Category: Flavor

Montana Latest State to Propose Ban on Flavored E-Liquids

Credit: Mark McCollom
The health department in the U.S. state of Montana is proposing a permanent ban on the sale of flavored vaping products in response to increasing youth e-cigarette use, the agency said Tuesday.
“This is a serious health issue in Montana that is causing major health consequences for our youth, driving a lifelong addiction to nicotine,” Sheila Hogan, director of the Department of Public Health and Human Services said in a statement.
An estimated 22,500 Montana middle and high school students currently vaping, the health department said in supporting the ban.
“Sadly, most individuals who are currently addicted to nicotine started using these products before the age of 18, and youth are enticed by the flavors,” Todd Harwell, the health department’s Safety Division administrator, said in a statement.
The department has the authority to adopt and enforce rules regarding public health issues. The agency will take public comments on the proposed rule during a virtual hearing on July 16, as well as by mail, fax or email through July 24.
June 17, 2020
U.K. Menthol Ban Could Drive Smokers Towards Vapor

More smokers could turn to reduced-risk products like e-cigarettes after the U.K.’s menthol ban becomes enforceable today, new research suggests.
The study by TobaccoIntelligence shows that many retailers are planning to use the shelf space previously occupied by menthol cigarettes for alternatives such as vapour and heated tobacco products.
David Palacios, from TobaccoIntelligence, said: “The opportunities to convert menthol smokers to less risky alternatives are substantial.
“In the UK alone, for example, it is estimated that 1.3 million people currently using menthol cigarettes will need to find an alternative product.”
May 20, 2020
Los Angeles Vape Shops Challenging Flavor Ban

Credit: John Caroro
A new Los Angeles County ordinance that prevents the sale of flavored tobacco products is being challenged in court by vape shop owners.
On May 4, CA Smoke & Vape Association and Ace Smoke Shop filed a federal lawsuit against the rule that also requires businesses to obtain two additional licenses and imposes new tobacco product standards according to legalnewsline.com, the “great majority” of vapor products and devices will be prohibited, the lawsuit says. It complains that products containing THC are exempted, even though it is “the primary source linked to the outbreak” of recent illnesses, the lawsuit states.
“Similarly, the ordinance makes no distinction between the black-market vaping products at the center of that outbreak and the FDA-regulated products produced by legitimate manufacturers,” the lawsuit states. “Instead, the ordinance implements a blanket prohibition on the sale of flavored tobacco products to all persons, threatening to destroy an entire industry and the livelihoods of Los Angeles County residents.”
The plaintiffs in U.S. District Court for the Central District of California case number 2:20-cv-04065 are represented by Jawlakian Law Group.

May 16, 2020
New York’s Flavored Vapor Products Ban Begins May 18

Credit: Dylan Nolte
Sales of flavored vapor products come to close in the U.S. state of New York at retail stores beginning Monday May 18. Monday also brings a close to the sale of all tobacco products at pharmacies.
“Healthcare-related entities should not be in the business of selling tobacco, the leading cause of preventable death in New York State,” wrote Gov. Andrew Cuomo in a press release. “Ending the sale of tobacco and e-cigarette products in pharmacies will help reduce the availability, visibility and social acceptability of tobacco use, especially to youth.”
The measure also makes it illegal to sell electronic nicotine delivery systems (ENDS) online, by phone and by mail order.
New York became the first state in the country to ban flavored electronic cigarettes in September of last year. Cuomo announced the decision as part of a series of efforts to combat the increase in young people using vape products. Cuomo said in a statement that it was “undeniable” that flavors like bubblegum and cotton candy are deliberately designed to target youths.

May 15, 2020
California City Closes Vapor Flavor Loophole

Credit: Sarah J. – Pixabay
On Tuesday, the Oakland City Council closed a loophole that allowed for the sale of flavored tobacco products despite the city banning them in Feb. 2017. That loophole created an exemption for tobacco stores that were limited to adults, though had become exploited to create sections in gas stations and convenience stores.
The 8-0 vote closed the so-called “tobacco store” loophole in the city’s 2017 ordinance that banned the sale of flavored tobacco in Oakland. At that time, tobacco retailers requested and received an exemption to continue selling flavored tobacco at “adult-only” tobacco stores, according to a story on CBS local KPIX5.
“People have gone to great efforts to continue selling flavored and menthol tobacco,” Vice Mayor Larry Reid said. “I only wish they would put in equal effort to sell healthier products and join us to prevent a new generation of smokers.”
When the council passed the original ordinance, between two and five such stores existed, according to Reid. As of February, though, 56 adult-only tobacco stores were operating in Oakland, comprising roughly 15 percent of the city’s tobacco retailers.
