MoCRA is the Modernization of Cosmetics Regulation Act of 2022. The FDA calls it the most significant expansion of its power over cosmetics since 1938. The law adds facility registration and product listing. It adds safety records and adverse event reporting too.
The reach is wide. On average, people use 6 to 12 cosmetics products each day, the agency notes. Most duties fall on companies, not shoppers. Some small businesses qualify for exemptions. The FDA frames the goal in plain terms: the law helps ensure the safety of products many people use daily.
What did MoCRA change?
The FDA's MoCRA page lays out the shift from the old baseline. The core law dated to 1938, and the cosmetics aisle has changed a lot since then. MoCRA hands the agency two new tools. It can access company records, including safety files, when set conditions are met. It can also order a recall. That power applies when a product is likely tainted or mislabeled, poses serious health risks, and the company refuses to recall on its own. The scope stays narrow. It turns on serious health risk, not on a label someone dislikes.
Which products fall under the law?
The FDA counts everyday grooming among regulated cosmetics. Its MoCRA page lists common examples.
- Makeup and nail polish
- Perfume
- Shaving cream and grooming products
- Face and body cleansers
- Haircare products
- Moisturizers and other skincare
Perfume counts too, which matters because scent allergens get their own labeling rules later. Drugs and devices follow their own tracks, with some carve-outs written into the law.
What do register and listing rules require?
Makers and processors must register their facilities with the FDA. Renewals come every two years. Each marketed product must be listed as well, with its ingredients. Updates come once a year. The FDA can suspend a facility if products made there carry a serious risk. Small businesses are exempt from parts of this. The break ends for products that touch the eye area, get injected, are meant for internal use, or change looks for more than 24 hours. Readers following this should also see FDA approves first new sunscreen filter in 20 years.
What does safety substantiation mean?
The law requires the responsible person to keep records behind each product's safety case. The FDA defines that person as the company named on the label. No specific tests are required to prove safety. Animal testing is not required either. The data must still come from scientifically robust methods, whatever form it takes. The records must stay on file, ready for an FDA records request.
How do adverse events and recalls work now?
A responsible person must report serious adverse events within 15 business days. The agency ties that term to the most severe outcomes: death, a hospital stay, an infection, a birth defect, or major lasting harm, among others it lists. Reports must include the product label. Follow-up facts go to the FDA within one year. The clock starts when the company gets the report. Shoppers can browse reported events in the agency's public dashboard, so patterns become visible over time.
What is still in progress?
MoCRA also sets rulemaking in motion. The FDA must write good manufacturing practice rules for facilities. It must set rules for labeling fragrance allergens. It must standardize tests for asbestos in talc products. In December 2025, the agency published its report on PFAS use in cosmetics and the safety evidence around it. We covered a connected angle in PFAS in Cosmetics: FDA Report Finds Safety Data Gaps for Most Chemicals.
Conclusion: the paperwork era for cosmetics
MoCRA does not ban anything on its own. It moves US cosmetics off a 1938 baseline and into a system of filings and records. Brands now feed the FDA a paper trail: who made what, what is in it, and the safety case behind it. For now, shelves look the same. The paper trail behind them does not.
