MoCRA: The New Cosmetic Regulation Change

The modernization of the cosmetics regulation act of 2022, MoCRA, is the first major update issued by the FDA cosmetic authorities since 1938. It enhances the jurisdiction of the FDA over cosmetic regulations and covers a broader range of personal care and beauty products.

MoCRA: The New Cosmetic Regulation Change

The Modernization of Cosmetics Regulation Act – MoCRA – is coming into effect in 2023. By December of this year, cosmetic manufacturers will need to amend their facility registration and product listing practices to comply with the new law. The points to address include CGMP compliance, safety substantiation, labeling, record keeping, and adverse events reporting, with additional guidance expected to become available in the coming years. Here are some of the changes the Modernization of Cosmetics Regulation Act of 2022 brings about.     

• Facility Registration    

To lawfully market cosmetic products in the U.S., cosmetic manufacturers across the world are required to register with the FDA. This registration allows foreign facilities to be identifiable by the FDA authorities that oversee cosmetic manufacturing and processing facilities. The Modernization of Cosmetics Regulation Act of 2022 only holds the latter to this obligation. Plants dedicated solely to the packaging, repackaging, labeling, relabeling, holding, and/or distributing of cosmetic products don't need to register. The exception is facilities that package or repackage products by filling containers with cosmetic products.

Existing facilities have one year as of MoCRA's date of enactment to complete their registration. For new facilities, registration must happen within 60 days following the beginning of their operations or 60 days after existing facilities are expected to register, whichever is later. Registrations should be renewed every other year.  

• Product Listing    

The new FDA cosmetic regulations require "responsible persons" to list the cosmetic products they manufacture, package, or distribute. This doesn't constitute a premarket approval, though each listing must include information about the cosmetic category, where it was manufactured, the ingredients the formula contains – including flavors, colors, and fragrances – and a product listing number.

Responsible persons have one year following enactment to submit their listings for existing products. Once MoCRA comes into full effect, they will have 120 days to submit their listings for newly marketed products. Yearly updates also need to be filed.      

• CGMPs    

Under the Modernization of Cosmetics Regulation Act of 2022, the FDA establishes Good Manufacturing Practice Requirements. The CGMPs ensure consistency with national and international standards for the manufacturing and processing of cosmetic products. The enactment of MoCRA directs the FDA to issue a proposed rule within the next two years so that a final rule may be edited in the following year.    

•  Safety Substantiation    

Adequate safety substantiation is required for any cosmetic product to enter the U.S. market. Cosmetic manufacturers may comply by performing research analyses, tests, or studies to assess the safety of their products. In addition to having access to adverse event records, the FDA can request access to the information.      

• Adverse Event Reporting    

Under the new FDA cosmetic regulations, cosmetic companies will be required to keep records of any health-related adverse events imputable to the product. In cases where the incidents in question are considered severe (infection or significant disfigurement including second or third-degree burns, acute rashes, alteration of appearance, substantial hair loss, etc.), reports must be issued within 15 days. Records must be maintained for at least six years, and the FDA is authorized to access the information.       

• Labeling Requirements    

The Modernization of Cosmetics Regulation Act encompasses labeling requirements. For instance, cosmetic manufacturers will need to provide contact information where they can be notified of any adverse events and comply with the FDA's updated fragrance allergen rule.       

• Exemptions    

Small businesses will be granted a certain level of flexibility through simplified requirements and an extended compliance period. Registration and product listing obligations are lighter and record retention needs to go back three years instead of six.

The enactment of MoCRA grants the FDA three new enforcement powers:  

• Determining whether a cosmetic product could potentially cause serious adverse health consequences and suspend a facility's registration should it be the case.    
• Accessing records if there are reasons to believe a product or the ingredients it contains may present serious adverse health consequences.    
• Mandating recalls if the probability that a cosmetic product could be adulterated or misbranded exists.