Home Cosmetic Science Talk Formulating General Avoiding claims and staying on the FDA’s good side

  • Avoiding claims and staying on the FDA’s good side

    Posted by GeorgeBenson on January 1, 2023 at 1:32 am

    Prompted by a blog post on this website I was taking a look at some warning letters sent to various cosmetic companies by the FDA here:

    https://www.fda.gov/cosmetics/warning-letters-related-cosmetics/warning-letters-address-drug-claims-made-products-marketed-cosmetics

    I was surprised that there are so many huge brands that were in violation and that a lot of the product literature cited in the violations were worded carefully in ways that did not seem to me to be problematic. So many of the “claims” made are claims I still see made literally every day by popular brands while perusing different company’s websites.

    Things like “help to reduce the appearance of wrinkles”…I thought was the FDA-approved way of saying that, but things like this are cited in these letters as being in violation.

    So how exactly do we make sure we don’t say anything “wrong” on marketing material? Obviously things like “cures excema” are not allowed, but there seems to be this huge grey area of what is and isn’t ok, and even after reading some of the regulations I am still confused. 

    gordof replied 1 year, 3 months ago 2 Members · 1 Reply
  • 1 Reply
  • gordof

    Member
    January 2, 2023 at 8:07 am

    hi 

    As you mentioned it is a Grey area like all cosmetics are. In the end, if Cosmetic products have a real effect it would be a Pharmaceutical product:wink:

    Well, I guess a lot of what you can and can’t say on your Claims depends on the tests you performed with and for your product. if you have a Study that supports wrinkle reduction that is a fact you can talk about. If you don’t have any Study and you are just using materials that in other products show that they can reduce wrinkles that is probably a violation. all Claims need to Be Tested with your Product explicitly. Many companies don’t do that and they just claim what the supplier has tested with their raw material. 

    These studies are expensive so many skip them and just claim what the supplier has tested. I am not sure about US regulations but in Europe that is no longer allowed for 3 or 4 years now, you have to perform the tests with your product or there needs to be really good evidence in literature and practice that if you use this raw material it will give what your claim says (glycerin Humidity for skin, etc).  

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