FDA considers picamilon to be a substance that does not meet the statutory definition of a dietary ingredient.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) defines a dietary ingredient as 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 any dietary ingredient from the preceding categories. In contrast, picamilon is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid. Picamilon 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 any of the categories of dietary ingredients under the FD&C Act, any products marketed as dietary supplements that declare picamilon as a dietary ingredient are misbranded.
The FDA has provided expert testimony to the Oregon Attorney General’s office stating that picamilon is not a dietary ingredient.
Picamilon is used as a prescription drug in Russia for a variety of neurological conditions. It is not approved as a drug in the United States.
Picamilon is also known as:
- nicotinyl-gamma-aminobutyric acid
For More Information:
- Constituent Update (November 2015)
This webpage describes FDA’s views and recent actions with regard to an ingredient used in products marketed as dietary supplements. If you have evidence that calls FDA’s views into question, we invite you to submit it, along with your reasoning, to FDA at ODSP@fda.hhs.gov.
This page is not intended to provide a complete list of all FDA actions and communications with regard to this ingredient and its use in products marketed as dietary supplements.