Next Phase Of MoCRA Rollout: FDA Draft Guidance On Registration And Listing Of Cosmetic Product Facilities And Products - Food and Drugs Law

The Modernization of Cosmetics Regulation Act's (MoCRA) long-awaited rollout continues as, on August 7, 2023, FDA released draft guidance to assist persons submitting cosmetic product facility registrations and product listings under the newly added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act).

Background

Section 607(a) of the FD&C Act requires every person that owns or operates a facility that "engages in the manufacturing or processing of a cosmetic product for distribution in the United States" to register each facility with FDA, update content within 60 days of any changes and renew their registration every two years.

As of March 27, 2023, FDA ended its voluntary cosmetics registration program (VCRP) and advised that information submitted to VCRP would not be transferred over to any new system.

Section 607(c) of the FD&C Act further requires that, for each cosmetic product, the responsible person must submit to FDA annually "a cosmetic product listing," including ingredients.

MoCRA defines a "responsible person" as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with Section 609(a) of the FD&C Act or Section 4(a) of the Fair Packaging and Labeling Act.

Key Takeaways

Small Business Exemption

Small businesses?defined by Section 612 of the FD&C Act as having average gross annual sales in the United States of cosmetic products for the previous three-year period of less than $1 million, adjusted for inflation, and who do not manufacture or process certain cosmetic products described in Section 612(b)?are not required to register facilities and list cosmetic products.

Electronic Submission Portal

FDA's new electronic submission portal is expected to be available in October 2023, with FDA strongly encouraging electronic submissions. FDA is developing a paper form as an alternative submission tool.

Definitions

The draft guidance defines "contract manufacturer," "cosmetic products," "facility," "manufacturing or processing," "operator," "owner," "responsible person" and "small business."

Who Makes the Submissions?

Every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility and submit a cosmetic product listing unless it is exempt as a "small business" or the cosmetic product is also a drug or device subject to the requirements of Chapter V of the FD&C Act.

Registration

Information that must be submitted to FDA with a facility registration includes:

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 name and phone number for the U.S. agent of the facility and, if available, their 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 (listed in Appendix A of the draft guidance) and responsible person for each cosmetic product manufactured or processed at the facility; and
Type of submission (initial, amended, biennial renewal or abbreviated renewal).

FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. The owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

FDA also requests that the following additional optional information be submitted:

Parent company name (if applicable);
Facility Dun and Bradstreet (DUNS) number; and
Additional contact information for individuals associated with the registration.

Product Listing

Information that must be submitted to FDA with a product listing includes:

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 categories for the cosmetic product (listed in Appendix A of the draft guidance)
A list of ingredients in the cosmetic product, including any fragrances, flavors or 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; and
The product listing number, if any previously assigned, and type of submission (initial, update to content (annual), abbreviated renewal).

FDA also requests that the following additional optional information be submitted:

Parent company name (if applicable);
Type of business (as listed on the label), i.e., manufacturer, packer or distributor;
Image of the label;
Product webpage link;
Whether the cosmetic product is for professional use only;
Responsible person's DUNS number for the address listed on product label;
Unique ingredient identifiers; and
Additional contact information for individuals associated with the listing.

Multiple Listings

Under Section 607(c)(4)(B), a single listing for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents

Attestation

FDA requests that individuals submitting registration and listing information attest to the accuracy and veracity of the information submitted.

How and When to Submit

Stakeholders should plan to register and list in advance of the December 29, 2023, statutory deadline.

Fees

There is no fee to submit a registration or product listing to FDA under Section 607 of the FD&C Act.

Public Disclosure

Under Section 607 of the FD&C Act, FDA will not disclose information from a facility registration on the brand names under which cosmetic products manufactured or processed in the facility are sold, or from a product listing on the facility registration number of the facility where the cosmetic product is manufactured or processed, in response to a request under the Freedom of Information Act (FOIA) (5 U.S.C. 552).

All other information from cosmetic product facility registration and listing would be available for public disclosure consistent with the FOIA, FDA's disclosure regulations under 21 CFR Part 20 and other applicable federal law.

Drugs and Cosmetics?

Cosmetic products that are also drugs under Chapter V of the FD&C Act are not subject to listing requirements. Likewise, a facility that manufactures or processes cosmetic products that are also drugs is not subject to the registration requirement unless it also manufactures or processes cosmetic products that are not also drugs.

Enforceability

As a reminder, FDA's guidance documents do not establish legally enforceable responsibilities, but are intended to describe FDA's current thinking and should be viewed as recommendations.

Conclusion

The new draft guidance provides much-needed clarity regarding MoCRA's requirements and upcoming registration and listing deadlines. However, we expect further guidance in the upcoming months as to MoCRA's additional December 2023 deadlines and feedback with FDA regarding any flexibility in meeting these deadlines.

For More Information

If you have any questions about this Alert, please contact Alyson Walker Lotman, Frederick R. Ball, Robert Kum, Kelly A. Bonner, Coleen W. Hill, Anne A. Gruner, any of the attorneys in our Fashion, Retail and Consumer Branded Products Industry Group or the attorney in the firm with whom you are regularly in contact.

Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.