On December 29, 2022, Congress passed the Modernization of Cosmetics Regulation Act.  “MoCRA” is the most significant piece of legislation affecting cosmetics since 1938, when cosmetics was added to the Federal, Food, Drug, and Cosmetic Act.  It increases federal oversight of cosmetic products and introduces new mandatory requirements for cosmetics, some of which go into effect as early as December 29, 2023.

On November 1, 2023, the FDA announced that they will provide more information on the launch date for electronic submission and paper submission forms related to the new cosmetic product facility registration and cosmetic product listing mandated by MoCRA in the coming weeks.  A week later on November 8, 2023, the FDA announced their intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months to help ensure that industry has sufficient time to submit such facility registration and product listing information.  It should be noted that this delay is specific to facility registration and product listing only.  All other statutory requirements that go into effect on December 29, 2023 remain including adverse event tracking and reporting, safety substantiation, professional use labeling and records access.

Now that you have more time, here are five things you can do to fully prepare for the requirements of MoCRA:

1. Read the law.  In it there are definitions that would help to inform you whether or not certain requirements of MoCRA apply or do not apply to your business.  In tandem with that, you should also read the Draft Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products, which details the requirements for one of the most immediate and visible aspects of the law.
2. Know whether or not you are exempt from the law.  Small businesses whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products are exempt from the registration and listing requirements.
3. Now that you’ve done the first two and determined that the law applies to your business, here’s what you can do in preparation if you are a facility as defined by MoCRA:
   • If you are a foreign facility, please find and designate a U.S. agent.  Under MoCRA, the contact information for a U.S. agent is required to be included in your facility registration.  Note: this does not apply if you are a U.S. based facility.
   • For all facilities, foreign or domestic, you need to apply for a facility registration number (this is the FDA Establishment Identifier or FEI) BEFORE you can submit your facility registration and BEFORE your customers can submit product listings for the products you manufacture on their behalf, as they too will also need your facility registration number to include in their cosmetic product listings.
4. For the Responsible Person, which means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label i.e., the brand, establish a corporate culture of compliance:
   • By this I mean, designate who’s going to be responsible for implementing certain requirements of the law including product listing, labeling, safety substantiation, adverse event reporting, and record keeping.
   • Create SOPs on all of these requirements to specifically outline how your business will manage these and more importantly train the applicable functions on these SOPs.  That means you’ll need two additional SOPs, an SOP on how to create SOPs, and an SOP on training.
5. If you need help implementing any or all of these requirements, please reach out to a compliance professional like myself.  Vogue Regulatory can partner with you to:
   • Be your U.S. Agent
   • Submit your facility registration and cosmetic product listings on your behalf
   • Help create SOPs to implement MoCRA requirements and in general for the successful operation of your business
   • Review your product labels as you update them
   • Report serious adverse events to the FDA and MORE!

Contact us today!