Category: Science

Irrational hysteria
The sudden outbreak of lung illnesses and deaths have made headline news. But painting these adverse events as “vaping-related” is vague and inaccurate.
By Maria Verven
The headlines would make anyone swear off of vaping forever. A sudden rash of “vaping-related” illnesses and deaths—12 as of this writing—has made the front pages of almost every major news outlet.
But get past the headlines and you’ll find that these adverse events are not related to vaping legal e-cigarette products. The overwhelming majority of cases have been tied to vaping cartridges containing THC wax or oils. And most were purchased illegally on the black market.
Saying someone died from “vaping” is akin to saying someone died from “drinking” without specifying that they accidentally drank something poisonous.
In short, news stories that blame deaths on vaping are painting the story with an extremely large brush way outside the lines of reason.
Just apply the laws of epidemiology
Konstantinos Farsalinos, a cardiologist, clinical researcher and expert on e-cigarettes, says we need only apply the simple rules of epidemiology to understand the recent turn of events.
E-cigarettes have been on the global market for more than 10 years. Today, approximately 11 million people in the U.S. and millions more worldwide vape regularly. The typical adult vaper in the U.S. is around 40 years old, and many have been vaping daily for several years.
Up until this summer, no reports of respiratory diseases or deaths were reported anywhere in the world.
Then suddenly, we witness hundreds of acute cases but only in the U.S. and primarily among young adults—and all bearing a remarkable resemblance.
It absolutely defies the laws of epidemiology that these cases could be related to the long-term use of e-cigarettes that have been on the market for years, used by millions of consumers, according to Farsalinos.
Applying simple logic, he explained that these cases are not indicative of a disease related to vaping but rather poisoning from either a new product, a new raw ingredient or a new practice in the manufacturing process. Only this explains the timing of the outbreak, he says.
Indeed, all signs are pointing to an emulsifier called vitamin E acetate, a product that hasn’t been used in store-bought e-liquids.
“The emotional, irrational hysteria against e-cigarettes needs to stop as soon as possible,” Farsalinos said. “Yet I wonder if the passionate statements made by the media, scientists and authorities will ever be corrected once the exact cause of this outbreak has been firmly established?”
So what exactly is vitamin E acetate?
Found naturally in foods such as olive oil and almonds, vitamin E sounds completely innocuous as does the oil, vitamin E acetate, that’s derived from it. Vitamin E acetate is commonly used in skin creams and as a nutritional supplement—but ingesting it is far different than inhaling it. Its oil-like property could well account for the types of respiratory issues—shortness of breath, chest pain, etc.—reported by sickened patients.
After noting that the majority of the bootleg THC cartridges patients used tested positive for vitamin E acetate, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched a full-scale investigation.
New York Governor Andrew Cuomo also served subpoenas to three companies that sell thickening agents containing vitamin E acetate, ordering them to help with the FDA investigation.
Notably, the FDA told New York state officials that its lab tests found nothing unusual in the nicotine products it collected from sick patients. While some victims maintained that they only vaped nicotine products, it only stands to reason that patients in states where cannabis is not yet legal may not readily admit using illegally purchased THC vape cartridges.
The three companies at the heart of the investigation are Mass Terpenes, a Massachusetts-based company that sells Pure Diluent; Honey Cut, a California-based company that sells Honey Cut Diluting Agent; and Floraplex Terpenes, a Michigan-based manufacturer that sells Uber Thick. All three companies quickly removed their products from the market. The Honey Cut website is now gone while the website for Mass Terpenes has this notice on its front page:
“We are alarmed by recent reports linking vape ingredients containing vitamin E acetate to serious lung problems of consumers …. We have never sold a product without assurances of safety from the leading terpene suppliers and have taken steps to ensure that absolutely NO products on this site contain vitamin E acetate.”
The FDA has said it’s too soon in the investigation to determine whether vitamin E acetate is the sole culprit behind these events. “No one substance, including vitamin E acetate, has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about causality,” said an FDA spokesperson.
Yet we are clearly learning about the health risks of inhaling vitamin E acetate—at the very least, it appears to cause lipoid pneumonitis, which results from inhaling fat particles into the lungs. Chest pain, coughing and difficulty breathing were among the symptoms that were reported by patients who said they’d recently used black market THC cartridges.
In fact, safety instructions for vitamin E acetate specifically advise suppliers to avoid marketing vitamin E acetate for anything other than topical use, warning users to “keep away from heat and sources of ignition” and to “not ingest/do not breathe gas/fumes/vapor/spray.”
Aaron Riley, CEO at CannaSafe, the largest cannabis testing laboratory in California, says odorless, tasteless diluting agents such as Honey Cut are commonly used in the majority of black market vapes as a way to thicken vape oil and make it look more legitimate. “It looks like cannabis oil. It has the same color; it’s odorless. It was considered the best cutting agent,” he told Rolling Stone.
Protection is simple: Don’t buy THC vape juice illegally
The FDA’s public statement cautions consumers against buying “street” products: “Since consumers cannot be sure whether any THC vaping products may contain vitamin E acetate, consumers are urged to avoid buying vaping products on the street and to refrain from using THC oil or modifying/adding any substances to products purchased in stores.”
The best way to protect yourself from unsafe THC products is to purchase products from licensed dispensaries, Riley advised. “Dispensaries have a responsibility to protect consumer safety. If you’re not going in a dispensary, then the product you’re buying is not legitimate.”
“These unfortunate incidents reinforce the need for greater regulation, standardization and oversight of the cannabis market—principles which NORML has consistently called for in the cannabis space,” said NORML deputy director Paul Armentano in a prepared statement. “Consumers must be aware that quality control testing is critical and only exists in the legally regulated marketplace.”
Unfortunately, we may only be seeing the tip of this iceberg since purchasing illicit THC products is common in states where cannabis is illegal. Yet the legal cannabis industry may only account for a small portion (some estimate 22 percent) of the nation’s $52 billion cannabis market. Do the math, and 78 percent of the cannabis products are coming from a completely unregulated supply chain where profits rule the game.
The cannabis site Leafly estimates that as many as 50 million tainted carts may currently be circulating in the U.S. These carts likely originated in Shenzhen, China, where most carts are produced and where millions of people work long hours but rarely, if ever, partake in the products they make. And then these products are shipped in large pallets to Los Angeles, California, and Long Beach, California, where they quickly find their way into the illicit cart market.
Until this year, the health effects of street-purchased vape cartridges went largely unnoticed. It’s not clear whether that’s because doctors didn’t spot earlier vaping-related lung irregularities or if something dramatically changed in the vape oil itself in the past few months. All we know is that somehow, within the last year, a new additive entered the street THC vape cart supply.
Hysteria and overreactions
The sudden surge in cases prompted the CDC to activate its emergency operations center, which allows the CDC to assign additional staff and resources to aid in the investigation.
“[The] CDC has made it a priority to find out what is causing this outbreak of e-cigarette or vaping-related injuries and deaths,” Robert Redfield, the CDC’s director, said in a statement.
Meanwhile, the CDC also issued a broader advisory against using e-cigarettes and vapor devices, especially those “bought off the street,” implicating both nicotine and THC products.
Yet according to Michael Siegel, a Boston University School of Public Health professor who has 32 years’ experience in tobacco control including two years at the CDC’s Office on Smoking and Health, the CDC has irresponsibly botched its investigation of these vaping-related illnesses and deaths.
