Regulation Text
(a) Except as stated in paragraph (b) of this section, this part will take effect 24 months after May 10, 2016. The effective date will be with respect to the date of manufacture, provided that, in any case, beginning 30 days after the effective date, a manufacturer may not introduce into the domestic commerce of the United States any product, irrespective of the date of manufacture, that is not in conformance with this part.
(b) The requirement to submit a warning plan to FDA under § 1143.5(c)(3) will take effect 12 months after May 10, 2016.
Authority
21 U.S.C. 387a(b),387f(d),Pub. L. 117-103, 136 Stat. 49.
Related Guidelines (3)
Compliance Policy for Required Warning Statements on Small-Packaged Cigars: Guidance for Industry (Status: Final)
→Submission of Warning Plans for Cigars: Guidance for Industry (Status: Final)
→FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements: Guidance for Industry (Status: Final)
→