MoCRA: What Indie Beauty Brands Can Do Now To Prepare For MoCRA
Modernization Of Cosmetic Regulations Act (MoCRA) ( https://lnkd.in/gn-k8bD4 ) goes into effect December 29, 2023. MoCRA will affect Indie Beauty Brands to different extents depending on whether you are using a contract manufacturer or in-house production of your cosmetic products. Here are some tips to prepare for MoCRA.
(1) Responsible Person: Designate an individual Responsible Person or MoCRA Compliance Officer for your company who will be your primary/sole point of contact with the FDA for MoCRA compliance including Product Registration and Adverse Event Reporting.
(2) Adverse Event Reporting: Set up an Adverse Event reporting page on your website defining for consumers what are Adverse Events and Serious Adverse Events. The FDA provides a specific definition of Serious Adverse Event
( https://lnkd.in/gn-k8bD4 )
(3) Adverse Event Reporting: Set up a specific e-mail address for consumers to report Adverse Events such as adverseevent@Companyname.com. Develop an SOP for Adverse Events reporting and build an Adverse Event file management system.
(4) Adverse Event Reporting: Download the FDA MedWatch Forms for Medical Product Safety Information to use as a guide or use these forms until the FDA designates specific forms for Cosmetic Products ( https://lnkd.in/g28FaRXJ )
(5) Product Labels: Review your product labels to ensure they are compliant with the FDA labeling rules and that you have accurate contact information for the brand’s Responsible Person. Under MoCRA you will be able to use a website and e-mail address, for instance.
(6) Product Labels: If your products are fragranced, ask your fragrance supplier to provide to you a list of fragrance allergens in your fragances that are on the EU fragrance allergens list. You will need to add fragrance allergens to the List Of Ingredients on your product label.
Note: In September 2023, the EU will increase the list from 26 to 120 allergens that are required to be listed. The FDA will designate the fragrance allergens that must appear on your label by mid-year 2024. In the interim, the EU allergens list is a good proxy.
(7) Safety Substantiation:
a. Make certain you have records on Preservative Challenge Testing on all of your products.
b. Consider commissioning an EU-compliant Safety Assessment for your products including building a toxicology dossier on all ingredients in each product.
c. Consider conducting 48-Hour Patch Testing on all of your products
d. Maintain Safety Substantiation dossiers on all of your products
The FDA has yet to provide final guidance or requirements on what constitutes Safety Substantiation (and may not provide any specific requirements), for instance. But, this will help you prepare for MoCRA as the various requirements become more definitive.
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