FDA May Hate Their Guts, But the PMTA Process Favors JUUL

Juul Labs has filed its long-awaited PMTA, which includes no flavored products aside from tobacco and menthol pods. Juul filed six weeks before the Sept. 9 Premarket Tobacco Application deadline for all vaping products.

Assuming the company’s application is accepted for substantive review, Juul will be able to leave its current products on the market for a year, or until the FDA makes a final decision. The only low-risk tobacco products to receive PMTA approval so far have been snus from Swedish Match, and Philip Morris International’s heated tobacco product IQOS. FDA review of those products took more than two years.

Juul Labs (note the new capitalization convention: the company is Juul Labs, the product is still JUUL) announced the filing yesterday, referring to the products submitted as the “JUUL System.” Juul noted that only Virginia Tobacco and Menthol flavored pods (in both 5 and 3 percent nicotine strengths) were part of the application, but didn’t describe which devices made up the “system.” It is widely known that the company has new versions of its well-known pod vape with features that aren’t part of the currently sold device, including an age verification system for users.

To leave the original product on the market while the application is considered by the FDA, the JUUL PMTA must include both the current device and any advanced products. That means doing duplicate testing and research for each device submitted—something only a wealthy vape company like Juul Labs could afford.

Few if any small, independent vaping businesses have the financial resources to submit an effective PMTA. Industry advocates are pressing the FDA and its parent agency the Department of Health and Human Services (HHS) to adopt a simplified version of the approval pathway for small manufacturers. And while hundreds of small companies are proceeding with plans to submit PMTAs based on a model version of the simplified process, the federal agencies have offered no sign that the small companies' applications will be accepted for review. In January, HHS Secretary Alex Azar promised a “streamlined” PMTA process, but no changes to the onerous, expensive system have been made.

Approval of a PMTA requires a manufacturer to prove to the FDA that its product is “appropriate for the protection of public health”—a requirement defined in the 2009 Tobacco Control Act. That definition means that the product must benefit the health of the population as a whole, including not just the smokers likely to reduce their health risks by switching, but also non-smokers and kids who may desire to experiment with “tobacco products.”

The JUUL application, for example, contains “detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the product’s impact on both current users of tobacco products and nonusers, including those who are underage.” According to the company, its PMTA includes research showing:

Proving its product won’t attract additional youth vapers is a high bar for Juul to reach, and producing such evidence cost Juul Labs millions of dollars, and required a team of scientists working full time on nothing but the JUUL PMTA. Even with its history of antagonizing the FDA (just last week a story claimed that Juul secretly changed its product after the Aug. 8, 2016 cutoff date that froze products in place), and its position as the favorite whipping boy of anti-vaping tobacco control groups, Juul will face fewer PMTA hurdles than small vape companies.

“Preparing and satisfying a PMTA is no easy task, with applications that are millions of pages long, costing millions in resources, and requiring significant scientific support,” financial analyst Ryan Tompkins told Convenience Store News. Most of the companies submitting PMTAs are paying for their applications with money made by selling cigarettes.

The FDA PMTA guidance for manufacturers is intentionally vague and loosely defined. Everything is left up to the manufacturer—and without a staff of experienced regulatory compliance experts, it is impossible to even make an educated guess about what will or won’t be needed to satisfy the agency. The only PMTA approval history they have to base their guesses on comes from products very different from vapes.

A company like E-Alternative Solutions, for example—which just submitted its own PMTA—probably had to rely on freelance compliance consultants to do its testing and analysis. And EAS likely depended on the Chinese manufacturing facilities it contracts with to provide details about components and manufacturing processes.

Juul, on the other hand, controls its own production from raw materials to packaging, which makes study and explanation of manufacturing processes simpler and more accurate than would be possible for companies that depend on a variety of suppliers and sub-manufacturers. That is also true of the products that have already received PMTA approval.

The vaping industry’s rapid consumer-driven, bottom-up innovation is incompatible with the Tobacco Control Act, and the FDA’s Deeming Rule was designed to drive that point home. The process was deliberately created to get rid of thousands of small vape manufacturers, which are seen by the FDA as an unregulatable “wild west.”