Washington — FDA Expands Cosmetics Oversight Under MoCRA in 2026

In Washington, cosmetics companies that once sold serums, lipsticks and shampoos with almost no federal check-in now answer to a registry, a paper trail and a reporting clock. The Modernization of Cosmetics Regulation Act, known as MoCRA, is moving into fuller enforcement in 2026, and a client alert from Foley & Lardner LLP outlines what that shift means for an industry the U.S. Food and Drug Administration (FDA) had regulated only lightly for more than eight decades, according to the firm's analysis and the FDA's own program page for the law.

What does MoCRA require cosmetics companies to do?

Signed into law in December 2022, MoCRA gives the FDA authority it had lacked over most cosmetic products, according to the agency's official summary. The statute moves cosmetics closer to the compliance framework long applied to drugs and food, layering in facility registration, product listing, ingredient safety substantiation and adverse event reporting. Foley & Lardner's alert frames 2026 as a year in which these obligations are landing with more practical weight on manufacturers, packers and distributors who market products in the United States.

Who must register facilities and list products with the FDA?

Under MoCRA, facilities that manufacture or process cosmetic products for the U.S. market are required to register with the FDA, and responsible persons must submit product listings identifying ingredients and other product information, the agency states on its MoCRA page. That requirement extends beyond large manufacturers to smaller labels and contract producers that had previously operated outside any federal registry. The FDA's guidance describes registration and listing as foundational tools that let the agency identify who makes a product and what is in it before a safety question ever arises.

What counts as "safety substantiation" under the law?

MoCRA also directs responsible persons to ensure there is adequate substantiation that a cosmetic product is safe, a standard the FDA describes as requiring reliable scientific evidence, such as tests, studies, research or other data, to support safety claims. Foley & Lardner's alert notes that this substantiation duty is not a one-time filing but an ongoing documentation obligation — companies must be able to produce records showing why a product is considered safe for its intended use, not merely assert that it is.

How are adverse events reported to regulators?

The law creates a formal adverse event reporting system, requiring responsible persons to keep records of adverse events associated with a cosmetic product and to report serious adverse events to the FDA, according to the agency's published overview of the statute. That reporting channel gives the FDA visibility it previously lacked into consumer complaints of illness or injury tied to specific products, information the agency can use to flag emerging safety patterns across a category rather than relying on isolated reports.

What do these rules mean for independent and small beauty brands?

Foley & Lardner's analysis points to compliance costs and administrative burden as a live concern for smaller companies navigating registration, listing and recordkeeping requirements that were designed with the full industry — from multinational manufacturers to single-product startups — in mind. The FDA's MoCRA page does not distinguish enforcement priorities by company size, meaning the same registration and substantiation duties apply broadly across the market, according to the agency's published materials.

What key terms should beauty brands know?

• Responsible person: the manufacturer, packer or distributor whose name appears on a cosmetic label, and the party MoCRA holds accountable for listing and safety substantiation.
• Facility registration: the FDA filing that identifies where a cosmetic product is made or processed.
• Product listing: the ingredient and product-category information submitted to the FDA for each cosmetic.
• Safety substantiation: the scientific evidence a responsible person keeps on file to support a product's safety.
• Serious adverse event: an FDA-reportable health outcome, such as hospitalization or death, tied to product use.

Readers following ingredient safety in their own routines can compare that regulatory backdrop against practical guidance already published by this outlet, including science-backed tips for a skin care routine and an explainer on retinol versus retinal, both of which touch on the kind of ingredient claims MoCRA's substantiation rule is meant to test.

The FDA has not published a full enforcement timetable for every MoCRA provision beyond the materials on its program page, and Foley & Lardner's alert stops short of predicting how aggressively the agency will act against noncompliant brands in the near term. What the firm and the agency agree on, in their respective materials, is the direction: cosmetics regulation in the United States is moving from a largely self-policed industry toward one with a federal paper trail attached to nearly every product on the shelf.