Posted by Jason B. on Apr 2nd 2020
PMTA Deadline Delay
What Is The PMTA and Why You Should Know
Published by Jason B.
The PMTA which stands for Premarket Tobacco Applications is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States.
The FDA has been slow with regulating vaping but fast at times when it comes to creating reactionary policies. The PMTA was originally applicable to products like smokeless tobacco and cigarettes
The FDA Gets Another Delay
The FDA created a “deeming” rule in May 2016, stating the PMTA guidelines would cover both their traditional markets and the ever-growing industry of e-cigarettes and vapes we know and love. The FDA has now made it so any product produced after August 8, 2016, would need to file a PMTA before being available for sale. This gives the FDA the ability to verify any vaping products relative safety, the ingredients involved, and marketing tactics.
The original deadline for vaping manufacturers to submit PMTAs was Aug. 8, 2018, as mandated by the FDA’s 2016 Deeming Rule. In July 2017, newly appointed FDA Commissioner Scott Gottlieb announced the deadline would be postponed until Aug. 8, 2022. The date was later revised again and moved up a year, to 2021, for flavored products (other than tobacco, mint and menthol), and 2022 for tobacco-flavored products.
The FDA has asked a federal judge to allow a four-month delay of the deadline he imposed for submission of Premarket Tobacco Applications (PMTAs) by vaping manufacturers. If the judge grants the delay, the deadline will move from May 12 to September 9.
"It is not clear at this point what the precise impact of the COVID-19 outbreak will be on the scope of FDA’s ability to complete application reviews within the 12-month period of time once applications are filed,”
— Mitch Zeller
Anti-Vaping Campaigners On The Prowl
The plaintiffs whose lawsuit forced the FDA to speed up the PMTA process—including AAP, Campaign for Tobacco-Free Kids, and the American Cancer Society Cancer Action Network—have been consulted by the FDA and DOJ attorneys, and have “indicated that they do not intend to oppose the motion but wish to express their misgivings about the extension on the record and therefore request leave to file a response.”
The attorneys also notified the U.S. Court of Appeals for the Fourth Circuit that the request for a delay will not affect the FDA appeal of Judge Grimm’s decision. Both the FDA and vaping industry groups are challenging the decision in the appeals court.
In summary, the PMTA is inevitable but as for when the true deadline will stick remains to be seen. All we can do is prepare as much as possible, and keep positive because regulations have the potential to shed a more positive light on the vaping industry as a whole.