By continuing to state that they have no idea what’s causing this “mystery illness” and that “no single product” explains all of the cases, the CDC has confused policy makers and the public while putting the entire nation at risk, Siegel wrote on his blog, The rest of the story. These statements violate basic principles of epidemiological outbreak investigations, he said.
“Like all outbreak investigations, [this epidemic] is going to be solved by identifying a type of product that is common to an overwhelming majority of patients,” Siegel wrote. “Frankly, we already have that, and it’s called marijuana. There is just far too high a proportion of case patients who have admitted to using THC or CBD oils for this to be merely a coincidence.”
By demanding that clinicians test patients’ urine for evidence of THC, the CDC would easily be able to issue appropriate recommendations to the public that would curtail this epidemic of life-threatening respiratory failure.
Indeed, without knowing the true source of this outbreak, policymakers are moving to ban large segments of the e-cigarette market. The Trump administration announced plans to ban nontobacco-flavored e-cigarettes. Michigan was the first state to prohibit sales of most flavored e-cigarettes in its effort to curb underage vaping. And the governors of California and New York also recently announced emergency plans to ban the sale of flavored e-cigarettes.
“We know that nicotine vaping products are far less hazardous than smoking,” said Greg Conley, the American Vaping Association president. “Even the FDA notes that they can be very helpful and a great benefit to [the] public health of adult smokers who switch [from combustible cigarettes to vapor products]. Going straight to prohibition is a bad idea.”
“The most popular flavors among adult switchers are not tobacco or menthol. It’s fruit and sweet flavors. So Governor Cuomo is actually banning the most successful products at getting smokers off of cigarettes,” Conley said. “We need to keep these products available to smokers so they can use them to quit.”
“The CDC itself admits that about 80 percent of the outbreak patients admit to using THC oils. My count puts that figure closer to 90 percent. Apparently, it’s 100 percent before the CDC takes the appropriate actions and enables health authorities to put an end to the tremendous morbidity and mortality this outbreak is causing,” said Siegel.
“This is like reporting deaths from eating romaine lettuce and advising people to immediately stop eating all lettuce and cabbage—except it’s a lot worse because [there is] no harm when people stop eating cabbage.
“Severe harm is already resulting from ex-smokers stopping vaping and returning to smoking or to the black market,” he said.
Hysteria and overreactions
The sudden surge in cases prompted the CDC to activate its emergency operations center, which allows the CDC to assign additional staff and resources to aid in the investigation.
“[The] CDC has made it a priority to find out what is causing this outbreak of e-cigarette or vaping-related injuries and deaths,” Robert Redfield, the CDC’s director, said in a statement.
Meanwhile, the CDC also issued a broader advisory against using e-cigarettes and vapor devices, especially those “bought off the street,” implicating both nicotine and THC products.
Yet according to Michael Siegel, a Boston University School of Public Health professor who has 32 years’ experience in tobacco control including two years at the CDC’s Office on Smoking and Health, the CDC has irresponsibly botched its investigation of these vaping-related illnesses and deaths.
By continuing to state that they have no idea what’s causing this “mystery illness” and that “no single product” explains all of the cases, the CDC has confused policy makers and the public while putting the entire nation at risk, Siegel wrote on his blog, The rest of the story. These statements violate basic principles of epidemiological outbreak investigations, he said.
“Like all outbreak investigations, [this epidemic] is going to be solved by identifying a type of product that is common to an overwhelming majority of patients,” Siegel wrote. “Frankly, we already have that, and it’s called marijuana. There is just far too high a proportion of case patients who have admitted to using THC or CBD oils for this to be merely a coincidence.”
By demanding that clinicians test patients’ urine for evidence of THC, the CDC would easily be able to issue appropriate recommendations to the public that would curtail this epidemic of life-threatening respiratory failure.
Indeed, without knowing the true source of this outbreak, policymakers are moving to ban large segments of the e-cigarette market. The Trump administration announced plans to ban nontobacco-flavored e-cigarettes. Michigan was the first state to prohibit sales of most flavored e-cigarettes in its effort to curb underage vaping. And the governors of California and New York also recently announced emergency plans to ban the sale of flavored e-cigarettes.
“We know that nicotine vaping products are far less hazardous than smoking,” said Greg Conley, the American Vaping Association president. “Even the FDA notes that they can be very helpful and a great benefit to [the] public health of adult smokers who switch [from combustible cigarettes to vapor products]. Going straight to prohibition is a bad idea.”
“The most popular flavors among adult switchers are not tobacco or menthol. It’s fruit and sweet flavors. So Governor Cuomo is actually banning the most successful products at getting smokers off of cigarettes,” Conley said. “We need to keep these products available to smokers so they can use them to quit.”
“The CDC itself admits that about 80 percent of the outbreak patients admit to using THC oils. My count puts that figure closer to 90 percent. Apparently, it’s 100 percent before the CDC takes the appropriate actions and enables health authorities to put an end to the tremendous morbidity and mortality this outbreak is causing,” said Siegel.
“This is like reporting deaths from eating romaine lettuce and advising people to immediately stop eating all lettuce and cabbage—except it’s a lot worse because [there is] no harm when people stop eating cabbage.
“Severe harm is already resulting from ex-smokers stopping vaping and returning to smoking or to the black market,” he said.

September 1, 2019
Questioning accuracy
The director of the FDA’s CTP, Mitch Zeller, says the accuracy of self-reporting in respiratory cases should be questioned.
By Timothy S. Donahue
Things are still quite unclear. However, vaping is less risky than smoking combustible cigarettes, according to Mitch Zeller, director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP). He told more than 300 attendees of the Global Tobacco & Nicotine Forum (GTNF) that “if you are an addicted cigarette smoker and you have been able to successfully transition to e-cigarettes, the last thing [the FDA] would want to see is someone going back to a combustible product.”
He reminded the packed audience of British psychologist and tobacco harm reduction expert Michael Russell’s adage that people smoke for the nicotine but die from the tar. “Nicotine does not cause the cancer, lung disease and heart disease; the nicotine gets you hooked to a product that … with each puff of smoke, you are inhaling the chemicals associated with those diseases,” he said. “There is a public health opportunity to move smokers down the continuum [of risk].”
Most of those in attendance wanted to hear Zeller’s understanding of the current pulmonary illnesses that have caused, as of this writing, 18 deaths in 15 states. The FDA and Drug Enforcement Administration (DEA) have opened a criminal probe into the vaping-related illnesses. “We are working very closely with our colleagues at the CDC and the [U.S. states where illnesses have occurred] as we try to get to the bottom of … how many cases are we talking about?” he explained. “The numbers that you see … are only going one direction and that is up. The CDC will be revising the numbers shortly.”
Hours after Zeller’s keynote address, the CDC released new figures stating that 1,080 lung injury cases associated with using e-cigarette or vaping products had been reported to the CDC from 48 states and one U.S. territory. “Most patients report a history of using THC-containing products,” the CDC release states. “The latest national and regional findings suggest products containing THC play a role in the outbreak.”
The role of the FDA in the pulmonary cases is to work in a complementary role with the CDC and other necessary federal organizations, such as the DEA, Zeller said. “When states have collected product samples and have made the decision to share them with [the FDA] then those samples go to our forensic chemistry center—these are expert analytical chemists—as we try to understand what is in these products,” he said. “The challenge we are all facing is [that] there is no common thread … there is no common thread in these self-reports from patients who have informed state officials in the first place.”
Attendees were told that it is “certainly looking like many of the cases involve” THC-based vapor products. However, there were also cases of CBD and nicotine, and some patients claimed to use more than one product, according to Zeller, who added that all of reports were done on a voluntary basis. This means results may not be accurate. For example, a self-reporter may live in a state where THC products are illegal and doesn’t want to disclose THC use for fear of prosecution.