According to city officials, some of those adult-only stores were simply tobacco stores prior to the original flavored tobacco ban and added a sequestered adult-only area so after the ban they could continue displaying and selling flavored and menthol tobacco products.
May 13, 2020
Covid-19, Flavor Ban Could Crush New Jersey Vape Shops

Photo: mctic.gov.br | Flickr Creative Commons
As people rushed to stock up on toilet paper and hand sanitizer in March, Debi Meinwieser dropped thousands of dollars on more than 400 bottles of vape juice for e-cigarettes, according to an article on NJ.com.
The 56-year-old from Whiting Township said she sought out the supply not in anticipation of the coronavirus outbreak and stay-at-home order, but to avoid a drought when the state law banning flavored vaping products takes effect Monday.
“I stocked up,” she said. “But I’m concerned for the new vapers and the smokers who haven’t had the chance to start vaping yet.”
Meinwieser, like many others across the country, said she quit smoking cigarettes after three decades once she started vaping. She had tried nicotine gums and patches, but nothing helped to wean her off nicotine. Instead, she credits the flavored vaping products she has used for nearly five years for saving her life, according to the article.
As New Jersey officials watch for the forecasted peak in coronavirus cases later this month, another date looms: April 20, the day when vape shops must stop selling flavored products. Gov. Phil Murphy signed the law banning the sale of of flavored vaping products, which include candy and fruity flavors that may attract teens, in January. It came with a 90-day waiting period before going into effect.
The measure marked the nation’s first permanent flavor ban, going further than several emergency orders some states issued last year as a mysterious vaping health crisis took hold in the fall. Rhode Island has since made its temporary flavor ban permanent, too. The illness put 2,807 people into hospitals and killed 68, according to the U.S. Centers for Disease Control and Prevention, according to the article.
Supporters of the law say it will keep the products out of the hands of teens, who have taken up vaping years after youth cigarette use fell. But opponents say it will force adult users, many of whom previously smoked cigarettes, either back to those products or to the black market. And vape shops, largely small businesses employing a few thousand people across the state, have promised the ban will thrust them into bankruptcy. It will also rob the state of tax revenue as people shift to the web or stores over state lines to buy the products.
“They’re still easily accessible, ordering online, shipping in state,” said Sheryl Agro, owner of InnoVapes in Wrightstown. “You’ve effectively just given up your control over these products.” A former version of the flavored vaping bill included a ban on menthol cigarettes, but state Senate President Stephen Sweeney said lawmakers put that on hold, planning to bring it up again later this year during budget discussions. The change has vapor rights advocates accusing lawmakers of playing a political game, rather than looking out for the health of the state.
The stress on the industry was exacerbated when Murphy ordered non-essential businesses to close in an effort to contain the coronavirus outbreak. In mid-March, the vape shops suddenly found themselves fighting a tighter deadline to unload the products, but had no customers walking through their doors. Now, they’re pleading for an extension on the ban, and for the state to allow them to operate with curbside pickup as essential businesses. Activists and shop owners say they haven’t heard back from officials, according to the article.
“Cigarettes are still labeled to be sold. Cigarettes are proven to be killing,” said Shoaib Iqbal, CEO of Good Guy Vapes and a vice president of the New Jersey Vapor Rights Coalition. “We feel like an alternative should also be able to be sold.” Other countries under lockdown — including Spain, Italy and France — have kept vape shops open, and last week, Louisiana reversed a decision to close them.
And for those like Meinwieser, who found relief in a legal and regulated product, the policy is a gut punch. “When I started vaping, I had no clue that vaping was being attacked,” she said. “I just thought, ‘Oh my god, I finally found something to help me quit smoking.’”
She, too, wonders why vape shops have not been allowed to operate with curbside pickup as essential businesses, like takeout restaurants or stores that sell cigarettes. She bought some 400 bottles at $8 a piece, a wholesale price, but knows many others do not have the luxury to drop so much money at once.
In early March, with about five week left until the ban took effect, vape shop owners said they had not seen customers stocking up yet, both because time remained, and because some customers knew they could order online. Now they’re facing even larger stockpiles of soon-to-be banned product than expected.
“We’ve been kind of robbed of that time,” Iqbal said. “We’re hoping to get some sort of extension.” A spokeswoman for Murphy declined to comment on an extension of the enactment date. While they’ve started online ordering, Iqbal says many customers have reached out desperately — they do not know how to order products online, or do not have credit cards to pay for them.
During the 90-day period, vape shop owners were meant to unload product and pivot their business models. Agro sells some CBD products for people and pets, but most of her revenue to support five employees with benefits comes from the flavored vaping products purchased by military personnel at nearby Fort Dix. She did not think her shop would survive the ban, and said the closure of nonessential businesses in March put her further behind, according to the article.
