Ten USVA (United States Vaping Association), a trade association that represents the small vapor industry is suing the FDA. 

Ten lawsuit is challenging the PMTA final rule because the FDA failed to properly consider the impact this seemingly impossible and expensive process would have on small businesses.  In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time.  In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses. 

The lawsuit asks for relief for these businesses that are members of the USVA.  The relief the lawsuit is seeking is as follows: 

1. Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
2. Remand the PMTA Final Rule to the FDA; and 
3. Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement; and 

Not only did the FDA not create a small business pathway, through FOIA requests via Filter Magazine we learned that they prioritized manufacturers with the greatest market share, companies who clearly had the funds to afford to fully go through the entire PMTA process and even allowed these companies to make changes to issues with their submissions that smaller companies just received MDO’s for. 

Further FOIA requests via Filter shows us that once upon a time the FDA had originally intended to handle these PMTA applications in a very different way. In August of 2020 they released a memorandum titled “Bundling and Bracketing Approach for Review of ENDS Open E-Liquid PMTA’s” In this memorandum the message below shows what could have been for the small vapor industry.

“FDA anticipates that a substantial portion of PMTA ENDS submissions during the compliance period will consist of open e-liquids that contain hundreds to thousands of products with variations in CF [characterizing flavor], nicotine concentration, and PG:VG [propylene glycol and vegetable glycerin] ratio based on the tobacco ingredient listing submitted by tobacco product manufacturers and importers,” the memo reads. “To increase the likelihood that more tobacco products will be reviewed and receive marketing orders before the end of the compliance period, the Office of Science (OS) is implementing a bundling-bracketing review approach for ENDs open e-liquids PMTAs.”

By 2021 this was thrown out and replaced by the “Fatal Flaw” standard. This new standard was a death blow to the industry and ultimately has brought us here.

If the FDA will not do what they legally are obligated to do under the RFA (Regulatory Flexibility Act), consider this impact on small businesses and create a pathway that is feasible for these small entities then clearly the industry has no choice but to take them back to court.