Bill Proposes New FDA Regulations for Cosmetics
On April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced into the Senate the “Personal Care Products Safety Act”. The bill would provide the U.S. Food and Drug Administration (FDA) with various new authorities to induce stricter regulation of the cosmetic industry.
“Europe has a robust system, which includes consumer protections like product registration and ingredient reviews,” said Senator Feinstein. “I am pleased to be introducing this bipartisan legislation with Senator Collins that will require FDA to review chemicals used in these products and provide clear guidance on their safety.”
New regulations proposed by the Personal Care Products Safety Act include:
Registration and Good Manufacturing Practices
Cosmetic companies would be required to register annually with FDA and pay user fees based on their annual gross sales of cosmetics. The fees would be used to fund the new cosmetic safety regulations. FDA would be required to issue Good Manufacturing Practices for cosmetics.
FDA would be required to review at least five ingredients each year to determine their safety and appropriate use. FDA would need to provide guidance to the cosmetic industry regarding whether ingredients should be used and, if so, what concentration levels should be used. FDA would also need to determine which ingredients warrant a consumer warning, such as ingredients that are inappropriate for use in children’s products and ingredients that should be administered professionally. The bill identifies five ingredients to be considered in the fiscal year 2016: diazolidinyl urea, lead acetate, methylene glycol (also known as methanediol and formaldehyde), propyl paraben, and quaternium-15.
Adverse Event Reporting and Recalls
Cosmetic companies would be required to list their contact information on their products and report adverse events to FDA within 15 days of their occurrence. FDA would have authority to order mandatory recalls of certain cosmetics that threaten consumer safety.
The bill is backed by numerous large cosmetic companies and consumer groups, including Johnson & Johnson, Estee Lauder, L’Oreal, Environmental Working Group, HealthyWomen, and more. Registrar Corp will keep industry informed as the Personal Care Products Safety Act progresses through congress.
Registrar Corp is a U.S. FDA consulting firm that helps cosmetic companies comply with FDA regulations. For questions about current or upcoming FDA regulations for cosmetics, contact Registrar Corp at +1-757-224-0177 or chat with Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.