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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
Docket No.: FDA‐2015‐N‐2002
Dates: Submit comments by November 24, 2015
Summary: The Food and Drug Administration (FDA) is proposing regulations 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.
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Your role in shaping tobacco regulation
Our regulatory process generally follows these steps:
- Rule/ Regulation Proposed
We publish a proposed rule in the Federal Register.
- Public Comments Considered
Our proposals generally have a 60-90 day review period.
- Final Rule Issued
After considering all comments, we issue a final rule.
- Compliance with New Rule Enforced
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