FDA Delays MoCRA Enforcement Until July 2024

With an e-submission portal still forthcoming, cosmetic manufacturers have an extra six months to file manufacturing facility registrations and product listings

In a move that may prove a relief for some cosmetics manufacturers, on Nov. 8 the Food and Drug Administration announced that new cosmetic product listing requirements and facility registrations — part of the Modernization of Cosmetics Regulation Act (MoCRA) —  will not be enforced until July 1, 2024, giving industry another six months to meet the mandatory reporting deadline. 

Previously, FDA had set a statutory deadline of Dec. 29 and announced its e-submission portal Cosmetics Direct would debut in October. However, the portal and new paper registration systems remain forthcoming. Importantly, despite the six-month delay on product listing and facility registration requirements, MoCRA's new adverse event reporting requirements will still go into effect Dec. 29.

Preparing for MoCRA product listing and facility registration submissions

The Cosmetics Direct e-submission portal and July 2024 reporting deadline are key parts of MoCRA. To help industry prepare for the portal's validation requirements, in September FDA released an 81-page preview (Electronic Submission Portal Screenshots for Cosmetics) that maps the user journey for facility registrations and how to list cosmetic products.

The preview also demonstrated common validation failures that can occur during submission and explained the Structured Product Listing (SPL) format that must be included as an XML zip file for all submissions. SPL is a document markup standard approved by the global standard Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. 

By using Cosmetics Direct, cosmetics manufacturers will adopt the same digital filing process used by pharmaceutical manufacturers for FDA drug submissions. Respondents who use Cosmetics Direct can also access their previous entries and submissions.

More about MoCRA   

Signed into law in December 2022, MoCRA is the first update to the Food, Drug, and Cosmetic Act in 85 years. The act implements a robust regulatory process that requires cosmetics manufacturers to document product safety and will have a global impact on the cosmetics industry. MoCRA affects any facility that produces cosmetics for distribution in the U.S and any cosmetic product sold in the country. 

To demonstrate their product safety inside the agency's time frame, cosmetics manufacturers will need to develop a strategy to organize information on product ingredients, regulatory requirements, and any adverse reporting incidents. Since product listings must include the facility registration number for each facility where the products are manufactured, it is essential that facility registrations are carried out as soon as possible to enable the cosmetic product listings to proceed by the deadline. 

MoCRA also grants the FDA authority to request records and order recalls if the agency determines a cosmetic product is likely to cause injuries. By establishing a record of where cosmetics are manufactured, what they are made from, and who is responsible for their production, FDA can enforce regulations with greater transparency over the cosmetic supply chain.

While paper forms (Draft Form 5066 for facilities; Draft Form 5067 for cosmetic product listings) can still be submitted to FDA, use of the Cosmetics Direct portal is strongly encouraged for faster processing.