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Electric Shock
The U.S. FDA has released new guidance for batteries in vapor hardware and bottling improvements for e-liquids.
Battery safety in the vapor industry just got a whole lot better. On Nov. 26, the U.S. Food and Drug Administration (FDA) released an updated premarket tobacco product application (PMTA) guidance for the vapor industry. The new guidance will allow manufacturers of both hardware and e-liquids to provide safer, more effective products to consumers.
“We recognize there are certain modifications manufacturers can make to their tobacco products to address a voluntary industry battery standard and to comply with requirements related to safe packaging of liquid nicotine products, known as flow restrictors,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “We encourage these limited safety-related modifications because they are intended to ensure the public is protected from risks such as battery explosions or accidental exposure to toxic levels of nicotine.”
The new guidance, “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products,” explains the FDA’s compliance policy for making limited safety modifications to vaporizers and e-cigarettes that were on the market as of Aug. 8, 2016, the date all e-cigarettes and other electronic nicotine-delivery system (ENDS) products became subject to the FDA’s tobacco authorities.
The guidance allows for “battery-operated tobacco products modified solely and only to the extent necessary to comply” with the voluntary industry UL 8139 standard for batteries. The FDA worked alongside the U.S. Consumer Product Safety Commission, external stakeholders and UL to develop a voluntary UL 8139 industry standard in order to help manufacturers alleviate potential battery-related risks associated with ENDS products.
A global safety consulting and certification company headquartered in Northbrook, Illinois, USA, UL maintains offices in 46 countries. The 100-year-old company collaborates with a diverse array of stakeholders to establish standards that create level playing fields working to develop new pathways for the latest innovations.
With the new guidance, the FDA is essentially telling vapor companies that the industry should submit batteries used in vapor products to UL for U.S. and Canadian certification, according to Josh Church, chief regulatory and compliance officer with Joyetech Group. Church was a member of the team of scientists and consultants that helped develop the vapor product battery standards and testing guidelines for UL.
The UL 8139 guidelines, titled an “Outline of Investigation for Electrical Systems of Electronic Cigarettes,” evaluates the safety of the electrical, heating, battery and charging systems while also addressing fire safety concerns raised by North American fire officials. The new UL standard has been published with the acceptance of the American National Standard Institute (ANSI) and Canada Standards (CAN). “The acceptance and publication of this standard was a huge landmark for the e-cigarette and vapor industry in general,” said Church.
UL 8139 requirements include determining if lithium cells are operating within safety windows, assessing the battery management system for both normal use and foreseeable misuse, and evaluating compatibility among interconnected systems. It also factors in wide environmental parameters and conditions, tests reasonably expected mechanical stress in use/misuse and requires mechanisms to direct venting away from the inhaler.
UL 8139 standards were written specifically for electronic vapor devices and are part of the larger UL 1642 standards (UL 1642 standards were approved in 2014 by the FDA for use in medical devices) that cover a wide array of lithium-ion products. It’s important to note that neither UL 1642 standards nor UL 8139 standards cover e-liquids or any consumable products used in vaporizer systems. Plus, to qualify for UL 8139 standards, the battery cells must be inside a battery pack, like what you see in a power drill.
This means that the stand-alone standard 18650 e-cigarette battery could never be packaged with “UL” if it’s changeable and not inside a battery pack. However, it can receive a UL “Recognized Component Mark,” or “RU.” This quality mark may be applied to components that are part of a UL listed product but that cannot bear the full UL logo themselves.
The guidance also provides insight into how the FDA wants e-liquids bottled. E-liquid products containing nicotine are now allowed to be modified “solely and only to the extent necessary to comply with the restricted-flow requirements for liquid nicotine containers set out in the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA).” This guidance states that the FDA “does not intend to enforce violations” of the PMTA requirements for manufacturers making these limited modifications.
In order to help lessen the potential risks of accidental exposure to liquid nicotine by children, U.S. Congress passed the CNPPA, which requires liquid nicotine containers to have, among other things, special packaging that makes them difficult for children to open. “The FDA believes e-liquid containers that comply with the flow restrictor requirements will potentially mitigate the risk of children becoming accidentally exposed to toxic levels of nicotine from e-liquids,” a release from the FDA states.
“[This] guidance will provide clarity to manufacturers considering these limited safety-related modifications to their electronic nicotine-delivery system products by outlining our compliance policy for premarket review requirements for such modifications,” said Zeller.
December 23, 2019
Bad Science | Good Science
The science of vaping is like a big jigsaw puzzle with individual pieces of the puzzle representing specific scientific studies.
Lady Gaga sang about being caught in a “bad romance.” Is the vapor industry caught in “bad science?” Well, that depends on your definition of bad science.
Let’s take a step back and look at the scientific process.
Science can be summarized, in short, as the pursuit of knowledge through observation and/or experimentation. Scientists are an inquisitive bunch and want to know how things work or what happens if they push the big red button (often labeled “don’t push”). Scientists may have a preconceived opinion about what will happen (called a hypothesis), but equally, they would like to test this using robust scientific techniques. A typical hypothesis-based experimental study would thus follow these steps:

Issue identification—what is the scientific question being asked?

Hypothesis generation—what do you think the answer is?

Study design—how do you test the hypothesis?

Data collection—conduct the study and collect raw data.

Data analysis—format the raw data appropriately and conduct, for example, statistical analyses.

Data interpretation—consider the study design, data analysis methods used and other available scientific data related to the topic.

Conclusion—is the hypothesis proven? What follow-up studies may be needed?
