Tag: MIchelle Minton

Unnatural Response

Credit: Alexl MX
All nontobacco nicotine is now subject to the same regulations as tobacco-sourced nicotine in the U.S.
By Timothy S. Donahue
It was both expected and unexpected. Everyone in the vaping industry knew that at some point the U.S. Congress and the Food and Drug Administration were going to decide on how to handle synthetic and nontobacco nicotine. It was generally believed that regulation would appear in an appropriations bill in September, meaning vaping advocates thought they had time to fundraise and prepare for a battle.
They did not. Instead, the language for changing the definition of the Tobacco Control Act (TCA) to include all nicotine products was buried on page 1,861 of the 2,741-page omnibus spending bill that was signed by President Joe Biden in March. How the rider found its way into the omnibus has caught the ire of many in the industry who say major tobacco companies are seizing the vaping industry away from the small business owners who got it started.
Senator Richard Burr was allegedly approached by R.J. Reynolds and Juul Labs representatives about getting the synthetic nicotine rider in the omnibus that at the time was winding its way through Congress. Burr joined forces with fellow senators Dick Durbin and Patty Murray and Representative Frank Pallone to get the nontobacco nicotine language into the omnibus, according to two Senate sources familiar with the discussions, as reported by Bloomberg Law.
Azim Chowdhury
Azim Chowdhury, a partner with the law firm Keller and Heckman, said he interprets the rule to mean that all synthetic products already on the market or newly marketed within 30 days after the enactment date can continue to be marketed during the 60-day period following the enactment date. The law became effective on April 14, and manufacturers will have until May 14, 2022, to either submit a premarket tobacco product application (PMTA) to the FDA for each vaping product that contains synthetic nicotine or pull their products from the market.
Manufacturers that submit PMTAs to the agency by the May 14 deadline can continue marketing their products until July 13, 2022. Beyond that date, all products must be removed from retail stores unless the FDA has issued a marketing authorization, according to Chowdhury.
“We do not anticipate FDA authorizing any synthetic nicotine products by the end of the 90-day period, though they may take another Fatal Flaw (the term Fatal Flaw was used by the FDA for PMTA submissions that didn’t have specific studies and were subsequently denied) approach to quickly deny applications,” said Chowdhury. “Significantly, the rider in its current form indicates that a synthetic nicotine version of a product that already went through the PMTA process and is subject to a refuse-to-accept, refuse-to-file, marketing denial order (MDO) or withdrawal of a marketing order would have to come off the market as of the effective date—i.e., after 30 days of the law’s enactment.
“In simpler terms, for products that were previously formulated with tobacco-derived nicotine—and the only change was a switch to synthetic nicotine—and whose PMTAs have already been refused or denied, those products will effectively be banned on the effective date—30 days after enactment—with no opportunity to submit a new PMTA. This is Congress’ way of punishing companies whose PMTAs were denied and then, in their view, sought to circumvent the law by switching to synthetic nicotine.”
MIchelle Minton / Credit: Competitive Enterprise Institute
Michelle Minton, writing for the Competitive Enterprise Institute, states that given the FDA’s sluggish track record, many of the applications may not even be reviewed, let alone approved, in that time, which would make the bill a de facto prohibition on those products. “FDA has made it painfully clear that there is no way for those companies to earn its approval,” Minton said. “All it will do is guarantee that companies and consumers are pushed in ever-greater numbers toward a growing illicit market where there are no consumer protections and no age restrictions—or back to smoking.”
Stately response
Beyond the PMTA conditions, if a marketing order is granted, manufacturers of synthetic nicotine products are also subject to all the regulations for tobacco products. Keller and Heckman interpret this to include all additional TCA requirements, including tobacco product establishment registration and product listing; ingredient listing; ensuring that labeling is compliant, including required warning statements; and health document submissions, among others.
Many states had already started to ban synthetic nicotine unless a product gets marketing approval from the FDA. Legislation has been introduced in four state capitals and enacted in one state, Alabama, that effectively bans all products containing synthetic nicotine. Patrick Gleason, vice president of state affairs at Americans for Tax Reform, said Alabama, then Mississippi, Maryland and Georgia, were the first states to introduce legislation effectively banning synthetic nicotine products. However, he says there will be no need for more state legislation to ban synthetic nicotine now that the federal government has added it to the TCA.
