Month: July 2020

[ad_1]

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 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.

In January, HHS Secretary Alex Azar promised a “streamlined” PMTA process, but no changes to the onerous, expensive system have been made.

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 process was deliberately created to get rid of thousands of small vape manufacturers, which are seen by the FDA as an unregulatable “wild west.”

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:

• “The harm reduction potential of the product”
• “The controlled design and repeatable manufacturing processes associated with the JUUL System”
• “Data-driven measures to limit unintended consequences to the overall population, including initiation among nonusers”

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.

For the FDA, dealing with a handful of huge companies that already know how to play the compliance game was always the goal.

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.”

Even if the PMTA deadline gets pushed back till next year, the FDA can smell blood now.

The agency never intended to create a process that would allow small businesses to thrive and help customers migrate away from cigarettes. For the FDA, dealing with a handful of huge companies that already know how to play the compliance game was always the goal.

There may yet be additional delays of the deadline because of challenges created by the coronavirus pandemic. Even if the PMTA deadline gets pushed back till next year, the FDA can smell blood now. The agency is on the brink of getting what it has wanted since March 2009, when it seized e-cigarettes coming from China and tried to ban them as illegal drug devices.

Meanwhile, all of the tobacco companies that make vaping products—BAT/Reynolds (Vuse), Japan Tobacco (Logic), and Fontem/Imperial (blu)—have submitted their own applications, and probably have a good chance of approval. And if their PMTAs are rejected, they have the perfect backup plan: selling cigarettes.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep 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 recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy

[ad_2]

Source link

[ad_1]

[ad_2]

Source link

Around Thanksgiving 2019, two months after Governor Andrew Cuomo signed an executive order that banned sales of flavored vaping products in New York, Taobi Silva thought he’d give the vape business another shot.

Rob Ermolovich, the owner of a shop called Fluid Vapor and a local e-liquid manufacturing business, had given Silva a call, asking if he’d be interested in some kind of partnership. Silva and Ermolovich knew what was coming, as did many in the industry. Consumers, shop owners and manufacturers had already started to see prohibition as an inevitability, and had begun to prepare accordingly.

They weren’t wrong. Though a State Supreme Court justice eventually blocked Cuomo’s executive order months later, the governor soon managed to get what he wanted. On April 3, just past 3:30 am, the New York State Assembly passed a budget that included a flavor ban. It remains in effect.

But while everybody else was panicking, Silva was not. He felt, rather, the opposite. He is a member of the Shinnecock Nation, the 1,500-person tribe outside of South Hampton, Long Island. And he saw a distinct opportunity.

Because they are members of the tribe and conduct business on their sovereign land, the New York State flavor ban does not apply.

In March, on the reservation where his family has run a smoke shop for generations, Silva and his uncle, Jonathan Smith, opened up a brand-new, sister vape shop—to which, because they are members of the tribe and conduct business on their sovereign land, the New York State flavor ban does not apply.

Ermolovich had spotted this opening and had a proposal: He would close his storefront in Bohemia, about 40 miles west of the reservation, and set up his operations at Silva’s. So since the middle of March, that’s exactly what he has been doing—making his signature e-liquid in the back of the shop and selling it to his recurring customer base, which Silva estimated to be in the hundreds. Even during the COVID-19 shutdowns, their walk-up and drive-thru business remained steady. It also remains completely legal.

“Several smoke shops here, like mine, had tried vaping years ago, and the market was flooded with brands and flavors and strengths,” Silva told Filter. “To get into it, however, you’re talking about a five-figure investment into these products. And, before Juul, you didn’t even know who the leader was. Things, obviously, are different now.”

Because only Shinnecock tribe members can own property on tribal land, Silva had to hire Ermolovich and his wife, Kim, as 1099 subcontractors. The couple brought with them not only their loyal patrons, but also their e-liquids, registered with the Food and Drug Administration (FDA), which Silva hopes one day to put into disposables or pod-based cartridges compatible with Juul*—the latter of which are almost all currently banned under federal policy.

