Pushed by Federal Court, FDA Publishes PMTA Guidelines

Under pressure from a federal court, the FDA finally issued guidelines for the filing of pre-market tobacco claims (PMTA). And according to what's happening in the Maryland federal lawsuit, vape manufacturers could be forced to file multi-million dollar claims in less than four months or be forced to shut down.

No vape company has ever introduced a PMTA, and the FDA's Tobacco Center has approved only one PMTA for a nicotine-based inhalant product in its 10-year history. This product, IQOS from Philip Morris International, is not an e-liquid spray device. IQOS PMTA was approved in April after a review process that lasted more than two years.

Given that only a handful of companies would dare to risk millions of dollars on applications that would probably be denied, we could soon be facing the end of the independent and legal vaping industry. That would mean that tens of thousands of employees would lose their jobs, and maybe millions of vapers would turn to the black market for e-liquids and supplies, or return to smoking.

At this point, the vaping industry relies on its perpetual foe, the FDA to wage this legal battle, otherwise it will be forced to immediately submit tons of paperwork that most companies are not able to fill correctly but that are rejected by unprepared regulatory authorities. revise the. Nobody wants that to happen, with the exception of anti-vaping groups that have filed lawsuits against the FDA.

But let's start from the beginning.

On July 28, 2017, then-FDA Commissioner Scott Gottlieb announced a bold "global strategy" to fight tobacco and nicotine. Among other initiatives (such as reducing nicotine in cigarettes), he announced a four-year deadline for the 2018 PMTA deadline for manufacturers of "reputable tobacco products" – a delay that would leave a respite to companies when they are preparing. And Gottlieb promised that the vape industry would soon have "a solid foundation of rules and standards for newly reputed products."

Nearly two years later, when Gottlieb left office earlier this year, the deadline for submitting the PMTA 2022 had been extended from one year to 2021 for flavored vaping products, and it was not until 2021. there were still no published standards. Worse still, the country was plunged into a moral panic over vaping, partly fueled by Gottlieb's desire to make a flattering cover of news.

The same groups largely responsible for initiating the vaping panic – the American Academy of Pediatrics (AAP), the Cancer Society's network of action against the American Cancer Society, said: The American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Children, and the Truth Initiative – filed a lawsuit in March 2018 demanding that the FDA restore the original time limit and begin to apply the "no-smoking" campaign. requirement to conduct a pre-market review of all known products that were on the market as of August 8, 2016 (all products after that date are de facto illegal without FDA approval).

Many in the vaping industry have forgotten the lawsuit after filing. It was just one of the strangest moments in an endless series of incomprehensible ones. Since the courts tend to rely on federal agencies in such cases and allow them to regulate as they see fit, industry insiders have not been too worried about the lawsuit.

But last month, District Court Judge Paul Grimm ruled for the PAA and other anti-vaping plaintiffs, and said the FDA's delay in favor of the PMTA was tantamount to an "abdication." "of the regulatory responsibility of the agency. In a decision that looked like a cope made by a nicotine prohibitionist, Grimm decided that the FDA should be preparing to start looking at pre-marketing applications soon.

The judge gave the plaintiffs and the FDA two weeks each to submit their own draft schedules. Several interested parties have planned to file motions for intervention, including the Coalition for the Right to Refuse, Imperial Brands (Blu), Altria, JUUL Labs, NJOY and consumer advocacy organizations CASAA. [disclosure: I am on the CASAA board]. But Justice Grimm denied the interventions even before the filing of the motions. (This decision may be appealed.)

The PAA and its co-applicants asked the judge to force the FDA to begin reviewing PMTAs within 120 days. According to their proposal, once an application is submitted, an applicant can continue to sell the product for a year or until it is approved or refused (whichever comes first).

The FDA responded by asking the judge to "send the case back to the agency for further action". However, the agency argued that "even if the court decides to go further, it should not register the specific relief sought by the plaintiffs, and certainly not on the significantly accelerated timetable, they suggest. "

The agency said that any submittal deadline for PMTA less than 10 months would be a disaster for the vapers as well as for the agency. If the circumstances were not so disastrous, it would be really satisfying to see the FDA defend vaping as a benefit to public health.

The FDA notes in its brief that dealing with a mountain of hastily produced PMTA "would ultimately be counterproductive", and that "such a sudden deadline would threaten to abruptly clear the market for electronic cigarette products." The vaping industry would create a "real risk" that former smokers will return to smoking, and quotes Mitch Zeller, director of the FDA's Center for Tobacco Products, as saying that a "public health outcome which should be avoided as much as possible ".