Yaël Ossowski
Yael Ossowski, deputy director of the Consumer Choice Center, said that making companies ask permission to sell harm reduction products in the 21st century is “asinine.” Using “sleight of hand” during an emergency government funding bill to “castigate millions of vapers and the entrepreneurs who make and sell the products they rely on,” he noted, is the definition of active harm.
“Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hardworking American business owners will now be forced to close, depriving millions of adult consumers of harm-reducing options. Many will be forced back to cigarettes,” said Ossowski. “Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A backdoor bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
There is no sell-through period for retailers of synthetic nicotine products if the manufacturer does not file a PMTA with the FDA by May 14. While some manufacturers plan to end sales of their synthetic products by the deadline, as Ossowski suggests, others plan on submitting robust and timely applications. Patrick Mulcahy, CEO and co-founder of Streamline Group, parent to the Streamline Vape Co., wrote in an email that his company has been working toward a solution to navigate the regulatory landscape for newly deemed synthetic nicotine products.
“We have recently contracted with Accorto Regulatory Solutions to manage, submit and deliver a complete set of premarket tobacco [product] applications. To date, their track record of applications submitted have received zero MDOs. Their commitment to submitting a complete and robust PMTA is the level of service Streamline aims to provide the market with our current and future line of products,” he said.
“Streamline’s goal during this process is a commitment to provide full transparency, informational updates and other news related to these regulatory requirements as we progress through the various phases of the PMTA,” Mulcahy stated, adding that market confidence is a top priority for Streamline Group, which was submitting PMTAs for its Juice Head brand e-liquids, disposables and nicotine pouches along with its NIIN brand e-liquid and pouches.
Organized approach
April Meyers, SFATA
April Meyers, owner of Connecticut-based Northeast Vapor Supplies and CEO of the Smoke-Free Alternatives Trade Association (SFATA), told Vapor Voice that her organization believed the industry would have more time to hold discussions with legislators on the Clarifying Authority Over Nicotine Act of 2021 (HR 6286) introduced by Representative Mikie Sherrill in December of last year. SFATA members were aware of the mounting pressure on the subject of synthetic nicotine and had been developing strategies to counter the pressure.
Given the inclusion of vapor in the Prevent All Cigarette Trafficking (PACT) Act in the 2021 omnibus, the nonprofit vapor industry advocacy group was not completely surprised to learn that HR 6286’s language had been included in the 2022 omnibus bill, according to Meyers.
“We went immediately to work educating our members on the issue, executing a call to action and making a volley of calls to sources at the Capitol, including our contacts at the freedom caucus,” said Meyers. “Those sources confirmed that a handful of large vapor companies and several Big Tobacco companies were in support of the measure. We were also informed that the House and Senate votes would move quickly and that there was little opportunity to get the provision removed. This was discouraging, to say the least, but did not dissuade us from acting. This industry has learned to mobilize quickly and has achieved several victories under similar circumstances.”
Meyers said that while the sponsors of the synthetic nicotine rider claimed the intent was to close a loophole on synthetic nicotine-derived products from large companies now popular among youth, the rule, and others like it, are very unlikely to have that intended effect. Instead, she said, consumers using these products as a harm reduction option will suffer alongside all the small businesses that have always operated in full compliance with federal, state and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, gray and black markets emerge where there are no regulations requiring safe products or ID checks. The vapor industry is incredibly resourceful,” Meyers said. “SFATA believes our government should have learned its lesson from the 1920s that prohibitionist policies never work. In this country, and particularly, this industry, where there is a will, there is a way. Despite the attempt to bring the vapor industry to heel, adults have been vaping flavored products in the U.S. for [nearly 15 years]. It is delusional to think that will be snuffed out with the signing of a law. Our fear is that this will pave the way to a growing illicit trade market while simultaneously increasing smoking rates across the country as studies have already demonstrated in localities with flavor bans.”
Tony Abboud, VTA
Tony Abboud, president of the Vapor Technology Association (VTA), said that everyone who understands anything about PMTAs knows that an application cannot be filed within the 90-day time frame, particularly because the FDA requires at least six months of scientific data for such an application. He said the new rule could become a de facto ban on synthetic nicotine that would have some unintended consequences.
