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August 11, 2020

FDA Accepts a Flavored E-Liquid PMTA for Substantive Review

Virginia-based vaping retailer and e-liquid manufacturer AVAIL Vapor announced today that a PMTA for a flavored e-liquid submitted by AVAIL has been accepted by the FDA for substantive review. All vaping manufacturers must submit PMTAs (Premarket Tobacco Applications) by Sept. 9 for products they intend to sell on the legal market after that date.

AVAIL says the application is the first of “numerous applications that AVAIL plans to file” before the deadline, “which will enable AVAIL to provide a wide-ranging flavor portfolio” to customers. The company did not release the names of all products submitted, but confirmed that its mixed berry flavor Mardi Gras was among them.

Today’s announcement from AVAIL 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 that the products submitted may remain on the market for up to one year, or until the agency issues a final decision on whether they may be legally marketed.

Acceptance of the AVAIL submission for further review is important in two ways. First, it means that at least some bottled e-liquid will be available legally after the Sept. 9 PMTA deadline. Second, it indicates that the FDA will at least make a pretense of reviewing open-system products and bottled e-juice in flavors other than tobacco.

The Tobacco Control Act and the FDA’s Deeming Rule (which made vaping products subject to tobacco regulation) are both carefully designed to make it difficult for small businesses and open-system vaping products to successfully meet the required standard of being “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 vaping manufacturer known to be accepted for substantive review have been E-Alternative Solutions’ Leap and Leap Go devices, and prefilled, sealed Leap pods. EAS announced on July 8 that their Leap PMTA submissions had been accepted for substantive review.

Juul Labs announced its PMTA submission in July, and all of the tobacco companies that sell vaping products have submitted applications, the most recent being Imperial Brands/Fontem Ventures’ myblu. Except for Juul, all of those companies can finance the cost of their PMTA submissions with cigarette sales. That is not the case for small, independent vaping businesses.

While AVAIL was rightfully celebrating its successful completion of the first step toward PMTA approval, Arkansas e-liquid manufacturer eJuice Monkeys was making its own announcement—one that is likely to be repeated by many small vaping companies in the coming weeks.

“Though we have been fully compliant every step of this journey, we will not be submitting the PMTAs (Pre-Market Tobacco Applications) required to remain compliant,” the company announced. “Preparing enough PMTAs to survive is not only cost-prohibitive for 98% of vapor product businesses, it is an extraordinarily complex, time-consuming undertaking, making success nearly impossible for all but the large corporations. Big tobacco manufacturers have the resources to prepare and to submit half a dozen PMTAs for the limited number of products they want to offer vapers (a relatively minor cost, that’s recovered easily enough when you’re the only players in town). We simply do not have the resources to accomplish this and survive.

“But we’re not alone. The vast majority of vape businesses are in the same position. In a decade businesses and groups have built an industry from nothing, changed lives, fought the good fight, stayed the course, and now prepare to turn a page. We consider ourselves in very good company.”

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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2 years ago

Funny i just checked the FDA’s website cause i was curious as to the suggested guidance and says link not available. Wonder if a lawyer can catch this and use it against the FDA.