Cosmetovigilance: “Beautiful Is Pain”

Mochamad Yusuf Zainudin, Luthfi Chabib

Abstract


Cosmetics are defined as preparations used on the skin, mouth, nails, hair and eyes with the aim of increasing attractiveness, providing fragrance or protection of body odor, cleaning. The difference between drugs and cosmetics is sometimes not clear. Regulations covering cosmetic products that discuss the products used are safe and can be used by healthy people, product safety, and efficacious from cosmetic products approved by national authorities before being sold to consumers. Monitoring the safety of cosmetic products, and is a very important component of public health activities. After sales supervision of cosmetic products must be widely spread in the community, and problems related to these products can be solved, and identified in order to achieve a safe product. In August 2022, a search for the term cosmetovigilance in the Google search database returned 38 articles Family physicians and expert care practitioners, have a very useful role in providing an understanding of Adverse Drug Reactions (ADRs) caused by cosmetic products, and with such occurrences they can encourage patients to report Adverse Drug Reactions (ADRs) to the appropriate officials. authorized. Raise awareness of the new concept and become valuable commentary on public health at large.


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Keywords


Cosmetovigilance; Cosmetics; Adverse Drug Reactions (ADRs)

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References


BPOM RI. Peraturan Badan Pengawas Obat dan Makanan Nomor 30 Tahun 2020 Tentang Persyaratan Teknis Penandaan Kosmetika [Internet]. 2020 [cited 2022 Aug 25]. p. 2. Available from: https://jdih.pom.go.id/download/product/1202/30/2020

U.S Food & Drug Administration. Cosmetics Labeling Guide | FDA [Internet]. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-regulations/cosmetics-labeling-guide#clga

Eur-Lex. EUR-Lex - 31976L0768 - EN - EUR-Lex [Internet]. 2013 [cited 2022 Aug 25]. Available from: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A31976L0768

U.S Food & Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) | FDA [Internet]. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap

World Health Organization. Safety Monitoring of Medical Products: Reporting System for the General Public. Geneva: World Health Organization; 2012.

Toklu HZ. Pharmacovigilance of Herbal Medicine: Herbavigilance. 2016;

Vigan M, Castelain F. Cosmetovigilance: definition, regulation and use “in practice.” European Journal of Dermatology 2014 24:6 [Internet]. 2015 Feb 27 [cited 2022 Aug 25];24(6):643–9. Available from: https://link.springer.com/article/10.1684/ejd.2014.2493

Vigan M. The New Allergens In Cosmetics Cosmetovigilance. Ann Dermatol Venereol. 1997;124(8):571–5.

Tissier MH, Lepagnol F. [Cosmetovigilance: a French pharmacovigilance system for cosmetics developed by the French health products safety agency. A proposal for the future]. Therapie. 2002;57(3):273–82.

Moretti U, Velo G. Cosmetovigilance: the “beautiful” risk. Drug Saf. 2008;31(5):437–9.

Sautebin L. Understanding the Adverse Effects of Cosmetics. Drug Saf. 2008;31(5):433–6.

Sportiello L, Cammarota S, de Portu S, Sautebin L. Notification of undesirable effects of cosmetics and toiletries. Pharmacol Res. 2009 Feb;59(2):101–6.

Lindberg M, Tammela M. Primary Cutaneous Lymphoma View project. 2004 [cited 2022 Aug 25]; Available from: https://www.researchgate.net/publication/8373613

Lindberg M, Tammela M, Boström Å, Fischer T, Inerot A, Sundberg K, et al. Are adverse skin reactions to cosmetics underestimated in the clinical assessment of contact dermatitis? A prospective study among 1075 patients attending Swedish patch test clinics. Acta Derm Venereol. 2004;84(4).

Government of Canada. Regulatory information for cosmetics - Canada.ca [Internet]. 2021 [cited 2022 Aug 25]. Available from: https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html

U.S Food & Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program | FDA [Internet]. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program

U.S Food & Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated | FDA [Internet]. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/fda-authority-over-cosmetics-how-cosmetics-are-not-fda-approved-are-fda-regulated

Krasteva M, Bons B, Tozer S, Rich K, Hoting E, Hollenberg D, et al. Contact allergy to hair colouring products The cosmetovigilance experience of 4 companies (2003-2006). European Journal of Dermatology. 2010;20(1):85–95.

Kornfeld‐Lecanu S, Zajaczkowski F, Dubourg S, Martin L, Lefort S, Siest S. Vigilance in industry: cosmetics and household cleaning products. Balance sheet of case report from 2005 to 2007. Clinical and Experimental Dermatology: Clinical dermatology. 2010;35(8):874–80.