For her, the inability to open during the stay-at-home order only builds on the idea that the government has something against vape shops. “To deem vape shops as nonessential is just more blatancy from the government that they just don’t want to accept that this works as a smoking cessation product,” Agro said. “I quit the day I started vaping. I would never go back. I had a dream that if I could do this myself, I could help so many other people.”
April 21, 2020
Merchants of Doubt

Credit: Pathdoc
In the vaping debate, falsehood flies and the truth comes limping after it
For those of us who support the public health strategy of tobacco harm reduction, it has been a tough few months. Several crises emerged suddenly and the boundaries between them have become blurred: an outbreak of severe lung injuries and deaths, a sharp rise in youth vaping in the United States and the claim that e-liquid flavors are the problem and should be banned.
The satirist Jonathan Swift summed it up pretty well in 1710:
“Falsehood flies and truth comes limping after it so that when men come to be undeceived, it is too late; the jest is over, and the tale hath had its effect; like a man, who hath thought of a good repartee when the discourse is changed, or the company parted; or like a physician, who hath found out an infallible medicine, after the patient is dead.”
What can be done? Falsehood has certainly flown, but could the truth at least break into a jog? Let us examine these crises and try to determine what is true and what is false.
Vaping causes severe lung injury and death: true or false?
As of early December, 2,291 vaping-related lung injury hospitalizations and 48 deaths had been recorded in the United States. Many have assumed nicotine e-liquids are implicated. Because the problem emerged in a specific place (the United States) and at a specific time (from July 2019), it was already clear in July 2019 that this was a specific supply chain problem. It had not affected vaping before and had not affected the millions of vapers in the rest of the world. It soon emerged that the cases were dominated by specialized vapes used for cannabis THC oil. The focus should, at that point, have narrowed to the illicit THC vape suppliers with a clear message exonerating commercial nicotine liquids. Instead, major public health agencies became “merchants of doubt,” maintaining that any vapor product was suspect. However, the chance of a parallel problem occurring in the legal and regulated nicotine e-liquid supply chain at the same time, in the same geography and with the identical symptoms is vanishingly small.
A minority of the users afflicted had denied or refused to confirm use of THC, so there was some doubt. Of course there was doubt! People do not readily admit to using illicit substances because it can get them into trouble with parents, at school or college, or with their employer. Whenever actual tests were done or when users were pressed harder to tell the truth, THC vaping reliably emerged.
The mystery doesn’t end there because THC oil itself is not the issue—there are many THC vapes that do not cause this problem. The investigation narrowed further to identify vitamin E acetate as one likely cause. This is used as a thickener to cut expensive THC oil for economic reasons. This is a lipid, a fatty substance that can have exactly the effect on the lungs that has been seen. There is no question of this being added to nicotine liquids. It is not soluble in nicotine liquids and would serve no purpose as there is no reason to thicken nicotine liquids.
The truth: The lung injuries are a serious problem, but they are nothing at all to do with commercially available nicotine e-liquids. The ultimate problem here is a black market supply chain opportunistically experimenting with novel and untested formulations with no accountability for health consequences. To pretend otherwise is to cause three harms: sending a diluted and contradictory message to THC vapers that may put more lives at direct risk; frightening regular nicotine vapers back to smoking and smokers away from vaping with longer term health consequences; and promoting bad policy responses, like flavor bans, that will tend to increase black market activity and make the problem of adulteration in the supply chain more likely and vaping more risky.
There is a youth vaping epidemic: true or false?
The falsehoods here lie in the interpretation of the headline statistics—what you see if you drill down into the data. First, the headlines. In the United States, vaping among high school students rose from 11.7 percent in 2017 up to 20.8 percent in 2018 and on to 27.5 percent in 2019. A dramatic rise by anyone’s standard and undoubtedly a cause for concern.
But there are three other factors to consider in a drill down. The headline figures refer to any use of an e-cigarette, even a single puff, in the past 30 days, so what is the breakdown between infrequent and frequent use? How many of the frequent vapers also use other tobacco products? For them, vaping may be beneficial. The rise in youth e-cigarette use has been described as an “epidemic of nicotine addiction.” How many show signs of dependence?
The data to address these questions is only available for 2018, but this breakdown of the headline 20.8 percent vaping figure provides a useful illustration:
NYTS 2018 dataPercentage of high school students using e-cigarettes Total = 20.8%High school students No past tobacco use Any past tobacco useFrequent e-cig use: ? 20
days per month0.6%5.2%Infrequent e-cig use: ? 19
days per month4.7%10.3%
First, most adolescent vapers (72 percent) are not frequent users and therefore provide less reason to be concerned. Second, most of the frequent adolescent vapers (90 percent) were already tobacco users. Only 0.6 percent of high school age vapers are both frequent users and have no prior history of tobacco use—and it is also important to recall that smoking is much more harmful than vaping, but in 2018, 13.9 percent had used any combustible product in the past 30 days. Smoking remains the bigger problem.
