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Cosmetics · United States
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), most cosmetics sold in the US need a registered facility, a listed product, safety substantiation records and a compliant label. FDA does not approve cosmetics before sale, so the responsibility sits with the company. We support the route, whether you export to the US or are already there.
Registration and listing in FDA Cosmetics Direct
The US in numbers
The FDA register
What MoCRA asks
Official sources, checked on 8 November 2026.
Is this for you?
The rules are the same. What changes is who acts in the US for you.
Your company is outside the US
Your company is in the US
The route
What it includes
Step 2 of 5
Records that show each product is safe as used.
Required records · Section 608What it includes
Step 3 of 5
A label that meets FDA rules and MoCRA additions.
On every pack · FPLA and MoCRAWhat it includes
Step 4 of 5
Facility registered, products listed, US agent in place.
Cosmetics Direct · Section 607What it includes
Step 5 of 5
Procedures prepared while the FDA GMP rule is pending.
Rule pending · Section 606What it includes
What changes and when
Dates checked on 8 November 2026. We confirm the current status in every project.
Coming from the EU or Brazil?
You already have
You need for the US
Why Sobel
Four disciplines work on every project, in the same team, from the first decision to post-market.
Classification and market sequence decided first. The right class from day one avoids rework.
Biological, clinical and toxicological evaluation by our own Clinical Evidence & Product Safety team.
ANVISA, FDA, EU MDR, MHRA and Health Canada, coordinated together.
A dedicated technology team builds the workflows that keep every project traceable and on time.
“We know how auditors think, because we’ve been one of them.”
Maik Endler
Founder & CEO
Questions, answered
Rules cited on this page: Modernization of Cosmetics Regulation Act of 2022 (MoCRA) · Federal Food, Drug, and Cosmetic Act, Chapter VI · Fair Packaging and Labeling Act · 21 CFR Parts 700–740
The Modernization of Cosmetics Regulation Act of 2022, signed on 29 December 2022. It is the most significant expansion of FDA's authority over cosmetics since 1938 and added facility registration, product listing, safety substantiation, adverse event reporting, labeling changes, GMP rules and mandatory recall authority.
Facilities that manufacture or process cosmetics for the US market register with FDA and renew every two years. The responsible person lists each product, with its ingredients, and updates the listing every year. Both are filed in FDA Cosmetics Direct. Some small businesses are exempt, but not for products such as eye-area, injected, internal-use or long-wear products.
No. Apart from color additives, cosmetics do not need FDA approval before sale. Under MoCRA, the responsible person must keep records that adequately substantiate the safety of each product.
Yes, for facility registration. A foreign facility that registers with FDA must name a US agent. The product listing is filed by the responsible person whose name appears on the label.
In English: the identity of the product, the net quantity, the ingredient list, the name and place of business and the required warnings. Since MoCRA, the label must also give a domestic address, phone number or electronic contact for adverse event reports.
The manufacturer, packer or distributor whose name appears on the label. The responsible person lists the products, keeps the safety substantiation and handles the obligations linked to each product.
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