Amazon Topicals vs Cosmetics and FDA or CoA Requirements

Hey everyone, just wanted to thank you all for your time. I know this topic has been vaguely covered but I just wanted to come to you guys for your expert opinions here as I feel a little in the dark on this subject.

I have made a balm intended for the use on mens beards. Amazons ingestion process has decided that this is a topical and I need either CoA, FDA registration or GMP. 

I don't have a Certificate of Analysis of my product as I am the manufacturer at home. I can get all the CoA information for each individual ingredient (all plant based) from my supplier however, but not the culmination of the ingredients.

As far as I'm aware the FDA registration my not be valid in my case? As the FDA doesn't really govern cosmetics. The FDA does offer a Voluntary Cosmetic Registration Program but that's all that applies to my product.

If the label on my plant based cosmetic product has the ingredients listed to the specifications of the FDA and I'm not making any claims other than what the listed ingredients claim they can do, should I be needing to provide this information to amazon that's required for topicals or should I be able able to be approved under the FDA's interpretation of a cosmetic?

I apologize in advance if the answer to this question seems obvious but I appreciate your help in any case.

David


Comments

  • MicroformulationMicroformulation Member, Professional Chemist
    Simply, you will not likely be able to sell a home manufactured product on Amazon.

    Google the FDA definition of Cosmetic. Your product is a Cosmetic. "Topical" is not a category in this case.
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PerryPerry Administrator, Professional Chemist
    The FDA does govern cosmetics. They set the rules, do some inspections, and is the agency who goes after people who are not in compliance with cosmetic regulations.

    However, the FDA does not certify cosmetics. They do certify colors used in cosmetics but not the finished product.

    Topical is a term used by Amazon and as @Microformulation suggests, it's not really an FDA regulated term.

    Your claims might be a problem. You have to write them in a way that is truthful and that you can prove is true. For example, you can't say "This product contains vitamin C and will lighten your skin"

    There are a couple of problems with that claim
    • skin lightening is a drug claim
    • you attribute a function to to formula rather than the ingredient
    So, you have to be thoughtful in how you write your claims.

    I'm not really sure what Amazon considers a suitable COA.

  • I just wanted to thank you both for your replies. They were both very helpful towards resolving my issue!
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