All pretty logical and linear: why (do the experiment), how (to do it) and what (are the results). However, the dark art is in step six, and getting this wrong is usually the root of most claims of bad science. But is this a fair criticism?
It is important to realize that data is exactly what it says on the tin: data. There is no such thing as bad data. It may come from a poorly designed study, but this can be taken into consideration during the interpretation step. The important question to ask, and keep asking, is what conclusions can actually be drawn based on the study design and what conclusions are a step too far? Many of the recent vaping health-related headlines are classic instances of this.
For example, we have seen results in mice used to confidently predict health outcomes in humans. Now, a study in mice may tell you important things about mouse biology, but to directly equate the findings to humans is fraught with danger (or at least confounding factors). The last time I checked, mice are different from humans, not only in terms of appearance but also in terms of metabolic rate, brain structure, etc. At best, experiments in mice can give some indication of what may be happening in humans (i.e., may give rise to a new hypothesis), but this also needs to be confirmed scientifically.
The real problem occurs when data is misinterpreted, either in error or, worse, to fit a particular preconceived expectation. This can, in many cases, be unintentional—a bit like the placebo effect (a subconscious bias toward a particular interpretation). Unfortunately, and unforgivably, in some cases, however, there can be a deliberate, intentional effort to make the data fit a particular hypothesis. Ideally, the scientific peer-review process should spot such instances of biased interpretation, but it’s not foolproof (and sometimes study results are communicated in the absence of being subject to peer review).
Personally, I like to think about the science of vaping as a big jigsaw puzzle with the individual pieces of the puzzle representing specific scientific studies. On their own, each jigsaw puzzle piece (i.e., study) does not tell you a lot about the bigger picture. Start fitting them together properly (i.e., with appropriate interpretation of the data) and you start to reveal the bigger picture. Forcing pieces together, however, that are not meant to be connected (e.g., by misinterpreting the data) risks distorting the bigger picture.
So where are we at with vaping science? Well, we have many of the jigsaw pieces, and the bigger picture is starting to emerge (as noted by Public Health England). We’re not there yet, though, and there are still some key pieces to gather, such as those related to the long-term health effects of vaping. We just need to ensure that, as they arrive, the new pieces of the jigsaw puzzle are connected properly and not shoehorned into the puzzle to fit someone’s preconceived view of what the final picture should be.
Coming back to my original question—“Is the vapor industry caught in bad science?”—I am not convinced—to be honest, the more science the better at this time. We still have a jigsaw puzzle to complete. I do feel that the industry, at least on occasion, is being subject to poor scientific practice, in particular with respect to the (over) interpretation of scientific study data.
This is distorting the jigsaw puzzle image and leading to overall confusion, especially among consumers. Everyone involved in helping construct the scientific jigsaw puzzle should be pulling in the same direction, fitting the pieces together properly. This is not just a mere scientific exercise. It’s a fundamental responsibility to consumers so that they can make their own informed choices about what products to use or not use.
Ian Jones
Ian Jones is the vice president of reduced-risk products science at Japan Tobacco International.
December 23, 2019
The Gender Gap
It’s harder for women than men to quit smoking. But a new study found that women are even more likely to experience significant improvements in their vascular health within one month of switching to e-cigarettes.
No matter who you are, it’s notoriously tough to quit smoking. But it’s even harder if you’re a woman.
A new study with 200 patients corroborated a plethora of earlier research that concludes it’s harder for women than men to stop smoking. Researchers at the University of Toronto found that women experience more anxiety and depression, which may interfere with their desire and ability to quit smoking.
But another new study has encouraging news for women who switch to e-cigarettes.
That research found that smokers—and particularly women—who switched to e-cigarettes enjoyed a significant improvement in their vascular health within one month of switching.
WHY IT’S HARDER FOR WOMEN TO QUIT
A 2019 study of more than 200 patients at St. Michael’s Hospital in Toronto supports earlier evidence that gender is the biggest factor in the odds of successfully quitting smoking.
This study found that women were roughly 50 percent less likely than men to quit smoking. Researchers said the biggest reason was because women are more likely to have mood disorders; 41 percent of women in the study suffered from anxiety or depression compared to only 21 percent of men.
Beth Abramson, an associate professor of medicine at the University of Toronto and the study’s senior author, said depression and other mood disorders need to be addressed in women who smoke and especially those with a history of heart disease and stroke.
A propensity toward anxiety and depression is not the only factor making it more difficult for women to quit smoking.
The female brain also reacts differently to nicotine, according to epidemiological data that shows women’s brains are more sensitive than men’s brains to nicotine’s deleterious effects.
Although hard-pressed to determine the exact mechanisms underlying women’s greater sensitivity to developing nicotine dependence, researchers from the University of California at Irvine point to “gonadal hormone-mediated sexual differentiation of the brain,” particularly during the perinatal and adolescent periods.
Exposure to nicotine during these developmental periods can produce long-lasting, sex-dependent changes in neuronal structure and function, they concluded.
The study, published in 2017 by the National Center for Biotechnology Information, stresses that there are important age and sex differences in nicotine’s effects and opines that preclinical research into tobacco dependence include these factors.
Other studies conducted at the University of Pittsburgh School of Medicine conclude that women benefit less from nicotine-replacement therapy (NRT) relative to men.
“Smoking cessation treatment for women must address several other issues that often emerge, and these are most likely to require behavioral counseling tailored to these problems,” said Kenneth A. Perkins, who authored the study.
