What does MoCRA require of cosmetics companies selling in the US?

MoCRA was enacted on 29 December 2022 as part of the Consolidated Appropriations Act, 2023 (Public Law 117-328). It added sections 604 to 614 to Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act), codified at 21 U.S.C. 364–364j.

Most duties fall on the “responsible person”: the manufacturer, packer or distributor whose name appears on the label (§ 604(4)). FDA’s guidance confirms that a company outside the US can be the responsible person.

Facility duties fall on whoever owns or operates a site that manufactures or processes cosmetics for US distribution, including sites abroad. Sites that only label, package, hold or distribute are not “facilities”; filling containers does not count as packaging (§ 604(3)).

Cosmetics that are also drugs, such as sunscreens or anti-dandruff shampoos, follow drug rules for most MoCRA duties (§ 613). The fragrance allergen and professional-use labelling provisions still apply to them.

MoCRA’s enforcement provisions took effect on 29 December 2023 (MoCRA § 3503(b)(1)). FDA chose not to enforce registration and listing until 1 July 2024, and has enforced them since.

Mandatory recall (§ 611): FDA may act when there is a reasonable probability that a cosmetic is adulterated or misbranded and will cause serious harm or death. If the responsible person refuses a voluntary recall, FDA can order distribution to stop, then a recall. FDA finalised its recall guidance on 23 October 2026.

Records access (§ 610): if FDA reasonably believes a product is adulterated and threatens serious harm or death, it can inspect and copy related records. Formulas, financial and pricing data are excluded, but safety substantiation data are not. FDA’s guidance on this power is still a draft (January 2026).

Registration suspension (§ 607(f)): FDA can suspend a facility’s registration if a product risks serious harm and the failure may affect other products. Products from a suspended facility cannot be sold in the US.

Failing to register or list, or ignoring a recall order, is a prohibited act under FD&C Act § 301(hhh) and (iii).

A product without adequate safety substantiation is deemed adulterated (§ 601(g)). A label missing the information required by § 609, such as the adverse event contact, makes the product misbranded (§ 602(b)(3)). Introducing an adulterated or misbranded cosmetic into interstate commerce is a prohibited act (§ 301(a)), as is failing to keep the adverse event records or submit the reports required by § 605 (§ 301(e)).

FDA has missed MoCRA’s deadlines for three rules. None has a proposed rule pending on 26 October 2026, based on the Federal Register and the 2026 Unified Agenda (published August 2026).

Until these rules exist, the related duties cannot be enforced. General adulteration law still applies: asbestos in talc or insanitary manufacturing can make a product adulterated (§ 601). FDA’s 2013 draft GMP guidance, which draws on ISO 22716, is not binding.

FDA published the PFAS report required by MoCRA § 3506 on 29 December 2025. It found 51 PFAS in 1,744 listed formulations; 19 of the 25 PFAS reviewed lacked data for a safety conclusion, and 5 were of low safety concern. It flagged a potential safety concern for perfluorohexylethyl triethoxysilane in body lotion at the highest use level. The report sets no restriction.

A responsible person or facility qualifies if its average US cosmetic sales over the previous 3 years are below $1,000,000, adjusted for inflation (§ 612). FDA’s guidance recommends using the GDP implicit price deflator for that adjustment.

The exemption covers only facility registration, product listing and the future GMP rules. Small businesses still report serious adverse events, substantiate safety, meet labelling rules and face recalls. Their adverse event records need only be kept for 3 years.

FDA issues no exemption certificates. The exemption does not apply, whatever the sales, to businesses that manufacture or process any of these products:

States cannot keep or adopt rules that differ from MoCRA on registration and listing, GMP, records, recalls, adverse event reporting or safety substantiation (§ 614(a)).

Section 614(b) preserves state power to ban or limit cosmetic ingredients. States may also keep ingredient-reporting requirements that existed when MoCRA was enacted. California’s ingredient bans therefore still apply alongside MoCRA.

State product liability and damages claims are not preempted (§ 614(c), the savings clause). Labelling preemption still runs through FD&C Act § 752 (21 U.S.C. 379s). It spares state ballot-initiative rules adopted before 1 September 1997, such as California’s Proposition 65.