MoCRA explained: what the 2022 cosmetics law changed for brands

The Modernization of Cosmetics Regulation Act, usually shortened to MoCRA, was signed into US law in December 2022. It was the first major update to federal cosmetics oversight in decades.

This article is general information, not legal advice. Deadlines and requirements change, so confirm details with the FDA and a qualified advisor.

What changed

Before MoCRA, the FDA had limited tools to oversee cosmetics. The law gave the agency more authority and placed new duties on companies that make or sell these products.

The main obligations

• Facility registration: companies that manufacture or process cosmetics must register their facilities with the FDA.
• Product listing: products must be listed with the agency, including their ingredients.
• Adverse event reporting: serious adverse events linked to a product must be reported to the FDA.
• Safety substantiation: a responsible person must hold adequate evidence that each product is safe.
• Labeling: labels must include contact information for reporting adverse events.
• Recordkeeping: companies must keep records related to safety and adverse events.

The law also gave the FDA authority to order recalls of certain cosmetics when needed.

Who is the "responsible person"?

MoCRA assigns many duties to the responsible person, which is typically the manufacturer, packer or distributor whose name appears on the label.

What to do next

1. Read the FDA's current MoCRA guidance for exact deadlines, exemptions and forms.
2. Map your products and facilities against the requirements.
3. Document your safety substantiation for each product.
4. Set up an adverse event process before you need one.

The takeaway

MoCRA moves cosmetics oversight closer to how other regulated consumer products work. For brands, the practical work is documentation, registration and having a plan for complaints.

Common questions

What is MoCRA?

The Modernization of Cosmetics Regulation Act of 2022 is a US law that significantly expanded the FDA's authority over cosmetics.

Do small businesses have to comply?

Some requirements have limited exemptions for small businesses, but the rules are specific. Check the FDA's MoCRA pages for the current criteria and deadlines.