Bipartisan bill introduced to expand FDA’s authority over cosmetic products.

  • Although FDA currently has authority to regulate cosmetic products marketed in the United States, regulatory action in this space has been dormant for decades.  Unlike with other product categories, FDA lacks mandatory recall authority for cosmetics and manufacturers are not required to disclose adverse health effects reported by consumers.
  • In April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act, intended to expand FDA’s regulatory authority over cosmetic products.  Cosmetic manufacturers (including ingredient manufacturers) would be subject to a facility registration requirement and would be required to pay a registration fee based on the registrant’s average gross annual sales in the United States.  FDA would have mandatory recall authority over cosmetics where exposure to such products is likely to cause serious adverse health consequences or death.  Under the bill, cosmetic companies also would be required to report “serious” adverse health events (e.g., resulting in death, disfigurement, or hospitalization) reported by consumers within 15 business days.  Cosmetic labels would need to include a domestic phone number or electronic contact information.  The bill also proposes to require FDA to issue regulations on good manufacturing practices (GMPs) for cosmetics and to review the safety of at least five different cosmetic ingredients each year.  The first candidates for a safety review would be:  (1) diazolidinyl urea (formaldehyde-releasing preservative); (2) lead acetate (color additive in men’s hair dye); (3) methylene glycol/methanediol/formaldehyde (formaldehyde-releasing chemical used in hair-straightening treatments); (4) propyl paraben (preservative); and (5) quaternium-15 (formaldehyde-releasing preservative).  Each of these ingredients has been subject to varying degrees of consumer concern and controversy in recent years.
  • The bill is supported by diverse stakeholders including members of the cosmetics industry and the advocacy group, Environmental Working Group (EWG).  Although this bill is not the first attempt to reform FDA’s regulation of cosmetics, it is the most comprehensive.  Particularly considering the support this bill has garnered from both sides of the aisle, as well as industry and consumer advocates, it potentially could be the most promising reform effort to date.