Dr. Ligon:
Does your question relate to marketing just in the EU or in other countries such as the U.S.?
Please note that in the U.S., the claims made will be very important towards determining if the product is a drug or a cosmetic and FDA will look not only at the basic terminology that you use such as the examples you gave, but also other claims on your label, labeling and websites. Thus, it is hard to generalize as to which claim might be acceptable.
For a discussion of the distinction between drugs and cosmetic claims in the U.S., please see my chapter on cosmetic regulation, which is accessible at
http://www.fdacounsel.com/files/Swit_-_Yingling_Cosmetic_Law_Chapter.pdf. While this was written in 1991, the law has not changed since then.
You also might review warning letters on FDA's webpage as I believe there are several that review the distinction between drugs and cosmetics.
If you need any further help on how FDA treats these products, please feel free to contact me.
Good luck,
Michael Swit
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
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maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 05-19-2014 11:11
From: Samuel Ligon
Subject: skin cream claims
My question concerns how best to market a new anti-wrinkle skin cream. My thinking is that the specific claims of the product will dictate whether the product would be a cosmetic or an OTC or Class I Pharmaceutical. One difficulty is that cosmetics (at least in Europe) do not allow animal testing and new pharma products basically require it. Which terminology ("skin revitalizing","anti-wrinkle", "skin replenishing") tend to make a product require going the pharma route and which tend to ensure the cosmetic route? Also, are in-vitro methods alone sufficient to establish safety (or equivalence to an existing product) for marketing?
Thanks,
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Samuel Ligon PHD
Vienna University of Technology
Vienna
Austria
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