The FDA opened a listening session for public commentary of the GMP section of MoCRA (The Modernization of Cosmetics Regulation Act) on June 1st. The session lasted approximately 5 hours and was moderated by Dayle Lewis Cristinzio, Director, Stakeholder Engagement, Office of External Affairs of the FDA. It hosted approximately one hundred scheduled speakers from the US, as well as international participants. The participants’ representatives ranged from small businesses and non-profit organizations like Personal Care Product Council and the EWG, to speakers from large corporations like L’Oréal, P&G, Estee Lauder, and Mary Kay.
The FDA was urged by many of the speakers to consider ISO 22716:2007, which establishes the international standard for GMP compliance and already is observed by many international cosmetic companies. This standard “gives guidelines for the production, control, storage, and shipment of cosmetic products” and is internationally recognized as an existing GMP standard. The application of ISO 22716 would help companies looking to export products internationally and would also support cosmetics companies in other countries looking to export products to the US.
Small businesses representatives commented on concerns about undue burdens on small businesses, which the FDA defines as having no more than 500 employees, including affiliates. They raised concerns about the GMP regulations imposing undue burdens regarding compliance. MoCRA stipulates that small businesses with less than $1 million average annual turnover for the previous three years can qualify for some exemptions, though many small businesses operate on thin margins that just break that cap. Also, many of these small businesses are owned and operated by women or people of color; adhering to regulations could create additional financial stress.
Possible international impact
Many international commentators spoke in support of MoCRA’s GMP regulatory implementations. In China, the current GMP standards are stricter than the current standards in the US, which slows a US company’s attempted entries into the Chinese market. Reciprocally, clarifications to the US GMP regulations and definitions will also make it easier for Chinese companies to enter the US market. Currently the FDA (US) and CSAR (China) define cosmetics differently.
Most of the commentators urged the consideration of ISO 22716, which would clarify these issues by establishing an internationally recognized guideline for GMPs and provide a universal set of standards for all companies to follow regardless of origin. This would also solve issues with mislabeling of ingredients upon import and export.
The session concluded and all speakers and attendees were encouraged to submit additional comments to FDA docket by the July 3, 2023 deadline.