FDA Cosmetic Safety and Modernization Act (S2003)

Yesterday, October 2, 2018, Senator Orrin Hatch introduced the FDA Cosmetic Safety and Modernization Act (S2003). The proposed bill, like many of its predecessors, including Personal Care Products Safety Act (S.1113) and Cosmetic Modernization Amendments of 2017 bill (H.R. 575), would fundamentally change the cosmetic industry.  Senator Hatch’s FDA Cosmetic Safety and Modernization Act (S2003) includes familiar changes like mandatory adverse event reporting but would also introduce new changes. For example, modifying the definition of what constitutes an adulterated cosmetic. Currently, the adulteration standard for cosmetics includes a hefty shield contained in the “except that this” carveout which dilutes the “bears or contains” standard for adulteration. The amendment is bolder, stating “For purposes of this clause, a cosmetic may be adulterated regardless of whether it is known which particular substance or substances may render the cosmetic injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.”

Other amendments include, mandatory registration requirement, which would replace the current Voluntary Cosmetic Registration Program (VCRP), a corresponding ability to have a registration suspended which would effectively stop all sales, a requirement to label with a domestic address or web address by which adverse events could be reported, and the establishment of Good Manufacturing Practices. There will also be an annual FDA review of ingredients to determine safety under a new Cosmetic Safety Standard, which is defined as “a cosmetic is safe if there is reasonable certainty that the cosmetic is not injurious to users under conditions of use prescribed in labeling or under such conditions of use as are customary or usual.”

The changes will bring cosmetics on par with other FDA regulated categories, like foods or dietary supplements. Still, there is a significant risk in provisions, like suspended registration, adverse event reporting, and GMPs, and non-compliance would be costly both from a regulatory point-of-view and also a civil litigation one.

Summary of Key Provisions

• Establishes GMPs
• Requires Adverse Event Reporting
• Mandatory Registration
• FDA Authority to Suspend a Registration
• Mechanism for Restoring a Suspended Registration
• Labeling Requirements
• Annual FDA Safety Review of Ingredients
• Accredited Third Party Reviews
• Record Inspections