Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
other · Food and Drug Administration · Rule · Published 2017-01-09 · Effective 2017-02-08 · 82 FR 2193
Document
Document number
2016-31950
Federal Register citation
82 FR 2193
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-01-09
Effective date
2017-02-08
HHS docket
Docket No. FDA-2015-N-2002
Abstract
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.