21 C.F.R. §119.1 - Dietary supplements containing ephedrine alkaloids
| Cite as | 21 C.F.R. §119.1 |
-
- This document is available in original version only for vLex customers
View this document and try vLex for 7 days - TRY VLEX
- This document is available in original version only for vLex customers
6 cases
-
Nve, Inc. v. Department of Health and Human Serv., 04-4481.
...that dietary supplements containing ephedrine alkaloids ("EDS") were adulterated under the "unreasonable risk" standard of DSHEA. 21 C.F.R. § 119.1. The effect of the regulation was to prohibit the distribution of these supplements. NVE, a former manufacturer and distributor of EDS, brought......
-
Giordano v. Mkt. Am. Inc, Docket No. 06-2071-cv.
...banned ephedra by declaring dietary supplements[599 F.3d 91]containing ephedrine alkaloids "adulterated" under the FDCA. See 21 C.F.R. § 119.1; Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk ("FDA Final Rule"), 6......
-
U.S. v. 5 Unlabeled Boxes, 07-4352.
...the manufacturer bears the burden of proving that the drug or device is safe before it may be marketed. 3. 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 re......
-
United States v. Chan, 16-17797
...In 2004 the Food and Drug Administration banned dietary supplements containing ephedrine by deeming them "adulterated foods." 21 C.F.R. § 119; see 21 U.S.C. § 331(a) (prohibiting introduction of adulterated foods into interstate commerce). Because ephedrine can be used to make methamphetami......
Request a trial to view additional results