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I manufacture my products at home, how does MoCRA affect me?
I read that we are now required to register our facility, but since my facility is my home do I just register my home or is that no longer legal and will I have to find a lab to manufacture my product for me? Sorry if this has been asked before, I searched the forum but couldn’t find anything.
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6 Replies
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And exactly where are you located? This makes a difference……different countries have different compliance regulations.
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I’m in the USA, out of Arizona
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You can find info for small companies on the net - e.g. https://www.modernsoapmaking.com/blog/understanding-the-2022-united-states-cosmetic-regulation-changes-with-mocra
To your immediate question
small businesses are fully exempt from facility registration and product listing submission if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:
- 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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Thank you!
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As @PhilGeis pointed out, you are probably Small Business Exempt. Your situation is exactly why FDA created the Small Business Exemption … they did not want to have a registry of home-based businesses in FDA Direct, but they could have created a separate SBE Directory.
You are subject to all other mandates of MoCRA even if SBE. Your products must have Safety Substantiation dossiers - Preservative Challenge Test Results (Passing) + Cosmetic Ingredient Safety Reports (essentially a toxicology profile of each ingredient in your formula). You do not need to conduct Skin Patch Testing if you have a robust CISR. You also must comply with Serious Adverse Event/Adverse Event Reporting & Recordkeeping.
Reach out to me if you need help with MoCRA compliance.
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Hi @MarkBroussard thank you for the reply, I just sent you a private message with some more questions.
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