Smaller vape manufacturers are the biggest losers in the five-year long struggle since the US Food and Drug Administration (FDA) received regulatory authority over e-cigarette and vape products in August 2016. In its latest move, FDA has allowed vape products from big companies to stay on the market for an indeterminable time while removing millions of products from smaller manufacturers through its premarket tobacco application (PMTA) - a process that was seen as being stacked against small businesses from the beginning.
A PMTA is required for companies to continue marketing and selling their products on the US market. FDA already wiped out a large number of products from smaller manufacturers simply through the PMTA submission process, before even reaching a status to get accepted, reviewed, and subsequently rejected. The cost of submitting a PMTA, which FDA itself estimates at US$117,000-US$466,000 per product per application, plus the need to conduct “randomized controlled trials” or “longitudinal cohort studies” that FDA requires as part of the PMTA, were already beyond what smaller manufacturers could take on.
The court-mandated September 9 deadline came and went and as expected, FDA did not finish reviewing the more than 6.5 million PMTAs it received for e-cigarettes and vapes. FDA issued no authorizations or any exemptions or any direction on what vape and e-cigarette manufacturers with applications still under review are to do next. Luckily for them, the remaining applications generally are from big companies or companies with links to them.
When FDA previously acknowledged it would not be able to review all the PMTAs by the September 9 deadline, it said it would focus resources on applications for products that “will have the greatest health impact and have the largest market share”, which basically meant products from major players like Juul, Vuse, NJOY, Blu, and Logic. FDA also stated that it would extend the review period on a case-by-case basis, the first of which now seems to be Juul. FDA did not announce when it might rule on Juul or any of the other major manufacturers, effectively allowing them to stay on the market for an undefined period of time while other products from smaller players were wiped out, reinforcing concerns that FDA regulation would in effect kill the smaller players and hand over the industry to the big companies.
According to Mitch Zeller, director of FDA’s Center for Tobacco Products (CTP), by September 8 the agency processed 93% of the applications. Notably, FDA issued no authorizations for any product. Instead, FDA issued “refuse-to-accept” letters for over 200,000 products, 132 marketing denial orders (MDOs) for 946,000 products, and, in one fell swoop, “refuse to file” notices on an astounding 4.5 million applications (about 75% of the total PMTA applications) from a single e-liquid company JD Nova Group.
Usual FDA pals such as the Campaign for Tobacco-Free Kids and Parents Against Vaping E-cigarettes already called FDA’s extension for Juul and other major vapes “outrageous”, even saying they would take FDA back to court if the agency did not clarify a determined timeline for the remaining decisions.
The way things stand now, FDA conveniently removed products from smaller companies, paved the way for those from big companies, reduced the number of (potentially) safe choices available to consumers, and gained the displeasure of anti-vaping allies. The only ones who are benefiting from this situation seem to be the big vape manufacturers whose products can continue to be sold unhindered for an indefinite amount of time.