“These issues include concern about bodyweight gain, restrictions on medication use in pregnant smokers, variability in mood and withdrawal as a function of menstrual cycle phase, harnessing social support to foster abstinence, and the possibility that smoking-associated environmental cues may be more influential in smoking behavior in women than men,” he said.
WORRIED ABOUT WEIGHT GAIN
It’s a well-documented fact that most people, and particularly women, are concerned about gaining weight after they quit smoking. There’s good reason for their concern: Researchers estimate that people gain about 10 pounds on average after they quit smoking.
No woman is happy gaining weight, even when she knows that quitting smoking is vital for her health in the long run.
The reason that weight gain is associated with quitting smoking is because nicotine is a stimulant as well as an appetite suppressant.
That’s one of the key factors behind the growth in e-cigarettes; instead of quitting their daily oral habit or nicotine intake, the former smoker is simply quitting the thousands of chemicals in traditional cigarettes, including over 60 known carcinogens. While nicotine is highly addictive, it is not a carcinogen.
Multiple studies confirm that even if you gain weight, it’s still much better to quit smoking, as it lowers the risk of cardiovascular disease. Research has found that quitters who gain a few pounds still have about a 50 percent lower risk of heart disease than smokers.
The same reduction in risk holds true for people with diabetes. That may come as a surprise given that gaining weight can worsen or contribute to an onset of diabetes.
That’s why researchers and physicians would agree that it’s important to counsel women that some weight gain is to be expected after quitting cigarettes. That is, unless she chooses not to quit cold turkey and switches to e-cigarettes, which makes her less likely to substitute nicotine with food at the times when she used to smoke.
This type of gender-specific counseling and education could also make a dent in the quit rates for women who smoke.
THE PROBLEM WITH CHANTIX
Different women choose many different paths to quitting smoking. One of the more popular methods that’s prescribed by doctors is the drug Chantix, or varenicline.
However, both men and women run the risk of experiencing this drug’s serious side effects.
A 2018 study conducted by the Yale Specialized Center of Research found that Chantix was 46 percent more effective in women at the outset. Although after one year, the results were equally effective among women and men. The study’s author hypothesized that sex differences in the brain’s nicotine receptor system may be a key factor why Chantix was at least initially more effective for women.
However, Chantix has been associated with at least 2,748 adverse events—14.8 percent of all cases—including 293 suicides, 490 attempted suicides and many other cases involving self-injurious behavior or homicidal ideation. The Institute for Safe Medicine Practices, a nonprofit medication watchdog, concluded that Chantix was responsible for more reports of serious drug adverse events than any other drug in the U.S.
Not surprisingly, these adverse events spurred thousands of lawsuits by families of loved ones who suddenly and inexplicably committed suicide while on Chantix. In March 2013, Pfizer, the drug’s maker, settled 80 percent of these lawsuits out of court for an estimated $273 million.
Yet the differences between how the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the media are handling e-cigarettes versus the drug Chantix (varenicline) are dramatic.
While the FDA drafts increasingly strict enforcement policies for e-cigarettes, it removed the “black box” warning on Chantix that cautioned consumers of the risk of suicide and a host of psychiatric problems, including depression and mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety and panic.
Regardless of one’s age, it’s becoming easier to buy and take Chantix. In July 2019, Indiana joined 11 other states where anyone can pick up a box of Chantix without a doctor’s prescription.
A simple search on the CDC website for Chantix and you’ll get only 66 results versus more than 2,200 for e-cigarettes that mention “pulmonary disease,” “lung injury” and “youth tobacco use,” even though e-cigarettes contain no tobacco. Similarly, the FDA website also only lists 78 results in a search for Chantix, and the top result is an update on the September 2016 decision to remove the black box warning.
“I think Chantix should be recommended by public health officials as a Plan E smoking cessation remedy after cold turkey, e-cigarettes, smokeless tobacco and NRT, since Chantix poses far greater risks than these four other smoking cessation methods combined,” said Bill Godshall, founder and executive director of Smokefree Pennsylvania.
SMOKE LIKE MEN, DIE LIKE MEN
For years, it was thought that women were less likely to suffer the same negative consequences as men who smoked. A 2013 study published in The New England Journal of Medicine debunked that notion. After examining data from more than two million women in the U.S., the author, Richard Peto of Oxford University, concluded, “If women smoke like men, they die like men.”
“There was a big gap in our knowledge,” said Tim McAfee, director of the CDC’s Office on Smoking and Public Health. “This sort of puts the nail in the coffin around the idea that women might somehow be different or that they suffer fewer effects of smoking.”
Lung cancer is the second most common form of cancer but by far the leading cause of cancer deaths in both men and women. In 2018, over 234,000 new cases of lung cancer—121,680 men and 112,350 women—were diagnosed. More than 154,000 people died of the dreaded disease, including 83,550 men and 70,500 women.
Lung cancer claims the lives of more women than breast cancer, ovarian cancer and uterine cancer combined. Although lung cancer deaths dropped steadily in men since 1990, these cancers continued to rise in women.
The fact that women tend to start smoking at a younger age, smoke more cigarettes and continued to smoke in the 1960s and 1970s when men were quitting are the primary reasons behind the dramatic increase in lung cancer deaths among women.
While advances in treatment and management helped decrease the number of cancer deaths among women, the notable exception is lung cancer. And although it’s more difficult to identify the causal agents of breast cancer, there’s an obvious correlation between smoking and lung cancer.