“We maybe might want to question the accuracy of the self-report, but some of the self-reports are [from] individuals claiming the only product they used was a nicotine-containing product,” he said. “This is a challenge for everyone involved in this … investigation, but the right level of coordination exists between federal agencies and with the state health departments that are more boots on the ground for this. We are always looking for any information for any adverse effect for any tobacco product, including e-cigarettes, to be reported to the FDA.”
When asked whether consumers using nicotine-based pod systems should be concerned about pulmonary illness, Zeller said the FDA is still “trying to get around this on a case-by-case basis,” and some of the self-reports do claim to have only used nicotine-containing products. “When we are doing the analytical chemistry, obviously we are not talking to the person and are not asking questions about what products they used,” he said. “In some of these cases, there are multiple products being said they are being used with each case … many of these cases appear to be THC related … it’s complicated; it’s challenging.”
An attendee also asked Zeller if the FDA was concerned that current users may be switching back to combustible cigarettes. Zeller said that the FDA is a science-based agency that follows the science when it comes to this set of products (e-cigarettes). “Our point is that [electronic nicotine-delivery systems (ENDS)] are illegal and remain on the market through enforcement. Removing all vaping products from the market would be like pressing a reset button …. I want smokers to quit smoking or switch to less harmful products. The door is open for pre-submission meetings. The door is open for the companies to come in. The burden should be on companies to show the FDA that the products meet the burden of being for the protection of public health.”
Confronting other issues
Zeller told attendees that the FDA’s vision for the future of tobacco remains unchanged since the introduction of the regulatory agency’s Comprehensive Plan for Tobacco and Nicotine in July of 2017. “We still envision a world where cigarettes as we know them would no longer create or sustain addiction, and adults that are still [seeking to use nicotine] can get it from alternative and less harmful sources,” he said. “Even at this acute moment in time—as we are dealing with the vaping illnesses, as we are dealing with the epidemic use of e-cigarettes by kids in the United States—it’s still an opportunity to pause and acknowledge that the continuum exists.”
Products containing nicotine pose different levels of health risks to adult users with combustible products—like cigarettes with their toxic mix of more than 7,000 chemicals and efficient delivery of nicotine to maximize addiction potential—being the most harmful, nicotine replacement therapies (NRTs) being the least harmful and noncombustible products, such as ENDS products, falling somewhere in between, according to Zeller. “The public health return on this policy is generational,” he said.
The FDA is committed to protecting the public health of all Americans while regulating an addictive product that carries with it health risks, according to Zeller. To this end, the agency is conducting ongoing research on potentially less harmful forms of nicotine delivery for adults, such as ENDS products or e-cigarettes. “Though more research on both individual and population health effects is needed, many studies suggest e-cigarettes may be less harmful than combustible cigarettes,” Zeller said.
While ENDS products may be less risky than combustible products, Zeller said that recent proposals by the FDA to ban or restrict flavored tobacco products have been driven by an increase in use of ENDS products by youth. Zeller noted previously reported statistics from the 2018 National Youth Tobacco Survey (NYTS), which found that e-cigarette use among high schoolers had increased by 78 percent from 2017–2018.
“Think of it as a public health balancing act that has been made more challenging with the very disturbing 2019 NYTS results—more of which we will be sharing at a later date—where we saw the preliminary 2019 data showing more than 25 percent of high school students are current e-cigarette users. There will be more to come in [the] form of a paper [that] will be published,” Zeller said. “The reality is that not one of these products is lawfully on the market … not one of them—they have remained on the market since we gained regulatory authority in 2016 through regulatory enforcement. This balancing act by law requires us [to figure out] what’s going and what are the impacts on users and what are the impacts on nonusers … or what are the positive and negative impacts on initiation and the positive and negative impacts on cessation.”
There has been a lot of press lately surrounding teen use of Juul products because the device uses nicotine salts (in high concentrations), its small nature and how the product has been marketed. Zeller said that it is not just the Juul brand as there are numerous similar products on the market. “One of the real problems of concern are products that resemble USB flash drives,” said Zeller. “The product Juul has gotten most of the attention, but there are other products like Juul.”
In September of 2018, the FDA issued more than 1,300 warning letters and fines to numerous retailers for selling tobacco products to minors. Zeller said that what is more concerning is retailers who continue to sell products to youth despite warnings and fines from the FDA. In March, the FDA sent letters to 15 retailers for allegedly selling tobacco products to minors. These retailers include Walgreens, Walmart, Kroger, 7-Eleven, Family Dollar, BP and Citgo. The agency also requested information from more than 40 e-cigarette companies the agency thinks may have illegally introduced new products onto the market.
Concerning the premarket tobacco product application (PMTA) process, Zeller explained that the agency would soon release quality control requirements and considerations for tobacco-related good manufacturing practices (GMPs) or tobacco product manufacturing practices (TPMPs). Zeller could not comment on when the industry can expect this Foundational Rule and Guidance for TPMPs to be issued by the FDA; however, he did stress that the rule, along with the other foundational rules and guidances, is a priority for the CTP. “We take very seriously the commitment to making the process as efficient and transparent as possible,” he explained.
The FDA has already issued three advance notices of proposed rulemaking (ANPRMs) that have the potential to reframe the tobacco landscape. Zeller explained that the ANPRMs focus on “the role that flavors—including menthol—play in initiation, use and cessation of tobacco products.”
Input on these issues will assist in the consideration of the most impactful regulatory options the FDA could pursue to achieve the greatest public health benefit, according to Zeller. “We’re proceeding in a science-based fashion, building a strong administrative record by securing more information about the potential positives and negatives of flavors in both youth initiation and in getting adult smokers to quit or transition to potentially less harmful products,” Zeller stated in a press release about the ANPRMs.
Zeller also briefly discussed the PMTA authorization for the marketing of IQOS, a heat-not-burn device manufactured by Philip Morris. Following a rigorous science-based review through the PMTA pathway, the agency determined that authorizing these products for the U.S. market is appropriate for the protection of the public health because, among several key considerations, the products produce fewer or lower levels of some toxins than combustible cigarettes. “The FDA has placed stringent marketing restrictions on the products in an effort to prevent youth access and exposure,” said Zeller. “This was an application that got through the PMTA pathway because, at the end of the day, we were able to conclude that the marketing of this product would be appropriate for the protection of public health.”
Also speaking at the GTNF, Matthew Holman, the director of the CTP’s Office of Science, reiterated many of Zeller’s points. Holman said the FDA needs as much scientific data as it can possibly gather from numerous sources, and that is still a work in progress. Holman added that there was a “critical” need to share as much information as possible to work on regulations on new products of the tobacco industry that are less harmful for consumption. “Our goal is to be world leaders in understanding these products and regulations,” said Holman. “It is important to work in all disciplines, observing behavior, addiction, toxicity and many others, and not focus on a single point.”

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019
Reacting to roadblocks
During a recent Vapor Technology Association event, several experts discussed the major obstacles for the ENDS industry.
By Timothy S. Donahue
The e-cigarette is on the ropes. Over the last 18 months, especially the last four, three major developments have forced the vapor industry into an outright battle for its existence. These events have several states and even the U.S. government using the issues to either ban flavors in e-liquids or ban all vapor products entirely. Several industry experts say that an outright flavor ban (except tobacco flavor) would force thousands of businesses to close, eliminate nearly 200,000 jobs and cost tens of billions of dollars in negative economic impact.
