C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 119—DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

21 C.F.R. § 119.1

Dietary supplements containing ephedrine alkaloids

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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]
Notes of Decisions
Cited in 4 cases, 2005–2009 · leading case: In Re Ephedra Prods. Liab. Litig., 393 F. Supp. 2d 181 (S.D.N.Y. 2005).
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In Re Ephedra Prods. Liab. Litig., 393 F. Supp. 2d 181 (S.D.N.Y. 2005). · cites it 2× “See 21 C.F.R. § 119.1 ; FDA’s Response to Comment 19, Final Ride Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk (hereinafter “FDA Final Rule”), 69 Fed.”
United States v. 5 Unlabeled Boxes, 572 F.3d 169 (3rd Cir. 2009). “The Rule is codified at 21 C.F.R. § 119.1 and provides: “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…”
Hi-Tech Pharm., Inc. v. Crawford, 544 F.3d 1187 (11th Cir. 2008). “21 C.F.R. 119.1. The Final Rule was enacted under the Dietary Supplement Health Education Act of 1994 (DSHEA), Pub.”
NVE Inc. v. Dep't of Health & Human Servs., 436 F.3d 182 (3rd Cir. 2006). · cites it 2× “21 C.F.R. § 119.1 . The effect of the regulation was to prohibit the distribution of these supplements.”
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