Time for a makeover‐cosmetics regulation in the United States. (4th April 2019)

• Record Type: Journal Article
• Authors: Cornell, Erika M.; Janetos, Timothy M.; Xu, Shuai
• Is Part Of: Journal of cosmetic dermatology. Volume 18:Number 6(2019:Dec.)
• Page Start: 2041
• Page End: 2047
• Publication Date: 2019-04-04
• Subjects: cosmetic modernization amendments -- cosmetics regulation -- personal care products -- personal care products safety act; Skin -- Diseases -- Treatment -- Periodicals; Lasers in surgery -- Periodicals; Skin -- Pathophysiology -- Periodicals; Surgery, Plastic -- Periodicals; 616.5
• DOI: 10.1111/jocd.12886
• Languages: English
• ISSNs: 1473-2130

Abstract

Summary: Introduction: Cosmetics and personal care products are ubiquitous. Consumer pressure arising from recent episodes of products found to be unsafe has led to new policy proposals to modernize cosmetics regulation in the United States. Methods: We reviewed contemporary cosmetics regulation and collected major past and current policy proposals relating to cosmetics regulation with a focus on public health controversies. Results: Under a structure originally established in 1938 that places regulation of cosmetics under the Food and Drug Administration (FDA), cosmetics manufacturers in the United States are not required to register their products or forward consumer complaints to the FDA, leading to broad under‐reporting of adverse events. The FDA has limited authority to mandate product recalls. The existing FDA database system that collects adverse events related to cosmetics has limited public health utility. Current proposals for new cosmetics regulations seek to establish better systems for data collection and mandatory manufacturer registrations funded by cosmetic manufacturers. Additional policy changes could include a premarket review process for cosmeceuticals (cosmetics that make drug‐like claims) and more advanced real‐world data safety monitoring tools. Conclusions: With continued consumer concern and several recent cosmetic‐related public health controversies, the FDA should be given more resources and broader authority to protect consumer safety.