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The Food and Drug Administration (FDA) is issuing this final 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.

This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

The official document is scheduled to be published on 01/09/2017 and will be applicable 30 days later, on 09/02/2017.

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