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

Authors

  • Robert Falcone  Department of Clinical, Pharmaceutical and Biological Science, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
  • Nkiruka Umaru   Integrated DNA Technologies, USA
  • Bozena Michniak-Kohn  Department of Clinical, Pharmaceutical and Biological Science, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
  • Sam Salek  Ernest Mario School of Pharmacy, Rutgers University, USA

DOI:

https://doi.org/10.32628/IJSRST52411187

Keywords:

Consumer Reported Outcome Measure, for PerConsumer Reported Outcome Measure for Personal Care Productssonal Care Products

Abstract

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.

References

  1. https://commonthreadco.com/blogs/coachs-corner/beauty-industry-cosmetics-marketing-ecommerce. Accessed on July 25, 2021
  2. https://www.statista.com/statistics/717673/cosmetics-personal-care-products-markets-revenue/ Accessed on October 24, 2023
  3. https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-claims. Accessed on September 21, 2020.
  4. https://www.consumer.ftc.gov/blog/2014/06/cosmetics-company-crosses-lines. Accessed on July 26, 2021
  5. https://www.consumer.ftc.gov/blog/2019/10/cosmetic-company-wrote-fake-reviews Accessed on July 26, 2021
  6. https://www.ftc.gov/enforcement/cases-proceedings/172-3153/naturecity-llc. Accessed on July 26, 2021
  7. https://www.asa.org.uk/rulings/l-oral--uk--ltd-a18-440758.html Accessed on July 26, 2021
  8. https://www.asa.org.uk/advice-online/cosmetics-the-use-of-production-techniques.html Accessed on July 26, 2021
  9. https://cen.acs.org/articles/94/i19/Making-cosmetic-claims-stick.html?referral=BAEE8905-F3F6-4CF0-85FA-1A156B3FBBA4 Accessed on July 25, 2021((
  10. https://www.ahdbonline.com/issues/2016/june-2016-vol-9-no-4/2165-patient-reported-outcomes-in-oncology-drug-labeling-in-the-united-states-a-framework-for-navigating-early-challenges Accessed on July 26, 2021
  11. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims Accessed on July 26, 2021
  12. Ibid 2
  13. https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated#:~:text=to%20top-,Can%20FDA%20inspect%20cosmetics%20manufacturers%3F,the%20FD%26C%20Act%20or%20FPLA. Accessed on September 21, 2020.
  14. https://www.ftc.gov/enforcement/rules/rulemaking-regulatory-reform-proceedings/fair-packaging-labeling-act-regulations-0. Accessed on September 21, 2020
  15. https://www.ftc.gov/news-events/press-releases/2014/06/loreal-settles-ftc-charges-alleging-deceptive-advertising-anti. Accessed on September 21, 2020
  16. https://www.ftc.gov/news-events/press-releases/2020/08/ftc-letters-warning-20-more-marketers-stop-making-covid-19-claims. Accessed on September 21, 2020
  17. https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-address-drug-claims-made-products-marketed-cosmetics. Accessed on September 21, 2020
  18. https://www.ftc.gov/news-events/media-resources/truth-advertising. Accessed on September 21, 2020
  19. https://www.ftc.gov/news-events/media-resources/truth-advertising Accessed on July 26, 2021
  20. https://www.ftc.gov/tips-advice/business-center/guidance/ftcs-endorsement-guides-what-people-are-asking. Accessed on September 21, 2020
  21. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence. Accessed on September 21, 2020
  22. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-documents-using-real-world-data-and-real-world-evidence-fda-drugs-and-biologics-guidance. Accessed on September 21, 2020
  23. https://www.bad.org.uk/shared/get-file.ashx?id=1653&itemtype=document. Accessed on July 26, 2021
  24. https://pubmed.ncbi.nlm.nih.gov/8033378/ Accessed on July 26, 2021
  25. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4817440/ Accessed on July 26, 2021
  26. ASTM-E1958-20.pdf Accessed on October 24, 2023
  27. https://doi.org/10.6028/NIST.IR.8178r1 Accessed on October 30, 2023
  28. https://www.ftc.gov/legal-library/browse/rules/fair-packaging-labeling-act-regulations-under-section-4-fair-packaging-labeling-act Accessed on October 30, 2023
  29. Guidelines_for_Cosmetic_Product_Claim_Substantiation.pdf Accessed on October 24, 2023
  30. CELEX_32013R0655_EN_TXT (1).pdf Accessed on October 30, 2023
  31. https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide Accessed on October 30, 2023
  32. https://www.iso.org/obp/ui#iso:std:iso:20784:dis:ed-1:v1:en Accessed on October 24, 2023
  33. CTPA Tool for Claim Substantiation - January 2023 (1).pdf Accessed on October 30, 2023
  34. https://single-market-economy.ec.europa.eu/sectors/cosmetics/legislation_en#:~:text=Regulation%20(EC)%20N%C2%B0%201223,all%20operators%20in%20the%20sector .Accessed on October 31, 2023
  35. https://www.ftc.gov/news-events/topics/truth-advertising Accessed on October 31, 2023
  36. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry. Accessed on September 21, 2020
  37. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices. Accessed on September 21, 2020
  38. https://www.fda.gov/files/science%20&%20research/published/Accelerating-development-of-scientific-evidence-for-medical-products-within-the-existing-US-regulatory-framework.pdf. Accessed on September 21, 2020
  39. https://www.fda.gov/media/120060/download. Accessed on September 21, 2020
  40. Kamudoni, P, Johns, N. and Salek, S., Living with Chronic Disease: Measuring Important Patient-Reported Outcomes, Springer Nature Singapore Pte Ltd 2018

International Journal of Scientific Research in Science and Technology

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Published

2024-02-29

Issue

Volume 11, Issue 1, January-February-2024

Section

Research Articles

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This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

[1]
Robert Falcone, Nkiruka Umaru, Bozena Michniak-Kohn, Sam Salek "Development of a Consumer Reported Outcome Measure for Personal Care Products : The Rationale" International Journal of Scientific Research in Science and Technology(IJSRST), Online ISSN : 2395-602X, Print ISSN : 2395-6011,Volume 11, Issue 1, pp.526-533, January-February-2024. Available at doi : https://doi.org/10.32628/IJSRST52411187