U.S. Cosmetics Regulation Has Changed | What Became Mandatory Under MoCRA 2022

In the United States, the Modernization of Cosmetics Regulation Act (MoCRA) was enacted on December 29, 2022. The U.S. Food and Drug Administration (FDA) describes it as the law that most significantly expands FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938. Here, we organize what became newly mandatory based on materials published by the FDA.

The United States originally had “no premarket approval”

According to the FDA, in the United States there is no system under which the FDA approves cosmetics or cosmetic ingredients before sale, except for certain color additives. Ensuring safety has basically been regarded as the responsibility of the party that manufactures or sells the product. MoCRA can be described as a law that keeps this framework while adding tools for the authorities to understand market conditions and respond if problems arise.

Main obligations

• Facility registration: Cosmetic manufacturing and processing facilities must register with the FDA and renew every 2 years.
• Product listing: The responsible person (the manufacturer, packer, or distributor whose name appears on the label) submits the products they sell, together with their ingredients, to the FDA and updates the information annually. Enforcement of the registration and listing requirements began on July 1, 2024.
• Serious adverse event reporting: If a serious adverse event related to the use of a cosmetic product in the United States becomes known, it must be reported to the FDA within 15 business days.
• Label contact information: The label must include a domestic address, domestic telephone number, website, or other electronic contact point for receiving adverse event reports.
• Safety substantiation: Records that support the safety of the product must be secured and maintained.

In addition, the FDA was given authority to access safety-related records and, in certain cases, to order recalls. Small businesses below a certain size are exempt from requirements such as registration and listing, but products that routinely come into contact with the mucous membrane of the eye, products that are injected, products used inside the body, and products that alter appearance for more than 24 hours are not eligible for the exemption.

According to the FDA’s public information, as of June 30, 2026, there were 16,398 active facility registrations and 1,298,361 product listings under MoCRA. Under a system without premarket approval, it has become possible to understand numerically which facilities handle which products.

What remains to be decided

MoCRA also requires the FDA to establish rules on fragrance allergen labeling and Good Manufacturing Practice (GMP). In December 2025, the FDA also published a report on the use of PFAS (per- and polyfluoroalkyl substances) in cosmetics and related risks. The EU is ahead in the individual labeling of fragrance allergens. For trends in cosmetics imports and exports, see this article as well.

Reference: U.S. Food and Drug Administration (FDA)

—The Value Village Editorial Team