21 CFR 119.1 - Dietary supplements containing ephedrine alkaloids
| Cite as | 21 CFR 119.1 |
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11 practice notes
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Part II
...to proposed Sec. 111.125(b). 3. Final Sec. 111.605(c) Final Sec. 111.605(c) requires that all electronic records comply with part 11 (21 CFR part 11). Final Sec. 111.605(c) derives from proposed Sec. [[Page 34913]] (Comment 327) One comment believes part 11 should only apply to records that......
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Food for human consumption:
Current good manufacturing practice
Dietary supplements; manufacturing, packaging, labeling, or holding operations,
...to proposed Sec. 111.125(b). 3. Final Sec. 111.605(c) Final Sec. 111.605(c) requires that all electronic records comply with part 11 (21 CFR part 11). Final Sec. 111.605(c) derives from proposed Sec. [[Page 34913]] (Comment 327) One comment believes part 11 should only apply to records that......
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Nve, Inc. v. Department of Health and Human Serv., No. 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......
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4 OTC, Inc.; Decision and Order
...delivery, or the receipt of an adulterated product in interstate commerce. 21 U.S.C. 331 (a)-(c). See 69 FR 6,788 (FDA 2003); 21 C.F.R 119.1 (2010). The FDA further prohibits the marketing of a bronchodilator as a dietary supplement as such constitutes misbranding. 21 U.S.C. 331(b). Consequ......
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6 cases
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Nve, Inc. v. Department of Health and Human Serv., No. 04-4481.
...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 this......
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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 ......
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U.S. v. 5 Unlabeled Boxes, No. 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 u......
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United States v. Chan, No. 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 met......
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