Definition Of A Dietary Supplement Under The Fd C Act

5 definition of dietary supplement product other than tobacco that is intended to supplement the diet product that is intended for ingestion.

Definition of a dietary supplement under the fd c act. The dietary supplement health and education act of 1994 dshea is a 1994 statute of united states federal legislation which defines and regulates dietary supplements. I read the fda s warning letter to the guy selling tianeptine as a supplement and found this footnote describing other exemptions from the food additive definition which can legally appear in food and dietary supplements here in the us. The fd c act provides that a dietary supplement that contains a new dietary ingredient shall be deemed adulterated under section 402 f of the fd c act 21 u s c. Under the act supplements are effectively regulated by the fda for good manufacturing practices under 21 cfr part 111.

321 s the following types of. A food or dietary supplement for which a claim subject to sections 343 r 1 b and 343 r 3 of this title or sections 343 r 1 b and 343 r 5 d of this title is made in accordance with the requirements of section 343 r of this title is not a drug solely because the label or the labeling contains such a claim. Included dietary supplements under the adulteration provisions www fda gov. 342 f unless it meets one of.

Under section 201 s of the fd c act 21 u s c.