United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2004_register executive 2010-09-23 article Part III Rules and Regulations D09002ee1c81686a6 D09002ee1c81687c3 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, we, our) is issuing a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. We are taking this action based upon the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids. 69 FR 6788 https://www.govinfo.gov/app/details/FR-2004-02-11/04-2912 04-2912 fr11fe04-40 RIN 0910-AA59 4160-01-S Docket No. 1995N-0304 https://www.govinfo.gov/app/details/FR-2004-02-11/04-2912 https://www.govinfo.gov/content/pkg/FR-2004-02-11/html/04-2912.htm https://www.govinfo.gov/content/pkg/FR-2004-02-11/pdf/04-2912.pdf 67 p. 6788 6854 69 FR 6788 Title 21 Part 119 21 CFR Part 119 RIN 0910-AA59 Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk; Federal Register Vol. 69, Issue RULE 04-2912 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2004-04-12 Docket No. 1995N-0304 4160-01-S 04-2912 Final rule.

The Food and Drug Administration (FDA, we, our) is issuing a final regulation declaring dietary supplements containing ephedrine alkaloids adulterated under the Federal Food, Drug, and Cosmetic Act (the act) because they present an unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in labeling, under ordinary conditions of use. We are taking this action based upon the well-known pharmacology of ephedrine alkaloids, the peer-reviewed scientific literature on the effects of ephedrine alkaloids, and the adverse events reported to have occurred in individuals following consumption of dietary supplements containing ephedrine alkaloids.

This rule is effective on April 12, 2004. Wayne Amchin, Center for Food Safety and Applied Nutrition (HFS-007), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6733. Food for human consumption: Dietary supplements containing ephedrine alkaloids, DrugFacts.com http://nccam.nih.gov/health/alerts/ephedra/working-group.htm http://www.annals.org/cgi/content/full/138/12/1012 http://www.annals.org/cgi/content/full/139/5_Part_1/385-b http://www.cdc.gov/nchs/fastats/lifexpec.htm http://www.cfsan.fda.gov/˜dms/ds-ltr3.html http://www.cfsan.fda.gov/˜dms/rafw-toc.html http://www.cfsan.fda.gov/˜dms/ssaguide.html http://www.crnusa.org/cantoxreportindex.html http://www.factsandcomparisons.com http://www.fda.gov/bbs/topics/NEWS/ephedra/letterslist.html http://www.fda.gov/bbs/topics/NEWS/ephedra/warning.html http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html http://www.fda.gov/cder/guidance/1221dft.pdf http://www.fda.gov/cder/guidance/3602fnl.pdf http://www.fda.gov/cder/guidance/4461fnl.pdf http://www.fda.gov/OHRMS/DOCKETS/98fr/95n-0304-bkg0003-ref-07-01-index.htm http://www.foodriskclearinghouse.umd.edu/dspd.htm http://www.foodriskclearinghouse.umd.edu/smpds.htm http://www.hcup.ahrq.gov/HCUPnet.asp http://www.hhs.gov/infoquality/fda.html#i http://www.house.gov/reform/min/pdfs/ http://www.laegemiddelstyrelsen.dk/en/news/letigen_6_en.asp http://www.nhlbi.nih.gov/guidelines/cholesterol http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.htm http://www.nnfa.org/facts http://www.rand.org/publications/randreview/issues/spring2003/evidence.html http://www.stedmans.com/ http://www.washingtonpost.com/ac2/wp-dyn http://www.washingtonpost.com/wp-dyn/articles/A52270-2003Jan13.html http://www.whitehouse.gov/omb/circulars/a004/a-4.html Vol. 69, no. 28 Office of the Federal Register, National Archives and Records Administration 2004-02-11 continuing daily deposited born digital 389 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2004-02-11 P0b002ee1809733f7 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11fe04 https://www.govinfo.gov/app/details/FR-2004-02-11 https://www.govinfo.gov/content/pkg/FR-2004-02-11/pdf/FR-2004-02-11.pdf https://www.govinfo.gov/content/pkg/FR-2004-02-11/xml/FR-2004-02-11.xml fdlp 6525 6903 DGPO 2010-09-23 2024-06-07 FR-2004-02-11 machine generated eng FR FR-2004-02-11 69 28