Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale

Robert Falcone, Nikkie Umaru, Bozena michniak-kohn, Sam Salek

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Background: Cosmetic products are one of the fastest-growing segments of personal care products in the United States. One of the critical elements in the sales and growth of cosmetics is leveraging claims. Unlike pharmaceuticals in the US, claims in personal care products are usually not reviewed nor require regulatory approvals before products are sold in the US. However, regulatory agencies have no oversight of how the advertisement is presented to the consumers and have cited known companies and brands for promoting deceptive advertising and forcing costly market withdrawal, impacting the financial values of investors and customers' confidence alike.
Objectives: We conducted a literature search and a survey. The literature search was to identify the current methodologies available for substantiating the advertisement of personal care products (including cosmetics). The survey was conducted with regulatory professionals aiming to understand the use of the current methodologies.
Methods: The survey was developed and distributed to regulatory professionals in different capacities within the Cosmetic and Personal Care industry who had extensive experience constructing and substantiating advertising claims regulatory for cosmetic and personal care products. The questionnaire comprised 9 questions with socio-demographic characteristics and regulatory experience validating claims.
Results: We received 63 responses from 1354 forms sent from regulatory professionals validating advertising claims. The results show that 85 % of the respondents use the FDA guidance while the remaining 15 % use in-house or other non-governmental guides. Moreover, 58 % use some Risk Benefit, while 42 % do not use it when evaluating claim substantiation. Conclusion: Although the respondents qualifying the claims possess the experience and technical knowledge of Cosmetic and Personal Care Products, the presently available standards used in the US are not designed to validate the substantiation of advertising claims. Therefore, there is a need to develop a more robust methodology for the evaluation of the validation and substantiation of advertising claims. A technique of using personal experiences is already approved and used for pharmaceutical products known as Personal Reported Outcomes (PRO). Leveraging the PRO techniques can help develop a “consumer reported outcome measure” (CROM) tool for claim substantiation validation for the advertising of cosmetic and personal care products.
Keywords : Personal Reported Outcomes, CROM, FDA, FTC, Cosmetic products
Original languageEnglish
Pages (from-to)526-533
Number of pages10
JournalInternational Journal of Scientific & Technology Research (IJSTR)
Issue number1
Publication statusPublished - 30 Jan 2024


  • Personal Reported Outcomes
  • CROM
  • FDA
  • FTC
  • Cosmetic products


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