FDA Issues Warning Letters Over Misbranded Dietary Supplements | Practical Law

FDA Issues Warning Letters Over Misbranded Dietary Supplements | Practical Law

The Food and Drug Administration (FDA) recently issued warning letters to companies marketing products containing picamilon as dietary supplements. In the warning letters, the FDA announced that picamilon does not meet the statutory definition of a dietary ingredient. Products marketed as dietary supplements because they contain picamilon are considered misbranded.

FDA Issues Warning Letters Over Misbranded Dietary Supplements

Practical Law Legal Update w-001-0342 (Approx. 3 pages)

FDA Issues Warning Letters Over Misbranded Dietary Supplements

by Practical Law Commercial Transactions
Published on 10 Dec 2015 • USA (National/Federal)
The Food and Drug Administration (FDA) recently issued warning letters to companies marketing products containing picamilon as dietary supplements. In the warning letters, the FDA announced that picamilon does not meet the statutory definition of a dietary ingredient. Products marketed as dietary supplements because they contain picamilon are considered misbranded.
On November 30, 2015, the Food and Drug Administration (FDA) issued warning letters to five companies that marketed products containing picamilon as dietary supplements. The FDA stated that it does not classify picamilon as a dietary ingredient. Products that are marketed as dietary supplements because they contain picamilon are considered misbranded.

Statutory Definition of Dietary Ingredient

The Food, Drug, and Cosmetic Act (FDCA) defines a dietary ingredient as either a:
  • Vitamin, mineral, herb or other botanical, amino acid, or dietary substance for use by man to supplement the diet by increasing the dietary intake.
  • A concentrate, metabolite constituent, extract, or combination of the preceding substances.
The FDA does not categorize picamilon as a dietary ingredient because picamilon is:
  • A unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid.
  • 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 FDCA, the FDA has declared that any products that contain picamilon and are labeled and marketed as a dietary ingredient are misbranded.

The Warning Letters

Under existing law, including the Dietary Supplement Health and Education Act, as applied to picamilon, the FDA has the authority to remove products from the market once it has established that such products are misbranded. Each company has fifteen business days from the date of receipt of the letter to communicate to the agency the specific steps it will take to bring its products into compliance with the law.

Practical Implications

The FDA's warning letters demonstrate that the FDA continually monitors products that make novel claims and incorporate unusual ingredients. The FDA will continue to enforce the statutory definitions for product and ingredient classifications under the FDCA. Counsel for companies that sell FDA-regulated products should ensure their product labeling and marketing are in compliance with the law.
For more information on the FDA and FDCA, see Practice Note, Advertising: Overview: The Food, Drug, and Cosmetic Act.