21 CFR 119.1 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 100.1 To § 169.182) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Parts 100 To 169) (§ 100.1 To § 169.182) — Food For Human Consumption (§ 100.1 To § 169.182) — 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.