Home Cosmetic Science Talk Formulating General Toothpaste regulation in USA

  • Toothpaste regulation in USA

    Posted by Herbnerd on April 4, 2023 at 9:15 pm

    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?

    PhilGeis replied 1 year ago 2 Members · 2 Replies
  • 2 Replies

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