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  4. Rules, Regulations, and Guidance Related to Tobacco Products
  5. Withdrawn/Replaced Guidances
  1. Rules, Regulations, and Guidance Related to Tobacco Products

Withdrawn/Replaced Guidances

Title Date of Issuance Date of Withdrawal / Replacement
Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products 01/06/11 10/17/23
Investigational Use of Deemed, Finished Tobacco Products That Were on the U.S. Market on August 8, 2016, During the Deeming Compliance Periods 10/13/16 10/17/23
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product 07/15/14 10/17/23
Applications for Premarket Review of New Tobacco Products; Withdrawal 09/27/11 10/05/21
Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule  (Revised)* 03/08/19 04/30/20
Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act 11/27/09 05/06/15
Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products; Withdrawal of Guidance 06/08/10 11/28/12
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