21 CFR Part 119

Part 119—Dietary Supplements That Present a Significant or Unreasonable Risk

Food and Drugs · Chapter I, Chapter I—Food and Drug Administration, Department of Health and Human Services · Subchapter B

21 CFR Part 119

Official text on eCFR ↗

Words: 60
Sections: 1
Last amended: December 19, 2016
Administered by: Food and Drug Administration, Department of Health and Human Services

21 CFR Part 119

Text as published by eCFR on 2026-07-30.

PART 119—DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

Authority:

21 U.S.C. 321, 342, 343, 371.

§ 119.1 Dietary supplements containing ephedrine alkaloids.

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]