21 CFR 201.10 - Drugs; statement of ingredients

Cite as21 CFR 201.10
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21 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
    ...requirements as express claims); 21 CFR 101.95 (prescribing conditions under which implied claims of freshness may be made for foods); 21 CFR 201.10(c)(3) (prohibiting use in ingredient statement of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some un......
  • DeLarosa v. Boiron, Inc., Case No. 8:10–CV–1569–JST (CWx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • July 25, 2011
    ...adequate directions for use, a statement of ingredients, the dilution, and at least one major OTC indication for use. See 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62. In determining whether the labeling or advertising is misleading, the Court should consider “not only representations made or......
  • Pharmacia Corp. v. Alcon Laboratories, Inc., Civ. No. 01-1539(WGB).
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • May 14, 2002
    ...in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient." 21 C.F.R. § 201.10(c)(5); see also 12/17 Tr., at 173 (Barton); Garanzini Tr., at 53. Prior to October 1999, the FDA name review process was conducted under the......
  • Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 23, 2020
    ...requirements, including:Statement of Ingredients: Ingredient information shall appear in accord with Section 502(e) of the Act and 21 CFR 201.10. Labeling must bear a statement of the quantity and amount of ingredient(s) in the product in conformance with Section 502(b) of the Act, as well ......
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7 cases
  • DeLarosa v. Boiron, Inc., Case No. 8:10–CV–1569–JST (CWx).
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Central District of California
    • July 25, 2011
    ...adequate directions for use, a statement of ingredients, the dilution, and at least one major OTC indication for use. See 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62. In determining whether the labeling or advertising is misleading, the Court should consider “not only representations made or......
  • Pharmacia Corp. v. Alcon Laboratories, Inc., Civ. No. 01-1539(WGB).
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • May 14, 2002
    ...in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient." 21 C.F.R. § 201.10(c)(5); see also 12/17 Tr., at 173 (Barton); Garanzini Tr., at 53. Prior to October 1999, the FDA name review process was conducted under the......
  • Medinatura, Inc. v. Food & Drug Admin., Civil Action No. 20-2066 (RDM)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • October 23, 2020
    ...requirements, including:Statement of Ingredients: Ingredient information shall appear in accord with Section 502(e) of the Act and 21 CFR 201.10. Labeling must bear a statement of the quantity and amount of ingredient(s) in the product in conformance with Section 502(b) of the Act, as well ......
  • Al Haj v. Pfizer Inc., 17 C 6730
    • United States
    • United States District Courts. 7th Circuit. United States District Court (Northern District of Illinois)
    • April 13, 2018
    ...them to use the term "Maximum Strength," see ibid. , and in fact forbids them from using "misleading" labels, see 21 U.S.C. § 352(a); 21 C.F.R. § 201.10(c). Because the complaint plausibly alleges that designating the product as "Maximum Strength" Robitussin was misleading, the ICFA's safe ......
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4 firm's commentaries
  • Homeopathic Drugs – Eh, We Don’t Know
    • United States
    • LexBlog United States
    • January 22, 2015
    ...meaning that their labels must include directions for use, ingredients, the dilution and the indication. Id.; see also 21 C.F.R. §§ 201.5, 201.10, 201.61, 201.62. Depending on certain particulars, homeopathic drugs must also be recognized by and comply with requirements of the Homeopathic P......
  • FDA Guidance Regarding Structure-Function Claims for Dietary Supplements
    • United States
    • LexBlog United States
    • October 12, 2009
    ...requirements as express claims); 21 CFR 101.95 (prescribing conditions under which implied claims of freshness may be made for foods); 21 CFR 201.10(c)(3) (prohibiting use in ingredient statement of fanciful drug or ingredient names that falsely imply that the drug or ingredient has some un......
  • CBD Regulation: Recent FDA Enforcement Casts a Wider Net Over CBD Products
    • United States
    • LexBlog United States
    • April 5, 2021
    ...or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation.” (21 CFR 201.10(c)(4)). The FDA has generally been less interested in so called “wellness language” such as “rejuvenating”, and, for this reason, industry part......
  • CBD Regulation: Recent FDA Enforcement Casts A Wider Net Over CBD Products
    • United States
    • Mondaq United States
    • May 6, 2021
    ...or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation." (21 CFR 201.10(c)(4)). The FDA has generally been less interested in so called "wellness language" such as "rejuvenating", and, for this reason, industry part......

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