Silva said that he was unaware of any other Native American reservation in New York State where flavored e-liquids are being manufactured, and believed that he and Ermolovich could very well be the sole example of this sort of partnership.

As it turns out, that might not be the case. Filter later spoke with another e-liquid manufacturer in the state, who requested anonymity out of fear of reprisal.

“The best way to describe it,” he said, treading carefully as he outlined a similar scenario, “is that a manufacturer in New York State helped a Native American set up a new business to sell [the manufacturer’s] flavored e-liquid on sovereign land.”

There are plenty of rumors, too. Several vape shop owners around Buffalo and Niagara Falls, for instance, insisted off-the-record that rivals had packed up and somehow moved onto neighboring Native land, probably by partnering up as Silva and Ermolovich did.

It was less a question of if this would happen, and more of when.

It wasn’t possible to independently verify these claims, but they seem plausible when the scenario was not necessarily unfamiliar or unpredictable. Last fall, when Washington State issued a flavor ban that would later be reversed, local tribes were reportedly torn on whether or not to follow suit.

It was less a question of if this would happen, said Andrew Osborne, the vice president of the New York Vapor Association, and more of when—as the entire vape economy in New York and other restricted states has begun to shift to gray and illicit markets following the pandemic and a variety of prohibitive measures. (For manufacturers, there is also the anticipation of having to file what many claim to be exhaustive and expensive premarket tobacco product applications, or PMTAs, with the FDA in September.)

Flavors, much of the industry asserts, constitute a bulk of sales, and without them, most vape shops would simply shutter. Vape shop owners and e-liquid manufacturers have been forced to stop altogether, or to defy their state governments and get creative with workarounds.

“The reservations are certainly part of that gray market and will keep being so,” Osborne told Filter. “In the immediate days after the flavor ban, people were either calling or coming to my store, and telling me that reservations still had flavors available.”

“If I didn’t have a business partner,” he continued, “I’d have more seriously considered moving to the reservation myself somehow.”

It’s not just the ability to produce and sell flavors that’s appealing. New York State’s 20 percent excise tax on vapor products and nearly 9 percent sales tax also do not apply to the Shinnecock and other tribes. Essentially, Silva said, patrons can spend almost 30 percent less than they normally spend, and nobody has to worry about breaking the law.

The Shinnecock Nation’s Office of Tribal Tobacco Products (OTTP) regulates the industry on the reservation, and so far, there has not been much concern about vaping.

“The OTTP will continue to monitor the totality of the e-cig debate and will advise and recommend any necessary regulations or public-health concerns with the Council of Trustees,” Bryan Polite, the tribe’s chairman, wrote in an email to Filter. “The Shinnecock Nation takes great pride in our self-governance on our ancestral territory, but also has always understood the enormous responsibility.”

Yet the issue with tobacco has always been a contentious one. Native Americans and Native Alaskans have “the highest prevalence of cigarette smoking among all racial/ethnic groups” in the United States, according to the Centers for Disease Control and Prevention, and the Shinnecock and New York have often butt heads about it: They’ve long been engaged, especially, in back-and-forth litigation about the tribe’s right to sell untaxed cigarettes.

Flavored vapes, far safer than cigarettes, are nonetheless equally contentious in New York legislators’ eyes.

Most recently, however, the Shinneock Nation has made news after building a pair of massive billboards on their land, much to the chagrin of the wealthy Hamptonites who drive past them on the way to the beach. Over the last year, the Shinneock have been battling local and state governments in court for the right to construct them, and in May, the State Supreme Court sided with the tribe.

The members thought the billboards—which they refer to as “monuments”—could bolster their economy by attracting the Hamptons’ high-end clientele to purchase luxury brands on the reservation. They saw an opening, just as Silva did with flavored vaping products.

But like the builders of the billboard, Silva hasn’t had things all his own way.

“I’m going to speculate, but I think the black market is still so significant that we’re not seeing any spillover,” he said of his solid business so far. “You would figure that we’d be stampeded. That’s not been the case.”

“It’s not disappointing,” he continued, “but it’s not meeting my growth expectations.”

[ad_1]

[ad_2]

Source link