Turning to the third question of dependence, the analysis of U.S. youth e-cigarette data by epidemiologists Martin Jarvis and colleagues (Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA?) shows little sign of teenage vaping uptake causing nicotine addiction.
“Data from the National Youth Tobacco Survey do not support claims of a new epidemic of nicotine addiction stemming from use of e-cigarettes …. Among current e-cigarette users who had never tried tobacco products, responses consistently pointed to minimal dependence.”
The truth: Many young Americans are trying vaping, but most are not vaping frequently, and it isn’t an especially dangerous youth behavior compared to smoking, using illicit drugs and using alcohol excessively. The frequent or daily vapers are mainly those using other tobacco products. For them, vaping may be a beneficial diversion from smoking. There is reason for concern, but there should not be an overreaction.
The rise in U.S. youth vaping is driven by flavors: true or false?
At one level, it is obvious that e-liquid flavors are important—if vendors could only sell unflavored products, there would be few buyers of any age. E-cigarettes are an inherently flavored product in much the same way that pizza would not be pizza without a topping.
There is much to suggest that flavors form part of the appeal, but they are not the main reason why young people take up vaping. The story is far more complicated: The more credible academic work (e.g., see Nicksic et al. 2019) suggests uptake of vaping is driven by replacing cigarettes and by the “wider social environment.” Flavors are a factor, but they are far from the most important factor. The most recent official analysis of U.S. youth data included reasons for youth vaping uptake (MMWR Table 6). The most important reason given was “I was curious about them,” cited by 56.1 percent of exclusive e-cigarette users. “They are available in flavors, such as mint, candy, fruit or chocolate” came a distant third at 22.3 percent.
The idea of limiting flavors to just tobacco flavor would be like limiting pizza toppings to allow only a simple Marherita. In both cases, it would kill the category and shut down all the vape shops. The likely response would be an uptick in smoking, a black market in flavored products, home flavor mixing and more international internet trade. No one would gain, and many would lose.
The high score for curiosity raises an intriguing question. Has the barrage of breathless media coverage, official school-based anti-vaping campaigns, parent mobilization and political outrage actually been a stimulus for youth curiosity about vaping? Is the reaction part of the cause? We can safely assume that no one involved will fund that research.
The truth: The reasons young people take up vaping are similar to the reasons they take up smoking and can include unpredictable and largely uncontrollable fads and fashions. Vapor products would be nothing without flavors, and banning them would have a range of harmful effects and do little to protect youth from actual harms. If governments want to control flavors, they should focus on flavor descriptors and branded imagery that are aimed at adolescents, not the actual flavors themselves.

Clive Bates
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
February 18, 2020
Prioritized Enforcement
PRIORITIZED ENFORCEMENT
The U.S. government has banned all nontobacco flavors in closed pod systems without a PMTA.
By Timothy S. Donahue
The new year had barely begun. On Jan. 2, the U.S. Food and Drug Administration (FDA) finalized its policy for banning flavors in some vapor products. It could have been much worse. The FDA is only currently enforcing the flavor ban in closed pod systems (prefilled tanks with separate batteries), so the industry should still survive. “We have to protect our families,” U.S. President Donald Trump said about the ban. “At the same time, it’s a big industry, [and] we want to protect the industry.”
The new regulatory guidelines came just weeks after Trump approved raising the federal minimum age for buying and consuming tobacco products from 18 to 21. Trump signed the new tobacco minimum-age language into law Dec. 20 as part of a federal spending bill. The flavored pod ban is a step back from the nearly complete flavored vape ban the Trump administration initially expressed back in September as lung injuries from vaping were on the rise.
The regulations, which went into effect on Feb. 6, require that companies stop manufacturing or distributing, or selling “any flavored, cartridge-based ENDS [electronic nicotine-delivery system] product (other than a tobacco-[flavored] or menthol-flavored ENDS product)” or face the risk of FDA enforcement actions. The rule does not include open-tank systems or completely self-contained, disposable products. Any product that markets toward “kids” or “youth” is also illegal.
The FDA defines an e-liquid cartridge as “any small, enclosed unit sealed or unsealed, designed to fit within or operate as part of an electronic nicotine delivery system (ENDS). Ray Keller, CEO of GoodCat Laboratories, a Naples, Florida-based e-liquid manufacturer, says he believes the FDA language was intended to delineate between a mod system and a small stick pod system. “The thought being there that the larger mod systems are too bulky[;] they’ll have to have a bottle [of e-liquid] with them,” explains Keller. “[Youth] can’t hide them as easily. The mod systems make a lot of vapor that you can’t really hide. So, I think that’s what they were trying to get at.”