Add alcohol into the mix, and women take an even greater risk, according to a European study that followed a group of 380,000 people over age 40 for around 12 years. The mortality rate was anywhere from 1.5 times to 3 times higher for smokers than for people who never smoked.
And although there were no differences between men and women when only the amount they smoked was taken into account, these risks changed dramatically when alcohol was thrown into the mix. In that case, the mortality rate was 3.88 times higher among women who smoked more than 26 cigarettes and drank more than 30 grams of alcohol a day.
“Women who consume excessive amounts of alcohol have a significantly higher risk from tobacco use than those who consume little or no alcohol,” the authors concluded.
But there’s still good news for former smokers. Former smokers who quit before they turn 35 can gain most if not all of that decade back, and even those who wait until middle age to kick the habit can add about five years back to their life expectancies.
E-CIGARETTES AND WOMEN
Nicotine exposure during pregnancy is never advised—whether the mother smokes regular cigarettes, e-cigarettes or even uses nicotine patches or gums. Ample research has shown that nicotine use during pregnancy doesn’t just increase morbidity and mortality in the neonatal period, it also increases risk of sudden infant death syndrome and can have lifelong consequences.
However, research published in November 2019 in The Journal of the American College of Cardiology shows that women who switch to e-cigarettes at other times in their lives can enjoy significant health benefits, including a major improvement in vascular function.
Smokers, particularly women, demonstrated substantial improvement in their vascular health within one month of switching from traditional cigarettes to e-cigarettes, leading researchers to conclude that switching was an important and significant harm reduction measure.
Interestingly, the researchers found no difference in vascular effects between those who used e-cigarettes with nicotine and e-cigarettes without nicotine. The authors hypothesized that “early improvement appears to be unrelated to the abstinence from nicotine but rather from other toxic material produced by combustion” in conventional cigarettes.
In summary, women are at greater risk than men of the deleterious effects of smoking. Yet, quitting is even harder for women for a variety of physiological and psychological reasons.
But if “first do no harm” is truly the health community’s mantra, then we need to do a better job educating women on the best alternative to quitting tobacco altogether.
Maria Verven
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
December 23, 2019
Mirror Image
Even as synthetic nicotine is gaining acceptance among customers, the product remains in a regulatory void.
Though still a niche compared to tobacco-derived nicotine (TDN), the synthetic nicotine (SN) segment has been growing in the past years. In late August, California-based Next Generation Labs (NGL), a producer of bulk R, R-S and S nontobacco-derived nicotine, announced a doubling of its annual production capacity to meet increasing demand. Orders have been coming from vapor product manufacturers and device cartridge fillers, among other customers, with strong demand in the United States and South Korea.
Established in 2014, NGL markets its synthetic nicotine under the tobacco-free nicotine (TFN) trademark. Because adult consumers are displaying an increasing preference for nicotine not sourced from tobacco and free of tobacco-derived components, trade customers have been increasing both order sizes and frequency, according to the company. “Our direct clients have reported transitioning from online and vape specialty retail into the convenience segment,” explains Ron Tully, a founding member of NGL.
Tully is reluctant to share customer or production forecasts, however. “What we can say is that over the past five years, NGL has created this market for nicotine that did not exist prior to our innovation and commercialization of TFN,” he says. “As we have become more established and our TFN nicotine has gained acceptance with manufacturers, the trade and consumers, we have scaled accordingly. The current market demand for synthetic nicotine has increased annually and continues to grow year on year.”
The substance, initially created in a lab but now manufactured in large-scale production facilities, could play a much greater role in the future, says Torsten Siemann, managing director of Contraf-Nicotex-Tobacco (CNT). “If you think 10 to 15 years ahead and keep in mind the next-generation products market’s development of the past 11 years, tobacco-derived nicotine capacity might reach certain limits at one point,” he says. “Synthetic nicotine can become important in supplying markets such as China, India and Russia where you’ve got many nicotine users who still have to carry out the switch to next-generation products. We see enormous demand there, and the capacity for synthesis of chemicals is unlimited.”
Since its creation in 1982, the German company has evolved into the world’s leading supplier of tobacco-derived, highly purified nicotine and nicotine derivatives to the pharmaceutical industry. In recent years, CNT has also become a significant provider of pharmaceutical-grade tobacco-derived nicotine to the e-cigarette industry. In 2015, CNT started research on SN. Since 2018, it offers synthetic S nicotine to its customers. The processing takes place at CNT’s exclusive manufacturer, Siegfried, in Switzerland. The companies jointly hold a patent on the manufacturing process of synthetic pharmaceutical-grade S nicotine. The share of SN in CNT’s business accounts for less than 1 percent, according to Siemann. “Presently, synthetic nicotine clearly is a negligible product for us in terms of volume,” he says.
SAME BUT DIFFERENT
Whether manufactured naturally or artificially, the nicotine molecule has the same chemical structure, C10H14N2, meaning that it comprises 10 carbon atoms, 14 hydrogen atoms and two nitrogen atoms. What makes it special, independent of its origin, is that it is a “chiral” molecule: It has two stereoisomers that are mirror images of each other.
The most prevalent form is S nicotine, the physiologically active variant. Its mirror isomer, R nicotine, also occurs in plant-derived nicotine in very small amounts but is basically considered physiologically ineffective. NGL presently focuses on combinations of the R to S isomers for their potential physiological activity. The company has secured a U.S. patent for the use of R-S nicotine in nicotine reduction strategies. But the company also sells full U.S. Pharmecopeia (USP) S nicotine to customers, Tully says.
