Hi Laura.
Simple answer is that a regenerative claim is almost certainly going to be looked at as a drug claim. There really isn't much you can do to fix that because it is obviously going to fall into either a "structure-function" effect or will fall under a skin growth effect - both of which are generally considered drug claims.
That said, there may be some gray area in the requirements if you were to reword the claim in such a way as to avoid making such a strong claim statement here. Feel free to contact me to discuss further if you would like!
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Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
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Original Message:
Sent: 18-Oct-2017 19:07
From: LAURA HOSHUE
Subject: Regenerate skin....A Cosmetic or drug claim?
Colleagues,
One of the masks that we are launching has a claim that it has an excellent regenerating skin effect. I know that to claim regeneration at the cellular level is an issue, but was not sure if the aforementioned skin regeneration claim would be considered a drug as opposed to a cosmetic claim. I suppose that could be considered somewhat like exfoliation or perhaps it would have made a difference if they said "Skin cell regeneration"?
Please advise.
Cheers,
Laura
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Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
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