Companies should be aware that the flavor ban DOES cover pod systems that are refillable and non-refillable, however, the FDA hasn’t been clear on how it will regulate refillable pods that do not contain e-liquid, according to Agustin Rodriguez, an attorney with Troutman-Sanders, a law firm with 12 offices across the U.S. that specializes in the vapor and tobacco industries. “Because empty refillable pods don’t yet contain a flavor, it is our expectation that [the] FDA will not prioritize refillable pods that contain no liquid unless the particular product or the circumstances of its sale raise another regulatory concern beyond product format,” Rodriguez said.
Companies should also be aware that flavor-ban guidance does not affect the existing deadline for the filing of premarket tobacco product applications (PMTAs) with the FDA, Rodriguez explains. Manufacturers must submit a PMTA for their e-cigarette and vaping products by May 12. “From that date, every nicotine vapor product for sale on the market (whether an open or closed system and regardless of flavor profile) must be the subject of a PMTA and will be permissible for sale for another period of 12 months so long as [the] FDA takes no negative action with respect to that PMTA,” Rodriguez said. “While the guidance may lead to additional legal actions by [the] industry to attempt to delay the May 2020 implementation date, we are strongly counseling tobacco product manufacturers not to rely solely on a litigation strategy with respect to the question of PMTAs.”
Keller says that flavored disposable systems aren’t currently being regulated by the FDA, but if the rule is abused (and youth start using flavored disposables), the FDA can change it. “Everybody’s going to try to get by the rules,” he says. “The people selling; the people buying it; they’re all going to try and get around this. And then on May 13th, if there’s no PMTA, it’s not on the market anyway.”
The PMTA requirement will greatly impact vape shops that produce their own e-liquids in-house. These shops are considered manufacturers and must submit PMTAs in order to continue to sell their products while the FDA reviews their PMTA application, according to the FDA. “A vape shop that is in the business of manufacturing, by mixing nicotine and flavors, has a decision that it has to make about what business it wants to be in going forward,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “If they are involved in the manufacturing process, they are subject to the law.”
The FDA has stated that it advises retailers and wholesalers to adopt practices to ensure compliance with the prohibition on marketing or selling flavored ENDS products. The agency stated that it recognizes that retailers and wholesalers may need to store unsold products beyond the Feb. 6 deadline until products can be returned to a distributor or manufacturer.
It’s hard to predict what the vapor market will look like post-May 12, but there is a high risk of significant confusion over what products are lawfully being sold. This is because the FDA does not publish products that are the subject of a PMTA, states Rodriguez. “The opportunity for the industry is to come up with ways to assure the public that the products still for sale are lawfully being made available,” he says. “We are working with our clients on ways to address that opportunity.”
On May 13, the day after the PMTA deadline, Keller thinks that most companies are going to be out of business. He says there’s also the possibility that there is a mass exodus from the market before the May 12 deadline. He also predicts a rise in the availability of illegal products. “I just don’t see how anybody except the largest players are going to be able to put this [PMTA] together and have it handed over in completion on May 12,” he says. “So, I think a lot of shops are going to close. I think the internet business will pick up. At first, there’s going to be some black market activity. But that’s going to happen any time prohibition gets involved, and no matter what the product, there’s always going to be a little black market activity.”
The ban was not met with enthusiasm from anti-vaping groups. Gary Reedy, chief executive of the American Cancer Society, called it “a hollowed-out policy that will allow the tobacco industry to continue to attract kids to a lifetime of nicotine addiction.” Matt Myers, president of the Campaign for Tobacco-Free Kids, said that “the evidence indicates that if menthol e-cigarettes are left on the market, kids will shift to them. Decades of experience with menthol cigarettes demonstrate that menthol appeals to kids.”
Many vaping industry insiders also don’t agree with the FDA’s approach to youth use. They say a flavor ban (other than tobacco-related flavors) simply won’t work and better options are available. Flavors aren’t the issue; it’s the nicotine, according to Keller. He says that youth aren’t using vapor products because they like the strawberry or the watermelon taste; they want the nicotine. “In essence, I think what this is going to do is it’s just going to teach [kids] to like tobacco flavors. Right? It’s an acquired taste,” he explains. “They’re going to get used to it. It’s just like drinking coffee. Remember your first cup of coffee? It wasn’t really that good and now I can’t drink enough black coffee.”
The amount of nicotine allowed in vapor products is also a potential issue, according to Keller. With some products offering 50 mL of nicotine or more, users get a “buzz” instead of just satisfaction. “You have to take that buzz away. If you have a 50 mL mix, it’s going to spin your head a little bit,” he says. “Take that buzz away and I think you would have a better chance of quitting rather than just putting it down and giving up. But now, they’re going to start using other products and other flavors. Maybe tobacco becomes popular or they switch to disposable devices. There are better options than banning flavors to end the uptick in youth use.”
