MoCra

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA), marks the first significant update to the Federal Food, Drug, and Cosmetic Act since 1938. The law takes effect on December 29^th 2024 and will help ensure the safety of cosmetic products many consumers use daily.

MoCRA grants the FDA more control over cosmetics, introducing recall authority, facility registration requirements and improved labelling.

SME with gross annual sales in the U.S. from cosmetic products totalling less than $1M over the past three years are exempt from GMP, registration, and product listing requirements.

New FDA powers under MoCRA :

• Reporting adverse events to the FDA:  Companies must report such events within 15 days, with records maintained for six years. 
• Recall authority overview: The FDA is now empowered to intervene in health-related events caused by cosmetics, requesting recalls. Non-compliance can lead to an immediate stop to distribution.
• Facility Registration (updated biennially): Cosmetic facilities must be registered with the FDA and new facilities need to be registered within 60 days of production. The FDA launched a portal for companies to register facilities and list their personal care products
• Good manufacturing processes: MoCRA grants the FDA authority to set standards for cosmetic facilities, emphasizing quality control and sanitary conditions.
• Improved labels:  Product labels must include domestic contact information for reporting adverse events. 
• Disclose fragrance allergens: Fragrance allergens must be labelled on personal care products.
• Safety substantiation: Companies must maintain records supporting safety substantiation, even though the FDA isn’t mandated to review them. 

These changes will impact all cosmetic companies involved in the manufacturing and distribution of cosmetics within the USA.  All the above points are mandatory for facilities looking to export to the United States.

• MoCRA places full liability on a “facility” and a “responsible person” to confirm who will be accountable for assuring completion of the mandatory requirements.