The easiest product to create is a combination of S and R nicotine. However, to replicate the natural type, meet the established pharmaceutical monographs and have the same effect, the substance would have to undergo a second process to remove the R isomers. Otherwise, the amount of the combined R-S nicotine would have to be at least doubled.
Opinions about the use of the R form in synthetic nicotine widely differ. “We think R-S nicotine, which contains a significant amount of R nicotine, can only be considered to be an intermediate, which requires further purification to the S form,” says Siemann.
“There is not enough scientific evidence about the effects of the R form, but it is common knowledge in the pharmaceutical industry that enantiomers often exhibit profound differences in pharmacology and toxicology, some of which could be potentially harmful. In the best case, the same quantity of R-S nicotine can be considered to be only 50 percent effective, but we also foresee mislabeling concerns by describing R-S nicotine as equivalent to nicotine USP/EUP. For these reasons, CNT does not sell R-S nicotine.” He adds that his company has tested a number of SN samples, among them products from Chinese and Indian manufacturers, and 100 percent of them were R-S nicotine. “If you look at the European [EUP] and the U.S. Pharmacopeias, the percentage of S isomers in nicotine must be higher than 99 percent,” Siemann explains. “The nicotine used in the pharmaceutical industry needs to have a specific optical rotation that only S nicotine can achieve.”
NGL markets R, R-S and S nontobacco-derived nicotine. “Nicotine has been studied extensively in its naturally derived tobacco form, which includes the naturally occurring S and R isomers, which are metabolized in the consumption of current cigarette, vape and smokeless tobacco products,” explains Tully. “Although the uptake pathway for the R isomer is not fully elaborated, there is nothing to indicate that the R isomer is anything other than a positive attribute to the nicotine molecule. We are at an early stage in the evolution of isomeric nicotine and its utility. NGL is trying to ensure that companies have the option based on their evaluation of the utility and safety of synthetic nicotine in their products.”
BENEFITS
Synthetic nicotine offers a number of advantages over its natural counterpart. “Manufacturers have access to nicotine in its chiral R and S forms that may offer distinct benefits to consumers in potential takeup pathways for nicotine satiation,” says Tully. In November 2017, the U.S. company reported on research it had carried out on the isomeric character of its SN products. According to a press release, the studies revealed that specific ratios of the R to the S isomers could potentially offer nicotine use at satisfying but nonaddictive or less addictive levels. If proven, the artificially created nicotine might become a useful tool to help producers achieve the U.S. Food and Drug Administration’s (FDA) objective of lowering nicotine content in tobacco products to minimally addictive levels.
SN can be produced in unlimited amounts independent of nature. In addition, its manufacture doesn’t involve the challenges associated with tobacco cultivation. “Synthetic nicotine requires fewer direct inputs environmentally than tobacco-derived nicotine,” says Tully. “We are not dependent on land availability, soil suitability, fertilizers, herbicides, seeds, labor, firewood, seasonal variations, or any other factor that may impact the finished product as a supply input.”
Due to its artificial character, synthetic nicotine will also remain untouched by general agricultural challenges, Siemann adds. However, he doesn’t buy the frequently heard argument that synthetic nicotine provides a better taste to e-liquids due to TDN impurities. “This may be true for inferior quality TDN,” says Siemann. “However, CNT’s tobacco-derived nicotine has a purity of more than 99.9 percent, thus ensuring that it is of the highest standard from a sensory perspective.”
For the time being, SN’s greatest downside is price. Siemann estimates that due to difficulty in purifying the synthetic S nicotine from the R-S form and the comparably small amounts in which SN is currently produced, the artificial variant is about 20 to 30 times more expensive to manufacture than its natural counterpart, a factor that will decrease with growing demand and the upscaling of production.
Tully notes that the price of SN has come down dramatically over the past five years. “As demand has gone up and production has scaled, pricing has decreased,” he says. “We have moved from pricing from a multiple that was 10 times greater than tobacco nicotine to a most favored nation (MFN) pricing level that is only three to four times the current cost of tobacco-derived nicotine. The suggestion that synthetic nicotine manufacturers are not adjusting pricing to meet market demand is simply not true. Any company that commits to a TFN strategy and works with NGL will receive the benefit of MFN pricing as they scale.”
REGULATORY VOID
Despite its growing popularity, SN remains in a regulatory void. Because the product is not derived from tobacco, it does not necessarily fall under the 2009 Family Smoking Prevention and Tobacco Control Act. Neither does SN meet the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product. The FDA has suggested it would evaluate synthetic nicotine products on a case-by-case basis.
“NGL has made clear to manufacturing customers that TFN is a tobacco-free nicotine designed to offer adult consumers the benefits of a nicotine that is free of all tobacco-derived components and contaminants,” says Tully. “It is an alternative recreational nicotine that aims to allow adult consumers to make a choice to separate their nicotine consumption from all forms of tobacco consumption. That is a laudable aim for all companies in the nicotine business that have the objective of separating nicotine use from tobacco use.”
Various jurisdictions are trying to regulate TFN in the same way as tobacco nicotine. “We believe treating all nicotine within the same regulatory framework is not in the best interests of adult consumers who are seeking an alternative nontobacco recreational nicotine experience,” says Tully. He argues for science-based regulation of SN.
Siemann expects regulation of SN in the U.S. as soon as the market has reached a critical size. He is optimistic, though, that the FDA will find a way to regulate synthetic nicotine differently than TDN. “SN could be taxed differently from TDN,” he suggests. “Perhaps it would be an interesting possibility for health authorities to reach public health goals in cooperation.”