The VTA hired economic research firm John Dunham & Associates to evaluate the negative economic impacts that a synthetic nicotine ban would have in the U.S., according to Abboud. The results included 16,100 lost jobs, over $800 million in lost wages and $2.5 billion in lost economic output. It would also cost the U.S. more than $500 million in yearly taxes.
Amanda Wheeler
Amanda Wheeler, owner of Jvapes and president of American Vapor Manufacturers, said during the 103rd annual meeting of Vapor Voice’s parent company, TMA, that she hopes the FDA offers “some kind of enforcement discretion” to small businesses, especially those manufacturers that are trying to follow the rules.
“I can only plead with the FDA at this point not to repeat the mistakes of 2020 and 2021, finding an arbitrary reason to toss all of those applications out on their ear. The consequences this time are even more dire,” said Wheeler. “We have this serious handicap on our hands as far as the time frame … I think we need to treat businesses equitably and recognize that there is only so much that people can do in 60 days. And enforcement discretion would be the thing that’s most helpful to prevent companies from having to look for an alternative solution.”

May 11, 2022
Minton: Mail Ban Will Push Vapers Back to Cigarettes

Amid the economic devastation caused by Covid-19, one industry has actually thrived: the cigarette business. Some people are smoking to relieve the emotional and economic stress of lockdowns. But many others returned to smoking when the lower-risk options they relied on, such as nicotine vapor products, became too expensive or hard to find when compared with the combustible tobacco available at every gas station and corner store.
Now, Congress wants to eliminate the ability for adults to receive e-cigarettes by mail, a measure that will reduce access to these life-saving options even after the lockdowns end, Minton writes in National Review.
Buried within the omnibus spending bill passed at the end of last year was the “Preventing Online Sales of E-Cigarettes to Children Act.” The Act, colloquially called the “vape mail ban,” prohibits the U.S. Postal Service (USPS) from delivering nicotine or cannabis vaping products.
One might think that e-cigarette makers could simply switch to private carriers, such as FedEx or UPS. But these private carriers don’t deliver to all addresses, particularly in rural areas. Private carriers actually rely on USPS to make “last mile” deliveries. Even if private carriers did deliver everywhere in the U.S., most — including FedEx, UPS, and DHL — have yielded to the anti-vaping mob, voluntarily ending e-cigarette deliveries.
For any carrier hoping to fill the gap, the new law also imposes strict requirements on records-keeping, tax collection, and reporting. These requirements will significantly raise the cost of e-cigarette deliveries, which will be passed on to consumers. And that added expense, even if relatively small, will be enough to discourage many adults — particularly those in lower-income brackets — from continuing to use e-cigarettes.
Supporters of the law seem to think that if they force adults to quit vaping, they will simply quit using nicotine altogether. They’re dead wrong.
Study after study has shown that policies that make e-cigarettes more expensive can reduce e-cigarette use. But they also increase smoking. The same is true for convenience: The harder it is for smokers to access e-cigarettes, the less willing and able they’ll be to choose e-cigarettes over combustible cigarettes, which are available almost everywhere.
Perhaps some think that more adult smoking is a small price to pay to protect children. More adults smoking is, in their mind, a small price to pay to stop the small percentage of minors willing to break the law to get their hands on e-cigarettes.
MIchelle Minton / Credit: Competitive Enterprise Institute
As the name of the law implies, the purpose of the Preventing Online Sales of E-cigarettes to Children Act is to stop those under 21 years old from illegally purchasing nicotine products online. But if that were really the goal, there are less-extreme approaches, such as requiring an ID check on delivery, a service offered by all major delivery services (and USPS) and that has proved sufficient for alcohol deliveries.
But that’s not the purpose of the law. The real goal is to hurt the legal vaping industry, which the vape mail ban will almost certainly do. It will also be a boon to the illegal vaping market, as well as the traditional cigarette business. What it won’t do is stop youth from buying e-cigarettes. Ironically, it may only make it easier, as less respectable businesses step up to fill the gap in the market that the law is creating.
