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United States • Title 21 CFR • Part 119

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

Part 119 declares dietary supplements containing ephedrine alkaloids adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act, as they present an unreasonable risk of illness or injury.

What this part covers

  • Dietary supplements with ephedrine alkaloids are considered adulterated.
  • This adulteration is based on presenting an unreasonable risk of illness or injury.
  • The risk is assessed under recommended or ordinary conditions of use.
  • This regulation is codified under Title 21 CFR Part 119.

Sections in Part 119

§ 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]

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