First came a large increase in youth use, and later, the U.S. Food and Drug Administration (FDA) was forced to ramp up its premarket tobacco product application (PMTA) deadline, then the lung illnesses started happening. In early June, the U.S. Centers for Disease Control and Prevention (CDC) and the FDA began to receive reports surrounding an outbreak of respiratory illnesses linked to what the FDA and CDC claim were “vapor and e-cigarette” products (see “Irrational Hysteria,” page 18). In response to the epidemic, several states, the FDA and even President Trump himself have called for a ban on all flavored e-cigarette products.
At least four states, New York, California, Michigan, Rhode Island and Massachusetts, have enacted some type of vapor ban. Vapor Technology Association (VTA) Executive Director Tony Abboud, in response to the flavor bans, said his organization is “going to make it clear that this is the wrong approach, that it will literally cut down an entire industry that has grown up, with 166,000 jobs, to challenge the tobacco industry, and they are mostly small businesses.”
The industry is also struggling to get PMTAs submitted to the FDA by a court-ordered deadline. On July 12, Judge Paul Grimm of the U.S. District Court for Maryland ruled in a lawsuit filed by anti-tobacco groups that the regulatory agency had exceeded its authority in allowing electronic nicotine-delivery systems (ENDS) to remain on the market until 2022 before companies applied for regulatory approval. Grimm subsequently ordered vapor companies to submit costly PMTAs to the FDA by May 12, 2020, or remove the lifesaving products from the market. The FDA would then have one year to approve or deny those submissions.
The possibility does exist that the deadline could be moved, however. Several vapor organizations, including the VTA, have been granted a motion to Iitervene exclusively for the limited purpose of filing an appeal of the Memorandum Opinion and Order and the Remedy Order that forced vapor companies to submit PMTAs to the FDA by the new deadline. “The vapor associations have no other opportunity to provide their views on the deadline imposed in the Remedy Order, and the government’s objectives appear to have diverged from the interests of the vapor associations that seek to intervene,” Grimm wrote in his ruling.
The judge denied a motion to stay the order. “I also will deny the vapor associations’ motion to stay because, as noted, the Remedy Order does not impose immediate deadlines, and the vapor associations have not shown that ‘a pressing need exists,’” Grimm wrote.
Lawyers with the law office of Keller and Heckman (KH), a Washington, D.C., law firm that represents the VTA and other vapor industry stakeholders, filed motions to intervene and stay with the U.S. District Court for the District of Maryland pending appeal of the July 12, 2019, Memorandum Opinion and Order (Remedies Order) on behalf of several vapor trade associations. KH also filed a notice of appeal with the United States Court of Appeals for the Fourth Circuit on July 30, informing the appellate court of its intent to appeal the District Court’s order denying the trade associations’ initial attempt to intervene in the case on the remedies issue.
During the VTA’s fourth annual Vape & the FDA event, these topics were at the forefront of discussion as the more than 270 attendees from 42 U.S. states and four countries fretted over the future of the U.S. vapor industry. Combating youth initiation, fighting to keep flavors legal and forcing the FDA and the CDC to be truthful about the causes of the lung illnesses are primary goals of the VTA’s more than 90 members, including 26 state vapor advocacy organizations.
Several speakers told attendees about various segments of the vapor industry. Chris Howard, vice president, general counsel and chief compliance office for E-Alternative Solutions, discussed the history of the vapor industry and the oddball way the FDA has attempted to regulate it. “The deeming rule, PMTA process, flavors, speculation … it has been a crazy ride,” says Howard.
Brad Rodu, endowed chair in tobacco harm reduction at the University of Louisville, said vaping is driving smoking rates down as e-cigarette use rises. Studies like the FDA’s National Youth Tobacco Survey (NYTS) are intentionally misinterpreted in order to give the vapor industry a black eye. He says that laws that ban flavors just aren’t going to work, but more importantly, “federal agencies aren’t accountable to anyone.” This is why the rash of lung-related illnesses has been placed at the feet of the vapor industry instead of the marijuana industry where it belongs.
Factual distortion
As of Oct. 1, more than 1,000 people had been hospitalized for a serious respiratory illness, and at least 18 deaths had been possibly attributed to a thickening agent, vitamin E acetate, that only recently began to be used in THC-containing cartomizers, according to data from the CDC and the FDA. Several vapor industry experts have accused both the FDA and the CDC of intentionally misleading the public as to the circumstances surrounding the outbreak and accused the government agencies of wrongly placing some of the blame on nicotine-based vapor products.
During the VTA event, Michael Siegel, a professor with the Boston University School of Public Health, told attendees that CDC protocols for outbreak investigations are being ignored by the agency itself. Siegel trained with the CDC for two years in how to properly respond to an epidemiological outbreak. “They are telling you to ignore the facts. This is completely against the CDC’s protocol for outbreak investigations,” says Siegel. “I was trained by the CDC to conduct these investigations. You never find a single exposure in any outbreak. That’s not the way the world works; it’s not the way data works.”
A major issue the CDC, the FDA and even the Department of Health and Human Services (HHS) have is that none of the organizations recommend that clinicians test for THC in the patients with lung illnesses, according to Siegel. He says that tells him that the organizations do not want to know or be forced to tell the public that this is a THC problem and not a nicotine problem.
“I believe they are not telling clinicians to do THC testing because they know the majority [would test positive]. That would completely destroy their ability to blame this on e-cigarettes, and I believe that is what they want to do. They saw this as an incredible opportunity,” he says. “They have been against e-cigarettes since the beginning, and nothing bad has been happening. Then you have this [outbreak of lung illnesses,] and they wanted to be able to say, ‘I told you so. We told you how bad e-cigarettes were.’ Even the secretary of HHS says to stop using e-cigarettes and doesn’t mention THC on their website.”
Siegel goes on to say that this is an inexcusable public health practice. He even goes as far as to label the actions by the CDC and the FDA as public health malpractice. “Could you imagine if we had an outbreak of e-coli from contaminated lettuce and the CDC put out a statement that didn’t mention the word lettuce anywhere? That would be completely irresponsible,” he says. “Even if they didn’t know for sure … it would be inexcusable. It isn’t just the CDC; it’s every major health organization that deals with the anti-tobacco groups [spreading vaping illness misinformation].”
When trying to determine the cause of an outbreak, Siegel says the CDC must look at the data. The CDC trains epidemiologists to look at certain characteristics such as age, sex, race, location and timing. When looking at the timing of the lung illness outbreak, it was around May of 2019 that there was a sharp spike in vaping-related illnesses. “Why did it start now? Any explanation must explain that,” said Siegel. Second is looking at the distribution of cases. “If it were a nationally sold product, why would entire states be spared completely, at least early on,” he says.
Siegel goes on to explain that the majority of patients were aged between 16–53 with a median age of 19. This means a full half of these cases are between the ages of 16–19. There are twice as many adult vapers between the ages of 25 and 44. The number of people under the age of 20 that use e-cigarettes is very low, according to Siegel. “It doesn’t fit the pattern,” he says. “It doesn’t make sense that this is electronic cigarettes.”
By his estimates, Siegel says that 90 percent of cases reported using black market THC vaping cartridges. In New York state, every THC cartridge tested was found to contain the thickening agent vitamin E acetate. He stated that in New York state, every patient used THC products. There were also no abnormalities in any of the e-liquids tested.
