In recent years, the cosmetics industry has experienced exponential growth, with new products being introduced almost daily. The average American consumer uses six to 12 cosmetics products daily. This growth has resulted in a need for more comprehensive regulation of cosmetic products to ensure consumer safety. The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a new law that aims to modernize and strengthen cosmetic regulations in the United States.

MoCRA was signed into law on January 1, 2022, and replaces the previous Cosmetic Act, which had not been updated since 1938. MoCRA brings significant changes to the cosmetic industry and regulations under MoCRA will impact the entire lifecycle of cosmetics products from manufacturing to marketing.

New MoCRA requirements include:

  • FDA registration for cosmetics facilities
  • Product listings for each cosmetic product
  • Adverse event reporting
  • Safety substantiation
  • Compliance with Good Manufacturing Practices (GMPs)
  • Fragrance allergen labeling

MoCRA also gives the FDA new records access and mandatory recall authority. In issuing MoCRA regulations, FDA’s aim is to help ensure the overall safety of cosmetic products, and significantly expand the Agency’s ability to trace and track non-compliant products and facilities.

Facility Registration and Product Listing 

Cosmetic facilities must register with the FDA (deadline has been extended to July 1, 2024) and renew their registration every two years thereafter . The term “facility” means any establishment that either manufactures or process cosmetic products distributed in the United States. New facilities must be registered within 60 days after they start manufacturing cosmetics.

The FDA may suspend a facility’s registration if the FDA determines that:

  1. A product manufactured or processed by the facility has a reasonable probability of causing death or serious adverse health consequences to humans;
  2. The agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated or the failure is sufficiently pervasive to raise concerns about other products in the facility.

If a facility’s registration is suspended, it is a prohibited from selling or distributing cosmetics products in the U.S. from the facility.

In addition to the registration requirement, “responsible persons” – defined as manufacturers, distributors, or packers of a cosmetic product whose name appears on the label must list their product with the FDA. This listing must include product ingredients and responsible persons must provide the FDA with any updates annually.

To complete a valid listing, companies should collect the following information:

  • An FDA Establishment Identification Number (FEI)
  • A list of all products
  • A list of ingredients in all products
  • The regulation name or common name of all ingredients

It is critical for cosmetics companies to sort out who is required to register (manufacturer, brand owner) and submit the listing in a timely manner.

 The Voluntary Cosmetic Regulations Program (VRCP) 

The VCRP was a voluntary program that allowed manufacturers, packers, and distributors of cosmetic products to submit product information to the FDA. However, as of March 27, 2023, the FDA has ceased accepting submissions to the VCRP and has now transitioned to the new registration portal: Cosmetics Direct 

Safety and Disclosure Requirements

One of the most significant changes that the MoCRA introduces is the requirement for cosmetic manufacturers to submit safety information about their products to the Food and Drug Administration (FDA). This information includes any adverse reactions reported by consumers and information about any potentially harmful ingredients used in the products. The FDA will then use this information to evaluate the safety of the products and take any necessary actions to protect consumers.

Companies must report serious adverse events within 15 days after receiving the report. Companies must also report material updates about the event for one year following the initial submission. Businesses are also required to maintain records of any health-related adverse events associated with its product for six years.

MoCRA also requires cosmetic manufacturers to adhere to good manufacturing practices (GMPs), which are a set of guidelines that ensure the quality and safety of cosmetic products. This includes requirements for the use of clean equipment, the appropriate handling and storage of ingredients, and the implementation of quality control measures.

Another important aspect of MoCRA is the requirement for cosmetic manufacturers to disclose the full list of ingredients used in their products on the product label. This is a significant change from previous regulations, which allowed manufacturers to use vague terms such as “fragrance” to avoid disclosing specific ingredients. This change will provide consumers with more transparency and allow them to make more informed decisions about the products they use.

Safety Substantiation

While current FDA regulations do not require specific tests to demonstrate the safety of individual ingredients or products, companies and individuals who manufacture cosmetics have a responsibility to ensure the safety of their products. Under MoCRA, responsible persons must maintain records supporting adequate product safety substantiation. Manufacturers can use existing data to support the safety of their products, but the data must be derived from scientifically robust methods.

 MoCRA Exceptions 

MoCRA exempts cosmetic/drug and cosmetic/device combination products from some requirements such as GMPs, adverse event reporting, registration and listing, safety substantiating, and recordkeeping. However, these exemptions do not apply to facilities that manufacture both combination products and cosmetics.

Additionally, small businesses are exempt from the GMP and registration and listing requirements. A “small business” is defined a business with average gross annual sales in the U.S. for the previous 3-year period of less than 1,000,000 adjusted for inflation. The small business exemption does not apply if the business manufactures products that: come into contact with eyes, are injected, are intended for internal use, alter the appearance for more than 24 hours.

Enforcement & Mandatory Recall Authority

 MoCRA gives the FDA new powers to enforce the requirements of the law. The FDA may suspend a facility’s registration if the agency determines that a product has a reasonable probability of causing serious adverse health consequences or death. The agency also has new authority to inspect records of a cosmetics facility.

Perhaps the most significant new authority is the ability to issue mandatory recalls. If the FDA determines that there is a reasonable probability that a cosmetic is misbranded or adulterated, and the use of the cosmetic will cause serious adverse health consequences or death, the agency may issue a mandatory recall. The FDA must provide companies with an informal hearing as well as the opportunity to voluntarily recall the product.

 Conclusion 

Overall, MoCRA represents an important step towards modernizing the regulation of cosmetics in the US. MoCRA has been welcomed by many in the beauty industry, including consumer advocacy groups and cosmetic manufacturers. The increased transparency and regulation provided by the new law will help to build trust between consumers and the industry, while also ensuring that cosmetic products are safe for use.

Companies should establish who is responsible for registering products and facilities, and also put in place processes for adverse event reporting, recall inquiries, and record keeping.

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com today to assess the impacts of MoCRA on your cosmetic products.

 

Learn more about MoCRA in our webinar: “Getting MoCRA Compliant.