As deadlines approach for cosmetic manufactures to comply with all requirements of MoCRA, there might be some worry on where to start. Husch Blackwell’s chapter by chapter breakdown of MoCRA provides guidance on where to begin. This chapter discusses the requirements of facility registration and product listing with compliance due date of December 29, 2023.
Facility Registration: What Is a Facility and Who Has to Register?
Section 607 of MoCRA requires the registration of facilities that manufacture or process cosmetics for distribution in the United States. While this requirement applies to foreign facilities, establishments that solely perform labeling, relabeling, holding, distributing, packaging and repackaging (but not filling containers with product) are not required to register. Similarly, establishments such as beauty shops and salons, retailers, retail distribution facilities, pharmacies, hospitals, physicians’ offices, and health care clinics are also not required to register, so long as they do not manufacture or process cosmetic products. Fuhrer, small businesses with average gross annual sales less than $1,000,000 for the previous 3-year period are exempt from the facility registration and product listing requirements, so long as they do not manufacture cosmetics that:
- come in contact with mucus membranes of the eye;
- are injected;
- are intended for internal use; or
- are intended to alter the appearance for more than 24 hours.
At times, the line between what is and is not a facility can be blurry and will require a fact-intensive analysis of your business, including a consideration of the company’s operations, the types of products manufactured or processed at your facility, and even your financials for the past three years. Be sure to keep meticulous records pertaining to these aspects of your operations to aid in the potential determination as to whether you are subject to MoCRA’s new facility registration requirement.
A facility only needs to submit one registration, regardless of whether that facility manufactures or produces cosmetic products on the behalf of multiple responsible persons. This registration must be renewed biennially.
Product listing and facility registration will be available via paper form on online portal, both of which are under development. FDA is currently seeking public comments on its proposed online portal and on the paper form. All constituents are encouraged to weigh in. Meanwhile, you can prepare for the upcoming registration by keeping track of the information that will have to be submitted for each facility, which includes:
- the facility’s name, address, email address, and telephone number;
- any prior facility registration numbers;
- all brand names under which cosmetics manufactured by the facility are sold; and
- the product category or categories;
- the contact information, in the United States, for a “responsible person” for each cosmetic product manufactured or processed at the facility.
The data previously entered to register through the FDA’s voluntary cometic registration program (“VCRP”) will not be automatically transferred to the FDA’s MoCRA facility registration portal. Potential registrants and their commercial partners should work closely with one another to ensure that the appropriate responsible person is designated for the cosmetic products manufactured or produced by the registrant.
Product Listing: Which Products Must Be Listed and What Information Is Required?
Separate from the facility registration requirement, MoCRA also mandates the submission of cosmetic product listings. The responsible person is required to either submit these product listings to the FDA or ensure that product listings are submitted. Although the product listing website is likewise under construction at the moment, the information that will have to be submitted includes:
- the registration number of the facility manufacturing or producing the product;
- the name and contact information for the “responsible person;”
- the cosmetic product’s name;
- the cosmetic category or categories for the product;
- a list of ingredients, including any fragrances, flavors, or colors;
- the cosmetic product’s listing number, unless the submission is the initial listing, whereupon a listing number will be assigned.
The product listing requirement pertains to formulas, not brand names. In other words, one formula sold under various brand names needs only to be listed once, along with a disclosure of all of the brand names assigned to it. If the formula from product-to-product varies only by color, fragrance, or flavor, these variations may be covered in a single listing. For example, an eye shadow coming in a multitude of different colors requires only one product listing, as opposed to a separate and distinct listing for every color variety.
One final point is that product listing numbers are confidential. To the extent possible, they should only be shared with partners when required. For example, the cosmetic product listing number may need to be shared with the importer’s broker so it may be submitted to U.S. Customs and Border Protection (“CBP”) during importation of the cosmetic product into the U.S., but it should not be displayed on the product’s label.
When Is Compliance Required?
The facility registration and product listing requirements must be met by the following deadlines:
|Prior to MoCRA*||After MoCRA||Renewal|
|All Existing Products||December 29, 2023||N/A||Annually|
|New Products||N/A||Product listing within 120 days of marketing the cosmetic product in interstate commerce||Annual|
|All Existing Facilities||December 29, 2023||N/A||Biennially|
|New facilities||N/A||Facility registration within the later of (a) 60 days of engaging in the manufacture or processing of cosmetic products, or (b) one year plus 60 days after the enactment of the MoCRA||Biennially|
Written with the assistance of Luis Hidalgo, a summer associate in the Husch Blackwell LLP Washington, DC office.