New Guidance Extending Compliance Deadlines to Submit Deemed Tobacco Product Applications

The FDA is announcing the publication of a revised guidance, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, which formalizes the extension outlined in a recent announcement by FDA Commissioner Dr. Scott Gottlieb. The agency is extending timelines to submit tobacco product review applications for “deemed” tobacco products that were on the market as of Aug. 8, 2016.


In May 2016, the FDA issued a final rule deeming all products that meet the statutory definition of a tobacco product, except accessories, to be subject to the FDA’s tobacco product authority. In May 2017, the FDA published the first edition of this guidance document, under which it provided a three-month extension of all future compliance deadlines for requirements under the final deeming rule.


Initially, the compliance deadlines for deemed tobacco products were based on which type of application, or “pathway to market,” the applicant was submitting: substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), or premarket tobacco product applications (PMTAs). However, under this new guidance, the revised deadlines are based on whether or not the product is combustible—regardless of the pathway chosen. As such, the new dates are as follows:

  • August 8, 2021 (SE EX requests, SE reports, and PMTAs for deemed combustible tobacco products, such as most cigars, pipe tobacco, and hookah tobacco)
  • August 8, 2022 (SE EX requests, SE reports, and PMTAs for deemed noncombustible tobacco products, such as most electronic nicotine delivery systems or e-cigarettes)


In addition, under this guidance, for products in which applications are submitted to the FDA by the deadlines outlined above, there will be a continued compliance period pending review of those applications, and the FDA expects manufacturers will continue to market those products while under agency review.


Lastly and importantly, no other provisions in the final deeming rule or its preamble are being altered, either those already in effect, such as mandatory age and photo ID checks to prevent illegal sales to minors, or those scheduled to go into effect at a later date, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of the reduced risk claims, i.e., "light," "low," or "mild," and similar descriptors. Also, this new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco.


For more information, please read the revised guidance.

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