In the EU, SN’s status is similarly unclear. “The revised Tobacco Products Directive, which governs electronic cigarettes in the EU, specifies the use of high purity ingredients,” explains Siemann. “In the case of nicotine, TDN meeting USP/EUP has been adopted as the established norm here. Hence in keeping with this, S form nicotine would be the only equivalent synthetic alternative.”
FUTURE POTENTIAL
The future for nicotine from the lab looks bright, according to Siemann and Tully. “There will be markets where products containing tobacco-derived nicotine will not be allowed but where synthetic nicotine will be permitted in consultation with health authorities,” says Siemann. “In the end, we will hopefully see an equivalence between SN and TDN where customers can decide which one to use for their products.”
“Every market in which tobacco is consumed is a potential market for synthetic nicotine in the future for innovative product entrants for those markets,” says Tully. “Specific short-term opportunities for synthetic nicotine may develop in some markets for regulatory definitional or tax reasons, but those aside, the real opportunity will be in finding a commercialization pathway that marries TFN synthetic nicotine isomers with products that adult consumers are seeking,” he says.
“The opportunities for TFN nicotine are limited not by the regulatory framework but by the mindset of the tobacco, vape and pharmaceutical [industries] and their willingness to explore the opportunities that the separated and selectively combined R and S isomers of nicotine offer to adult consumers,” says Tully. “A deeper understanding of synthetic nicotine, the uptake pathways of the isomers and the application of this unique product need to be better funded and developed for synthetic nicotine to find its place as the next big leap in adult nicotine consumption.”
In a world where manufacturers are increasingly promoting products with descriptors such as “natural” and “organic,” it may be difficult to imagine selling a product on its artificial merits. In the case of nicotine, however, “synthetic” may be just the ticket.

Stefanie Rossel
December 23, 2019
A Call for Common Sense
A group of EU citizens is petitioning European regulators to stop treating vapor products as tobacco.
These are busy days for Dustin Dahlmann. The chairman of the Bundnis fur Tabakfreien Genuss (BfTG), Germany’s only e-cigarette trade association independent of the tobacco industry, has been a sought-after interviewee since the country’s vapor market experienced a dramatic sales drop in October. In a BfTG survey of 600 German e-cigarette retailers, more than half of respondents reported sales declines of 30 percent to 40 percent whereas almost one-fifth related revenue losses of more than 50 percent.
The market slump occurred in the wake of an outbreak of vaping-related lung injuries and deaths in the U.S. Although regulation is stricter in the European Union (EU) and the main chemicals under suspicion in the U.S., including THC and vitamin E acetate oil, are prohibited in e-cigarettes in the EU, the news has unsettled German consumers, says Dahlmann. “Many customers find themselves in a Catch- 22 situation. We observe that many who would like to quit cigarettes with the help of vape products are returning to combustibles following the events in the U.S.”
The situation looks similar in France: According to L’Express, sales of e-cigarettes have recently fallen between 10 percent and 40 percent. The downturn in two of the EU’s leading vapor markets comes at a time when an European Citizens’ Initiative (ECI) is calling upon European regulators to take vapor products out of the Tobacco Products Directive (TPD2), differentiate them from pharmaceutical products and create a proportionate and evidence-based regulatory environment.
Called Vaping is Not Tobacco, the campaign was initiated by eight EU citizens from Germany, France, the U.K., Italy, Belgium, Romania, Ireland and the Czech Republic, among them Dahlmann, who has been registered as its official representative. As its main goals, the initiative lists helping smokers access vapor products that can help them transition out of tobacco, allowing flavored vapor liquids, preventing access by young people to vapor products, reducing risks for vapers by introducing robust product quality, manufacturing and safety standards, and ensuring responsible marketing of vapor products that do not target youth.
Introduced in the 2007 Treaty of Lisbon, the ECI was designed as a tool to improve democracy by enabling citizens to participate directly in the development of EU policies. If a group of citizens representing at least one quarter of EU member states gathers 1 million signatures supporting their initiative, they can call directly on the European Commission to propose a legal act. The commission then decides on what follow-up action to take. An ECI cannot be submitted by organizations or companies.
Dahlmann’s petition, which started in late April, has until February 2020 to collect the required signatures. At press time, 47,000 people had signed. “We are grateful for this, but we had expected more support from vapers,” says Dahlmann. “We still have three more months to improve this result, and we will make good use of this time. Each vaper should understand how important a differentiation between e-cigarettes and combustible cigarettes is in legislation and in public awareness.”
The initiative is using all marketing tools available, from classical tools to social media communication. It also participates in events such as international e-cigarette exhibitions to clarify the differences between tobacco and vapor products. “Besides, a large number of retailers throughout Europe support our campaign and have lists of signatures available,” says Dahlmann.
A DIFFERENT SITUATION
According to Dahlmann, the outbreak of vaping-related illnesses in the U.S. and the subsequent crackdown on the sector by regulators has boosted the number of signatures. “In light of the partly very unfair media reporting about the vaping-related illnesses in the states, we have noted a strong alliance of solidarity among consumers and retailers,” says Dahlmann. “Many users are aware that regulated e-cigarettes have nothing to do with the lung injuries and deaths. The issue in the U.S. is about e-joints, illegal products for the consumption of drugs. Only if the public is informed about the true cause of the disease as well as the tremendous advantages of vapor products, a change in thinking can take place again. Everyone who is of the same opinion should support Vaping is Not Tobacco.”
