The Modernization of Cosmetics Regulation Act of 2022 expanded FDA authority over cosmetics and created requirements that include cosmetic facility registration, cosmetic product listing, serious adverse-event reporting, safety substantiation, and other obligations.

Manufacturers and processors of cosmetic products distributed in the United States generally must register covered facilities with FDA unless an exemption applies. Certain small businesses and certain facilities or products subject to drug or device requirements may be exempt.

Covered cosmetic facility registrations are renewed biennially — every two years — under section 607(a)(2) of the FD&C Act. FDA states that the renewal date is based on the facility's initial registration date, not a universal October-through-December annual window.

No. That schedule does not apply to MoCRA cosmetic facility registration. FDA's current 2026 guidance states that a cosmetic facility renews every two years from its initial registration date. Cosmetics Direct now displays each facility's registration status and renewal date.

A facility that is required to register should keep its registration current and complete the required biennial renewal by its FDA renewal date. Failure to meet the registration requirement can create a compliance issue. FDA suspension of a cosmetic facility registration is a separate enforcement authority and should not be confused with simply missing a renewal date.

Yes, foreign cosmetic manufacturing and processing facilities can be subject to the same facility-registration requirements when their cosmetics are distributed in the United States and no exemption applies. A covered foreign facility must also provide U.S. Agent contact information in its facility registration.

A responsible person must list each covered marketed cosmetic product with FDA, including product and ingredient information. Product listing is separate from facility registration and is submitted using Form FDA 5067 or another FDA-supported submission method.

The responsible person must provide product-listing updates annually. FDA also provides an abbreviated renewal option when the listing information has not changed.

Not necessarily. Facility registration renewal is biennial and tied to the facility's initial registration date. Product listing updates are annual obligations of the responsible person, so the two maintenance cycles should be tracked separately.

FDA states that cosmetic facility registration information must be updated within 60 days of a change to required registration information. A facility should not wait for its next biennial renewal if the 60-day update requirement applies.

FDA's current Form FDA 5066 provides a Biennial Registration Renewal option when the facility registration has changes and an Abbreviated Registration Renewal option when no registration information has changed since the previous submission.

The review can include facility name and address, FEI, facility contact information, owner or operator information, brand names, responsible-person names, product category codes, and U.S. Agent information for foreign facilities, as applicable.

The responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. The responsible person has the product-listing obligation, while the facility owner or operator is responsible for facility registration.

Our MoCRA registration and listing maintenance service is $849 USD per year. This is our annual professional service fee for ongoing maintenance support; it does not mean FDA requires the cosmetic facility itself to renew every year.

MoCRA exempts certain qualifying small businesses from facility registration and product listing requirements, but the exemption does not apply to specified higher-risk product categories. Eligibility should be reviewed based on the business and products involved.

Send us the facility name, FEI, initial registration date or current FDA renewal date, registration records, responsible-person information, product listing information, and U.S. Agent details when applicable. We will review the current status and identify the next required maintenance actions.