The U.S. cosmetics industry has recently undergone significant regulatory updates, including the discontinuation of the Voluntary Cosmetic Registration Program (VCRP) and the launch of a new webpage dedicated to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA, it can be downloaded via the button at the end of this news), which is the country’s new overarching cosmetic regulation.
On March 27, 2023, the U.S. Food and Drug Administration (FDA) announced that it would no longer accept and process submissions to the VCRP and would close the existing VCRP portal. The decision is in response to the introduction of MoCRA, which mandates facility registrations and product listings. 1
Every person, who owns or operates a facility engaged in the manufacturing or processing of cosmetic products for distribution in the United States, shall register each facility with FDA within one year after the date of enactment of the Act. In the case of a new facility engaging in the manufacturing or processing of cosmetic products for distribution in the United States for the first time, the owner or operator shall register such facility with FDA within 60 days after first engaging in such activity or 60 days after the existing facility registration deadline, whichever is later. All registrations must be renewed every two years.
The required registration information includes:
The facility’s name, physical address, email address, and telephone number;
For any foreign facility, the contact for the United States agent of the facility, and the electronic contact information (if available);
The facility registration number, if any, previously assigned by the FDA;
All cosmetic products’ brand names if the products are manufactured or processed in the facility;
The product category or categories and responsible person of each cosmetic product manufactured or processed at the facility.
Cosmetic Product Listing
For a cosmetic product that is marketed on the date of enactment of MoCRA, the responsible person shall submit to FDA a cosmetic product listing not later than one year after the date of enactment of MoCRA, or for a cosmetic product that is first marketed after the date of enactment of the Act, within 120 days of marketing such product in interstate commerce. The product listing shall be updated annually.
In general, each cosmetic product listing shall include:
The facility registration number of each facility where the cosmetic product is manufactured or processed;
The name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label;
The applicable cosmetic category or categories for the cosmetic product;
A list of ingredients in the cosmetic product, including any fragrances, flavors, and colors, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
The product listing number, if any, previously assigned by the FDA.
As such, FDA is developing a new system for handling the large number of submissions that will occur due to these new regulations. However, the exact date when this new system will be operational has yet to be announced.
It is important to note that the existing information and reports in the VCRP will not be transferred to the new system. Instead, FDA will archive the data, which companies cannot alter moving forward. Cosmetic companies must register their facilities and list their products, regardless of whether they had previously entered the information into the VCRP.
Therefore, it is recommended that stakeholders stop reporting to the VCRP and wait to register with FDA until the new system is available.
MoCRA Dedicated Webpage
In addition, as MoCRA brings greater scrutiny and oversight to the cosmetics industry, FDA launched a new web page which compiles information about the Act on the same day to keep stakeholders informed about MoCRA activities. 2
The webpage includes bullet points of the Act, a mailbox allowing companies to submit specific compliance inquiries to FDA, and related resources.