21 C.F.R. 101.36 - Nutrition labeling of dietary supplements

Cite as21 C.F.R. 101.36
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46 practice notes
  • Food for human consumption: Food labeling— Dietary supplements; effect on structure or function of body; types of statements, definition,
    • United States
    • Federal Register January 06, 2000
    • 6 Enero 2000
    ...value (DRV) that a dietary supplement contains to be given for dietary ingredients that have an RDI or DRV (see Sec. 101.36(b)(2)(iii) (21 CFR 101.36(b)(2)(iii))). In addition, the amount in units must be given, regardless of whether an RDI or DRV has been established (see Sec. 101.36(b)(2)......
  • Food Labeling: Revision of the Nutrition and Supplement Facts Labels
    • United States
    • Federal Register May 27, 2016
    • 27 Mayo 2016
    ...of Page 33935 nutrients in their varying forms on dietary supplements in Sec. 101.36(b) and (d) and Sec. 101.9(c). Our regulation (21 CFR 101.36(b)(2)) provides for the labeling on the nutrition label of dietary ingredients with RDIs such as vitamins or minerals listed in Sec. 101.9(c)(8)(i......
  • Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
    • United States
    • Federal Register December 15, 2015
    • 15 Diciembre 2015
    ...affect the private sector under Pub. L. 104-4. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 CFR Citation: 21 CFR 101.9; 21 CFR 101.36. Legal Deadline: Abstract: FDA is amending the labeling regulations for conventional foods and dietary supplements to provide updated nutriti......
  • Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions
    • United States
    • Federal Register January 07, 2014
    • 7 Enero 2014
    ...affect the private sector under Pub. L. 104-4. Legal Authority: 21 U.S.C. 321; 21 U.S.C. 343; 21 U.S.C. 371 CFR Citation: 21 CFR 101.9; 21 CFR 101.36. Legal Deadline: Abstract: FDA is proposing to amend the labeling regulations for conventional foods and dietary supplements to provide updat......
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18 cases
  • Jarrow Formulas, Inc. v. Nutrition Now, Inc., No. 01-55154.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • 4 Junio 2002
    ...should be measured from 1999, when the FDA enacted regulations pertaining to the labeling of nutritional supplements, 21 C.F.R. §§ 101.4, 101.36. This argument is entirely without...
  • Colella v. Atkins Nutritionals, Inc., 17-cv-5867 (KAM)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • 7 Diciembre 2018
    ...(last visited December 7, 2018) ).)3 Section 101.36 governs the nutrition labeling of dietary supplements. 21 C.F.R. § 101.36.4 District courts may take judicial notice of public records of the FDA on a motion to dismiss. See e.g., Apotex Inc. v. Acorda Therapeutics, Inc. , 823 F.3d 51, 60 ......
  • Bruaner v. Musclepharm Corp., Case No. CV 14-8869 FMO (AGRx)
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • 11 Agosto 2015
    ...cases, to be representative of a lot." 21 C.F.R. § 101.9(g)(2). A similar methodology must also be used to determine "compliance with 21 C.F.R. § 101.36, which regulation addresses which 'dietary ingredients' must be contained in the ingredient list in the Supplement Facts section of a diet......
  • Durnford v. Musclepharm Corp., No. 16-15374
    • United States
    • United States Courts of Appeals. United States Court of Appeals (9th Circuit)
    • 12 Octubre 2018
    ...number of packages in the same inspection 907 F.3d 601lot, whichever is smaller, randomly selected to be representative of the lot." 21 C.F.R. § 101.36(f)(1). Section 343(r) addresses statements concerning nutritional content other than those required to be included in the nutrition panel. ......
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8 firm's commentaries
  • Summary of U.S. Advertising Laws and Regulations for Malt Beverages and Energy Drinks
    • United States
    • JD Supra United States
    • 29 Enero 2020
    ...lxii Id. lxiii Id. lxiv 21 C.F.R. § 101.9; 21 U.S.C. § 343(q). lxv 21 C.F.R. § 101.36 ; 21 U.S.C. § lxvi https://www.fda.gov/regulatory-information/ search-fda-guidance-documents/guidance-industry-distinguishing-liquid-dietary-supplements-beverages lxvii 21 U.S.C. § 343(a)(1). lxviii See Wh......
  • Don’t Go Changing to Try and Please Me…
    • United States
    • LexBlog United States
    • 28 Febrero 2014
    ...The proposed changes come in the form of two proposed rules. One rule consists of revisions to the language in 21 CFR 101.9 and 21 CFR 101.36 regarding Nutrition Facts and Supplement Facts panels, respectively. The other rule will modify the current regulation found at 21 CFR 101.12 regardi......
  • FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
    • United States
    • LexBlog United States
    • 12 Octubre 2009
    ...value (DRV) that a dietary supplement contains to be given for dietary ingredients that have an RDI or DRV (see Sec. 101.36(b)(2)(iii) (21 CFR 101.36(b)(2)(iii))). In addition, the amount in units must be given, regardless of whether an RDI or DRV has been established (see Sec. 101.36(b)(2)......
  • Decoding New FDA Nutrition And Supplement Facts Guidance
    • United States
    • JD Supra United States
    • 16 Febrero 2017
    ...on the supplement facts label if they are present in amounts corresponding to less than 2 percent of the RDI for vitamins and minerals (21 CFR 101.36(b)(2)(i)). The FDA recognized that the declaration requirements are different between conventional foods (i.e., quantitative amounts may be d......
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