What the Modernization of Cosmetics Regulation Act requires of beauty brands

The Modernization of Cosmetics Regulation Act, known as MoCRA, gives the Food and Drug Administration a set of registration, reporting, record-keeping and recall powers over makeup, skincare, haircare and similar products.

For a founder building a beauty or personal care line, or a lifestyle brand adding one, the law sets out what must be filed, what must be kept on record and what must be reported. Some of its rules are still being written.

Registration and listing: what FDA now keeps on file

The law sets two filing duties. Facilities that manufacture or process cosmetics for distribution in the United States must register with FDA and renew that registration every two years.

Separately, the "responsible person" for each marketed cosmetic product must list the product with FDA, including its ingredients, and submit updates annually. The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.

FDA can suspend a facility's registration if a cosmetic product made there has a reasonable probability of causing serious adverse health consequences or death, and the agency has a reasonable belief that other products from the same facility may be similarly affected. Distributing products from a suspended facility is prohibited.

FDA published summary data on registrations and listings on March 13, 2025. The agency directs readers to its registration and listing page for the tabulated figures.

The small-business exemption and its four exclusions

MoCRA exempts certain small businesses from facility registration and product listing. It also exempts them from good manufacturing practice rules. FDA's materials describe the exemption as applying to "certain" small businesses.

The exemption does not reach every product a small company might sell. It does not apply to manufacturers of products that fall into four categories:

Products that regularly contact the mucous membrane of the eye under customary use. Products that are injected. Products intended for internal use. Products intended to alter appearance for more than 24 hours, where removal by the consumer is not part of customary use.

Some products and facilities already subject to drug or device requirements have their own exemptions.

FDA's fact sheet for small and homemade makers adds that making cosmetics at home is not against the law, but it is the maker's responsibility to keep products from becoming adulterated. Salon owners and homemade-cosmetic makers may be exempt from good manufacturing practice requirements, which FDA is still developing.

Adverse event reports and safety records apply to responsible persons

The registration exemption does not remove the duty to report serious adverse events. The responsible person must report a serious adverse event to FDA within 15 business days. The report must include a copy of the label on or within its retail packaging.

If new medical or other information about the event arrives within one year of the initial report, the responsible person must submit it to FDA within 15 business days. FDA can also access adverse event reports during inspections.

Responsible persons must also ensure their products are safe and keep records supporting adequate safety substantiation. FDA's guidance says neither the law nor its regulations require particular tests. Existing relevant safety data can be used, and animal testing is not required. It is important that all data used to support safety come from scientifically robust methods.

FDA has records access authority over certain cosmetic product records, including safety records, if specified conditions are met.

Labeling rules that already apply

Basic labeling rules apply to small and large brands alike. Labels must be truthful and not misleading. They must identify the manufacturer, packer or distributor with a physical address, not just a P.O. box or website, and ingredients must appear under their common or usual names.

Ingredient restrictions in 21 CFR 700.11 to 700.35 apply, and color additives must be approved by FDA for their intended use. Products do not need to be sterile, but they must not contain harmful microorganisms. Contaminants such as asbestos can make a product adulterated.

MoCRA requires FDA to set fragrance allergen labeling requirements by regulation, and the agency's page says only that this must be done through rulemaking.

Mandatory recalls and the rules FDA has not finished

The law now lets FDA order a recall if it finds a reasonable probability that a cosmetic is adulterated or misbranded and that its use will cause serious adverse health consequences or death, and the responsible person refuses to recall it voluntarily. FDA issued final guidance on mandatory recalls on Oct. 29, 2026.

Good manufacturing practices are one of the unfinished pieces. MoCRA requires FDA to establish regulations for cosmetic manufacturing facilities. FDA has held a public listening session and has issued draft guidance, but no final rule is listed.

Talc is another open item. FDA published a proposed rule on testing methods for asbestos in talc-containing cosmetics in December 2024, then published a withdrawal of that proposal in November 2025.

On PFAS, FDA published its "Report on the Use of PFAS in Cosmetic Products and Associated Risks" on Dec. 29, 2025.

What the sequence means for a brand's paperwork

The duties that apply today are registration, listing, adverse event reports and safety records. Each has a defined timing: registration every two years, listing updates annually, and serious adverse events within 15 business days.

MoCRA requires FDA to establish good manufacturing practice and fragrance allergen labeling rules, and no final rule for either is listed. Brands that fall within the small-business exemption are exempt from registration and listing but not from adverse event reporting, safety substantiation or the labeling rules.

Questions about specific products can be directed to FDA's Food and Cosmetic Information Center.