Most of us would prefer to buy the things we want from licensed, reputable businesses, especially given the dangers associated with illicit goods. But, if regulation prohibits those things or makes them too expensive, it rapidly opens the door for illegal markets. The more unmet demand there is, the larger the illegal market. For example, New York City’s high cigarette taxes led to a vibrant underground market for cheap cigarettes.
The bootleg cigarette business became so widespread, in fact, that by 2013 more than 60 percent of all cigarettes sold in the state were illegal. The continued prohibition on recreational cannabis in some states and high taxes in states where it is legal also explain the continued existence of an illicit THC market, which in 2019 caused thousands of people to be hospitalized and several deaths due to contaminated products.
The illegal market for nicotine vapor is small at the moment, because there remains a relatively vibrant, legal market for adults. But it will grow if lawmakers continue their irrational push to make e-cigarettes as expensive and hard-to-get as possible. And the larger it grows, the easier it will be for youth to buy these products online. That is because, in addition to ignoring shipping laws and skirting taxes, dealers on Snapchat and Facebook aren’t likely to verify the age of their customers.
So, by banning vape mail, Congress is not only kicking legal vapor businesses when they are down, forcing adults back to smoking tobacco, and forfeiting much-needed tax revenue; it is also making youth vaping more likely and more dangerous by encouraging an illicit vapor market and forcing consumers into it.
Michelle Minton is a senior fellow specializing in consumer policy for the Competitive Enterprise Institute, a free-market public policy organization based in Washington, D.C. The author’s opinion may not be the same as Vapor Voice staff.
March 11, 2021
Minton: U.S. Spreads Fake Fear Over Vaping Dangers
The international health profession is rightly focused on the SARS-CoV-2 virus threat at the moment. Meanwhile, another multinational threat has insidiously spread: Alarmism about nicotine vapor products (aka e-cigarettes) has infected a growing number of governments around the world, causing authorities to eschew science, logic, and human nature. Out of blind panic, they are disregarding the indisputable evidence that giving smokers legal access to nicotine vapor can save millions of lives. Instead, they embrace prohibitionist policies that will keep people smoking and dying. The main culprit behind spreading this mass psychosis is, sadly, the United States.
MIchelle Minton / Credit: Competitive Enterprise Institute
I have written extensively about agencies, health charities, and activists who have orchestrated the campaign of fear and doubt around e-cigarettes—products that even notorious anti-vaping advocates, like University of California San Francisco Professor Stanton Glantz, admit are substantially less toxic than smoking. I and others have dissected the financial and professional benefits that drive the campaign to ban nicotine vapor products even while deadly cigarettes remain freely available. Here, I will discuss the methods by which these entities cultivate and export e-cigarette alarmism worldwide.
The three main players in the tragicomedy public discourse on e-cigarettes are: representatives of government agencies, public health activists, and the media. The media has acted mostly as a megaphone for government agencies and activists, parroting and amplifying the narrative disseminated by government actors and activists. This post will focus primarily on how anti-tobacco activists, in and outside of government, created and sold those narratives.
Statistical Sleights of Hand
Authorities in the U.S. have become pioneers in the art of statistical hocus pocus. They managed to transform limited evidence about shifting trends in vaping among young people into supposed proof of a full-blown nicotine-use crisis. And, like any good magician, performing this trick often involves misdirection. In the case of statistics, such misdirection is often achieved by:

Focusing on the scariest-sounding data;

Using the scariest language to describe data; and

Ignoring or downplaying details that put the data in a less scary context.
A good example is the way government, media, and anti-vaping activists used the results of the 2018 National Youth Tobacco Survey (NYTS), a survey of middle and high school students, administered annual by the Centers for Disease Control and Prevention.
Months before the 2018 NYTS data were made public, the Food and Drug Administration (FDA) announced that the results showed youth vaping had become an “epidemic.” The media repeated the information, as dictated by the FDA, over and over again so that, by the time results were actually released, it hardly mattered what the survey really showed. The narrative had been set in the public mind: Teens were now vaping nicotine in epidemic proportions. Of course, once researchers were finally able to analyze the data, they found little more than smoke and mirrors.
Highlight the scariest data. Media outlets from Fox News to National Public Radio ran headlines with some variation of the talking point that between 2017 and 2018 youth vaping had doubled and now one in five youth were users of nicotine vapor products. This generated public concern and interest in solving the problem, which, of course, was the goal.
