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OTC, actives, cosmetics regulations
I have read in multiple places that colloidal oatmeal is an active ingredient that requires drug regulation instead of cosmetic regulation. Several things have said that ANYTHING that contains it becomes OTC regardless of intended use or claims.
However, looking at this from the FDA it looks like it’s only OTC if it’s used in conjunction with mineral oil? I read elsewhere that if you use it in a cosmetic, like lotion for example, with no claims or OTC intentions, you are not allowed to call it colloidal oatmeal. Instead, it’s supposed to be labeled as oat kernel meal. Can anyone shed some light/clarification on this?
accessdata.fda.gov
CFR - Code of Federal Regulations Title 21
CFR - Code of Federal Regulations Title 21
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4 Replies
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the INCI name I see for colloidal oatmeal is Avena Sativa (Oat) Kernel Flour . The difference between OTC and cosmetics really comes down to intended use. See FDAs page on this: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
and their definitions of cosmetics vs drugs.
If you want to include colloidal oatmeal in a cosmetic, you cannot claim to treat or prevent any disease. Colloidal oatmeal is a registered OTC active for skin protectant claims, so if you make that claim on your product (or even if it is strongly implied, the FDA also considers consumers understanding vs companies explicit descriptions) the FDA could determine your product is a drug and needs to go through proper process. Take a look at commercial products with OTC claims (ex Aveeno Baby Ezcema Therapy ) vs cosmetic claims (ex Aveeno Calm + Restore Facial Moisturizer for Sensitive Skin). Skin dryness is a fine line for claims and I’m not a regulatory expert, but some level of moisturization/hydration related claims seem to be fine, it’s the prevention or disease mitigation that veers away from cosmetic territory.
fda.gov
Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
An overview of the legal differences between cosmetics and drugs, and whether a cosmetic can be both or just a soap.
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Thank you! That’s what I was kind of leaning towards after reading the FDA guides, but I wanted to get a second opinion from people that probably have more experience than I do in case I was misunderstanding anything. I’m a bit paranoid about accidentally breaking any regulations and getting in financial trouble over it. Since I’m just starting out, I don’t have the financial means to weather any fines or anything yet and would just go under without even having the chance to learn from my mistakes.
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Correct, it’s all about the claims (for the most part). Petrolatum is also an OTC skin protectant active but it’s used in cosmetic products all the time.
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Awesome, thank you for that confirmation!
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