On August 8, 2016, the FDA issued a final rule outlining its refuse to accept policy for premarket tobacco product submissions failing to meet the minimum threshold of acceptability for FDA review. At that time, the Agency asked interested parties to submit comments by October 24th, and the rule was set to take effect on December 21st. However, after receiving significant adverse comments, the FDA withdrew the rule on November 16, 2016.
On December 29th, the second final rule was issued regarding this policy. In this final rule, the FDA also included the comments that it received during the initial rule’s comment period. Under the revised version of the FDA’s rule, the Agency states that it “will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.”
When this rule was published in December 2016, it was set to take effect on January 30, 2017. However, in accordance with the memorandum issued on January 20th from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” the Agency is delaying the effective date for the final rule until March 21, 2017.
For additional information, view FDA’s announcement in the Federal Register.