US21 CFR21 CFR Part 119Secondary legislationIn force

Dietary Supplements That Present a Significant or Unreasonable Risk

This regulation designates dietary supplements containing ephedrine alkaloids as adulterated products under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under recommended or ordinary conditions of use.

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العرض المستخرج للقراءة · النص الأصلي للأدلة الامتثالية

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

§ 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.

المصدر

https://www.ecfr.gov/current/title-21/part-119

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US14 CFR14 CFR Part 1216Secondary legislationIn force

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