2016-31950: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
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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 (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
The agency’s own summary, as published.
What this changes
Amends 3 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
We haven’t pulled this rulemaking’s full docket yet. View docket FDA-2015-N-2002 on Regulations.gov →
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