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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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11 Replies
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I’m an Australian, and we co-founded a skincare manufacturing company in Malaysia that we run for 20 years, and in March 2023 I retired. What we did was set up and run our manufacturing facility as GMP Certified. This required annual and periodic inspections of our facility by departmental officers.
The advantage of adopting the GMP Certified mindset was that it required the adoption of all the points identified by the original poster here. I would recommend this to anyone going down the MoCRA route.
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Be aware FDA has two years to get their GMP draft reg’s out for comment and three to finalize. Agency is also charged to develop simplified GMP practices for smaller businesses to ensure that these regulation do not impose undue economic hardship for these businesses.
Further - small businesses are exempt from Section 606 mandatory GMP if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make cosmetics that:
- cosmetics that come in contact with mucus membranes of the eye
- cosmetics that are injected
- cosmetics that are intended for internal use
- cosmetics that intend to alter the appearance for more than 24 hours
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Yes indeed….provides a fair bit of wriggle room for the unscrupulous.
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Sure does Mike - for the unscupulous and ignorant, softens and eliminates enforcement for those most likely to be compromised.. Ironic that big guys and their industry org were all in on it from the start and, in the final statute, lost the primary and very reasonable element they wanted - state preemption.
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The FDA focused on the requirements that make the most sense. No company, regardless of size, is exempt from Safety Substantiation, which is what really matters. It will be interesting to see if Amazon and Etsy both modify their listing criteria to require companies to submit PCT test results, for instance, before a product can be listed.
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I se your point, Mark but doubt it will make any diff in chemical safety tho it certainly lets the small guy off the quality hook.
We’ll see what passes for safety substatiation. Comprehensive approach of the bg companies will be much too costly for indies and iI wonder even at cost of HRIPT of finished product. Certainly EWG et al. will want to cash in credentialing. In the end - doubt it will make that much of an impact, esp as the body count isnlt there now.
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Here’s the FDA’s take on Safety Substantiation under MoCRA: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.
A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all data used to support the safety are derived from scientifically robust methods.
It looks like Preservative Challenge Testing and Toxicology Review (similar to EU Safety Assessment) will be the minimum requirements.
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For what it’s worth, AET is largely routine now. Do you see a gap in the indies you know?
Wonder at EU style safety assessment. We’ll see.
Still think this regulation for regulation sake.
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It would be impractical to have Amazon and
Etsy require companies to submit
PCT test results before a product can be listed. Would Amazon and Etsy have the qualified staff to make sense of these test results? And the extra workload for Amazon and Etsy would be enormous.A far more practical and cost-effective approach would need to be developed.
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Amazon already has listing criteria information that they require a brand submit prior to being listed on the site. This is something they are already doing. Yes, Amazon will do this as a liability prevention measure to ensure they do not become ensnared in a lawsuit by listing products by a company that is not in compliance with MoCRA. Seriously, any idiot can look at a PCT test results from a certified lab that is deemed a Pass (which is stated by the lab on the PCT final report) and determine that the product passed PCT.
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Yes, they are deficient in pulling together a toxicology dossier, so this will be something new to most Indies.
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