Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements. 

Consult the following Draft Guidance to know more on the information to provide. 

Under MoCRA, the Responsible Person has to ensure, and maintain records supporting that there is adequate substantiation of safety of a cosmetic product.

Adequate substantiation: tests or studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a cosmetic product is safe.

Safe: not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.At this time, FDA has not been exhaustive on how to substantiate safety under MoCRA.

💡 Advice from EcoMundo regulatory experts:
We recommend that you gather all the documents and data you need to justify the safety of your cosmetics as of now. You will certainly need to carry out additional reports and analyses to prove that your products are safe for consumers. 

Here are three different types of assessment we recommend you carry out:

Contact us to assess the safety of your products with our regulatory experts and toxicologists.

Starting December 18, 2023, the FDA's Cosmetics Direct portal for the Modernization of Cosmetics Regulation Act (MoCRA) is now live.

Contact us for expert registration.

A US agent is required for foreign cosmetic facilities. It should be a person based in the US. EcoMundo can provide this service, contact us to know more. 

The responsible person could be the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.

Adverse events: Each cosmetic label must include a domestic address, domestic phone number, or electronic contact information, which may include a website, through which the responsible person can receive adverse event reports with respect to such cosmetic product. These elements must appear on both the outer and inner packaging. (You can  overlabel packaging to make it compliant with the new requirements.)

Fragrance allergens: Fragrance allergens must be outlined on the label. A notice of
proposed rulemaking establishing a list of fragrance allergens will be published by
the FDA no later than June 29, 2024 and a final rulemaking must be published no
later than 180 days after the date on which the public comment period on the
proposed rulemaking closes. The FDA may establish threshold levels of amount (we
may see something similar to the EU allergen disclosure rule).

Professional use: The label shall contain a clear and prominent statement that the
product shall be administered or used only by licensed professionals.

Our regulatory experts can help you review your labels, contact us to check your packaging.

Facilities will have to follow GMP for cosmetics published by FDA by the end of 2025, under the deadline that FDA will determine.

It is not expected that certification from a third party will be required, but authorities can run an audit at any time. 

Small businesses are responsible persons, owners and operators of facilities, whose average gross annual sales in the
United States 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 the cosmetic products.

Small businesses are exempted from facility registration, product listing. They might also benefit from simplified GMP, or extended deadlines. 

According to MoCRA, the FDA now enforces mandatory reporting of serious adverse events related to cosmetic products from December 29, 2023. Responsible persons must report incidents within 15 business days, including the product label. Additional information received within one year must also be reported within 15 business days.