What Happened to FDA's Final Rule for Tobacco Products?

FDA's Final Rule for Premarket Tobacco Product Applications On Hold

The Case of FDA's Missing Final Rule for PreMarket Tobacco Product Applications

If you operate in the tobacco and vapor products sector, you may be wondering what happened to the 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.

As the Biden administration took over government on January 20, 2021, Biden officials froze all recently completed rules of the previous administration, pending review by the new administration. 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 the 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 potentially killing the much-anticipated 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 rules and publish updates as they become available.

Read our full article on the Biden administration's rule freeze by clicking the button below, and be sure to follow our Legal Guides webpage for additional updates to this important regulation. In our full article you will also find a link to President Biden's announcement of the freeze.

If you have additional questions about tobacco and vapor compliance and how the recent regulatory freeze may affect your current operations, please contact us at contact@clarkespositolaw.com. As always, feel free to share this email with your industry colleagues and contacts who may be interested.

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