Personal Care Companies and the Implementation of MoCRA
In December of 2022, President Biden signed the Modernization of Cosmetics Regulation Act (MoCRA) into law, ushering in new regulations that significantly expanded the authority of the FDA over personal care companies. There have been years-long efforts to increase the FDA's oversight of the personal care and cosmetic industry, stemming from growing concerns regarding product safety. In 2018, there was an avalanche of lawsuits against Johnson & Johnson, alleging that the company's Baby Powder and other talc products were contaminated with asbestos. In November 2020, the Environmental Working Group (EWG) found asbestos in almost 15% of 21 powder-based cosmetic products, including make-up marketed to children.¹,²
MoCRA Boosts FDA Oversight with New GMP Requirements
New registration and listing requirements under MoCRA were enacted in July, and by the end of 2025, new Good Manufacturing Practices will become an FDA-mandated requirement.³ The FDA's cosmetics program will also receive significant funding increases. Previously operating under a limited budget of approximately 10M per year and with limited enforcement tools, MoCRA has authorized an increase in funding to the program, with nearly 26M allocated for 2024 and approximately 42M per year for 2025, 2026 and 2027.⁴ This funding will likely increase inspections and other enforcement activities by the FDA.
Considering these new changes, personal care companies should review their current manufacturing, marketing, and quality procedures to limit their risk of prompting unwanted FDA enforcement action.
Hardy Diagnostics understands the unique challenges of personal care and cosmetics companies and specializes in regulatory compliance and microbial testing solutions. Check out our newly updated Personal Care and Cosmetics catalog to learn more.
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Meet the author
PHARMACEUTICAL PRODUCT MANAGER at HARDY DIAGNOSTICS
Joelle Brackeen, B.S. Marketing
Joelle Brackeen is the Pharmaceutical Product Manager at Hardy Diagnostics and has over a decade of experience in Marketing and Product Management. Before transitioning to the pharma sector, Joelle had the privilege of co-founding and helping to grow a business into a highly profitable, multinational enterprise. Her unique blend of entrepreneurial spirit and product management expertise contributes to her innovative approach and ability to drive successful products and strategic initiatives in the pharmaceutical industry. In her free time, she enjoys playing the piano and spending time at the beach.
