Phenibut is a substance that does not meet the statutory definition of a dietary ingredient.
The Federal Food, Drug, and Cosmetic Act (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 the preceding substances. Because phenibut does not fit any of the categories of dietary ingredients under the FD&C Act, any dietary supplements that declare phenibut as a dietary ingredient are misbranded.
Phenibut is also known as:
- 4-Amino-3-phenylbutanoic acid
- β-(aminomethyl)benzenepropanoic acid
- beta-(Aminomethyl)hydrocinnamic acid
- β-phenyl-γ-aminobutyric acid
FDA Issued Warning Letters:
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