21 CFR 101.14 - Health claims: general requirements

Cite as21 CFR 101.14
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141 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
    • January 6, 2000
    ...a new definition of disease, FDA will use the preexisting definition of ``disease or health-related condition'' in Sec. 101.14(a)(5) (21 CFR 101.14(a)(5)) (formerly Sec. 101.14(a)(6)), which was issued as part of the implementation of the health claims provisions of the Nutrition Labeling a......
  • Bruton v. Gerber Prods. Co., Case No.: 12–CV–02412–LHK
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • September 6, 2013
    ...claims, 21 U.S.C. § 343(r)(1)(A); the FDA's “natural” policy, see21 C.F.R. § 101.22; 58 Fed. Reg. at 2407; the “health” claims, see21 C.F.R. § 101.14; and the “sugar-related” claims, see21 C.F.R. § 101.60. According to Defendants, “there is no label element Plaintiff challenges that FDA reg......
  • Pearson v. Shalala, No. 98-5043
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • January 15, 1999
    ...that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants' Page 652 four claims links the consumption of a particular supplement to the reduction in risk of a particular......
  • 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
    • August 10, 2017
    ...outlines requirements for when a party may or may not use "nutrient content claims" or "health claims" on food labels.Specifically, 21 C.F.R. §§ 101.14 and 101.65 regulate when nutrient content claims or health claims can be made in the presence of other harmful nutrients. If fats, saturate......
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66 cases
  • Bruton v. Gerber Prods. Co., Case No.: 12–CV–02412–LHK
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • September 6, 2013
    ...claims, 21 U.S.C. § 343(r)(1)(A); the FDA's “natural” policy, see21 C.F.R. § 101.22; 58 Fed. Reg. at 2407; the “health” claims, see21 C.F.R. § 101.14; and the “sugar-related” claims, see21 C.F.R. § 101.60. According to Defendants, “there is no label element Plaintiff challenges that FDA reg......
  • Pearson v. Shalala, No. 98-5043
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • January 15, 1999
    ...that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants' Page 652 four claims links the consumption of a particular supplement to the reduction in risk of a particular......
  • 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
    • August 10, 2017
    ...outlines requirements for when a party may or may not use "nutrient content claims" or "health claims" on food labels.Specifically, 21 C.F.R. §§ 101.14 and 101.65 regulate when nutrient content claims or health claims can be made in the presence of other harmful nutrients. If fats, saturate......
  • In re Conagra Foods Inc., Case No. CV 11–05379 MMM (AGRx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • November 15, 2012
    ...21 C.F.R § 101.13 (limits on claims that can be made about the nutritional content of food, such as labeling a product “low sodium”); 21 C.F.R § 101.14 (health claims). Indeed, as ConAgra notes, 38 the FDA has regulated use of the term “natural.” 21 C.F.R § 101.22.39 While, as explained in ......
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18 firm's commentaries
  • Is the FDA rule prohibiting the use of disclaimers, and instead outright prohibiting product labeling that is not supported by significant scientific research, an unconstitutional prior restraint...
    • United States
    • JD Supra United States
    • January 15, 1999
    ...that expressly or by implication ... characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1) (1998). Each of appellants' four claims links the consumption of a particular supplement to the reduction in risk of a particular [*3] dis......
  • Finger Lickin’ Good
    • United States
    • LexBlog United States
    • May 4, 2007
    ...from the perils of poultry would not quit. No, they argued, these statements amount to “actionable health claims in violation of 21 C.F.R. §101.14.” 2007 U.S. Dist. Lexis 32041, at *8. They claimed they could enforce §101.14 as “negligence per se” and under certain state statutes allowing f......
  • Food And Beverage Law Update: April 2016
    • United States
    • Mondaq United States
    • April 28, 2016
    ...federal requirements for "health claims" are contained in the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. §343 et seq. and 21 C.F.R. Part 101 (see §101.14), and for "organic" food labeling in 7 C.F.R. Part 205. A "health claim" is defined, in short, as any claim made on the label......
  • Food and Beverage Law Update: April 2016
    • United States
    • JD Supra United States
    • April 27, 2016
    ...federal requirements for "health claims" are contained in the Nutrition Labeling and Education Act (NLEA), 21 U.S.C. §343 et seq. and 21 C.F.R. Part 101 (see §101.14), and for "organic" food labeling in 7 C.F.R. Part 205. A "health claim" is defined, in short, as any claim made on the label......
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1 books & journal articles
  • The First Amendment and Disclosure Regulations: Compelled Speech or Corporate Opportunism?
    • United States
    • American Business Law Journal Nbr. 51-3, September 2014
    • September 1, 2014
    ...supports the claim.”See id. at 197; Nutrition Labeling and Education Act of 1990, 21 U.S.C. § 343 (r)(3)(B)(i)(2012); see also 21 C.F.R. § 101.14(c) (2012) (adopting the “significant scientific agreement”standard for health claims relating to dietary supplements). The FDA rejected the petitio......

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