In a few days, the plaintiffs will respond to the FDA's request, and the judge will review his final decision. According to the Vapor Technology Association (VTA), the final order of Judge Grimm is probably in at least a month. After that, the FDA has 30 days to file a notice of appeal with the Fourth Circuit Court of Appeal. The FDA may also request that the decision be suspended (postponed) during the appeal.

Of course, the FDA does not have to appeal the decision. The agency could let go and try to impose an almost total ban on vaping products. This would result in the growth of a black market impossible to control by the agency. Between internet commerce, inexpensive global shipments and the easy availability of most necessary ingredients, the new market could be almost as big as the old market – and this time a real Wild West. The FDA would be a laughingstock. The agency does not want that to happen.

The day before filing its brief with the district court, the FDA finally released the PMTA guidelines promised for the first time when the agency announced the rule of presumption in May 2016.

For the small manufacturers of vape, nothing in the indications leaves hope for their survival. The requirements are as complex and rigorous as anyone would have read the rule of presumption would expect. The process is deliberately intimidating for small businesses, to make them give up and leave.

Completing the studies and analyzes required to submit a PMTA – whether successful or not – will cost a lot more than almost any vaping manufacturer can afford. There are no sensible rules based on standards to reassure uncertain producers of e-liquids or equipment manufacturers.

For every product submitted, hundreds or even thousands of hours of work from scientists, lab technicians, expert researchers and consultants will be needed. For example, here is the FDA's description of the groups that will need to be studied to help determine the effects of a vaping product at the population level:

"Considerations regarding the impact of a new tobacco product on human health may include, but not be limited to:

• Tobacco users who can switch from other tobacco products to the new tobacco product;
• Tobacco users and non-users who, after adopting the new tobacco product, may opt for other tobacco products that may pose higher health risks;
• Tobacco users who may choose to use the new tobacco product rather than quit smoking altogether;
• Tobacco users who may choose to use the new tobacco product rather than an FDA approved smoking cessation drug;
• Tobacco users who can use the new tobacco product with other tobacco products;
• Non-users, such as youth, non-users and former users, who could initiate or relapse into tobacco use with the new tobacco product;
• The health effects of users of the new tobacco product; and
• Non-users who experience the adverse health effects of the new tobacco product "

In other words, a manufacturer of e-liquids will have to show the FDA that, among other things, the product is "appropriate for the protection of public health" even though some former smokers may "relapse into tobacco use" using the submitted product. e-liquid (which the FDA defines as a tobacco product).

The manufacturer will need to hire a qualified scientist to investigate all possible reasons why the product may be denied, and explain in detail how the benefits will outweigh the costs. And unless other similar studies have examined exactly the same product – or very close to it – in terms of content, flavor and all other properties – the manufacturer will not be allowed to consider similar product studies. in the application.

"The described process remains sophisticated and prohibitively expensive, and it will be extremely difficult for small businesses to meet the requirements of the FDA," VTA said in a statement.

In the end, just about the only companies able to afford and navigate the PMTA process have "tobacco" in their names. Apart from JUUL and probably NJOY (and the largest Chinese manufacturers), no independent vaping manufacturer will be able to handle such a demanding and restrictive regulatory regime.

It is not certain that even JUUL, with its billions of assets (from the investment of 35% of Altria last December), succeed with a PMTA at this stage. After all, the company is at the epicenter of the vaping panic, which everyone, from tobacco control groups to high school principals, blame for the "new generation addiction" to nicotine. How could JUUL prove that his product would not be used by nicotine-naive teens? According to the CDC and Truth Initiative, it has already done so.

Bonnie Herzog, Wells Fargo analyst, thinks everything will be fine for JUUL. Herzog is "confident that Juul will be able to comply given his resources / access to Altria's legal / regulatory expertise," according to Convenience Store News. But Scott Gottlieb is not so sure. The former boss of the FDA, who always feels the need to take into account every decision made by his former agency, says on Twitter that "the crisis created by products such as JUUL puts this entire market segment at risk and makes it difficult to demonstrate a net benefit to the public health of a product similar to JUUL".

But even if some products are approved, the legal and independent industry will die. A handful of products are not enough to support a vape store, which depends on the transportation of a wide variety of popular e-liquids. And it's the e-liquid that generates the profits of the vaping retailers. How many vapers will buy new equipment when they only have four e-liquids flavored with tobacco? Without much choice in e-liquids, the market for open-system vaping products will have to go underground. Perhaps an enterprising entrepreneur in the field of vape will find a way around the ban, but it's hard to imagine what it might look like.

