As part of the government Omnibus spending bill passed at the end of 2022, Congress enacted the Modernization of Cosmetics Regulation Act.  “MoCRA”, as it is commonly known, is the first significant cosmetics regulation in the U.S. since 1938, when cosmetics was added to the Federal Food, Drug and Cosmetic Act.  It expands the Food and Drug Administration’s (FDA) authority to regulate cosmetics and immediately preempts state and local laws that differ from the federal framework.  The preemption provision does have some carveouts, however, such as a state’s ability to ban ingredients in cosmetic products.

For the cosmetics industry, key requirements of MoCRA include:

• Adverse Event Recordkeeping and Serious Adverse Event Reporting
• Mandatory Facility Registration and Product and Ingredient Listing
• Cosmetic Safety Substantiation
• Cosmetic Labeling and Fragrance Allergen Transparency
• Good Manufacturing Practices

Under MoCRA, the FDA was given new enforcement authorities:

• Facility Suspension
• Records Access
• Mandatory Recall Authority

Also notable, the FDA must issue three new rules via the notice-and-comment rulemaking process: 

• The cGMP rule will require cosmetic manufacturers to meet cosmetic manufacturing and processing standards.
• The fragrance allergen rule will require cosmetic product labels to indicate when the product contains certain fragrance allergens.
• The talc rule will require industry to use standardized testing methods to detect asbestos in talc- containing cosmetics.

The FDA will issue a proposed cGMP rule within two years after MoCRA’s enactment, and a final rule within three years.  The fragrance allergen and talc rules must be proposed within 18 months after MoCRA’s enactment, and final rules issued no later than 180 days after the close of each rule’s public comment period.

What can the cosmetic industry do in preparation for MoCRA?  

• Stay in the know and get involved.  There will be plenty of opportunity to provide comments to the FDA during the rulemaking process.
• As the process moves along, evaluate your current internal procedures to identify gaps and assemble your compliance dream team.
• Contact us to see how we can help!