MoCRA: What Changed for US Skincare Shoppers

MoCRA — the Modernization of Cosmetics Regulation Act of 2022 — is the largest expansion of FDA authority over cosmetics since 1938. It requires cosmetic manufacturers to register their facilities, list their products with the FDA, keep safety substantiation records, and report serious adverse events. It does not mean the FDA approves cosmetics before sale, and no brand can claim it does.

What it actually requires of brands

• Facility registration. Manufacturers and processors register with the FDA and renew periodically.
• Product listing. Each marketed cosmetic product is listed with its ingredients.
• Safety substantiation. Brands must hold records supporting that a product is safe as used.
• Adverse event reporting. Serious adverse events must be reported to the FDA within 15 business days.
• A Responsible Person named on the label, who carries these duties.

The FDA maintains its own overview of the Modernization of Cosmetics Regulation Act.

What it does not mean

This is the part worth being clear about, because it is already being misrepresented in marketing.

• Cosmetics are still not FDA-approved. Registration and listing are not approval. A brand implying otherwise is making a claim MoCRA does not support.
• It does not make a product effective. Safety substantiation is about safety, not results.
• “MoCRA compliant” is not a certification. There is no badge, seal or logo. Any that you see is invented.

What it changes for you as a shopper

1. A Responsible Person is named. There is an identifiable entity behind the product, not just a brand name.
2. Adverse events get reported. If a product causes a serious problem, there is now a route for that to reach the FDA.
3. Fragrance allergen labelling is coming. MoCRA directs the FDA to require disclosure of fragrance allergens — significant if you react to scent.

A reasonable thing to ask a brand

Not “are you MoCRA compliant” — every brand will say yes. Better questions: who is the Responsible Person, where is the product manufactured, and is the full ingredient list published. Those have checkable answers.

If a brand cannot answer the third one, the first two are unlikely to be forthcoming either.

Common questions

Does MoCRA apply to imported cosmetics?

Yes. Products marketed in the US fall under it regardless of where they are made, and a foreign manufacturer needs a US agent.

Does it cover supplements?

No. Dietary supplements are regulated separately under DSHEA, which is why supplement pages carry a different disclaimer to cosmetic ones.

Can I look up a registered facility?

FDA registration data is not published as a consumer-facing searchable directory in the way food facility data is. Ask the brand.

We publish the full ingredient list for every product in the range, and where a certification is not held, we do not imply one. Our disclaimer sets out how we treat cosmetic and supplement claims differently.