Vitamin C Serums FDA regulation question.

Hello all,
I've been formulating a vitamin C serum to release a line. The intention of the serum is to increasing subcutaneous antioxidant levels and collagen gene up-regulation. Which from scientific articles I read vitamin C does. I read from the FDA website if it modifies the body its a drug. Are vitamin C serums considered a drug? Or would it only be considered a drug if I made claims? Thank you for your help.
  • "But, products intended to affect the structure or function of the body, such as the skin, are drugs, or sometimes medical devices, even if they affect the appearance. So, if a product is intended, for example, to remove wrinkles or increase the skin’s production of collagen, it’s a drug or a medical device."
https://www.fda.gov/cosmetics/cosmetic-products/wrinkle-treatments-and-other-anti-aging-products

AH

Comments

  • PerryPerry Administrator, Professional Chemist
    If the purpose of you adding Vitamin C is to up-regulate genes to affect collagen production, then YES you would be making an illegal drug. Whether you make claims about that or not wouldn't matter.

    If you have some other purpose for adding vitamin C to your formula & don't make any drug claims, then it's likely a cosmetic.
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