On December 29, 2022, President Biden signed into law the Omnibus Appropriations Act 2023 (H.R.2617), The bill includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), It marks the first major revision of the Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 and the first statutory change to FDA's cosmetic regulatory regulations in 85 years.

MoCRA puts new demands on industry

Recording of adverse events and reporting of serious adverse events

The responsible person has an obligation to record adverse reactions and to report serious adverse reactions, including infections or major disfigurements, such as severe and persistent rashes, second - or third-degree burns, significant hair loss, or unanticipated persistent or significant changes in appearance, under normal conditions of use.

After receiving a serious adverse event report, the responsible person is obligated to submit it to the FDA within 15 days and to report certain additional information, such as new medical information, within one year of the initial report. All records related to serious adverse events are retained for at least six years (3 years for small businesses).

Facility registration

“ Facilities ” Manufacturers and processors of cosmetics sold in the United States, whether located in or outside the United States (so-called “ Facilities Facility”) The registration must be registered with the FDA and renewed every two years. Existing businesses must complete registration by December 29, 2023; New businesses must register within 60 days of starting production of cosmetics, or 60 days after the deadline for existing businesses, whichever is later.

FDA has the right to suspend the registration of a facility if reasonable. However, facilities that only perform activities related to the labeling, re-labeling, packaging, repackaging, holding and/or distribution of cosmetics do not need to be registered.

Product list registration

The Responsible Person must provide FDA with information about each cosmetic product marketed, including the ingredients of the product, where it was manufactured, the cosmetic label, and contact information.

For products sold before the enactment of MoCRA, the responsible person must submit the product registration information by December 29, 2023;

For products that are first marketed after promulgation, the responsible person must submit product registration information within 120 days of listing. Cosmetic product registration must be renewed annually.

Safety certificate

The Responsible Person must ensure that the safety of cosmetic ingredients and products has sufficient safety evidence. It is clear that cosmetics without sufficient evidence of safety will be considered adulterated and shoddy products.

Other

In terms of labelling, cosmetics labels must include information about contacts (implementation date December 29, 2024); The information requirements required for professional cosmetic labels will be the same as those required for the labels of products intended for sale to general consumers (December 29, 2023).

The MoCRA requires the FDA to evaluate the scientific evidence for the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products. This assessment will be published within three years from the date of enactment of the MoCRA.

MoCRA includes a statement from the US Congress stating that animal testing should not be used for cosmetic safety testing and should be phased out.

For over-the-counter (OTC) products, it is clear that MoCRA does not apply to OTC products. For OTC products, the OTC Pharmaceutical regulations apply, with the exception of the provisions relating to the disclosure of allergen information about perfumes and the labeling of professional use.

In addition, MoCRA requires the FDA to develop and issue regulations and requires industry to comply with the following:

a.  Good Manufacturing Practice (GMP) requirements for cosmetic manufacturers: The MoCRA requires FDA to issue mandatory GMP regulations for cosmetic products and grants FDA access to GMP-related data during inspections.

b.  The label must contain the essence allergen information;  

MoCRA requires FDA to issue specific labeling forms and formats;

c. Detection and identification of asbestos in products containing talc:

The MoCRA requires the FDA to establish and publish standard testing methods for the detection and identification of asbestos in products containing talc. The FDA will issue a draft rule within one year from the date of enactment of the MoCRA.    

Exemption

The MoCRA exempts certain small businesses (those with average annual sales of less than $1 million over a 3-year period) from the GMP, business registration, and product registration requirements. However, exemptions do not apply to certain product types.

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Record access

FDA may access and copy cosmetics-related records, including safety records, provided certain conditions are met.

Right to mandatory recall

For “ Adulteration and shoddy products ” Or “ Error identify” And if a cosmetic product causes a serious adverse reaction, the FDA can mandate a recall.