Adverse Event Reporting Now Required for Cosmetic Products

Small Minnesota Company Leads Implementation of New FDA Legislation

It is a little-known business story that sounds too good to be true. A small start-up company from Minneapolis transforms consumer product safety across an entire industry – and then goes on to lead seismic shifts in two additional industries and counting. And it all began with a tainted bottle of …

FDA updates 3500A instructions to provide direction for mandatory cosmetics reporting

FDA released an updated guidance for industry to include instructions on mandatory adverse event reporting for cosmetics. Mandatory reporting was included in the sweeping legislative update for cosmetics last year, passed as part of the appropriations package that was signed into law on December 29th, 2022. These are the most significant changes for the industry since cosmetics initially …

What We Know About MoCRA

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938. Among other changes in requirements,  MoCRA establishes the first ever requirement for cosmetic companies to monitor and document all consumer allegations of adverse health effects and report to the FDA …

SafetyCall Attends The Personal Care Product Council’s (PCPC) Legal & Regulatory Conference

Earlier this month, SafetyCall attended The Personal Care Product Council’s (PCPC) Legal & Regulatory Conference in Quebec City, Canada. The conference was well attended by legal and regulatory leaders within the personal care space, and covered a variety of topics including clean beauty, updates on sunscreen regulations, pending and passed poly- and perfluoroakyl (PFAS) regulations, an address by Dr. Katz …