; mineral; herb or other 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 preceding substances. Picamilon is not a vitamin, a mineral, an herb or other botanical, or an amino acid. In addition, according to our research, picamilon is not a dietary substance for use by man to supplement the diet by increasing the total dietary intake. Finally, picamilon is not a concentrate, metabolite, constituent, extract, or combination of a vitamin; mineral; herb or other botanical; amino acid; or dietary substance for use by man to supplement the diet by increasing the total dietary intake. Rather, picamilon is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid.  As such, it is absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity. Because picamilon does not fit in any of the dietary ingredient categories under section 201(ff)(1) of the Act, it is not a dietary ingredient as defined in the Act. Declaring picamilon in your product labeling as a dietary ingredient causes your products marketed as dietary supplements to be misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false or misleading in any particular.

The FDA Picamilon status can now only be cured by a New Dietary Ingredient submission. This would need to tackle the analysis presented by the FDA. FDA Warning Letters are not new regulations or final opinions, but they do represent current thinking. The more entrenched the thinking or the stronger the analysis the harder it becomes to change the FDA Picamilon status.