October 20, 2023
The new e-submission process will streamline updated facility registrations, product listings for cosmetics manufacturers
Cosmetics manufacturers are anticipating the October opening of Cosmetics Direct, a new Food and Drug Administration electronic submission portal, where companies can update their facility registrations, document product listings, and substantiate safety claims in advance of federal Dec. 29 deadlines.
The new submission portal and year-end deadlines are key parts of the Modernization of Cosmetics Regulation Act (MoCRA), signed into law last year. MoCRA seeks to implement a robust regulatory process that will soon require manufacturers to document the safety of their cosmetics products and comply with new adverse event reporting requirements by the end of 2023.
Preparing submissions for Cosmetics Direct
With less than 60 business days until the federal deadline, manufacturers will soon be able to begin the documentation process with the official launch of Cosmetics Direct. To help industry prepare for the website's validation requirements, FDA released an 81-page preview (Electronic Submission Portal Screenshots for Cosmetics) last month that maps the user journey for facility registration and how to list cosmetic products. The preview also demonstrated common validation failures that can occur during submission.
The agency preview also explains 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, cosmetic 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.
Although paper forms can still be submitted to FDA (Draft Form 5066 for facilities and Draft Form 5067 for cosmetic products), the agency strongly encourages using the Cosmetics Direct portal for faster processing.
First major update to U.S. cosmetics regulation in almost a century
MoCRA is the first update to the Food, Drug, and Cosmetic Act in 85 years. The act requires manufacturers to document product safety and will have a global impact on the cosmetics industry. MoCRA affects any cosmetic facility that produces or sells in the U.S.
To demonstrate product safety in the short time frame left, cosmetics manufacturers will want 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 immediately to enable cosmetic product listings to meet the deadline.
MoCRA also grants FDA the 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 is seeking to enforce regulations with greater transparency over the cosmetics supply chain.
What Can We Help You Solve?
For both U.S. and international companies, Exponent can support cosmetics manufacturers in navigating the implementation of MoCRA. Our multidisciplinary international teams provide unparalleled expertise in cosmetic safety evaluations and testing to help you optimize product compliance and quality.