FDA Accepts Flavored E-Liquid PMTA for Further Review
AVAIL Vapor, a Virginia-based vape retailer and e-liquid manufacturer, today announced that a PMTA for flavored e-liquid submitted by AVAIL has been accepted by the FDA for further review. All vape manufacturers must submit PMTAs (Premarket Tobacco Applications) by September 9 for products they intend to sell on the legal market after that date.
AVAIL says the app is the first of “many apps AVAIL plans to drop” before the deadline, “which will allow AVAIL to provide a wide range of flavors” to customers. The company did not disclose the names of all of the submitted products, but did confirm that its Mardi Gras Mixed Berry flavor was among them.
Today’s AVAIL announcement marks the first known example of a flavored bottled e-liquid (or open-system vaping product of any kind) being accepted for further study by federal regulators. . Reaching the substantive review stage means submitted products can stay on the market for up to a year, or until the agency makes a final decision on whether they can be legally marketed.
Accepting the AVAIL submission for further review is important in two respects. First, it means that at least some bottled e-liquids will be legally available after the September 9 PMTA deadline. Second, it indicates that the FDA will at least pretend to review open-system products and bottled e-juices in non-tobacco flavors.
Both the Tobacco Control Act and the FDA’s Deeming Rule (which subjects vaping products to tobacco regulation) are carefully designed to make it difficult for small businesses and open-system vaping products to respond with pass the standard required to be “appropriate for the protection of public health.” Because they can be used in tens of thousands of configurations (making every combination impossible to test), the FDA could have simply refused to review any of them.
Until now, the only products made by an independent vape manufacturer known to be accepted for in-depth review were E-Alternative Solutions’ Leap and Leap Go devices, and sealed, prefilled Leap pods. The EAS announced on July 8 that its Leap PMTA submissions had been accepted for further review.
Juul Labs announced its PMTA submission in July, and all tobacco companies that sell vaping products have submitted applications, the most recent being Imperial Brands/Fontem Ventures’ myblu. With the exception of Juul, all of these companies can fund the cost of their PMTA submissions with cigarette sales. This is not the case with small independent vaping companies.
While AVAIL was rightly celebrating the successful completion of the first step toward PMTA approval, Arkansas-based e-liquid maker eJuice Monkeys made its own announcement, which will likely be repeated by many small vaping companies in the coming weeks.
“While we have been fully compliant at every step of this journey, we will not be submitting any PMTAs (pre-market tobacco applications) required to remain compliant,” the company announced. “Preparing enough PMTA to survive is not only cost-prohibitive for 98% of vapor product companies, it’s an extraordinarily complex and time-consuming undertaking, making success nearly impossible for all but the big companies. The big manufacturers tobacco companies have the resources to prepare and submit half a dozen PMTAs for the limited number of products they wish to offer vapers (a relatively minor cost, which is quite easily recouped when you’re the only players in town). We simply don’t have the resources to accomplish this and survive.
“But we are not alone. The vast majority of vaping companies are in the same position. In a decade, companies and groups have built an industry from the ground up, changed lives, fought the good fight, stayed the course, and are now preparing to turn the page. We consider ourselves in very good company.