Gottlieb said in the same Twitter feed that the FDA could consider a new regulatory system that would give open-system products and vape shops an edge over big players like JUUL and tobacco companies, apparently by applying different standards. for small businesses.

The question now, writes Gottlieb, is whether the FDA could – or should – make policy distinctions through different regulatory pathways that take into account the different patterns of use of JUUL-like products and reservoir systems. open; or if these data are even strong enough to deserve such an approach. "

Why does the ex-commissioner suggest this now, rather than during the two years he has been in charge of the agency, remains a mystery. It is unlikely that Mitch Zeller's Center for Tobacco Products – under incredible pressure to regulate vapors to the point of prohibiting – strives to simplify the life of the small vaping companies that make up what the FDA considers it a "Wild West". If the CTP had acted this way, it would have been during Gottlieb's first months at the FDA, before he decided that JUUL's fad was an epidemic.

Despite Gottlieb's thoughts on Twitter, there is no viable path in the guidance document for small business ventures to follow. Even if it existed, one might wonder whether a company that was now deciding to apply for pre-market approval would have the time to do the necessary research. Even if the judge let the FDA maintain the 2021 deadline for PMTA flavored products, it would probably not be enough time – especially if a large number of small manufacturers decided to pursue a PMTA at the same time.

And even companies that were already planning to submit applications are probably not ready to submit them soon. If AAP and its other applicants get the four-month time limit they want (or even if the judge sets it to 10 months), the companies that targeted a 2021 bid are probably not ready in time. This would mean withdrawing their products from the market and surviving through savings while doing research to submit a very uncertain request (and wait for a decision) later.

"Preparing and satisfying a PMTA is not an easy task, with applications of millions of pages, costing millions of resources and requiring significant scientific support," said financial analyst Ryan Tompkins, according to Convenience Store News. "It is highly likely that now that the PMTA deadline is postponed, small steam manufacturers will not be able to meet the requirements and will have to withdraw their products from the market."

Manufacturers with enough money or credit to finalize a PMTA would probably be better advised to spend their millions on increasing sales in other countries with more predictable regulatory systems. Although the European Union's Tobacco Products Directive (TPD) provides for senseless requirements, such as the 20 mg / ml limit on nicotine concentration and a maximum bottle size of 10 ml, it indicates at least what is allowed and what is not. And Canada and New Zealand offer an even more reasonable regulatory approach (but smaller markets).

Even though the FDA is appealing the AAP decision, the vaping industry, as we know, is running out of time. As the PMTAs prescribed in the FDA guidance document are due in four or 24 months, the number of products approved and available for sale will be insufficient to support vape stores and legal online retailers.

There can be no rapid innovation or growth under such a regime. Even if the second, third and fourth PMTA of a company cost only a fraction of the first, no small manufacturer would dare to risk hundreds of thousands of dollars on a product whose success was not assured. It does not mean new products. It is a regulatory model designed for fuel tobacco, a product that never really changes.

Of course, cigarettes have never had to go through this process; they were preserved in the market when the law on tobacco control was adopted. These are only safer products that will have to go through endless stages to gain the opportunity to compete with Marlboro and Newport. The Tobacco Control Act and the rule of presumption actually protect cigarettes.

When PMTAs are the only legal way to sell steam-based products, manufacturers of e-liquids and other small manufacturers will basically have three choices: illegally selling, selling in other countries or closing their doors. What would be the logic of spending all you have on a PMTA that the FDA could (and probably will) easily dismissed? But entering the black market will not cost anything.

The presumption rule and the PMTA process are more like trolling than regulation. Requiring small-scale entrepreneurs who serve ex-smoker customers to do research showing the impact of their products on public health at the population level is a big mistake.

It is even more infuriating to ask them to prove that their products are "appropriate for the protection of public health", while all convenience stores and US service stations sell thousands of cigarettes every day. It may be an irony that zealots and tobacco control politicians do not like, but it is the fact that the vape industry feels like a punch every day.

Assuming there is no last-minute miracle to save the vaping industry – a surprise decision blocking the application of the rule of presumption in the Pacific Legal Foundation trials, or a victory in the Call Nicopure / Right to be Smoke-Free – this is how the legal sector ends. Approximately one year after the coming into effect of the PMTA requirements, some products sold in convenience stores will be FDA approved.

But the PMTA process will lead to a robust black market as soon as it comes into effect. The FDA has neither the resources nor the experience to apply the rule of presumption. Rather than establishing a simple set of quality and safety principles and compiling a list of banned components, the FDA sent an invitation to flout the law to all the country's small-scale manufacturers. And many of them will accept the invitation and will continue to serve their customers in defiance of the FDA.