2017-10036: 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

Summary

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.

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.

• 21 CFR 201 Labeling
• 21 CFR 801 Labeling
• 21 CFR 1100 General