The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the largest change to US cosmetics law since the Federal Food, Drug, and Cosmetic Act was passed in 1938. For brands based outside the US, it turned a market with few pre-launch formalities into one with registration, listing, safety records and reporting duties.
This guide covers what international brands should have in place before the first shipment.
The rules in force
At federal level, cosmetics fall under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). MoCRA, signed into law on December 29, 2022, added:
- facility registration
- product listing
- safety substantiation
- serious adverse event reporting
- new label content
- stronger FDA powers, including mandatory recall authority
State law sits on top. California’s Proposition 65 and ingredient restrictions in states such as Washington, Maryland and Vermont can go further than federal rules. A summary of FDA and MoCRA requirements for cosmetics helps map which obligations apply to a given product.
Cosmetic, drug, or both?
Under the FD&C Act, cosmetics are articles applied to the body for cleansing, beautifying, promoting attractiveness or altering appearance. Intended use decides the category. A moisturizer sold to improve the look of dry skin is a cosmetic. A similar product that claims to treat a disease or affect the body’s structure or function is a drug, or both a drug and a cosmetic.
Sunscreens and anti-dandruff shampoos, for example, are regulated as over-the-counter drugs. Acne, hair loss and other therapeutic skin claims raise the same question. Settle classification before any registration or label work starts.
Identify the responsible person
MoCRA places most duties on the “responsible person”: the manufacturer, packer or distributor whose name appears on the label. That company handles product listing, safety substantiation, adverse event reporting, label contact details and record keeping. Decide early whether this will be the brand, its importer or a US distributor.
Register manufacturing facilities
Facilities that manufacture or process cosmetics for the US market must register with FDA through the Cosmetics Direct portal.
- Obtain an FDA Establishment Identifier (FEI) before registering.
- Foreign facilities must name a US agent.
- New facilities register within 60 days of starting to manufacture or process products.
- Registrations are renewed every two years.
Facilities that only label, package, hold or distribute products are not covered. Registration is not approval: FDA does not certify facilities or products, and it does not issue registration certificates.
List every product
The responsible person must list each cosmetic product with FDA, also through Cosmetics Direct. A listing includes the facility registration number, product name, product category and ingredients, including fragrances, flavors and colors.
New products must be listed within 120 days of entering interstate commerce, and listings are updated every year. Products whose formulas differ only in color, fragrance, flavor or quantity can share one listing.
Check whether the small business exemption applies
Businesses with average US gross annual sales under $1 million over the previous three years (adjusted for inflation) are exempt from facility registration, product listing and the GMP requirements. The exemption does not apply to products that:
- come into contact with the mucous membrane of the eye
- are injected
- are intended for internal use
- alter appearance for more than 24 hours under normal use
The exemption does not remove duties such as adverse event reporting, safety substantiation or labeling.
Keep safety substantiation on file
MoCRA requires adequate substantiation of safety: tests, studies, research, analyses or other evidence that qualified experts would consider sufficient to support a reasonable certainty that the product is safe. The law does not prescribe a fixed test list, so the responsible person decides what evidence each product needs.
Ingredient rules still apply. Color additives, apart from coal tar hair dyes, need FDA approval for their intended use before they can be used in cosmetics.
Get the label right
Labels must meet FD&C Act and FPLA requirements on product identity, net contents, ingredient declaration and the name of the responsible company. MoCRA adds:
- a US address, US phone number or electronic contact (such as a website) for adverse event reports
- a “for professional use only” statement on professional-use products
MoCRA also requires fragrance allergen disclosure, but this depends on an FDA rule that, at the time of writing, has not been finalized. FDA is likewise required to set cosmetic GMP regulations. Check the current status of both before finalizing artwork and production plans.
Report serious adverse events
The responsible person must report serious adverse events linked to a cosmetic used in the US to FDA within 15 business days. New medical information received within a year of the report must also be submitted within 15 business days. Adverse event records are kept for six years, or three years for qualifying small businesses.
For international brands, customer service, distributors and regulatory staff often sit in different countries. Set up one route for complaints so that reportable events reach the right person in time.
Pre-launch checklist
- Confirm classification and review all claims
- Name the responsible person
- Review the formula, including color additives and state restrictions
- Prepare safety substantiation
- Review the label against FD&C Act, FPLA and MoCRA requirements
- Obtain an FEI, appoint a US agent and register the facility, unless exempt
- List each product within 120 days of launch
- Set up adverse event intake and record keeping
E-commerce makes products available across all 50 states from day one, so state rules apply from the start. Brands that work through this list during product development, not after it, reach the US market with fewer surprises.