What neither the FDA nor the media highlighted, however, was that this data point only referred to the number of students who reported any vaping in the 30 days prior to the survey. While it could mean some of those youth were vaping nicotine every day, it also meant some portion may have only vaped once, perhaps for the first time, and never again. That’s what a later examination of the data found. The vast majority of youth who reported “vaping” on the NYTS did so on a handful of days. In fact, less than 1 percent of underage students who never smoked reported vaping regularly.
Use scary language. In 2017, 11.7 percent of students reported any past-month use of e-cigarettes in the NYTS. In 2018, that number rose to 20.8 percent, a 9 percent increase year over year. But a 9 percent increase in youth vaping just doesn’t sound as scary as youth vaping “doubled.” Again, that’s the point. The use of relative versus absolute numbers is often employed specifically to make something appear more important.
Downplay mitigating details. Within weeks of the FDA’s announcement, the existence of a youth vaping epidemic took on the status of indisputable truth. And the matter of how e-cigarettes impact youth health eclipsed considerations about the products’ potential benefits for adults and the hazards that always accompany any sort of prohibition. The national survey had, after all, shown a doubling in the numbers with over 20 percent of students (one in five) now vaping nicotine. Except, in addition to ignoring the fact that most youth were not vaping regularly, both the FDA and the media ignored the fact that the survey did not say what youth were vaping.
The NYTS questionnaire asked students about their use of “e-cigarettes,” which it describes as “battery powered devices that usually contain a nicotine-based liquid that is vaporized and inhaled.” However, researchers have found that most of the students who report “vaping” on surveys about e-cigarettes don’t use nicotine. For example, a study from 2016 found that approximately 65 percent of the 12^th, 10^th, and eighth grade students who used e-cigarettes reporting using “just flavoring” without nicotine. More recent research indicates that a substantial portion of youth who report “vaping” also use cannabis. In fact, 50 percent of students who reported any e-cigarette use and 70 percent of those who reported frequent use on NYTS also said they had used marijuana in e-cigarettes.
Arguably the most important detail ignored in panic over youth vaping was the fact that, despite fears about vaping leading to smoking, youth smoking rates were continuing to decline. In fact, the rate of smoking among both adolescents and adults hit a record low in 2018 and have continued to decline since. But the FDA and most media outlets paid little attention to the details about how often youth were vaping, what they were vaping, and what effect it might be having on health because these details might not produce the same level of alarm as the idea of an “epidemic,” which again, is the point. And it worked.
Over the following years, not a day would pass without some new headline about the problem of youth vaping, the evil e-cigarette companies targeting teens, or the need for authorities to do something. As a result, counties and states have begun to prohibit e-cigarettes, the federal government raised the national minimum tobacco purchasing age to 21, banned non-tobacco flavors for pre-filled vaping devices, and is currently considering a bevy of additional restrictions to make these products less attractive, harder to obtain, and more expensive for adult smokers. Given that e-cigarettes, particularly flavored e-cigarettes, are the most effective means of helping smokers quit smoking, this should not be hailed as a victory. But, at least among those morally opposed to nicotine use, it was. Now they are seeking to export that “successful” strategy to the rest of the world.
American Panic Down Under
Despite the irrefutable evidence that non-combustible forms of nicotine are vastly safer than combustible tobacco, a long and growing list of countries now ban the sale, importation, or even possession of such products, like India, Brazil, Thailand, Singapore and Uruguay. Whenever the debate about such bans arises in any new country, invariably it is followed by attempts to infect that debate with American-style vape panic.
A recent example has unfolded in Australia over the last few months, where, though nicotine vaping is banned, the country’s estimated 300,000 vapers have managed to skirt the prohibition by having nicotine shipped from overseas. This June, however, Health Minister Greg Hunt threatened to close that loophole by banning the importation of nicotine beginning in July—weeks before Parliament returned from their summer holiday. The justifications for the ban were the youth vaping “epidemic” in America, rising incidence of nicotine poisoning in Australia, and increases in vaping among young adults.
