MoCRA vs VCRP: What Changed and What You Need to Do Now

What Was the VCRP?

The Voluntary Cosmetic Registration Program (VCRP) was an FDA program established in the 1970s that allowed cosmetics companies to voluntarily register their manufacturing facilities and file ingredient statements for their products. As its name implied, the VCRP was entirely voluntary — there were no penalties for not participating, and FDA had no authority to compel registration.

Under the VCRP, companies submitted Form FDA 2511 (Cosmetic Product Establishment Registration) and Form FDA 2512 (Cosmetic Product Ingredient Statement). FDA used this data to monitor the cosmetics market, but participation was low — only an estimated 30–40% of cosmetics companies registered voluntarily.

The VCRP had no provisions for adverse event reporting, safety substantiation, or labeling requirements beyond what was already in the FD&C Act. FDA could not take enforcement action against companies that chose not to participate.

What Changed with MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law on December 29, 2022, as part of the Consolidated Appropriations Act of 2023, replaced the VCRP with a mandatory regulatory framework. Key changes include:

What Happened to VCRP Registrations?

If your company was registered under the old VCRP, that registration does not automatically transfer to MoCRA. FDA retired the VCRP system and launched Cosmetics Direct as the new portal for MoCRA registrations and product listings.

Companies that were previously registered under VCRP must create a new account in Cosmetics Direct, submit a new facility registration, and list all products under the MoCRA framework. There is no grandfathering or automatic migration.

This caught many companies off guard in 2024. If you relied on your VCRP registration and have not yet re-registered under MoCRA, you are currently non-compliant and should act immediately.

New Obligations You Didn't Have Under VCRP

Beyond registration and listing, MoCRA introduced several obligations that did not exist under the VCRP:

• Responsible Person designation: Every product must have a designated Responsible Person (the entity on the label) who bears legal obligations for compliance
• Contact information on labels: Labels must include a domestic phone number or electronic contact for consumers to report adverse events (FD&C Act §609)
• GMP requirements: FDA is authorized to establish Good Manufacturing Practice regulations for cosmetics (rulemaking anticipated in 2026)
• Fragrance allergen disclosure: FDA has proposed requiring specific fragrance allergens to be listed on labels (NPRM pending)
• FDA inspection authority: FDA can now inspect cosmetics facilities and access records related to safety substantiation and adverse events

What You Need to Do Now

If you are a cosmetics company that was previously registered under VCRP — or never registered at all — here is your action plan:

1. Register in Cosmetics Direct: Create an account and submit your facility registration immediately
2. List all products: Submit product listings for every cosmetic product currently marketed in the U.S.
3. Designate a U.S. Agent (if foreign): Foreign facilities must have a U.S. Agent. Assurentry can serve as your U.S. Agent.
4. Set up adverse event reporting: Establish an SOP for receiving, assessing, and reporting serious adverse events
5. Update labels: Add the Responsible Person's contact information for adverse event reporting
6. Compile safety substantiation: Document the safety data supporting each product's formulation