The Law Catches Up: America’s Cosmetics Act of 2022

For most of a century the FDA could act against a cosmetic once it was on the market and breaking the law,^[1] but it had no systematic way of knowing who made cosmetics, where, or with what.^[2]

In the agency’s own words: “This changed on December 29, 2022.”^[2]

The Federal Food, Drug, and Cosmetic Act of 1938 gave the FDA authority over cosmetics, and for the next eighty-four years that authority, in the agency’s words, “saw limited expansion”, the Fair Packaging and Labeling Act being the notable exception.^[3] Cosmetics, unlike drugs or medical devices, did not, and still do not, need FDA approval before they go on sale; colour additives are the exception.^[4]

The gaps were practical. Companies were responsible for the safety of their products, but there was no requirement to register a cosmetics facility, to list a cosmetic product or to report a serious adverse event, as many other FDA-regulated companies had to. A voluntary programme existed. Before the new law it had received 5,176 establishment registrations and 35,102 product listings.^[3]

The Modernization of Cosmetics Regulation Act, known as MoCRA, came after what the FDA calls “more than a decade-long bipartisan effort”.^[5] Manufacturers and processors must register their facilities with the FDA and renew the registration every two years. The “responsible person” — the manufacturer, packer or distributor named on the label — must list each marketed product, with its ingredients, and update the listing annually.^[6]

That person must also report any serious adverse event to the FDA within 15 business days. The definition is wide and plainly written with cosmetics in mind: besides death and hospitalisation it covers an infection and “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance)”.^[6] Companies must keep records supporting the safety of their products, and the FDA gained the power to order a recall when a company refuses to recall voluntarily, and to suspend a facility’s registration.^[6]

Small businesses are exempt from registration and listing, with an exception that falls squarely on makeup: the exemption does not cover products that regularly touch the mucous membrane of the eye, nor products meant to alter the appearance for more than twenty-four hours.^[6]

The registers filled quickly. Counting from 18 December 2023, the FDA recorded 16,398 active facility registrations and 1,298,361 active product listings by 30 June 2026.^[8] Its own comparison, made when the totals had passed 15,000 and a million, was a nearly three-fold rise in facilities and a thirty-fold rise in listings over the voluntary scheme; reports of adverse events from industry had more than tripled once they became mandatory.^[9]

The agency was careful about what the numbers meant. It issues no certificate of registration, and a registration or listing number “does not indicate FDA approval of the facility or its cosmetic products.”^[8] The listings had uses of their own. From them the FDA identified the twenty-five PFAS most commonly used in American cosmetics for the report on those substances that the Act required, published in December 2025; products containing them were 0.41 per cent of those listed as of August 2024.^[9]

The Act also ordered the FDA to make regulations: good manufacturing practice for cosmetics facilities, labelling of fragrance allergens, and standardised methods for testing talc-containing cosmetics for asbestos. As the agency’s page stood in August 2026, the first had reached a draft guidance and a listening session, and no proposal was listed for the second.^[10]

The third went furthest, and then back. On 27 December 2024 the FDA proposed a rule that would have required manufacturers to test talc-containing cosmetics, or the talc used in them, for asbestos, and would have treated any asbestos found as making the product adulterated. It drew 49 comments, among them warnings that it would reach many other consumer products and requests that its definition of asbestos match other federal agencies’. On 28 November 2025 the proposal was withdrawn, citing the Make America Healthy Again priorities, the technical issues raised and the complexity of asbestos testing, with a statement that a new proposed rule would be issued.^[11]

When the three rules will be final is not known. The withdrawal notice promises a new talc proposal without a date, and the agency’s page lists no proposal on fragrance allergens at all.^[12][13]

Nor is it known how many businesses that should have registered have not; the FDA’s figures count those that did. The rise in adverse-event reports is the agency’s own figure, and more reports are not the same thing as more harm.^[14] Even the agency’s history varies in its details: its blog dates the Fair Packaging and Labeling Act to 1967, while its chronology of food and drug law lists it under 1966.^[14][15]