Highlight the scariest data with the scariest language. In announcing his proposed ban, Hunt pointed both to the “78 percent increase” in youth vaping in the United States and a claim that nicotine poisonings in Australia had doubled since 2018, which according to him, was caused primarily by “imported products of dubious quality and safety.” Never mind that the only reason Australians must import nicotine of dubious quality is because the country banned nicotine vaping. The relative language Hunt uses about poisonings certainly sounds scary. But, as you might guess, the absolute numbers seem far less dire.
Downplay mitigating details. The source for Hunt’s claim comes from the Victorian Poisons Centre, which as Hunt noted in a press release, reported 21 cases of nicotine poisoning in 2018 and 41 cases in 2019. A look at the data for 2018 (2019 is not yet publicly available) shows that there were actually 100 calls made to the Centre related to “antismoking products,” which it defines as nicotine gum, lozenges, patches, Chantix, and e-cigarettes. What this means, assuming Hunt’s figure is correct, is that while 21 calls were related to e-cigarettes, 79 calls were related to other products. To put that in panic-speak, products that are legally sold over the counter in Australia caused almost four times as many poisonings as e-cigarettes, which Hunt wants to ban.
Thanks to backlash from vapers around the world, as well as members of his own government, Hunt was compelled to back away from his proposed ban, at least temporarily. But this seems to have inspired anti-vaping advocates to try harder in copying successful, panic-inducing tactics employed in the United States. Most recently, it appears they are trying to replicate exactly the slight of hand American activists pulled off with the 2018 NYTS.
When All Else Fails: Lie
On July 16, the Australian Institute of Health and Welfare released the 2019 results of their national survey on drug use, which is conducted every three years. According to news reports, like this one in The Guardian, it found that e-cigarette use among young Australian non-smokers had quadrupled since 2013! Furthermore, a shocking 65 percent of adolescents and 39 percent of young “report using e-cigarettes despite having never smoked.” As is the point, stories like this are sure to shock Australians and spur efforts to keep or even strengthen the country’s nicotine vaping ban to get this problem under control. Of course, as with the youth vaping “epidemic” in America, the problem doesn’t exist; it’s statistical hocus pocus.
The data released by the Australian Institute of Health and Welfare is, admittedly, confusing. So, it is at least possible that the author of The Guardian article simply erred in stating that 65 percent of non-smoking adolescents reported “vaping.” Nonetheless, this isn’t just misdirection; it’s outright wrong. What the data show is that among the respondents who said they had ever used an e-cigarette in their life, almost 65 percent of those aged 14 to 17 said they were non-smokers at the time they first tried an e-cigarette (table 2.27.) First, this doesn’t mean they were “never smokers,” only that they hadn’t smoked more than 100 cigarettes in their lifetime, nor does it mean they continued using an e-cigarette. The survey, in fact, indicates that only 8 percent of youth, aged 14 to 17, ever tried an e-cigarette (table 2.19), and among all respondents who ever tried an e-cigarette, most—87 percent—tried it only once or twice and never again (table 2.28). So, how many non-smoking youngsters in Australia are actually currently “vaping?” From what the survey reveals, almost none.
The survey perplexingly defines “current use” as using e-cigarettes “daily, weekly, monthly, or less than monthly.” [Emphasis added] Functionally, it seems as if any use in the last 12 months counts as current use. But, even with that broad definition, the proportion of non-smoking youth who currently use e-cigarettes has remained strikingly small at 1.3 percent among those aged 14 to 17.
As for the statement about “quadrupling” e-cigarette use among non-smokers, you can see from the numbers that this is false. They could accurately say that current use of e-cigarettes among non-smokers increased 75 percent among adolescents and 50 percent among young adults. But it would still be misleading, a prime example of how using relative terms can exaggerate insignificant changes to extremely small absolute numbers. And that is exactly how unwarranted panics are generated. It’s not clear if the author of The Guardian article meant to mislead or simply misunderstood the data. But we can certainly expect more of this sort of statistical sleight of hand if and when the debate over whether Australia should continue to deny smokers a life-saving alternative takes center stage.
Michelle Minton is a senior fellow at the Competitive Enterprise Institute. Minton specializes in consumer policy, covering regulatory issues that include gambling, tobacco harm reduction, cannabis legalization, alcohol, and nutrition.
July 23, 2020