Picamilon is a substance that does not meet the statutory definition of a dietary ingredient.
The Federal Food, Drug, and Cosmetic Act (the 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 the preceding substances. 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 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 U.S.
Picamilon is also known as:
- nicotinyl-gamma-aminobutyric acid
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