Tony Abboud, executive director at the Vapor Technology Association (VTA), a vapor industry advocacy group, explains that his organization doesn’t see flavor bans as the appropriate approach to youth use either. He says the current ban could easily lead to a domino effect that will wipe out the broader industry.
“It is safe to say that the opponents of public health will not stop until they ban all flavors and we will not rest in our efforts to defend and preserve flavor options for adult smokers that are desperately trying to quit smoking,” Abboud wrote in an email. “We have fought just about every battle and have won many. But, as with all things, we maintain a steely-eyed focus on winning the war and creating the regulatory framework for a well-regulated industry filled with a diverse array of products and flavors to give adult consumers the choices they are demanding and the choices that they need.

Sidebar
Tempered expectations
It was like a flashback to 1994. In early February, The House Energy and Commerce oversight and investigations subcommittee grilled the CEOs of Juul Labs, Reynolds American (RAI) and NJOY, as well as the presidents of Logic Technology Development and Fontem U.S. It was reminiscent of when, in 1994, the CEOs from seven major tobacco companies testified before Congress about the marketing tactics for tobacco products. The tension in the rooms was also similar.
Ryan Nivakoff, CEO of NJOY, reminded lawmakers about comments from former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb that support the harm reduction of vapor products. “[Gottlieb] said: ‘If you can fully switch every currently addicted adult smoker who is using combustible tobacco products onto e-cigarettes, you will have a profound impact on public health,’” said Nivakoff. “The National Academies of Sciences, Engineering, and Medicine has said: ‘complete switching from combustible tobacco cigarettes to e-cigarettes would be expected to reduce tobacco-related health risk.’”
For more than two hours, lawmakers on the House Energy and Commerce Subcommittee on Oversight and Investigations asked questions ranging from marketing strategies to how to curb youth usage of these products. K.C. Crosthwaite, CEO of Juul Labs, expressed his understanding of the serious need for companies to combat the uptick in youth use.
“I fully recognize that the opportunity for the millions of adult smokers who still use combustible cigarettes to have an alternative is at risk if we don’t address this issue,” K.C. Crosthwaite, Juul’s CEO, said. “We are focused on combating underage access because I know it puts it all at risk if we don’t make progress here.”
Legislators also wanted to understand the possible health effects vapor products pose to consumers and the role each company sees itself playing in the ongoing effort to curb the nation’s uptick of youth use. Antoine Blonde, president of Fontem, said the company had a detailed youth access prevention program and maintained efforts to safeguard its products from youth.
“Fontem uses industry-standard online age-gating and age-verification mechanisms to prevent youth access to its products online,” Blonde said. “For example, for all purchases through our website, Fontem relies on industry-standard age-verification technology that compares a potential purchaser’s information against records of trusted data sources to verify the age of the purchaser.”
Blonde said Fontem recognizes that there “may be” bad actors in the marketplace who attempt to purchase bulk quantities of its products through e-commerce websites in order to resell them (a practice often called “strawman sales”). “Fontem has always had policies in place to monitor for strawman sales and further is implementing a strict 4-stage standard to monitor site access for any potential strawman purchases on its online platform,” Blonde explained. “This standard will track registered adult consumers’ monthly order frequency of pods from its online platform and will flag potential strawman sales.”
The companies are said to represent nearly 97 percent of the $19.3 billion U.S. e-cigarette market, according to Rep. Diana DeGette, chairwoman of the subcommittee. That data only includes convenience store sales, and many industry insiders say the figure is grossly inaccurate. Vape shop sales are not included in the Nielsen data DeGette is citing.
“While consumers remain in the dark of the possible health consequences, these companies are making billions of dollars as they lure a new generation of young people into a lifetime of nicotine addiction,” DeGette, the chair of the oversight panel conducting the hearing, wrote in a press release.
Ricardo Oberlander, president and CEO of RAI, said the increase in youth vaping over the past two years, and serious health issues from illicit products, are now at the heart of a national discussion. “These issues are being discussed within families, by educators, and in state and local governments. They are being discussed in law enforcement communities, the White House, and here today, in the United States Congress,” he said, adding his company had submitted products for the PMTA. “Looking forward, [the] FDA’s premarket tobacco application process provides a pathway for vapor products aligned with public health priorities. We believe vapor products can be manufactured and marketed responsibly within this framework.”
Instead of imposing new requirements, such as “one size fits all” flavor bans that unfairly penalize responsible companies and limit consumer choice, Jerry Loftin, president of Logic, said that his company believes that regulators must strengthen the enforcement of existing requirements. “The [FDA] should immediately enforce premarket authorization requirements for all ENDS [electronic nicotine-delivery system] products currently on the market and take action against companies that make unauthorized modified risk or smoking cessation claims or who market their products in ways that are uniquely appealing to minors,” he said. “Failure to do so disadvantages companies that are acting responsibly and distorts the ENDS marketplace to the public detriment.”