Zweers PGMA, Gilmour NJ, Hepburn PA, Gerritsen RF, van Puijenbroek EP. Causality methods in Cosmetovigilance: Comparison of Colipa and PLM versus global introspection. Regulatory Toxicology and Pharmacology. 2012 Aug;63(3):409–17.

Bons B, Audebert F, Bitaudeau C, Cachin N, Colson L, Farr C, et al. Assessment of undesirable events in cosmetic market surveillance: Background, description and use of a causality assessment method in cosmetovigilance. Regulatory Toxicology and Pharmacology. 2010;58(3):349–53.

Sautebin L. A cosmetovigilance survey in Europe. Pharmacol Res. 2007;55(5):455–60.

Toklu HZ, Mensah E. Why do we need pharmacists in pharmacovigilance systems? Online J Public Health Inform. 2016;8(2).

Sencan N, Duman G, Koparan M. Community pharmacists and cosmetics: Current state in Turkey. Journal of Faculty of Pharmacy of Ankara University. 2008;37(4):269–84.

di Giovanni C, Arcoraci V, Gambardella L, Sautebin L. Cosmetovigilance survey: are cosmetics considered safe by consumers? Pharmacol Res. 2006;53(1):16–21.

Salverda JGW, Bragt PJC, de Wit‐Bos L, Rustemeyer T, Coenraads PJ, Tupker RA, et al. Results of a cosmetovigilance survey in The Netherlands. Contact Dermatitis. 2013;68(3):139–48.

Huf G, Rito P da N, Presgrave R de F, Bôas MHSV. Adverse reactions to cosmetic products and the Notification System in Health Surveillance: a survey. Revista Brasileira de Epidemiologia. 2013;16:1017–20.

Bilal AI, Tilahun Z, Osman ED, Mulugeta A, Shekabdulahi M, Berhe DF. Cosmetics use-related adverse events and determinants among Jigjiga town residents, Eastern Ethiopia. Dermatol Ther (Heidelb). 2017;7(1):143–53.

Sauver JLS, Warner DO, Yawn BP, Jacobson DJ, McGree ME, Pankratz JJ, et al. Why patients visit their doctors: assessing the most prevalent conditions in a defined American population. In: Mayo Clinic Proceedings. Elsevier; 2013. p. 56–67.

Drake LA, Dorner W, Goltz RW, Graham GF, Lewis CW, Pariser DM, et al. Guidelines of care for contact dermatitis. J Am Acad Dermatol. 1995;32(1):109–13.

Krob HA, Fleischer Jr AB, D’Agostino Jr R, Haverstock CL, Feldman S. Prevalence and relevance of contact dermatitis allergens: a meta-analysis of 15 years of published TRUE test data. J Am Acad Dermatol. 2004;51(3):349–53.

Usatine R, Riojas M. Diagnosis and management of contact dermatitis. Am Fam Physician. 2010;82(3):249–55.

Zug KA, McGinley-Smith D, Warshaw EM, Taylor JS, Rietschel RL, Maibach HI, et al. Contact allergy in children referred for patch testing: North American Contact Dermatitis Group data, 2001-2004. Arch Dermatol. 2008;144(10):1329–36.

Lazzarini R, Hafner M de FS, Rangel MG. Evaluation of the presence of allergens in children’s products available for sale in a big city. An Bras Dermatol. 2018;93:457–9.

U.S Food & Drug Administration. “Hypoallergenic” Cosmetics | FDA [Internet]. FDA. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/cosmetics/cosmetics-labeling-claims/hypoallergenic-cosmetics#Hypoallergenic_Cosmetics

Hamann CR, Bernard S, Hamann D, Hansen R, Thyssen JP. Is there a risk using hypoallergenic cosmetic pediatric products in the United States? Journal of Allergy and Clinical Immunology. 2015;135(4):1070–1.

U.S Food & Drug Administration. Using Adverse Event Reports to Monitor Cosmetic Safety | FDA [Internet]. 2022 [cited 2022 Aug 25]. Available from: https://www.fda.gov/cosmetics/how-report-cosmetic-related-complaint/using-adverse-event-reports-monitor-cosmetic-safety

Berne B, Tammela M, Färm G, Inerot A, Lindberg M. Can the reporting of adverse skin reactions to cosmetics be improved? A prospective clinical study using a structured protocol. Contact Dermatitis. 2008 Apr;58(4):223–7.




DOI: https://doi.org/10.33508/jfst.v10i1.4132