21 CFR Part 119 (Feb. 21, 2025) This content is from the eCFR and is authoritative but unofficial. Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B —Food for Human Consumption
21 CFR Part 119 (up to date as of 2/21/2025) Dietary Supplements That Present a Significant or Unreasonable Risk
Dietary supplements containing ephedrine alkaloids.
Part 119 Dietary Supplements That Present a Significant or Unreasonable Risk § 119.1
21 U.S.C. 321, 342, 343, 371.
Dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury under conditions of use recommended or suggested in the labeling, or if no conditions of use are recommended or suggested in the labeling, under ordinary conditions of use. Therefore, dietary supplements containing ephedrine alkaloids are adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act. [69 FR 6853, Feb. 11, 2004]