Apart from the petition, the initiative also includes a campaign to enable European citizens to get in touch with their respective national candidates for the European Elections that took place in May. Dahlmann says that this part of the initiative reached many candidates and members of European Parliament. “The theme is education and motivation towards a clear distinction between tobacco and e-cigarettes. The basic campaign is being used a lot, and we hope for a new political valuation of vaping in Europe.”
Recently, he adds, numerous measures had been taken to educate the public with regard to vaping, with many of them being highly successful. Together with other trade organizations, the BfTG has been educating the European media about the events in the U.S.
WELL ORGANIZED
The petition for smarter vaping regulation is not the first attempt at influencing e-cigarette legislation in Europe. In contrast to its predecessors—none of which succeeded—the current initiative has been meticulously planned. With all of the petitioners representing vapor companies and organizations, including the Czech Vaping Association and the organizers of Vapitaly, a leading Italian trade fair, the initiative has financial support. However, critics have seized on the fact that €10,000 ($11,077) of the €35,000 in donations collected so far came from Imperial Brands.
For Dahlmann, it is irrelevant. “Like many others, Imperial Brands has supported the campaign financially,” he says. “All participants have jointly developed the wording of the campaign, not only Imperial. That’s why we are 100 percent behind the initiative. The committee members are the only ones to take on official responsibility and decide on the execution of the campaign. Imperial doesn’t have any control of it. It’s an initiative for e-cigarettes and hence the exact opposite of a tobacco campaign. Otherwise, the BfTG as a tobacco-free association would not have supported the campaign.”
HIGHLIGHTING THE ISSUE
Collecting 1 million signatures by February seems ambitious. Even if it is achieved, the EU can still object to considering the initiative. Nevertheless, Dahlmann remains confident. “The initiative is about to find as many supporters as possible so that the necessity of the campaign becomes obvious. Achieving that would be a success for us. If we don’t reach our goal of 1 million signatures, we will continue with our political work to draw attention to the urgency of this issue. If the required number of signatures is gathered, the European Commission is not obliged to submit a proposal for a legislative act. However, it has to meet with the initiators so that they can elucidate the topics covered by the initiative. Furthermore, the organizers have the opportunity to present their initiative in a public hearing at the European Parliament.”
Even if the petition succeeds, the desired legislation would still be a long way off. “If the commission decides to submit a proposal for a legal act, the regular legislative process will get started,” explains Dahlmann. “The commission’s proposal will be presented to the legislator, which usually is the European Parliament and the European Council—in some cases only the latter. If the proposal is adopted, it will become law.”

Stefanie Rossel
December 23, 2019
Cloudy Perspective
President Trump’s listening session on vapor products provided a much needed forum for the vapor industry.
It was a contentious situation. Groups both for and against flavored vapor products spoke passionately about their position during a listening session with U.S. President Donald Trump. Held in late November, the roundtable discussion centered on e-liquid flavors and youth vaping. Overall, Trump seemed to have softened his opinion of an outright ban on all flavored vapor products except tobacco.
During the meeting, Trump announced that the federal rule for purchasing tobacco products will be raised from age 18 to 21. “We’re going to be doing that. Twenty-one, we’re going to be doing that,” Trump said. While whether he favors a flavor ban is clouded in uncertainty, Trump did show concern that an all-out flavor ban could push consumers toward the black market and counterfeit products. Trump stated that a decision on the flavor ban “would be coming soon.”
“This is a very big subject, and it’s a very complex subject. Probably a little bit less complex than some people think. But I’m here to listen, and I have very divergent views,” said Trump. “We’re going to be announcing very soon. We did have an instinct, but we’ll be announcing, and we’re going to continue this meeting for a little while.”
Only the first hour of the meeting was open to the media. Held at the White House, the session included vapor industry leaders, public health advocates, politicians, regulatory officials and others to address a surge in underage vaping and what would happen to the industry if flavored e-liquids were to be banned. It became heated at times as both sides tried to convince the president of their point of view. A Washington Post columnist likened the ordeal to a public policy version of the reality TV show The Apprentice as industry and government representatives randomly shouted at each other in hopes of swaying Trump.
Ryan Nivakoff, CEO at NJoy, for example, stated that a hundred thousand Americans were going to lose their jobs (if flavors were banned), adding that it’s not disputed by anybody in the public health sector. Tony Abboud, executive director for the Vapor Technology Association (VTA), which recently released an independent economic impact study that puts the number of jobs lost at over 150,000 (see “Significant Impact”), stated, “Actually, the number is higher, Mr. President.” Senator Mitt Romney, sitting at the right hand of the president, then stated, “[It’s actually] much lower.”
Romney later stated that there are approximately 10,000 vape shops in the U.S. with an average of four employees and conceded the “flavors” segment of the industry only accounted for about “50,000” jobs and that not all those jobs would be lost if flavors were banned. Romney did not include in his assessment employees at e-liquid manufacturing companies or flavor houses that also serve the industry as well as numerous other ancillary players in the market.
“They will lose their jobs, sir. They sell—I’d like to finish [Romney was trying to speak over Nivakoff]. [Vape shops]
sell exclusively flavors. So … I don’t think we need to argue the virtue of youth not using these products,” said Nivakoff. “We all agree that they shouldn’t.”
Overall, the vapor industry represented itself well. As one of the first speakers, Greg Conley, president of the American Vaping Association, explained to Trump that unlike on Sept. 11, when he initially announced his intent to ban flavors, Trump now knows the U.S. Centers for Disease Control and Prevention (CDC) was wrong in saying nicotine vapor products were killing people. “But now we know from the CDC that their main focus of their investigation, it’s not store-bought nicotine products,” said Conley. “It’s not the companies that Tony Abboud represents. It was illicit THC oil cartridges.”
