Review of the standards of proof (of safety) for FDA regulated consumer products and how the generally recognized as safe criteria could be applied to cosmetics.

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  • Author(s): Burdock GA;Burdock GA
  • Source:
    Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2024 May; Vol. 149, pp. 105603. Date of Electronic Publication: 2024 Mar 15.
  • Publication Type:
    Journal Article; Review
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Elsevier Country of Publication: Netherlands NLM ID: 8214983 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1096-0295 (Electronic) Linking ISSN: 02732300 NLM ISO Abbreviation: Regul Toxicol Pharmacol Subsets: MEDLINE
    • Publication Information:
      Publication: <2003>- : Amsterdam : Elsevier
      Original Publication: New York : Academic Press, [c1981-
    • Subject Terms:
      Cosmetics*/standards ; United States Food and Drug Administration*/standards ; Consumer Product Safety*/standards ; Consumer Product Safety*/legislation & jurisprudence; United States ; Humans ; Animals ; Risk Assessment
    • Abstract:
      The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amends the Food, Drug and Cosmetic Act (FDCA), elevating the standard of proof of safety (better known as a "safety standard") for cosmetics to the standard of a "reasonable certainty … [of] … safe."a standard equal to that of food ingredients. The standards of the proof of safety differ for various classes of FDA-regulated product categories e.g., cosmetics, dietary supplements, food ingredients and food itself. This manuscript describes the various standards of proof, the essential differences between the standards, key elements required to achieve a particular standard and, compares the standards to more familiar legal terms such as "a preponderance of the evidence" or "beyond reasonable doubt." The standards of proof for these product categories are also ranked according to increasing threshold for achievement of "safe" status. Lastly, this manuscript suggests how the requirements for the high standard of a "reasonable certainty of safe" (or "reasonable certainty of no harm") might be met.
      Competing Interests: Declaration of competing interest The author declares that he has no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
      (Copyright © 2024 Elsevier Inc. All rights reserved.)
    • Accession Number:
      0 (Cosmetics)
    • Publication Date:
      Date Created: 20240317 Date Completed: 20240430 Latest Revision: 20240430
    • Publication Date:
      20240430
    • Accession Number:
      10.1016/j.yrtph.2024.105603
    • Accession Number:
      38494042