• Deanna Clark-Esposito

Where is FDA’s Final Rule on Tobacco & Vapor Products?



Many businesses operating in the vapor and tobacco product sectors have been wondering what happened to the much-anticipated US Food and Drug Administration (FDA) Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) final rule. After all, the final rule was completed way back on January 19, 2021.


The PMTA and SE final rule was intended to serve as the comprehensive one-stop-shop for tobacco product manufacturers hoping to legally introduce new or substantially equivalent products into the U.S. marketplace after publication in the Federal Register (with the temporary exception of premium cigars, which were removed from the scheme following a court challenge).


The completed final rule was indeed announced the day before the Biden administration took over government on January 20, 2021. On inauguration day, Biden officials announced a freeze on all recently completed rules of the previous administration, pending review. Such a move is designed to prevent so-called “midnight-hour rulemaking” by outgoing administrations, and while common, this freeze is sure to displease industry stakeholders who have been waiting quite a long time for FDA’s final rule on PMTA and SE.


Unfortunately, this means even more waiting and more uncertainty for the tobacco industry, as the Biden administration has a number of options going forward, from reviewing and implementing the rule as-is, to revision, and even killing the long-awaited final rule.

There seems to be no clear consensus on what the Biden administration is likely to do with the Trump-era final rule as-written. You can be certain, however, that the Clark-Esposito Law Firm, P.C. will continue to closely monitor developments on the PMTA and SE final rule and publish updates as they become available.


If you have additional questions about tobacco and ENDS compliance and how the regulatory freeze may affect your current operations, please contact us at contact@clarkespositolaw.com. Additionally, you may send us an inquiry through our contact form on the home page here.


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