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Warning: MoCRA Deadlines Ahead!

Categories: Government Affairs

December 29, 2023, is fast approaching and marks the effective date for several major MoCRA requirements—most notably facility registration and cosmetic product listing.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), among other things, added Section 607 of the Federal Food, Drug, and Cosmetic Act that requires:

1. Facilities that manufacture or process cosmetic products for U.S. distribution to register the facility with the U.S. Food and Drug Administration (FDA)
2. “Responsible Persons” (i.e., manufacturer or distributor whose name appears on the product) to list cosmetic products and ingredients with FDA.

Note: the definition of “cosmetic products” includes products such as body and hand washes as well as cleansing wipes intended for use on the body or parts thereof.

Draft Guidance. In anticipation of the impending December 29 deadline, FDA recently issued draft guidance for industry titled Registration and Listing of Cosmetic Product Facilities and Products (“Draft Guidance”). The summary below is based on the Draft Guidance and has been prepared to assist ISSA members subject to MoCRA in meeting their new facility registration and product listing obligations.

Facility Registration. MoCRA requires the owners or operators of a “facility” (as defined in MoCRA) that manufactures or processes cosmetic products for U.S. distribution to register the facility with FDA, unless an exemption applies. For facilities that manufactured or processed cosmetic products for U.S. distribution as of December 29, 2022, and that are not exempt under MoCRA, the owners or operators of such facilities must register the relevant facilities with FDA by December 29, 2023.

For facilities that began manufacturing or processing cosmetic products for U.S. distribution after December 29, 2022, and that are not exempt under MoCRA, the owner or operator of such facilities must register the relevant facilities with FDA within 60 days of first engaging in the activities or by February 27, 2024, whichever is later. All registrations must be renewed biennially.

An exempt facility is one that qualifies as a “small business” under MoCRA, as well as a facility that is subject to registration with FDA as a drug or device establishment, unless such facility additionally manufactures or processes cosmetic products that are not also subject to FDA’s drug or device authorities.

Please note further that the MoCRA definition of “facility” includes a number of exceptions. Most notably, an establishment that solely performs labeling, relabeling, packaging, repackaging, holding, and/or distributing of cosmetic products is not a “facility” subject to the MoCRA facility registration requirements. Other exceptions to the definition of “facility” include establishments that manufacture or process cosmetic products that are solely for use in research or evaluation, including for production testing, and not offered for retail sale, and establishments that manufacture cosmetic ingredients but not cosmetic products.

The Draft Guidance notes that facilities that manufacture or process cosmetic products on behalf of one or more “Responsible Persons” (such as contract manufacturers) need only register once, and that a “Responsible Person” (defined below under Cosmetic Product Listing) for whom the facility manufacturers or processes products may choose to submit the registration on behalf of that facility.

The Draft Guidance summarizes the information that must be submitted in a facility registration as including:

• The name of the owner and/or operator of the facility
• The facility’s name, physical address, email address, and telephone number
• With respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email)
• The facility registration number, if any, previously assigned
• All brand names under which cosmetic products manufactured or processed in the facility are sold
• The product category or categories and responsible person for each cosmetic product manufactured or processed at the facility
• Type of submission (initial, amended, biennial renewal, or abbreviated renewal.

Note: If an FDA Establishment Identifier (FEI) is already assigned to the facility, the FEI must be included in the registration submission. If no FEI has been assigned, the company must first obtain an FEI before proceeding. Before seeking a new FEI, companies should check the FEI Search Portal to see if they have an existing FEI. Companies without an FEI can obtain one by submitting a request to [email protected].

Cosmetic Product Listing. The “Responsible Person” (as defined in MoCRA) for a cosmetic product marketed on December 29, 2022, must submit to FDA a cosmetic product listing by December 29, 2023. For a product first marketed after December 29, 2022, the Responsible Person must list the cosmetic product with FDA by 120 days after first marketing the product in interstate commerce, or within 120 days of December 29, 2023, whichever is later. Responsible Persons who qualify as small businesses are exempt from the listing requirements, as are cosmetic products that are also subject to FDA’s drug or device authorities. Appendix A of the Draft Guidance provides a list of cosmetic product categories and codes to be used in cosmetic product listings.

The Draft Guidance also explains that FDA will not make available for public disclosure the product listing number, brand names under which cosmetic products manufactured at a particular facility are sold, or the facility number of the facility where a cosmetic product is manufactured or processed, but will make all other information available consistent with the Freedom of Information Act (5 U.S.C. § 552).

Electronic Submission Portal. On September 15, 2023, FDA announced its newly developed draft electronic submission portal, Cosmetics Direct, to assist persons submitting cosmetic product facility registrations and product listings under newly added Section 607 of the Federal Food, Drug and Cosmetic Act. Draft screenshots of the electronic system, including example submissions, are available for review and comment. 

In addition, FDA published drafts of paper forms (registration; listing) that companies can use as an alternative to electronic submissions through Cosmetics Direct. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency; however, those who wish to submit paper forms still have the option to do so via FDA Forms 5066 and 5067.

Finally, FDA launched its cosmetics registration and listing website, which outlines registration and listing requirements under MoCRA and provides related resources.

Cometic Product Defined. It is important to note that the term cosmetic product is defined by the Federal Food Drug and Cosmetic Act as “a product, except soap, intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” However, the term “soap” is defined very narrowly by the FFDCA to mean “a product in which the non-volatile portion consists principally of an alkali salt of fatty acids.” The vast majority of body or hand washes and cleansing wipes include synthetic detergents or other ingredients and therefore do not meet the definition of “soap” and are instead regulated as a “cosmetic product.”

Products that do meet the definition of “soap” may still be considered a cosmetic if moisturizing or deodorizing claims are made in conjunction with the product.

Next Steps. ISSA encourages ISSA member companies subject to MoCRA to prepare for the fast-approaching effective date by: 1) reviewing the Draft Guidance; and 2) studying the screenshots in the draft slide deck for the purpose of preparing to submit product listings and facility registrations through the portal, and to help you estimate the resources you will need to complete all your product and facility listings prior to the December 29 deadline.

About the Author.

ISSA Director of Legislative Affairs Bill Balek has more than 25 years of experience working with various legislative and regulatory organizations that create rules that have a direct impact on the cleaning products industry, including antimicrobial pesticide registration, hazardous material transportation, safety and health regulations, and general environmental laws.