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E22 The new FDA MoCRA regulations that will affect your personal care, cosmetic and topical business - Dahlia Kelada
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This episode is introduces probably the most important piece of information that will have a profound impact on your business, especially if you are selling or making personal care products, skin care, and other topicals. So yes, to all my hemp customers, this will apply to you as well.
It's time to talk about the FDA and the new guidelines for cosmetic products. I will put out other episodes later for FDA labeling guidelines and product claims, but I need to share the hot potato topic which is the new cosmetic act that's about to slap us all in the face. It's called the Modernization of Cosmetic Regulation Act (MoCRA).
I'll break today's discussion into 5 notable topics to consider from the new MoCRA regulations, and this includes facility and product registration, GMP and product safety testing, adverse event reporting and recalls, labeling and product claims, and we'll discuss who may be exempt from certain parts of MoCRA.
If you're like me, you'll probably take a few deep breaths listening to the news in this episode. But don't worry, you're not alone, and I am working on something big that will help you with this transition so you can focus on your business and not the regulatory chaos that's about to come.
Please subscribe to this Making it to Market podcast to keep current on MoCRA and the new project I'm working on that will help your business make lemonade out of these FDA lemons.
Important Links
- The Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- Product Testing of Cosmetics
- Draft Guidance for Industry: Cosmetic Good Manufacturing Practices
- FDA Adverse Event Reporting System (FAERS) Electronic Submissions
- Volunteer Cosmetics Registration Program (VCRP)
- Safety Reporting Portal (SRP) - please request an SRP account by emailing faersesub@fda.hhs.gov.
- Inquiries about MoCRA can be directed to QuestionsAboutMoCRA@fda.hhs.gov.
Comments or Questions? 832-800-2144 or dahlia@makingittomarket.com
Host: Dahlia Kelada
Copyright 2023 Making it to Market - Dahlia Kelada
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