Conley explained that he agreed with Trump’s decision to raise the age to purchase tobacco products to 21, but more can be done. “We need bulk sales purchase limits. We need marketing restrictions. And also, most importantly, there is—in May of 2020, every single vaping product on the market has to go through what’s known as a premarket review,” explained Conley. “That’s going to cost several million dollars per product. So even if we solved this crisis today—which I hope we do—in five, six months, we’re back where we started with potentially only the largest multibillion-dollar companies being able to survive … and all these small businesses, they’re the ones that are employing people—70,000, 80,000 direct jobs, 70,000 indirect jobs.”
Regarding the flavor ban, Trump asked members of the meeting if banning flavors would lead to any negative consequences for the consumer. “Isn’t that going to be just sold, you know, illegally, or somebody is going to open up a shop in China and ship it in with flavors and you don’t know what standard you’re getting? Isn’t that a problem?” Trump asked. Most members of the industry agreed. “In New York City, if you go to a bodega to buy the Juul pods, you can buy 15 different versions of Juul mango, which have been off the market since September,” Nivakoff explained.
Abboud explained to Trump that this is a complex problem, so it needs a sophisticated plan. “A flavor ban will not work. And you’ve articulated one critical reason why it will not work: People will just go to the black market. And that’s because adults are demanding these flavors,” said Abboud. “And I think the better approach would be to raise the age to 21, put severe restrictions on how you market the product. Then, on top of that, you have to increase penalties for retailers because our retailers are fine with the increasing penalties because they do know that they are age-gating and keeping these products out of the hands of kids.”
Additionally, Abboud said his organization supports a “three strikes and you’re out” rule for sales violations to underage customers. “Today, the FDA can allow you to have seven strikes before you’re actually told to stop selling tobacco products. That’s unacceptable,” he said. “On top of that: age verification. We are in the day, age, of technology. And that is what this is; this is a technology product that is helping people quit smoking.”
Trump likened the situation to the prohibition of alcohol. “You watch prohibition, you look at—you know, with the alcohol—you look at cigarettes, you look at [it] all—if you don’t give it to them, it’s going to come here illegally, OK? They’re going to make it,” Trump said. “But instead of Reynolds or Juul or, you know, legitimate companies, good companies, making something that’s safe, they’re going to be selling stuff on a street corner that could be horrible. That’s the one problem I can’t seem to forget. I mean, I’ve seen it. You just have to look—you have to look at the history of it. And now, instead of having a flavor that’s at least safe, they’re going to be having a flavor that’s—that’s poison.That’s a big problem.”
The anti-vapor groups never acknowledged the black market growth potential. They did, however, talk about the rise in youth vaping and their position that flavors don’t help smokers quit. “Mr. President, we have 5.3 million kids who are addicted, and it’s separate from the lung disease— 5.3 million kids. A million kids a day are using these products repetitively with addiction,” said the Campaign for Tobacco- Free Kids’ president, Matt Myers. “Since the flavors have been introduced, we have seen a meteoric rise in use by kids. We have seen no increase whatsoever before flavors were marketed so heavily … the No. 1 flavor of e-cigarette on the market was tobacco flavor.” Romney agreed with Myers, adding that “most adults are not using flavors.”
No Nielsen data or any other study could be found that showed tobacco flavor was once a market leader. However, several studies and all available Nielsen data shows nontobacco flavors to be the most popular in every market. Nivakoff said that “92 percent of my revenue is flavors, and I had 1.2 percent of [the] U.S. [market].”
Sally Goza, president of the American Lung Association, called the situation of youth vaping “a crisis.” She suggested to Trump that she represented “the nation’s doctors … and we’re all of the same message—that we need to take all flavors off the market, pending FDA investigation of that. And then we are worried that if we leave one flavor on the market—even menthol—that the children will go to that because they’re going to want something to help—they’re going to want something. And that’s why action is so desperately needed here.”
However, when asked by Trump what she would do about the potential problem of a black market and the public health issues that could arise (similar to the black market THC deaths), she had no answer. “I’m looking at Secretary Azar and hoping he has the great solution for that,” she said. “Well, it’s the problem,” replied Trump. “I think you have the same [black market] problem with drugs and everything else.”
Robin Koval, CEO and president of the Truth Initiative, said that the black market isn’t a problem; addicted kids will just quit. “If I may, on the counterfeit issue: We know, actually, that many of these kids want to quit. They need help quitting,” she said. “We asked kids, ‘What would you do if all the flavors were taken off the market, including menthol?’ Sixty percent—the No. 1 answer was ‘quit.’”
Toward the end of the open session, Abboud explained to Trump that the vapor industry is a new industry that’s—for the first time—competing for the cigarette smoker with a less harmful product. “You have a new industry that’s competing … trying to yank [cigarette smokers] off of that cigarette. And so, we have to do both things. There is no reason we can’t do both things in this country [have vapor products and combustible cigarettes],” said Abboud. “But if you eliminate flavors … because flavors make up about 85 [percent] to 90 percent of their sales … [many small businesses] will go out of business. There is no question about that because no small-business owner could take that kind of hit to their revenue.”
“It’ll destroy the business,” replied the president.

Timothy S. Donahue
December 23, 2019
The No. 1 source for global vapor-industry news
June 9, 2014