“So put all this together … because of the timing we know this is not any electronic cigarette or e-liquid. Then, what youth is going to readily admit to using marijuana?” Siegel asks. “The most important thing is that the CDC is not recommending patients be tested for THC. This is a striking revelation. There is no way to tell if a youth is using marijuana without testing. This is something the CDC should be recommending …. The CDC conclusion is … it’s electronic cigarettes. There is no way that could be the case. Even without looking at the data, we knew that wasn’t the case. The CDC recommendation was don’t use e-cigarettes. Kids are dying from buying black market THC cartridges, and the CDC is telling them to stop using e-cigarettes.”
Unfortunately, this transfers into public policy, Siegel explains. The president has said he is going to ban flavored e-cigarettes. The FDA is saying they will ban flavored e-cigarettes. The pieces are starting to come together. “What is happening is the CDC, the FDA, the Trump administration and all the anti-tobacco groups are saying ‘we have a THC cartridge problem.’ So, we should ban all e-cigarettes,” Siegel says. “It’s a complete disconnect. They are using a crisis in one industry to attack another.”
Power push
The FDA does not have the authority to do anything about marijuana-based products. Federal law prohibits the federal sale of marijuana, so it makes it very difficult to regulate, according to Siegel. He says it is also the opinion of many people, including former FDA Commissioner Scott Gottlieb, that the FDA could be given a limited amount of authority over these products through Congress. States, however, have the power to regulate THC products.
“There is nothing to stop states from their own enforcement. If states were really concerned about this outbreak, what they should be doing is spending less time demonizing e-cigarettes and spending more time trying to find the illicit distribution channels for these illicit THC vaping carts,” Siegel says. “E-cigarettes are becoming the scapegoat for a situation that has nothing to do with nicotine. In 2007, when vaping products first hit the market, I was adamantly opposed to them. Everything you hear the FDA, [the] CDC and anti-vaping groups saying now, I was saying in 2007.”
Siegel says he then did something that none of these anti-tobacco groups has done in the last 12 years: He started to talk to some human beings who were actual vapers to try to figure out what these products were and how they helped people quit smoking cigarettes.
“When I found out the truth, that completely changed my point of view. That is not what’s happening. These anti-tobacco groups state their position, stake their ground and confirm to their preexisting [beliefs] to the point that when they have information which directly contradicts their preexisting conclusion, they are twisting it in a certain way and are really going through great lengths of desperation to try and twist it to make it fit even though it doesn’t.”
Seigel says another issue that continues to plague the vapor industry is the term “e-cigarettes.” He says that what you call something has incredible implications. “I think it is unfortunate that e-cigarettes took on the term ‘e-cigarettes’ from the very beginning because that just fed right into the anti-smoking groups propaganda that this is just another form of smoking,” he said. “I think it is very critical that we make the difference [between e-cigarettes and e-joints clear]. We need to come up with terms that make the two very different.”
The VTA has been an active voice in the vapor industry over the past several years. It has also been doing its part to help get the word out that THC products, not nicotine, are at the center of the lung illness epidemic. Abboud says that the VTA has “applauded government when it acts responsibly. We have been holding our decision makers accountable when they are not acting responsibly. Because we represent all the different sectors of this industry, we are able to speak clearly to our leaders in terms of a rational comprehensive policy around this industry segment.”
He’s right. The VTA has fought anti-vaping bills in nearly every U.S. state and has prevented the industry from becoming regulated out of existence. That’s pretty positive since the vapor industry makes an enormous economic impact of $24.5 billion on the U.S. economy, according to the VTA. It provides over $7.9 billion in wages alone. He believes that flavors aren’t the real problem, but the real problem is what companies name those flavors and how they market those products.
Abboud says that vape shops should not have flavors banned because they are better at verifying age than a traditional gas station or convenience store. “Vape shops are a place of community, and this [is] why they are better able to protect youth from getting these products. We need to remind people all the time that all of these products have flavors, and even tobacco is a flavor,” he says. “The real issue is marketing not flavors. Flavors are needed to make these products consumable. Banning flavors is too simplistic of an argument. We need to look at all the marketing issues that exist. Unicorn puke, cotton candy—news flash, these are not flavors, they are marketing gimmicks. The real issue is how do we control these things.”
There have been several studies as well as an enormous amount of survey data that have found that flavors are helping people quit smoking cigarettes, according to Abboud. He says that what most anti-vaping groups are really concerned about is the argument that vaping is a gateway to smoking. Siegel agreed with Abboud that the gateway does not exist, but anti-vapor groups misconstrue data to argue that it does.
Both agree that vapor products are safer than smoking cigarettes. “No serious person says that e-cigarettes aren’t at the lower end of the risk continuum,” says Abboud. “If flavors are banned, what will happen is the mass market exit of the vapor product. People will start smoking again, and that is a bad thing.”

The flavor ban caravan
In early September, Michigan became the first state to proclaim its intent to limit sales of vapor products. Governor Gretchen Whitmer later issued an emergency ban on the online and retail sale of nicotine vapor products in any flavor except tobacco for at least 180 days. On Sept. 17, New York became the first state to implement a statewide ban on most flavored nicotine vapor products, just days after Governor Andrew Cuomo called for emergency action.
The worst ban came on Sept. 24 when Massachusetts Governor Charlie Baker declared a public health emergency due to the then more than 500 vaping-related lung illnesses and at least seven deaths reported to the CDC. Five of those illnesses occurred in Massachusetts. Baker enacted the country’s strictest vaping prohibition: a four-month statewide ban on online and retail sales of all marijuana and tobacco vapor products (not only flavored products). According to a press release, Massachusetts lawmakers chose to ban both marijuana and nicotine products due to continuing uncertainty over what is causing the respiratory illnesses.
The day after the announcement for Massachusetts’ ban, Rhode Island Governor Gina Raimondo signed an executive order banning the sale of flavored e-cigarettes in the state for at least 120 days. Raimondo called vaping a “public health crisis” for youth, adding that she is assembling a group of medical experts to advise her on the best ways to combat the problem. Washington became the fourth state to ban flavored vapor products when its state Board of Health issued an emergency rule that bans the sale of flavored vaping products In mid-Oct. The ban lasts 120 days, according to the Washington State Board of Health. The ban will apply to products containing nicotine as well as THC.
In California, Governor Gavin Newsom took a less heavy-handed approach. On Sept. 16, he issued an executive order aimed at curtailing the state’s youth vaping epidemic by allocating at least $20 million for a “vaping awareness campaign” and asked state agencies to help end sales to anyone under 21 years old and end illegal and counterfeit vapor product sales entirely.

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019
Collective effort
A recently released white paper aims to motivate U.S. Congress, the FDA and the CDC to confront the two major issues facing the vapor industry.
By Timothy S. Donahue
The industry is starting to get organized. Two major concerns facing vapor companies have brought together a varied group of 70 industry stakeholders hoping to get the U.S. Congress to confront both youth initiation and the recent outbreak of acute pulmonary disease, which has caused several deaths. Each of these concerns will have significant public and economic impacts, according to a recently released white paper by the group that represents multiple domestic and foreign vapor hardware and e-liquid manufacturers as well as more than 600 vapor retail stores covering 35 states.
“Although state health departments and the FDA have continued to link recent respiratory illnesses with illegal THC use, the [U.S. Centers for Disease Control and Prevention] CDC reports did not adequately differentiate between THC and nicotine vape even though they are completely different industries,” said Sam Salaymeh, president of AMV Holdings, one of the largest U.S. vapor retailers. “The failure of the CDC to demand THC screening of patients who refuse to admit to such use is irresponsible and dangerous. This oversight has caused widespread panic among consumers and government policymakers and negatively impacted public health.”