In other congressional news, a bill was introduced in the U.S. Senate in late January that would charge e-cigarette manufacturers higher user fees, which fund many of the FDA’s regulatory activities. Six senators, led by Democrat Jeanne Shaheen, introduced the legislation. A corresponding bill led by Rep. Cheri Bustos has also been introduced in the House.
The Senate bill would raise the tobacco industry’s fees from $712 million to $812 million—the same increase as the Trump administration’s 2020 proposed budget. Vapor industry manufactures would be expected to pay fees based on their market share or risk fines and possibly even have products removed from the market. – VV staff

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.
February 18, 2020
Tasteful Insight
Tobacco flavors are often created by using multiple flavors brought together to taste like tobacco, but not everyone has the same taste.
By Timothy S. Donahue
Flavoring is a complex science. Imagine going out into a field to pick strawberries. If you pick one that is a little green, it’s going to taste tart. If you pick a bright red berry that is a little squishy, it’s going to taste very sweet. Both taste like a strawberry but not the same strawberry. Flavors can also taste different to different people at different times.
The recent U.S. ban on all flavors except tobacco and menthol in pod-style devices has everyone talking about taste. To the layman, an apple should taste like an apple. According to Ray Keller, CEO of GoodCat Laboratories, “Apples don’t necessarily taste the same to everyone.” GoodCat is a major Florida-based e-liquid manufacturer, and in 2019, GoodCat produced nearly 1,000 metric tons of finished product.
Keller goes on to say that an e-liquid is basically three elements: a base mix (usually propylene glycol and/or vegetable glycerin), a flavoring and nicotine. The flavor additive can also consist of many different flavor compounds in order to create a unique or desired flavor. “Tobacco flavors, for example, can consist of vanilla, cocoa, coffee, light fruits, sweet fruits and even oak moss,” explains Keller. He says that designing flavors is all about finding an endpoint that causes the consumer to think a flavor tastes like something specific.
“For example, a client will come to us with an idea and thinks a sweet strawberry flavor will do very well in a particular market. So, we’ll design our flavor blends to produce that sweet strawberry flavor,” says Keller. “That can be easily done by our flavorist. They will pick and choose different flavoring compounds to create the flavor we want. Some of the sweetness that we use may come from one of our flavor concentrates we call Five Fruit. It can taste like five different fruits (think pears and apples). We may add some Five Fruit to a strawberry flavor that is more earthy tasting to give the new liquid a sweet, fresh-picked strawberry taste.”
Vapor Voice sat down with Keller to discuss flavorings, regulation and recent developments in the vapor industry, including raising the age to purchase tobacco products and the flavor ban instituted by the U.S. Food and Drug Administration (FDA). He goes on to explain that these are hot-button issues that are coming up now because we are in an election cycle. “Vapor has been around for more than a decade, and all of a sudden, flavor is a big concern,” remarked Keller. “Just think how much work could get done if everybody worked together and supported this life-saving industry.”
Vapor Voice: Is there any interesting detail we should know about creating a flavor profile?
Keller: Yes, and we tell our clients this. When they come to sit down with our flavorist, we encourage them to reserve a couple of days in a row and at the same time of day. Perception of taste in the afternoon is not the same perception of taste in the morning. An example: If you just drank some coffee, it will affect the way you taste. You eat celery, that affects things. So, yeah, people are not always going to be tasting something the same way all the time.
Tobacco flavors can be complicated; what goes into producing a tobacco flavor?
The flavors that are used to produce an e-liquid that tastes like tobacco are not necessarily tobacco flavors. The coils and temperatures of different devices change what compounds are vaporized and in which order; this causes a different taste from one device to another using the same fluid. We have one tobacco flavor that is just three flavoring compounds. We have another that is 31 compounds. You also can’t really use pure tobacco extracts from tobacco leaf because that defeats the purpose of why you are using an e-cigarette—we were finding small amounts of unwanted chemicals in leaf-based flavor extracts.
How would the FDA regulate a flavor? Who is the judge on what tobacco tastes like?
This is very subjective. Somebody is going to say, “no, not tobacco.” They are either going to base it on a specified list of ingredients and/or percentages, or they are going to base it on what they taste when they sample it. So, it’s going to be a subjective thing. Would the FDA even taste a product to decide if it tastes like tobacco? I doubt that.
Let’s be honest. I don’t really know how they would do it unless they look at a list of ingredients and percentages. And OK, you’ve got vanilla in there at 3 percent. Well, maybe if you had vanilla at 10 percent, they may say that’s not tobacco. You need guidance, right? You need some kind of parameter. I want to know who’s going to write that guidance, and when do we get it?
