Most of what MoCRA asks of cosmetics companies is already enforceable. Serious adverse event reporting has been enforceable since December 29, 2023, and FDA's grace period for facility registration and product listing ended on July 1, 2024. The rules FDA itself was supposed to write are a different story. Several are late, one was withdrawn, and none of the big ones has been proposed.
What is in force now
Manufacturers and processors must register their facilities, update a registration within 60 days of a change, and renew every two years. The renewal clock runs from your own initial registration date, so facilities that registered around the 2024 deadline should check their renewal date now. FDA's Cosmetics Direct portal now shows it.
The responsible person, meaning the manufacturer, packer or distributor whose name appears on the label, must list each marketed product with its ingredients and the registration number of each facility that makes it, and must update listings every year. That same company must report serious adverse events to FDA within 15 business days, with a copy of the label, keep its adverse event records for six years (three for small businesses), and keep records supporting the product's safety substantiation. Of all of these, the substantiation file deserves the most attention. It is one of the first things we would expect FDA to ask for.
FDA's enforcement tools are filling in too. The agency can access and copy certain records, and it issued draft guidance on that in January 2026. It can order a recall when a company refuses to recall voluntarily, and it finalized question-and-answer guidance on mandatory recalls in October 2026.
Certain small businesses are exempt from registration and listing. The exemption does not cover products that regularly contact the mucous membrane of the eye, are injected, are meant for internal use, or are meant to alter appearance for more than 24 hours.
What is still waiting on FDA
MoCRA required FDA to propose cosmetic GMP regulations by December 29, 2024. The agency has not published a proposed rule and has not set a target date for one. Fragrance allergen labeling at least has a target date: the statute set June 29, 2024 as the deadline for a proposal, and FDA's current regulatory agenda now targets November 2026, after an earlier target of May 2026. A separate FDA rule to ban formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products also carries a November 2026 target. These are agency targets, not deadlines, and both have slipped before.
Talc went the other way. FDA proposed standardized asbestos testing methods for talc-containing cosmetics in December 2024 and withdrew the proposal in November 2025. And FDA's December 2025 report on PFAS in cosmetics found it lacked enough data to determine the safety of most of the PFAS it reviewed.
What to do now
Confirm your renewal dates and that every listing reflects the current formula and facilities. Test your adverse event intake: can a complaint that reaches customer service get to FDA in 15 business days? Then look at your safety files product by product. If you sell fragranced products or hair smoothing treatments, start mapping fragrance allergens and formaldehyde releasers in your formulas now. The EU's allergen list is a sensible starting point, and the work will be needed whatever FDA's final rules say.
How MDRXLaw can help
We help cosmetics brands, manufacturers and importers with MoCRA registration and listing, adverse event procedures, safety substantiation records, labeling and FDA recall or inspection issues. To review where your company stands, contact us at info@mdrxlaw.com or 212-668-0200.
Sources: FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA); FDA, Registration and Listing of Cosmetic Product Facilities and Products; reginfo.gov, Disclosure of Fragrance Allergens in Cosmetic Labeling (RIN 0910-AI90). This alert is for general information and is not legal advice.
