Cosmetic products were regulated in the USA by the U.S. Food and Drug Administration (FDA), but In December 2022, the Congress approved the Modernization of Cosmetics Regulation Act (MoCRA), giving the FDA authority to create more strict regulations regarding cosmetics.
1. The mandatory cosmetics registration for MoCRA.
Effective on 29/12/2023, the new MoCRA requires companies to register their manufacturing facility with the FDA and the Responsible Person to list (register) each cosmetic product sold in the American market. Also, all foreign companies must appoint during registration an US Agent, that will work as a communication link between the FDA and the company overseas.
2. Safety substantiation
After December 2023, it will be necessary to ensure and maintain records supporting that there is adequate substantiation of safety of such products. These records can include tests, studies, research, or other information, as the cumulative or other relevant exposure to the product, that may be considered by a specialist as sufficient to support a reasonable certainty that the cosmetic is safe.
3. Cosmetics labeling requirements for MoCRA
Modernization of Cosmetic Regulation Act (MoCRA) asks for the label of the products to contain a domestic (American) address, domestic telephone number or electronic contact (email or website) thought which the cosmetic company can receive adverse event reports. Also, professional cosmetic products must meet the same labelling requirements as regular cosmetics and must state that they are for professional use. Finally, MoCRA mandate that each fragrance allergen in a product should be displayed on the label, although FDA will define in the future what is the list of allergens. These label requirements will be enforced only after December 2024.
4. Adverse event reporting and record keeping for MoCRA
Regarding Adverse Event Reporting, MoCRA asks companies to maintain records of any Health-related Adverse Event associated with the use of the cosmetic products sold in the USA for six years. Small business, only need to maintain it for three years. In the case of any Serious Adverse Event, the Responsible Person should present to the FDA a report and they must update the Agency regarding any new medical information during one year after the initial report.
Also, FDA can require adverse event records during an inspection and the company must provide the information within 30 days. Also, FDA gained the possibility of suspending the facility’s registration to prevent it from operating, based on reasonable probability of causing serious adverse health consequences or death. Besides that, FDA will be able to mandate recalls based on the same principle.
Furthermore, MoCRA asks the FDA to propose a Cosmetic Good Manufacturing Practices (GMP) rule before December 2024. It also asks the FDA to issue a regulation for detection of asbestos in talc-containing cosmetics. Concerning animal welfare, the law is trying to reduce or to banish animal testing for safety of cosmetics.
How can Cosmeservice help you?
At Cosmeservice we know that MoCRA compliance for your cosmetics business can be difficult. That is why we have made it quick and easy for you. Choose us as your required U.S. Agent for FDA communication, and we will take care of properly registering your cosmetic products as soon as possible.
But our services do not stop there. We are committed to keeping you up-to-date as the FDA implements additional MoCRA guidelines, so you can focus on what you do best – creating amazing cosmetics. Trust Cosmeservice to help you stay compliant and successful.