21 CFR 101.70 - Petitions for health claims

Cite as21 CFR 101.70
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43 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
    ...interested person may submit a petition to FDA requesting the agency to issue a regulation authorizing the health claim (see Sec. 101.70 (21 CFR 101.70)). The petitioner must demonstrate, among other things, that the use of the substance at levels necessary to justify the claim is safe and ......
  • Food Labeling: Revision of the Nutrition and Supplement Facts Labels
    • United States
    • Federal Register May 27, 2016
    • 27 Mayo 2016
    ...could use to request an amendment to the definition of dietary fiber and the petition process for the authorization of a health claim (21 CFR 101.70) where a fiber that is the subject of an authorized claim would be considered a dietary fiber that we could add to the list of fibers in the d......
  • Pearson v. Shalala, No. 98-5043
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 15 Enero 1999
    ...21 C.F.R. § 101.14(c) (1998). The FDA's authorization comes by an informal rulemaking under the Administrative Procedure Act. See 21 C.F.R. § 101.70 (1998); 5 U.S.C. § 553 (1994). This choice of a rulemaking rather than an adjudication--which would seem a more natural fit for this individua......
  • Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • 10 Agosto 2017
    ...authorized under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. ......
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10 cases
  • Pearson v. Shalala, No. 98-5043
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • 15 Enero 1999
    ...21 C.F.R. § 101.14(c) (1998). The FDA's authorization comes by an informal rulemaking under the Administrative Procedure Act. See 21 C.F.R. § 101.70 (1998); 5 U.S.C. § 553 (1994). This choice of a rulemaking rather than an adjudication--which would seem a more natural fit for this individua......
  • Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • 10 Agosto 2017
    ...under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. §......
  • Hadley v. Kellogg Sales Co., Case No. 16–CV–04955–LHK
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Northern District of California
    • 21 Marzo 2017
    ...under "Subpart E" of the section of the Code of Federal Regulations concerning food labeling. Subpart E encompasses 21 C.F.R. §§ 101.70 – 83. There are two relevant provisions under Subpart E that apply to the link between fiber and cardiovascular disease. First, under 21 C.F.R. §......
  • Whitaker v. Thompson, No. 99-3247 GK.
    • United States
    • U.S. District Court — District of Columbia
    • 3 Enero 2003
    ...sections of the statute, including 21 U.S.C. § 343(r)(5)(D). In 1993, the FDA responded to the NLEA by promulgating 21 C.F.R. §§ 101.14 and 101.70, which explained the standards and procedures for FDA consideration of nutrient-disease claims. The FDA chose the same standard for authorizing ......
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