21 CFR 101.93 - Certain types of statements for dietary supplements

Cite as21 CFR 101.93
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78 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
    ...implementing these requirements were published in the Federal Register of September 23, 1997, and are codified at Sec. 101.93 (21 CFR 101.93) (62 FR 49883 at 49886, September 23, 1997). DSHEA did not alter the statutory treatment of dietary supplement claims related to disease (``disease cl......
  • 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
    • March 21, 2017
    ...Raisin Bran Omega-3 250 mg ALA from Flaxseed.5 This FDA guidance was published for a different kind of claim that is regulated under 21 C.F.R. § 101.93 rather than 21 C.F.R. § 101.71(a). However, the Court finds the guidance relevant to the instant inquiry as to whether the claim at issue r......
  • Corbett v. PharmaCare U.S., Inc., Case No.: 21cv137-GPC(AGS)
    • United States
    • United States District Courts. 9th Circuit. United States District Court (Southern District of California)
    • October 19, 2021
    ...as well as advertising that the Products "support[ ] immunity" or claim "immunity support", is making implied disease claims under 21 C.F.R. § 101.93(g)(2) and misbranded under 21 U.S.C. § 343(r)(6). (Id. ¶¶ 38-42, 44, 50 (citing 21 U.S.C. § 343(r)(6) ).) Under the FDCA, these phrases impro......
  • United States v. Hakim, 18 Civ. 5726 (ER)
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • May 26, 2020
    ...preventing a wide variety of diseases is a "disease claim." See Decl. of Milan S. McGorty ("McGorty Decl."), Doc. 29, ¶ 15; see also 21 C.F.R. 101.93(g).5 In the letter, Hakim generally represented to the FDA that he had made some adjustments regarding product complaints, equipment maintena......
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33 cases
  • 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
    • March 21, 2017
    ...Raisin Bran Omega-3 250 mg ALA from Flaxseed.5 This FDA guidance was published for a different kind of claim that is regulated under 21 C.F.R. § 101.93 rather than 21 C.F.R. § 101.71(a). However, the Court finds the guidance relevant to the instant inquiry as to whether the claim at issue r......
  • Corbett v. PharmaCare U.S., Inc., Case No.: 21cv137-GPC(AGS)
    • United States
    • United States District Courts. 9th Circuit. United States District Court (Southern District of California)
    • October 19, 2021
    ...as well as advertising that the Products "support[ ] immunity" or claim "immunity support", is making implied disease claims under 21 C.F.R. § 101.93(g)(2) and misbranded under 21 U.S.C. § 343(r)(6). (Id. ¶¶ 38-42, 44, 50 (citing 21 U.S.C. § 343(r)(6) ).) Under the FDCA, these phrases impro......
  • United States v. Hakim, 18 Civ. 5726 (ER)
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • May 26, 2020
    ...preventing a wide variety of diseases is a "disease claim." See Decl. of Milan S. McGorty ("McGorty Decl."), Doc. 29, ¶ 15; see also 21 C.F.R. 101.93(g).5 In the letter, Hakim generally represented to the FDA that he had made some adjustments regarding product complaints, equipment maintena......
  • Corbett v. Pharmacare U.S., Inc., 21cv137-GPC(AGS)
    • United States
    • United States District Courts. 9th Circuit. United States District Court (Southern District of California)
    • October 19, 2021
    ...as well as advertising that the Products “support[] immunity” or claim “immunity support”, is making implied disease claims under 21 C.F.R. § 101.93(g)(2) and misbranded under 21 U.S.C. § 343(r)(6). (Id. ¶¶ 38-42, 44, 50 (citing 21 U.S.C. § 343(r)(6).) Under the FDCA, these phrases improper......
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22 firm's commentaries
  • Both Sides Equal Under the First Amendment
    • United States
    • LexBlog United States
    • July 3, 2017
    ...the FDA (or some other entity) from exercising the power at least to review it first. As far as disclaimers, look no further than 21 C.F.R. §101.93(c)(2). Every lawyer advertisement about FDA-regulated products could quite constitutionally be required to state, “These statements have not be......
  • Both Sides Equal Under The First Amendment
    • United States
    • Mondaq United States
    • July 7, 2017
    ...the FDA (or some other entity) from exercising the power at least to review it first. As far as disclaimers, look no further than 21 C.F.R. §101.93(c)(2). Every lawyer advertisement about FDA-regulated products could quite constitutionally be required to state, "These statements have not be......
  • FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
    • United States
    • LexBlog United States
    • October 12, 2009
    ...implementing these requirements were published in the Federal Register of September 23, 1997, and are codified at Sec. 101.93 (21 CFR 101.93) (62 FR 49883 at 49886, September 23, 1997). DSHEA did not alter the statutory treatment of dietary supplement claims related to disease (“disease cla......
  • Preemption Should Have Taken Down Performance Enhancement Class Action
    • United States
    • LexBlog United States
    • November 13, 2015
    ...supplement regulations jibe with this—they state that if a product makes a “disease claim,” it is subject to regulation as a drug. 21 C.F.R. § 101.93(f). A “disease claim” is a representation that a product can “diagnose, mitigate, treat, cure, or prevent a specific disease,” which would in......
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