Salaymeh says that some vapers are going back to smoking traditional cigarettes, and there is a significant reduction in the rate of smokers who adopt nicotine vaping for harm reduction. The nicotine vapor industry is suffering “severe economic hardship,” according to Salaymeh. “We have had to shut down many stores and lay off more than 15 percent of our workforce due to the actions of drug dealers selling contaminated THC cartridges. That should not happen in a country founded on freedom and justice.”
These significant negative impacts with respect to public health are sending people back to smoking and black markets as well as the loss of potentially 80,000-plus jobs and $24 billion in industry economic output and direct political impacts, according to the paper. The group’s members collectively serve approximately one million customers a year, of which over 85 percent have used vaping to quit or substantially reduce smoking combustible cigarettes, according to the paper. Of these former smokers, the paper claims that 97.8 percent say vaping has improved their lives. None of these operators are owned by major tobacco companies.
“The consequences of the political action taken in response to these two fabrications have not been duly taken into consideration,” the paper states. “There is no evidence that [the U.S. Food and Drug Administration] FDA-regulated vapor products have resulted in any of the recent pulmonary disease-related deaths, and the overwhelming majority of the patients suffering from respiratory illness have reported the use of only THC vaping products with or without nicotine. The CDC has failed to properly distinguish illegal black market THC vaping cartridges from legally purchased nicotine-containing e-cigarettes. This oversight has caused significant consumer confusion resulting in customers returning to cigarettes and economic hardship for vape retail store operators.”
In confronting the issue of youth initiation, which the FDA claims is driven by flavored electronic nicotine-delivery system (ENDS) products, the paper states that “flavored ENDS products have existed worldwide for more than a decade. The acceleration of youth consumption only became an epidemic in the last two years along with the increased popularity of high-nicotine closed pod systems.” The paper states that Juul Labs’, the nation’s largest e-cigarette brand, growth and market penetration follow youth initiation growth patterns, and flavors are not the fundamental cause of the increase in youth uptake,.
“From a product standpoint, we believe there is ample evidence that the underlying cause for youth initiation is a combination of nicotine salts that contain high levels of nicotine and discreet devices,” the paper states. “The least important factor is nontobacco flavors. Lastly, we believe that the distribution channels of c-stores and online purchases drives youth initiation rather than the vape store channel.”
According to the paper, the group makes three data-driven, risk-based policy recommendations for regulators in response to helping curb youth initiation:
Limit flavors to lower nicotine products sold through adult-only age-verified retailers. “Our research shows flavors are not the underlying cause of the ‘youth epidemic.’ However, flavors combined with high nicotine strengths and discreet devices can increase youth initiation. We recommend limiting flavors to lower nicotine concentrations (30 mg [per] mL and below) sold through adult-only age-verified retailers.”
Examine nicotine strength and risk profiles. “The acceleration of youth vaping is highly correlated to the growing popularity of high nicotine concentration products, particularly 50 mg [per] mL. A nicotine level restriction has proven lower youth adoption rates in other countries where nontobacco flavors remain available. The FDA should recognize this heightened risk profile with respect to the distribution and marketing of all ENDS [products].”
Encourage manufacturers to build age verification tools into all hardware. “Discreet devices are a powerful tool for adult consumers; however, when combined with high nicotine concentrations, they also have the youngest customer age demographic. For hardware devices commercially marketed prior to Aug. 8, 2016, we recommend the FDA waive enforcement action to allow for the addition of age verification tools. Additionally, we recommend [the] FDA waive enforcement action for pre-Aug. 8, 2016, closed pod systems marketed with a high nicotine concentration in order for the manufacturer to reduce the nicotine level. These devices should only be sold in adult-only age-verified retailer establishments.”
The CDC has not stated outright that nicotine vapor products are not the cause of the recent pulmonary health issues. However, in early October, the FDA stated that the majority of samples tested by the states or by the FDA “related to this investigation have been identified as vaping products containing THC. Through this investigation, we have also found most of the patients impacted by these illnesses reported using THC-containing products, suggesting THC vaping products play a role in the outbreak. As this complex investigation continues, we urge consumers to take heed of our warning and stop using THC vaping products and to not use vaping products of any kind that are purchased off the street or from unknown sources.”
The claim that nicotine-based ENDS products have anything to do with the pulmonary disease issue is being widely published by the national media and is supported by statements made by the CDC, which has been vague at best, according to the paper. “This claim does not differentiate between regulated nicotine vapor products and black market THC vape cartridges. It has become overwhelmingly clear that the acute pulmonary diseases and multiple fatalities are the results of vaping illegal THC cartridges and other illicit products not FDA-regulated nicotine-containing products,” the paper states. “E-cigarettes have been widely used for more than a decade, and the current cases are focused on a very narrow epidemic, both in time and geography. This suggests that these respiratory illnesses are caused by specific batches of tainted black market products and not FDA-regulated vapor products.”
As far back as August, Brian King, deputy director of research translation at the Office on Smoking and Health at the CDC, said that potential irritants include “ultrafine particulates, some heavy metals, such as lead,” and, he said, there “are also concerns about some flavorings …. We haven’t specifically linked any of those ingredients to specific cases.”
On Sept. 5, 2019, the New York Department of Health (NYDH) released an update on the pulmonary cases of New York patients. They stated that lab results found extremely high levels of vitamin E acetate in nearly all cannabis-containing samples tested as part of the investigation. “At least one vitamin E acetate-containing vape product has been linked to each patient who submitted a product for testing,” NYDH stated in a release.
In Minnesota, the Department of Health’s news release on Sept. 6, 2019, stated that of the 32 cases of reported lung illnesses under investigation, those who were interviewed all disclosed that they were vaping illicit THC products. According to the recent New England Journal of Medicine report, 85 percent of patients’ lung illness incidences were tied to black market drugs. This study delved deeper into 53 pulmonary illness cases in Illinois and Wisconsin. Of those patients, 41 were extensively interviewed, and 80 percent reported using THC products.
“By linking nicotine-based vaping and illegal black market THC vaping, the CDC has caused widespread panic among consumers who have used vaping to quit smoking cigarettes. Further, they have discouraged current smokers from transitioning to the less harmful alternative of e-cigarettes,” according to the paper.
In order to help rectify the misinformation, the group suggests that the CDC should “immediately release a public announcement further clarifying FDA-regulated vapor products are not the cause of the respiratory illnesses and deaths that it is investigating.” They also ask that the CDC publicly acknowledge Public Health England’s statement that e-cigarettes are 95 percent safer than combustible cigarettes.
Consequences of misinformation
Claiming that nicotine-based vapor products cause pulmonary illness and youth use is motivated by nontobacco flavors has caused consumer confusion and poor policy implementation, according to the paper. This has also lead to a negative public health impact and the potential loss of 80,000 jobs.
Because the CDC has refused to differentiate between nicotine vaping and THC-based vaping, the agency has created massive confusion and panic among the 13 million consumers who vape nicotine-containing e-liquids, the paper states. In addition, the CDC statement has emboldened knee-jerk state action, which will be detrimental to public health.
As for flavors, President Trump, Health and Human Services Secretary Alex Azar and acting FDA Commissioner Ned Sharpless announced the intention of the Trump administration/FDA to take action against flavored e-products in early September. In a separate announcement soon after, Sharpless announced that in the “coming weeks,” the FDA’s Center for Tobacco Products would look to clear the market of flavored e-liquid via market authorization requirements based on preliminary results from the National Youth Tobacco Survey showing continued utilization of flavored e-products by youth.
