# Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
> **Food and Drug Administration** · Final rule; extension of comment period. · Published 2017-05-18 · 82 FR 22741
## Document
- **Document number:** 2017-10036
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 82 FR 22741
- **CFR reference:** 21 CFR 201
- **Publication date:** 2017-05-18
- **HHS docket:** Docket No. FDA-2015-N-2002
## Abstract

In the Federal Register of January 9, 2017, the Food and Drug Administration (FDA or the Agency) issued a final rule entitled "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' " (Final Rule). On March 20, 2017, FDA published a document in the Federal Register (Final Rule Extension) to delay the effective date of the Final Rule until March 19, 2018, and requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule. The petition for reconsideration raised questions about the amendments to the regulations regarding "intended uses" that are set forth in the Final Rule. In the Final Rule Extension FDA also requested comments regarding any aspect of the Final Rule, or with respect to issues relating to "intended uses" generally, and on whether the delay in the effective date should be modified or revoked. FDA is now issuing this document to extend the comment period. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2017/05/18/2017-10036/clarification-of-when-products-made-or-derived-from-tobacco-are-regulated-as-drugs-devices-or)
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