FDA Cosmetics Regulation

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Beauty Business

The United States federal regulatory framework governing cosmetic products, administered by the Food and Drug Administration, which has been significantly strengthened by the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, introducing mandatory facility registration, product listing, and adverse event reporting requirements.

Deep Dive

MoCRA Transformation

The 2022 Modernization of Cosmetics Regulation Act represents the most significant update to US cosmetics regulation since 1938. MoCRA introduced mandatory facility registration, product listing, safety substantiation, adverse event reporting, and GMP requirements, bringing US regulation closer to international standards.

Key Requirements

Under the updated framework, cosmetic manufacturers must register facilities with the FDA, list products and ingredients, report serious adverse events, maintain safety records, and follow good manufacturing practices. These requirements apply to both domestic manufacturers and foreign companies exporting to the US.

Industry Impact

MoCRA has increased compliance costs for beauty brands, particularly smaller companies with limited regulatory infrastructure. However, the standardization of safety requirements is expected to enhance consumer confidence and reduce the incidence of unsafe products reaching market.

OSF Perspective

OSF recognizes MoCRA as a watershed moment for US beauty regulation, one that raises the bar for all market participants while potentially advantaging larger companies with existing compliance infrastructure.

Notable Brands

FDA, Personal Care Products Council, Independent Beauty Association

Deep Dive

MoCRA Transformation

Key Requirements

Industry Impact

OSF Perspective

Related

Regulatory Compliance (Cosmetics)

EU Cosmetics Regulation