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In the September 25, 2015, Federal Register, FDA
provided notice of a proposed rule to describe the circumstances in
which a product made or derived from tobacco that is intended for
human consumption will be subject to regulation as a drug, device,
or a combination product under the Federal Food, Drug, and Cosmetic
Act ("FDCA"). In the same notice, FDA is proposing to
amend its existing "intended use" regulations for drugs
and devices. Comments are due November 24, 2015.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.