Personal Care Products Safety Act Calls for Modernization of Cosmetic Regulation

Reintroduction of the Personal Care Products Safety Act offers an opportunity for health care providers to integrate personal care product safety evaluation into patient care, leading to the tracking and reporting of adverse events that require medical attention, according to the results of a report published in the Journal of the American Academy of Dermatology.¹

Based on a survey by the Environmental Working Group, the average adult uses 9 personal care products, including cosmetic (hair care products, makeup) and medical (sunscreen, deodorant, toothpaste) products every day, which equates to daily exposure to 126 unique chemical ingredients.²

Other than fragrances and flavors, which are merely labeled as such and their components considered exempt from public disclosure, the label of every cosmetic product must list all of its ingredients. The US Food and Drug Administration (FDA) is thus able to investigate whether cosmetic products are appropriately labeled or are contaminated.

The FDA’s jurisdiction in monitoring the safety of cosmetic personal care products is nonetheless limited in comparison with its safety oversight of the medical, drug, and food industries. With no authority to require the reporting of adverse events linked to the use of cosmetic products, “the FDA is limited to an opaque perspective of the post-market effects of cosmetic products, thereby rendering consumers vulnerable to possibly more serious and long-term adverse events.”¹

The Personal Care Products Safety Act (S.1113), which was reintroduced to the Senate in May 2017, would establish an FDA Cosmetics Safety Advisory Committee, thus expanding the agency’s authority over personal care products through the following 4 major jurisdictional changes:

• All manufacturers that produce cosmetic products sold in the United States would be required to register their facilities with the FDA and to conform to good manufacturing practices.
• Companies would be required to submit a cosmetic ingredient statement, which includes a range of possible amounts of each ingredient, to the FDA, with this statement also available to consumers.
• Companies would be required to track and to report immediately to the FDA any serious adverse events, not including simple, transient rashes or product efficacy complaints.
• It would become mandatory for the FDA to evaluate the safety of ≥5 ingredients per year by reviewing available data and, if necessary, conducting its own investigative studies. 

The initial 5 chemicals to be investigated by the FDA under the Personal Care Products Act include: diazolidinyl urea (preservative in makeup, aftershave, baby products), lead acetate (color additive in hair dye), methylene glycol/methanediol/ formaldehyde (hair straightener and preservative in hair products), propylparaben (preservative in moisturizers, makeup, hair products, aftershave), and quaternium-15 (preservative and surfactant in moisturizers, makeup, hair products, baby products).

The investigators concluded that expanding FDA authority over the personal care product market is long overdue. They encourage Congress to vote in favor of protecting the public from potentially harmful personal care products, viewing the Personal Care Products Safety Act as an opportunity for health care providers to integrate the evaluation of personal care product safety into patient care. Further, the public has a right to understand the risk profile associated with any product that it uses.

References

1. Nguyen HP, Bergfeld WF, Forman HP, Belsito DV, Bolognia JL. Modernizing regulation of cosmetic products: reintroduction of the Personal Care Products Safety Act [published April 3, 2018]. J Am Acad Dermatol. doi:10.1016/j.jaad.2018.03.045
2. Environmental Working Group. Exposures add up – Survey results. 2004. www.ewg.org/skindeep/2004/06/15/exposures-add-up-survey-results/. Accessed May 6, 2018.