Final Countdown: PMTAs Due to the FDA by 4pm Today
The vapor industry is expected to look vastly different tomorrow. At 4pm today, all premarket tobacco product applications (PMTA) must be submitted to the U.S. Food and Drug Administration (FDA). Many industry players say that the regulatory rule will force more than 10,000 businesses to close and cause more than 100,000 jobs to be lost. It could also force millions of vapers back to smoking deadly combustible cigarettes.
The vapor industry is not dead, however, as several manufacturers have announced that their PMTA submissions have been accepted and filed by the FDA. This allows those products to remain on the market while the FDA conducts its substantive review phase of the PMTA. During this period, the FDA will evaluate whether marketing a specific electronic nicotine delivery system (ENDS) product is appropriate for the protection of public health.
If a company does not submit a PMTA by 4pm today, it must remove its products from the market. If the product was “verifiably” on the market prior to Aug. 8, 2016 (the FDA’s cutoff for new products) and submitted a PMTA application before Sept. 9 at 4pm, the product can stay on the market for up to a year or until the FDA approves or denies the PMTA. For any PMTA submitted after today’s deadline, a product may not be marketed until the FDA grants a marketing order, according to the FDA.
The FDA has said that it will release a list of products that can legally remain on the market, although no timeframe was established for when that list would be available to retailers. Beyond all the major tobacco companies, which all have submitted PMTAs for vapor products, only a few other companies have publicly announced PMTA submissions to the FDA for their products.
As of Aug. 31, the FDA had received applications for around 2,000 deemed products, of which around 40 percent have been resolved, according to Mitch Zeller, director of the agency’s Center for Tobacco Products. Only two brands have ever had a PMTA application approved, Swedish Match’s General snus products and Philip Morris International’s IQOS, HeatSticks and charger.
AMV Holdings (Madvapes, Kure, Aloma), Avail Vapor, Beard Vape Co., Charlie’s Chalk Dust, Bidi Stick, E-Alternative Solutions (Leap, Leap Go), Innoken, Jarvis Vaping Supply, KangerTech, Nicopure Labs, Prism (511 Solutions), Smok, Smoore/Vaporesso, Turning Point Brands and Voom are just some of the vapor manufacturers that are not affiliated with a major tobacco company that have filed PMTAs. It is expected that this list will grow exponentially throughout the day as companies submit applications before the deadline. Several companies have said they have submitted PMTAs already but are waiting for acceptance letters from the FDA before making the announcement public.
“We feel that we have met all documentation requirements in our over 3-million-page submission thus far,” wrote James Jarvis of Jarvis Vaping Supply in a press release. “We excited about the future opportunity to work with [the] FDA and the industry to achieve final authorization in the coming months.”
Receiving a marketing authorization to sell vapor products isn’t the end of the process for manufacturers. The FDA requires companies to conduct post-market surveillance and studies to determine the impact of the marketing orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.
These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the product does not have unintended consequences for youth use.