Are PMTAs Frozen?
Over the past few weeks, I continue to hear and receive questions regarding whether the Biden administration has frozen the PMTA process or rule.
The short answer is no.
The January 20th announcement from the Biden administration only concerns pending rules by federal agencies.
With respect to rules that have been sent to the OFR but not published in the Federal Register, immediately withdraw them from the OFR for review and approval…With respect to rules that have been published in the Federal Register, or rules that have been issued in any manner, but have not taken effect…
However, the Deeming Regulation under which PMTAs are currently being filed is a final rule that was finalized August 8, 2016. Therefore, any PMTAs currently filed will be reviewed as they ordinarily would be and FDA continues to accept PMTAs (any new PMTA can be filed but may be asked to remove from the market while the review is conducted). The same is true for any hookah, cigar, or other deemed tobacco products filing a PMTA or SE submission (or requesting grandfathered-in status).
The freeze on pending rules may impact the FDA Guidances, in particular those in draft status. But even the latest PMTA Guidance of any consequence, the Guidance on PMTA enforcement priorities, which was finalized in April 2020. This Guidance merely sets out that the enforcement priorities for enforcing the PMTA requirement and had no other impact. Furthermore, it is a very common practice for FDA to enforce using a draft guidance.
The PMTA process is well and alive and remains business as usual for the new administration.
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