News

news August 17, 2023

Modernization of Cosmetics Regulation Act of 2022 (MoCRA) – A Long Awaited Update from the FDA and a Request for Comments

Cosmetic brands and regulatory enthusiasts have been waiting with bated breath for an update regarding the Dec. 29, 2023 deadline for cosmetic product listings and facility registrations. When will the portal be available? What information will be required? Will submittals be allowed only via electronic means? What if my manufacturer is a “small business” but I am not? Indeed, MoCRA has raised many questions.

And finally…FDA has provided some answers.

On Aug. 7, 2023, FDA released the Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. The non-binding guidance and recommendations are offered for public comment until Sept. 7, 2023.

In the Guidance, FDA lists information intended to be mandatory for facility registrations and product listings and information intended to be optional, as follows:

Product Listings

Mandatory Information

  • 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 (refer to Appendix A);
  • 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;
  • The product listing number, if any previously assigned; and
  • Type of submission (initial, update to content (annual), abbreviated renewal).

Optional Information

  • 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 DUNS Number for address listed on product label;
  • Unique Ingredient Identifiers (UNIIs); and
  • Additional contact information for individuals associated with the listing

Facility Registrations

Mandatory Information

  • 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 (refer to Appendix A) and responsible person for each cosmetic product manufactured or processed at the facility; and
  • Type of submission (initial, amended, biennial renewal, or abbreviated renewal, for further information see discussion in section III.F.1).

Optional Information

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

The Guidance reiterates many of the same facts set forth in FDA’s earlier announcements with a few additional clarifications. For example:

  • Is your manufacturer a “small business” that is exempt from facility registration and product listing requirements under MoCRA? If so, if your company is not a “small business,” it still must go through the product listing process (even though the product manufacturer is exempt). However, rather than having to identify the manufacturer’s registration number, you will simply provide the small business manufacturer’s name and address. This is because “small businesses” are exempt from the facility registration requirement and, thus, would not have a facility registration number.
  • Does your company consider the identity of its manufacturers to be confidential information? If so, you will be happy to know that product listing numbers will not be shared publicly, not even through a Freedom of Information Act (FOIA) (5 U.S.C. 552) request. Neither will the brand names for products identified by a manufacturer in its facility registration nor the facility registration number of the facility where a cosmetic product is manufactured or processed, as identified in a product listing. However, all other information from a facility registration and product listing would be available for public disclosure consistent with the FOIA.

The Guidance also identifies several cosmetic product categories and seeks comment on the categories.

  • Review the product categories carefully to determine whether your categories are clearly listed. If not, consider filing a comment by September 7.

Electronic submissions via the portal:

  • The format to be used for facility registration and product listing data will be the structured product labeling (SPL) format – the same one used for drug product listings.
  • It is anticipated that the portal will be available in October. We are encouraging clients to have their data ready for submittal by no later than December 29 (and to begin preparations well in advance of that date).

We are here to help.

  • Would you like assistance submitting comments? Do you have questions or need assistance with registration or product listings, compiling safety substantiation, or updating operating procedures for maintaining records of adverse events? We can help. Please do not hesitate to contact the below members of our Cosmetics Industry Practice Group.

Angela Diesch | angelad@amintalati.com

Abhishek Gurnani | abhishek@amintalati.com

Ashish Talati | ashish@amintalati.com

Ivan Wasserman | ivan@amintalati.com

Jennifer Adams | jennifer@amintalati.com

Rend Al-Mondhiry | rend@amintalati.com

Lauren Aronson | lauren@amintalati.com

Karmina Fefferman | karmina@amintalati.com

Natascia Taken | natascia@amintalati.com

 

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