Former FDA Commissioner Scott Gottlieb stated last year that “e-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine-delivery products that may not have the same level of risks associated with them.”
Both Gottlieb and the FDA’s director of the Center for Tobacco Products, Mitch Zeller, have stated that if they can take every adult smoker and fully switch them to e-cigarettes, it would be good for public health. Since the public health announcement, daily sales for vape retail stores have decreased compared to the previous month’s sales, according to Salaymeh. “Sadly, numerous consumers have informed us that they will return to smoking cigarettes as it is now viewed as a ‘safer alternative,’” he says.

Timothy Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Tim spends much of his time on the road, attending conferences and interviewing industry representatives.
His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
September 1, 2019
When Myth Trumps Science
In some circles, social media influencers’ opinions are often more important than a medical doctor’s.
By George Gay
Almost four years ago, a Conservative-voting friend of mine became almost apoplectic when I suggested that the election of the left-wing politician Jeremy Corbyn as leader of the U.K.’s Labour Party might help bring a welcome, partial correction to the decades-long rightward shift that had occurred to what my friend had come to accept as the political center ground.
A few months ago, however, amid the continuing chaos of the Conservative Party’s Brexit breakdancing routine, the same friend told me, in another apoplectic outburst, that he would never under any circumstances vote for the Conservatives again. I have to say, I felt pretty smug at the small part I seemed to have played in wrestling a voter from the Conservatives. I had not lived in vain, I thought.
But there was something about my friend’s conversion that troubled me, and that was the size of the swing that had occurred in his position. I mean, even I have to admit that there could come a day, possibly one occurring in a parallel universe, when the Conservative Party manages to shrug off what even the party’s leader and Prime Minister (at the time of writing on May 24) Theresa May (whose resignation will take effect on June 7) have accepted as its nasty-party image.
Have too many of us, I wonder, lost sight of the center ground and moved beyond the fringes of reasoned debate? At a one-day forum staged recently by the UK Vaping Industry Association (UKVIA), a medical doctor and television presenter told how, after appearing on the television chat show Loose Women, where he had suggested that a woman who had tried and failed to give up smoking using traditional methods should try vaping, he was hit by a Twitter storm that wouldn’t have been more extreme if he’d “crapped on the floor.”
Christian Jessen, a medical doctor who works with health charities looking for new ways to educate people on health matters, gave the keynote address at the UKVIA forum held on May 9 at the London headquarters of the Royal Aeronautical Society. Jessen, who is a writer best known for his presentations of popular TV medical programs, is a public campaigner and the UKVIA’s official VApril (vaping awareness month) campaign ambassador.
Why was it that Jessen’s suggestion was met with such vehement opposition? Partly, I think, people react in this way simply because they can. Through social media, they have a route to express their opinions publicly to a huge audience in a way that was denied them in the past.
And for those who crave the limelight, there is no point in beating around the bush. Launching a foul-mouthed tweet at somebody with millions of Twitter followers surely generates more reaction and more satisfaction than could have been initiated using avenues previously available, such as writing a stiff letter to The Times that might or might not have been published.
But there are two things that need to be considered here: The first is that, no matter how things might seem, the people who react in the way described probably comprise a tiny minority of the population, and that it is only the echo chamber of Twitter that seems to indicate otherwise. The other point is that, whereas the above might explain why, in general, certain people choose to fly off the handle on Twitter, it doesn’t explain why they chose in this case to attack Jessen’s particular suggestion, which, after all, comprised a perfectly reasonable proposal from a fully qualified medical doctor.
The woman in question had tried all other methods of quitting, so the choice she was left with was between continuing to smoke or giving quitting one last try with vaping, and there are relatively few people, even among those opposed to vaping, who, given that binary choice, would suggest sticking with smoking combustible cigarettes.
Could it be, I wonder, that Jessen, in trying to use the power of television to help educate people about health matters, had come to be seen as just another TV pundit rather than a doctor? He didn’t suggest such a thing, but he did question whether the public at large was particularly interested in how qualified the person presenting them with advice was.
During his work in television, he said, he had never been asked by producers to show his medical credentials or to demonstrate why he was suited to give medical advice on television. And this lack of interest in credentials was reflected in the wellness industry where celebrities encouraged their millions of followers to take up regimens of exercise or supplementation that were rarely based on anything remotely resembling science, or the truth or evidence.
Jessen said that at a time when people were bombarded with health advice on almost an hourly basis, some of it good, much of it bad and some of it downright ugly, it was a constant source of frustration for him that so many people seemed to prefer the opinion of a social media influencer to that of a doctor, scientist or experienced expert. Why is it that myth increasingly trumps science today?
The main reasons, he suggested, were mistrust in science and complacency. Sections of the public had come to mistrust science, medicine and institutions, and, in doing so, they had lost sight of the true value of progress. But Jessen refused to sneer at these doubters because, he said, he could see why they doubted. He needed only to say a few words to explain what he meant: Chernobyl, Bhopal, Challenger, weapons of mass destruction, thalidomide. And the trouble was that once you planted the seeds of doubt, you could rarely dig them out of the public’s consciousness.
There were several parts of Jessen’s presentation that seemed to face both ways: describing the benefits that science had brought but highlighting, too, where it had gone wrong; expressing frustration at people who rejected science but highlighting, too, that perhaps they had a point. I guess a kinder interpretation would be that the presentation was balanced and that when he talked, as above, about “the true value of progress,” it was necessary to recognize that progress isn’t an uninterrupted journey.
In fact, he was specific about this when he said he believed the scientific method—which has gotten us to where we are today, the greatest time to be alive—involved trying stuff out, seeing if it worked and changing it if it didn’t.
This method probably works well in many fields, but there is a problem when it comes to stuff such as smoking and vaping because the science is pulled out of shape by political and economic imperatives and shenanigans. One has to look only at what has happened with the U.S. Food and Drug Administration’s (FDA) attempt to use science as the guide for the future of tobacco.
In 2010, the year after responsibility for the regulation of tobacco products was handed to the FDA with the signing of the U.S. Family Smoking Prevention and Tobacco Control Act (FSPTCA), Dr. David L. Ashley, then the director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), said that 443,000 Americans (U.S. citizens) died prematurely from tobacco use each year. Today, the U.S. Centers for Disease Control and Prevention’s website informs that cigarette smoking is responsible for 480,000 deaths annually in the U.S.
If you adjust the 2010 figure, 443,000, simply for population increase, annual deaths from tobacco use should now be at about 470,000. That is, the application of science to the tobacco issue seems to have an increase in deaths put down to this product by just over two percent, and that doesn’t take into account the fact that the 2010 figure includes deaths from tobacco use whereas today’s figure looks only at deaths from cigarette smoking.
OK, my figures are crude, and I’m sure that there are other factors that need to be taken into account in any robust comparison of the figures from 2010 with those of today, but I cannot help thinking that, nevertheless, the last 10 years have not been a roaring success for the FDA, assuming that the goal was to reduce tobacco’s public health toll.
It wasn’t meant to be this way. And in the heady days of 2010 when he gave his figure of 443,000, Ashley, who did so at the Coresta congress in Scotland, said that, for the first time ever, tobacco policy in the U.S. wasn’t being decided by politics—it was being driven by regulatory science.
I attended that conference and was skeptical about the claim that politics had been left behind, but I was also concerned that regulatory science was to be the sole driver. To my mind, there was a need to step outside the regulatory laboratory once in a while and take some risks. If the 443,000 statistic was correct, it was unconscionable to wait around for science to show us the way. Science is wonderful, but it can be slow.