That begs the question: What do you think a tobacco flavor should taste like?
There are so many different tobaccos. Every tobacco has a very distinctive flavor to it. Then there are the Virginia, Connecticut, Oriental [and] burley … tobaccos [that are] grown in different soils and climates [and] taste different too. For example, tobacco grown in Cuba tastes different from tobacco grown in Canada (yes, they grow tobacco in Canada). These all have their own flavors, and then they are modified with casings, and every brand could have its own special blend. So, there could be hundreds, if not thousands, of different tobacco flavors that have just slight differences in flavor.
Do you see that happening in the e-liquid market post-May 12?
I see everybody keeping their own tobacco flavors that they are running through the premarket tobacco product application (PMTA) required by the FDA for any product on the market after May 12, 2020. I guess that really matters because … it’s got flavoring and glycerin and nicotine. That’s all it’s got. Regulators will look at flavoring combinations, and somebody’s got to say, “this tastes like this.” I don’t know who is supposed to make that call. Again, who at the FDA is going to say what tastes like what?
Let’s say one company’s formulation doesn’t fall under this new definition of what a tobacco flavor is supposed to be. It certainly has been sold as tobacco, it tastes like tobacco, but it doesn’t meet this hypothetical standard. I just see a very bumpy road coming up here. These definitions must be made, and they have to be made with some reasonable method to make them. And then there are going to be those that don’t make the cut and there are going to be lawsuits.
Fair point. So, who should decide what is and isn’t a tobacco flavor?
To answer that, let’s remember the story about this old senator when he was asked about pornography. “Here’s a picture of a naked woman and here’s a picture of a woman in lingerie. At what point does this become pornography?” [someone asked]. He answered, “Well, I can’t really answer that question directly, but I know it when I see it.” So, that is probably what is going to happen with flavors.
What do you think might be an unintended consequence of the flavor ban?
It’s entirely possible that the flavor ban will force some to use the tobacco-flavored fluids and in effect cause them to develop the acquired taste that is tobacco. In short, banning flavors will teach some teens to like tobacco, moving them one step closer to combustibles. Whereas, if someone was vaping a fruit flavor, like watermelon or berry, chances are they would think combustibles smell really bad and wouldn’t get near them.
What are your thoughts on limiting the amount of nicotine in e-liquids, much like the U.K. has done?
I’m going to tell you, buddy; I would be fine with lowering nicotine levels. I think a lot of youth vaping is a function of the buzz you feel when you vape a 50 mg blend. One hit, you get a buzz, and little to no vapor is exhaled, making it fairly stealthy. Now, limit the nicotine level to 20 mg and you will need a few puffs to get a buzz, increasing the chance you may be caught due to the exhaled vapor hanging in the air.
Do you think Tobacco 21 was the right way to curb the recent uptick in youth use?
Listen, I get it, it’s a complicated situation. However, someone at 18 is old enough to put a rifle in his hand. Well, if that same 18-year-old wants to vape … why can’t he make that decision? He can vote. He can move to another country. Now with 16-year-olds, no guns for you, no voting and you shouldn’t be vaping.
I don’t know, man. I’m a veteran myself. If you’re going to ask a man to lay his life down, then you shouldn’t be trying to raise him like he’s your child. You should leave him alone. You shouldn’t nitpick. Yes, drugs like heroin should be illegal, but nicotine is not heroin, no matter how much the anti-vapor zealots of the world want to tell us it is.
Does the flavor ban have any type of impact on GoodCat Laboratories’ business?
We have put ourselves in a position where we are safe. We don’t have to worry about market fluctuations. We’ve got large clients, global clients that are very consistent with their orders. And even with the flavor ban here in the U.S., there’s still a big world out there that believes flavors are okay.
Is there anything final you want to say?
Yes. I just wanted to say that I think there is enough common sense within these decision-makers, regulators and government officials. I believe they see there is a benefit to e-cigarettes—that they’re better than lighting up a combustible cigarette. I think there’s a little common sense going on there, so I don’t think they want to get rid of them all. The vapor industry is going to be here for a very long time.

Timothy S. Donahue
Timothy S. Donahue is the co-founder and managing editor of Vapor Voice.
Timothy 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.
February 18, 2020
NJoy Removes Non-Tobacco Flavors From the U.S. Market
NJOY Holdings voluntarily ended sales of its fruit-flavored products in the U.S. market. The announcement came as lawmakers and anti-vaping advocates voice concerns that young users might migrate to the disposable devices.
The Food and Drug Administration’s (FDA) new electronic delivery system (ENDS) rules will remove all sweet and fruit-flavored products from the U.S. market. The agency also announced it wouldn’t restrict sales of “completely self-contained, disposable products.”
The flavor takes effect on Feb. 6.
February 3, 2020