The MoCRA Revolution: How New Regulations Will Transform the Cosmetics Industry

On December 29, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as part of the 2023 omnibus spending bill. Modernization Of Cosmetic Regulation. Act, “MoCRA”, Is The First Major Update To The Food And Drug Administration's (FDA) Cosmetics Authorities Since 1938 And Introduces Significant Changes.

MoCRA has expanded the FDA's regulatory authority over cosmetics and has introduced new requirements for "responsible persons" and certain "facilities" involved in cosmetics operations.

Some of the key provisions of the MoCRA include:

Mandatory registration of cosmetics manufacturing facilities

  • MoCRA requires that all companies selling cosmetics in the United States must register their manufacturing facilities with the FDA, and the owner/operator of each facility must update registration information every two years. Existing cosmetics manufacturing facilities must register with the FDA within one year of the new regulation's issuance, and the registration deadline for new facilities is within 60 days of commencing cosmetics manufacturing. Organizations involved only in labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetics do not need to register. For overseas manufacturing facilities, importers and agents in the United States must be provided during registration.

Cosmetic Product Listing

  • After MoCRA takes effect, filing of cosmetics products becomes a mandatory requirement. Cosmetics manufacturers, packagers, or distributors must submit specific information about each cosmetic product to the FDA for filing, including manufacturing location, ingredients, labels, etc., and must update the information annually. Existing cosmetics products must be filed with the FDA within one year of the new regulation's issuance, and the filing deadline for new cosmetics products is within 120 days of being marketed.

Safety assessment and proof

  • MoCRA has introduced safety proof requirements for responsible persons. According to MoCRA, cosmetics responsible persons must ensure that there is sufficient evidence of the safety of each cosmetic product and ingredient, and must retain necessary safety proof records. The FD&C Act has also added corresponding provisions to the definition of "adulterated cosmetics," namely that cosmetics without sufficient evidence to prove safety compliance with regulations will be considered "adulterated." Additionally, MoCRA grants the FDA the power to inspect records. When the FDA suspects that a product may be "adulterated" or has the potential to cause serious adverse reactions, it has the right to request safety proof for the product.

GMP regulations for cosmetics

  • The FDA has issued GMP guidelines as a reference for manufacturers' self-inspection, but it has not established mandatory GMP regulations for cosmetics. MoCRA requires the FDA to issue mandatory GMP regulations for cosmetics to ensure that cosmetic products are not adulterated or counterfeit, and to grant the FDA the power to review GMP-related records during inspections.

Adverse event reporting

  • MoCRA mandates that responsible persons have an obligation to record adverse reactions and report serious adverse reactions. MoCRA specifies that serious adverse reactions include seven categories ranging from death to severe disfigurement, and provides examples of serious adverse reactions that the cosmetics industry must report, such as "infection and severe disfigurement (including severe and persistent rashes, second or third-degree burns, severe hair loss, and persistent or significant changes in appearance)." Responsible persons must report to the FDA within 15 working days after receiving information about serious adverse reactions. In addition, responsible persons must retain records of all adverse reactions for six years (three years for small businesses).

Labeling requirements for allergens and contact information

  • MoCRA adds two mandatory labeling requirements based on existing cosmetics labeling regulations. Cosmetic labels must include the manufacturer's address and contact information in the United States for receiving feedback on adverse reactions and must disclose fragrance allergen information. MoCRA requires the FDA to issue regulations to determine the fragrance allergens that must be disclosed on cosmetics labels and the disclosure format.

Mandatory recall of defective products

  • Mandatory recall authority is also a key upgrade in the FDA's authority. Currently, when the FDA discovers adulterated or misbranded cosmetics, it can initiate regulatory procedures, including issuing warning letters and refusing cosmetics entry at ports. However, for products on the market, the FDA can only request that manufacturers voluntarily recall them. For uncooperative companies, the FDA can only release information to alert the public or take action through the courts. After the implementation of MoCRA, the FDA can require the recall of adulterated or misbranded cosmetics that cause serious adverse reactions.

Regulations surrounding talc and PFAS in cosmetics

  • MoCRA requires the FDA to issue regulations and establish standardized testing methods to test and identify asbestos content in talc-containing cosmetics. The FDA must publish proposed rules within one year after MoCRA is enacted and issue final rules within 180 days after the end of the public comment period.

  • MoCRA does not prohibit cosmetics companies from using perfluoroalkyl and polyfluoroalkyl substances (PFAS), but it requires the FDA to comprehensively evaluate the safety of PFAS used in cosmetics and publish relevant reports within three years after MoCRA is enacted, publicly assessing the results.

Eliminating animal testing for cosmetics

  • MoCRA includes a statement representing the attitude of the US Congress. The US Congress believes that animal testing should not be used for cosmetic safety testing and should be gradually eliminated except in special circumstances.

Providing exemptions policy for small businesses

  • MoCRA defines companies with an average annual sales of less than 1 million USD over 3 years as small businesses and provides corresponding exemptions policies. For example, small businesses are not required to comply with mandatory facility registration and product filing, are not subject

It is important to educate yourself with MoCRA Now!You should become familiar with the requirements that apply to your facility or cosmetic products under the forthcoming regulations.

XJ BEAUTY