At the end of 2022, into the Omnibus Spending bill was included the “Modernization of Cosmetics Regulation Act of 2022 (MOCRA)”. After almost 80 years, MOCRA is the first update over cosmetics law and significantly expand the reach of the US Food and Drug Administration (FDA’s Authority).A summary of the new MOCRA requirements for the cosmetics industry is as follow:
- It is necessary to register each facility that manufactures a cosmetic product for distribution in the U.S. and to renew each registration every two years. This does not apply to facilities that label, package, store or distribute cosmetic products, or to facilities that manufacture formulation ingredients.
- Companies must annually provide FDA with a list of ingredients and key product information, including any fragrance, flavor and/or color.
- Companies must keep records showing the history of serious adverse health effects caused by cosmetic products, retain them for six years, and report them to the FDA within fifteen days of becoming aware of the event.
Additional Labelling requirements:
- Indicate on the cosmetic product label a contact point for consumers to communicate any adverse event.
- Fragrance allergens must be listed on the product label.
- Clearly identify on the label the products intended for professional use. In addition, it is mandatory to include the contact information and the allergens of the fragrances that the product contains.
Substantiation requirements for business:
- Companies must record product information, including trials, research, analysis, and other information to show safety substantiation of the product.Additional FDA Rulemaking:
- FDA must establish Good Manufacturing Practices (GMPs) for each company to comply with the new regulations. Under MOCRA, FDA may be authorized to review GMP-related documents during inspections.
- FDA must define a regulation to comply with the fragrance allergens declarations on the label products, and eventually communicate the advance of the rulemaking process.
- FDA is required to define a standardized test method related to the identification of asbestos in talc-containing cosmetic products. Furthermore, FDA is required to publish an evaluation of the safety use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products.
- It allows the FDA to issue a mandatory recall in the event it determines that a cosmetic product is misbranded or adulterated, causing serious adverse consequences. Similarly, with product ingredients, FDA could access company records to confirm this.
- The FDA has obtained the authority to suspend the registration of any facility if the Agency believes that there is a possibility that the cosmetic product represents a serious adverse effect on public health.
Important points to consider:
- In the case of products regulated as drugs, they are exempt from complying with the new MOCRA law; however, these products must still comply with the new labeling requirements on fragrance allergens and professional use.
- Small businesses are exempt to meet the requirements of the new law.
If you need our services to adapt your products to the new Cosmetics Law in the USA, please contact us, we will be pleased to collaborate with you through our office in USA (Miami).
