The U.S. Food and Drug Administration (FDA) has recently released draft guidance regarding cosmetic facility registration and cosmetic product listings.

This new FDA draft guidance concerning the Modernization of Cosmetics Regulation Act (MoCRA) and its changes outline who is responsible for submitting cosmetic facility registration and product listings submissions, what information will be included, defines key terms, as well as identifies certain exemptions to these requirements.

Key Takeaways of the New FDA Draft Guidance For Cosmetics

FDA’s draft guidance states that the registration portal will open in October 2023 where cosmetic registration and listing data must be submitted electronically using the same format for submission of drug products: Structured Product Labeling (SPL).

The deadline for registration and product listings is December 29^th, 2023. For non-U.S. companies registering their cosmetic facilities with FDA, a U.S. Agent designation is also required.

A Look at Cosmetic Product Facility Registration

Under new FDA regulations, every person that owns or operates a facility that manufactures or processes a cosmetic product for distribution in the United States is required to register each facility, except in the following instances:

• A facility that is exempt from registration as a “small business” unless they engage in processing or manufacturing of cosmetic products that:
  • regularly come into contact with mucus membrane of the eye;
  • are injected;
  • are intended for internal use; or
  • are intended to alter appearance for more than 24 hours
• A facility that is also subject to the requirements for drugs and medical devices, unless the facility also manufactures or processes cosmetic products that are not subject to those requirements.

It’s important to note that if a facility manufactures or processes cosmetic products on behalf of multiple responsible persons, only a single registration is required. This also means the owner of or operator of a contract manufacturing facility would not need to register their facility if the responsible person submitted the facility registration.

Additionally, non-U.S. cosmetic facilities will be required to designate a U.S. Agent for FDA communications.

New FDA Cosmetic Product Listings Requirements

The new requirements outline that for each cosmetic product, the responsible person must submit a cosmetic product listing, except if:

• The responsible person is exempt as a “small business” unless they engage in processing or manufacturing cosmetic products that:
  • regularly come into contact with mucus membrane of the eye;
  • are injected;
  • are intended for internal use; or
  • are intended to alter appearance for more than 24 hours
• The cosmetic product being listed is also subject to the drug and medical device requirements.

For example, if a product is considered both a drug and a cosmetic product by FDA — like an anti-dandruff shampoo — a cosmetic product listing is not required to be submitted.

How to Navigate the Upcoming Changes

Registrar Corp has spent the last 20 years helping companies navigate the complexities of U.S. FDA compliance. With this historic overhaul of how FDA regulates cosmetics, manufacturers, owners, and responsible persons will need experienced regulatory assistance to make complying with the new requirements quick and easy.

Registrar Corp is a dedicated resource you can count on, and we invite you to learn more about the changes affecting the cosmetic industry.