ARTICLE
16 October 2015

FDA Proposes Rule To Clarify Regulatory Status Of Products Derived From Tobacco And Amendments To Regulations Regarding "Intended Uses"

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Jones Day

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In the same notice, FDA is proposing to amend its existing "intended use" regulations for drugs and devices.
United States Food, Drugs, Healthcare, Life Sciences

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.

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