On December 29, 2022, President Biden signed into law the "Modernization of the Cosmetics Regulation Act 2022 (MoCRA), which requires increased FDA oversight of cosmetics products.    

MoCRA requires obligatory cosmetics manufacturing facility registration and product listing. New labelling provisions, adverse events reporting and Good Manufacturing practices are imposed. Cosmetic companies need to start preparing in advance of MoCRA's December 29, 2023 effective date.

FDA is developing an implementation plan to address all of the new provisions in MoCRA and will share this information when available on the https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022 website over the next few months. 

Provisions mandated in MoCRA include:

• Domestic Responsible Person: Product label must include contact details for a domestic Responsible Person (RP) who is the manufacturer, packer, or distributor. This should include a domestic address, domestic phone number or electronic contact (which may include website) through which the RP can receive adverse event reports. 
  
  
• Facility Registration: Companies must register their manufacturing or processing facilities with the Food and Drug Administration (FDA) within 60 days of MoCRA coming into force (enters into force 29 December 2023). Registrations must be renewed every 2 year.
  
  
• Product Registration: Cosmetic products must be registered by 29th December 2023. Product registrations must be updated annually, and new products must be registered within 120 days of being placed on the market for sale.
  
  
• GMP: Must be in place by 2025 and products must be manufactured in accordance with GMP. The FDA must publish the final regulation by 29 December 2025, however in the interim, compliance to ISO 22716 will be good standard to comply with.
  
  
• Product Labelling: Cosmetic product labels must include fragrance allergen.
  
  
• Adverse Events: When a consumer has been harmed by a cosmetic product, the manufacturer or RP must report to the FDA. Records of adverse effects must be further kept and recorded duly.
  
  
• Safety Substantiation: Adequate documentation demonstrating product safety must be kept and be available upon request. A safety assessment compiled similarly to the the requirements of an UK/EU Cosmetic Product Safety Report (CPSR) may suffice. 
  
  
• Mandatory Recall: FDA can under MoCRA, issue a mandatory product recall in the event of non-compliance and/or safety issues pertaining to misbranded or adulterated products. In the case of serious health effects, the FDA has the authority to suspend a facility’s registration.

The 51st Amendment to the IFRA Standards

https://www.ni-hau.com.tw/news-detail/51st-amendment-to-the-ifra-standards.htm