Last week, FDA provided a glossy update on ongoing activities related to the new cosmetic product facility registration and cosmetic product listing requirements that are now mandated under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
In our prior News & Insights articles here and here, we discussed cosmetic facility registration requirements, which includes the requirement that cosmetic product manufacturers and processors register their facilities with the FDA, update content within 60 days of any changes, and renew their registration every 2 years, with a current registration deadline of December 29, 2023. This also requires a responsible person (defined as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of the cosmetic product) to list each marketed cosmetic product with the FDA, including product ingredients, and to provide FDA any updates annually. Note that small businesses (average sales of 1 million per year except those making eye products and a few other exceptions) are exempt. We have also discussed FDA’s issuance of its August 2023 draft guidance which provides the FDA’s recommendations and instructions to submit cosmetic product facility registrations and product listings to FDA.
If you think you have already met the requirements by registering with the FDA’s Voluntary Cosmetics Reporting Program (VCRP), you will be disappointed and may need to grab some extra CC cream to neutralize those registration induced dark circles! FDA discontinued taking VCRP registrations on March 27, 2023, and will not transfer information to the new system.
In terms of where things are at, FDA received more than 40 comments on the draft guidance and is in the process of evaluating the comments. FDA also announced an opportunity to comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067) in September 2023. FDA is now in the process of obtaining approval from the Office of Management and Budget (OMB) in the Executive Office of the President. Additionally, in October 2023, FDA announced publication of the Structured Product Labeling (SPL) Implementation Guide with Validation Procedures to help guide users on the transmission of SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG) for cosmetic product facility registrations and product listings.
The FDA intended to have the new system Cosmetic Direct running in October, but as of November 6, the Cosmetic Direct system is still getting plumped and polished.
In FDA’s latest update, the agency advised that it will provide additional information on the launch date for electronic submission and paper submission forms in the coming weeks. The Agency is strongly encouraging electronic submissions to facilitate efficiency and timeliness of data submission and management. FDA recommends companies proactively collect the information required to complete facility registration and product listing. This includes the following:
- An FDA Establishment Identification (FEI) number: this is required before beginning either facility registration or product listing. Companies will need to provide casic identification and contact information, activities at the plant, and company history including previous names and address to complete the FEI Portal application. The FEI portal may be found at: https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?action=portal.login. We recommend companies now obtain the FEI number if you have not done so already.
- A list of all brands and products, in addition to product category
- A list of ingredients in the cosmetic product, including any fragrances, flavors or colors, with each ingredient identified by the regulation name (under Section 701.3 of the CFRs) or by the common or usual name
- Type of submission (initial, amended, biannual renewal, or abbreviated renewal)
The responsible person must submit a cosmetic product listing for each cosmetic product they sell. Required information includes the FEI number of each facility where the cosmetic product is manufactured or processed, the name and contact number of the responsible person, the name for the cosmetic product as such name appears on the label, a qualitative ingredient list, the applicable cosmetic category or categories for the cosmetic product, the product listing number if any have been previously assigned and the type of submission (initial, update to content (annual), abbreviated renewal).
Every person that owns or operates a facility as of December 29, 2023 that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each that party is required to register. However, in the case of a contract manufacturer, either the manufacturer or brand owner can register. Additionally, facilities engaged in activities such as storing, retailing, labelling, packaging, distribution, and holding are not required to register. Research facilities not engaged in commercial distribution of cosmetic product are also exempt.
Every person that owns or operates a facility that first engages, after December 29, 2022, in manufacturing or processing of a cosmetic product for distribution in the United States, must register such facility within 60 days of first engaging in such activity or by February 27, 2024, whichever is later. Every person who is required to register must update their registration within 60 days of any changes to the information required for registration (an “amended” registration). This includes any changes that result in cancellation of the registration. Registration renewal is required biennially. We anticipate that FDA will push back the December 29th deadline by a few months and will continue to provide updates.
For small businesses, please also note that if your manufacturing facility makes a product that meets any one of the four exceptions to the exemption (e.g. products that regularly come into contact with the mucus membrane of the eye, products that are injected, products that are intended for internal use, and products that are intended to alter the appearance for more than 24 hours), even if you are technically considered a small business, FDA’s current interpretation is that this negates the exemption for all products. We will await FDA’s additional comments on this in the final guidance.
We recommend that all businesses identify their registration obligations under MoCRA and/or exemptions, and develop a regulatory rationale to file. We also recommend businesses obtain the FEI number as the portal gets finalized.
Garg Law continues to closely monitor the requirements and will keep readers informed of any updates – until then stay prepped and primed!
For any questions on U.S. cosmetics compliance and enforcement, please contact us at firstname.lastname@example.org.