Small Vaping Businesses: Less Than 10 Months of Operating Time Left

Small Vaping Businesses: Less Than 10 Months of Operating Time Left. According to an order issued by U.S. District Court Judge Paul W. Grimm on July 13, e-cigarette manufacturers must submit premarket tobacco applications (PMTA) within 10 months, or their products will be forced off the market.

Judge Grimm revoked the PMTA guidelines from 2017 in May, stating that the FDA had postponed the PMTA application deadline originally set for 2018 by four years to 2022, which did not comply with the "administrative procedure" rule-making process. Moreover, this delay in application is extremely drastic, equivalent to abandoning the FDA's statutory responsibilities.

In the 12-page legal document issued, the judge stated that e-cigarette manufacturers must submit PMTA applications within 10 months before the deadline of May 11, 2020, to retain the right to continue selling their products for another year, which will be used for the FDA's review process. However, the FDA can exempt relevant products from the PMTA mandatory application based on "good cause."
 
Starting July 13, the FDA has 30 days to appeal, requesting the Fourth Circuit Court of Appeals to stay Judge Grimm's ruling during the appeal period. Many observers in the e-cigarette industry believe that the FDA and the judicial department are likely to challenge this ruling and maintain a questioning and opposing stance, as it interferes with the powers of relevant government administrative departments.

Some believe the FDA will not appeal, as Judge Grimm's decision will achieve the agency's long-sought goal: to keep only large companies in the e-cigarette industry, particularly tobacco companies.

In a statement, acting FDA Commissioner Ned Sharpless seemed to suggest that the FDA would not appeal, stating: "Today's ruling is an important step forward for public health and fulfills the FDA's commitment to expedite the review of all e-cigarette products on the market, especially those appealing to young people."
 
The reality is that, to date, no e-cigarette manufacturer has submitted a PMTA to the FDA, as the required research and analysis costs are prohibitively high (estimated to exceed $1 million for each application). Furthermore, it was only last month, under the pressure of Judge Grimm, that the FDA finally published the long-overdue PMTA review standards.

Clearly, the guidance documents provided by the FDA do not offer any hope for survival to small e-cigarette manufacturers. Betting millions of dollars on proving that their products are "beneficial to public health" under high standards that are unlikely to be met is simply foolish.

Time will pass little by little. If PMTAs are not submitted within 10 months, will small businesses in the U.S. e-cigarette industry really have no choice but to "close their doors"?