Toothpaste regulation in USA
Apologies in advance - I’m not from USA and really not familiar with USA/FDA regs.
I currently work for a toothpaste manufacturer and we are looking to sell both fluoride and sensitive toothpaste into the US Market. Fluoride toothpaste appears to be considered to be a drug, whereas non-fluoride toothpaste is a cosmetic. I’m unsure of the status of a sensitive toothpaste.
Where I am fluoride toothpaste is a cosmetic and sensitive, depending on the formulation may or may not be considered a medical device. Potassium nitrate to desentise nerves is a cosmetic, but blocking dental tubules is a medical device.
Under what regulation can we manufacture fluoride an/or sensitive toothpaste for the US? Does it require a full pharmaceutical laboratory or can it be manufactured under ISO 13485 or does it sit somewhere else for regulatory and manufacturing purposes?
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