At the time the FDA took responsibility for tobacco products, there were already tobacco and nicotine products on the market that at least some smokers found to be reasonable substitutes for combustible cigarettes and that could reasonably be assumed, given the level of knowledge then, to be considerably less risky than combustible cigarettes.
Ten years later, little action has been taken in respect of combustible cigarettes—apparently the main cause of tobacco-related deaths—but the FDA has maneuvered itself into a position whereby vapor devices, one of the most successful, low-risk substitutes for combustible cigarettes, face an existential crisis.
If this is science at work, no wonder people are disillusioned with science. But, of course, the fault lies not with science but with the version of science served up by the FDA between two thick slices of organic bureaucracy—perhaps as a result of the way that it was hemmed in by the FSPTCA. I hesitate to say it, but, in this case, what was probably needed was more political interference, not less. The FDA needed to be cut some slack.
One of the many problems that the FDA ran into or created in respect of vaping concerned the young person issue where it, egged on by a media that had never been happy with the good news stories of converted smokers, seemed largely to abandon regulatory science in favor of more pagan arts in which smokers were to be sacrificed on the alter of youth. And as science was abandoned, the FDA found itself besieged and undermined by politicians and special interest groups. The influencers were not only influencing the public, but also those experts who should have been holding the line against policies based on blood cults and moral panic.
In the U.K., the uptake of vaping by young people has not happened to any degree, so it has not faced such problems, but it was interesting that, at the forum, a flavor pamphlet was given out that would surely have raised eyebrows at the FDA, which is convinced that certain flavors, when applied to e-liquids, prove irresistible to young people.
And as somebody pointed out during one of the forum’s seven panel sessions, if the U.K. started to see a spike in vaping among young people, the vapor industry would suffer reputational damage if the media could point to the availability of “child-friendly” flavors. And what has to be remembered is that, in the febrile atmosphere of 24-hour news, as the media cried out for bloodletting and sacrifices, it would matter not a jot whether the flavors in question were the ones that young people were using.
But, to end on a positive note, at least in the U.K., Jessen said he believed that the U.K. industry is approaching things in a considered and responsible manner, and he made particular reference to its commitment to quality and the development of standards. The continuing emergence of evidence supporting vaping would mean that it would ultimately prevail, he added. Vaping is a gift to public health—one that must continue to be embraced and encouraged.
Sorry, just one more thing. I assure you that I am not making this up. Last night, I was speaking to the mother of my friend mentioned at the start of this piece who told me that she would never again vote for the Conservatives. That’s two down.

George Gay
June 25, 2019
No Fire, No Smoke
A report by Knowledge-Action-Change explains the advantages of embracing harm reduction to help tackle the global smoking epidemic.
By George Gay
The existence of 101 countries that have no specific laws covering electronic cigarettes was reason enough to welcome the launch last year of a major report on tobacco harm reduction and the announcement that the report is to be taken on an international roadshow this year. And the existence of 62 countries that regulate e-cigarettes under tobacco legislation and 39 countries that have banned the sale of e-cigarettes and/or nicotine-containing e-liquids lends urgency to the roadshow.
While tobacco smoking is generally considered to be a major cause of preventable deaths, the use of the products described in the report, which have been shown to be acceptable substitutes for combustible cigarettes, is far less risky than smoking. So while it is bad enough that many smokers become ill and eventually die from indulging in their habit, they should not be condemned to suffer in this way because of ignorance about the existence of alternative products. Or perhaps that should read “condemned by the ignorance of regulators”—in 14 countries, e-cigarettes are banned but are widely available, suggesting that ordinary people are sometimes better informed than regulators.
No Fire, No Smoke: The Global State of Tobacco Harm Reduction 2018 was undertaken by Knowledge-Action-Change (KAC), a private sector public health agency, and supported solely by a grant from the Foundation for a Smoke-Free World¹. It was written by Harry Shapiro, a KAC consultant.
The report, which is more than 120 pages long, is said to be the first to map the global, regional, and national availability and use of safer nicotine products, the regulatory responses to these products, and the public health potential of tobacco harm reduction. It has an introductory chapter on tobacco harm reduction as well as others on the continuing global epidemic of cigarette smoking; safer nicotine products; consumers of safer nicotine products; safer nicotine products and consumer health; regulation and control; and human rights, public health and tobacco harm reduction advocacy. In addition, tucked away in the back is a useful “vaping timeline” that journeys from 1927, though it is important to stress that the report, while focused on vapor devices, also looks at other lower-risk products such as snus.
In conclusion, Shapiro describes the report as an attempt to enumerate and explain the advantages of embracing harm reduction as a legitimate approach to help tackle the global smoking epidemic. “Apart from being founded on the well-established principles of the right to health for the world’s citizens, as enshrined in many international documents, it is also grounded in evidence-based pragmatism,” he says.
Shapiro goes on to say that those seeking harm reduction should not be distracted by concerns about “gateway” effects or “renormalizing” smoking, for which there was no robust evidence. He also says that people should not be overly swayed by talk of nicotine “addiction,” a word freighted with the worst images of serious and chaotic drug and alcohol use that do not apply to nicotine.
And he adds that it is important to focus on the prize—the end of traditional smoking—and not allow over-prescriptive regulation and control to deny access to products that have the potential to be one of the most dramatic public health coups of modern times—a coup that costs governments, international agencies and nongovernmental organizations nothing.
This last point is worth emphasizing because it underlines possibly the most vital aspect of the report and the roadshow: their potential to influence regulators and those in tobacco control who are so far uncommitted to tobacco harm reduction but are receptive to it. Consumers understood from the outset that e-cigarettes offer a less-risky way to consume nicotine, and they were willing to pay to enjoy this substitute activity. One of the few things that have held them back is the seemingly malicious intervention of reactionary elements within tobacco control hostile to the concept of tobacco harm reduction and the acquiescence of ill-informed regulators to their regressive “quit or die” message. More than anything, the tobacco harm reduction message needs to be spread as widely as possible so that it builds unstoppable momentum.
The report, which can be downloaded free of charge, was launched unofficially in Geneva, Switzerland, in October 2018, when it was given out to any participants approaching the World Health Organization’s Conference of the Parties (COP8) to the Framework Convention on Tobacco Control who were open-minded enough to take one. What the participants did with the report is anybody’s guess, but it is understood that only one report was hurled back at those handing them out, which must be a positive sign.
It was launched in the U.K. at an event hosted and addressed by viscount Matt Ridley at the Palace of Westminster on Dec. 18, 2018. And it is due to be taken on the road early this year. Professor Gerry Stimson, a director of KAC who, together with fellow director Paddy Costall, project managed the report, said the report would be taken to “key” countries, perhaps including Australia and India—so into the lion’s den. The roadshow stops would involve daylong tobacco harm reduction events based on the report but also including local advocates, Stimson said.
Because, we are told, a person dies from a smoking-related disease every six seconds, the report and the roadshow are vital undertakings. And for this reason, it is to be hoped that funding is forthcoming to keep the momentum of this project going in the coming years—at least until every smoker of combustible cigarettes has had the opportunity to learn the truth about alternative products. To learn, as the report says, that “quit or die” is no longer the only option for those who cannot give up nicotine, that safer nicotine products, including e-cigarettes, heat-not-burn products and Swedish snus, offer another way: “quit or try.”

George Gay
1. The report’s acknowledgements include a note that the Foundation for a Smoke-Free World played no part in determining the content, analysis or conclusions in the report and that it provided input only at the initial concept stage. [↩]
February 18, 2019