A new bus tour to promote vaping in the U.S. began on Oct. 8. The event kicked off at American Vapor Manufacturers (AVM) president Amanda Wheeler’s vape shop, Jvapes Vape & Smoke Shop in Prescott, Arizona.
“Every American should have the right to use vaping to quit cigarettes. Critical health decisions should be up to the individual. Not the [U.S. Food and Drug Administration]. Not the [U.S. Centers for Disease Control and Prevention]. And certainly not nanny-state politicians in Congress,” the We Vape, We vote website states. “This fundamental belief underlies our entire effort. That’s why we need leaders who recognize vaping as a powerful harm reduction tool and the single most effective smoking cessation device ever created.”
The tour is designed to coincide with the midterm elections, and is intended to “amplify the voices of vapers in the 2022 elections,” according to Americans for Tax Reform (ATR), the Washington, D.C.-based organization sponsoring the tour. Events will include “rallies at vape shops, voter registration drives, discussions with lawmakers” and more, says ATR.
“Events will be covered by local media and promoted on our social media accounts, sending a clear message to lawmakers in state and federal legislatures that vaping saves lives and America’s vapers vote accordingly,” says ATR.
The tour will make 13 stops in 13 states, including Colorado, Iowa, Wisconsin, Illinois, Ohio, Pennsylvania, Washington, D.C. and, North Carolina, South Carolina, Georgia and Florida.
American Vapor Manufacturers (AVM) president Amanda Wheeler is asking the U.S. Department of Health and Human Services Inspector General (OIG) to launch an inquiry into whether “political pressure” is driving U.S. Food and Drug Administration Commissioner Robert Califf’s marketing denials for vaping products.
AVM wants the OIG to help the public learn about the commissioner’s coordination with elected officials, allied activists, and reporters as his agency continues its review of premarket tobacco product applications (PMTA), according to a press note.
“I am asking the Inspector General to intervene,” said Wheeler. “The PMTA process is rigged. Arbitrary standards rewritten behind closed doors corrupt any effective review. It’s embarrassing for the commissioner, but one U.S. senator’s call for his resignation was enough for Dr. Califf to override the standards set for the PMTA process. We are confident that OIG intervention will reveal what we have feared all along, ideology, not science, is driving decisions at the FDA.”
In a letter sent to HHS Inspector General Christi A. Grimm requesting an inquiry into “improper political pressure,” Wheeler contends that “interference has corrupted FDA’s statutory obligation to properly implement its premarket tobacco product application (PMTA) review process based solely on scientific, empirically-based judgment.”
Amanda Wheeler
A timeline of suspect events shows Califf’s decision to deny a marketing order for Juul Labs, Inc. came within hours of a U.S. senator calling for the commissioner’s resignation. Within days, a federal judge blocked the FDA from implementing its order, forcing the agency to re-open its review of the JUUL application.
The FDA backtracked on its decision, claiming there were “scientific issues unique to the Juul application that warrant additional review.” An OIG inquiry can show the public how the commissioner and his staff were forced into their decision by political pressure while ignoring salient facts.
“Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler said. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The OIG should open the door and hold the FDA accountable to its standards.”
Wheeler is requesting a full review to affirm the FDA’s assertion that the administrative stay was based on incomplete information. The agency is also thwarting Freedom of Information Act requests, so the OIG has an opportunity to create a new level of transparency.
Wheeler is requesting the OIG make public communication between the commissioner and members of Congress, the media, and ideologically aligned advocacy organizations.
When U.S Food and Drug Administration authorized several tobacco-flavored products from Logic Technology Development for sale in the U.S. the vapor industry wasn’t surprised. Vaping advocacy groups have long expected the FDA to approve many of the brands that had premarket tobacco product applications (PMTAs) submitted and are owned by major tobacco companies.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
Logic, based in Teaneck, New Jersey, is a part of the JT Group of companies. JTI is a international tobacco and vaping company headquartered in Geneva, Switzerland, with operations in more than 130 countries. JTI employs over 50,000 people. In a release, Logic stated that it submitted PMTAs for its Logic Pro, Logic Power, and Vapeleaf products on August 19, 2019, well before the Sept. 9, 2020, PMTA deadline.
“We take the quality of our products extremely seriously, along with the way they are marketed and sold, and we are proud that we have received marketing orders from FDA for our Logic products to remain on retailers’ shelves,” said Corrado Mautone, president of Logic. “By receiving FDA marketing orders now, Logic can remain a reliable partner for retailers going forward.”
Amanda Wheeler, owner of Jvapes and the president of American Vapor Manufacturers, said that it is good to see that the FDA is acknowledging that vaping is safer than combustible cigarettes, but the fight for small business owners continues.
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
The agency also issued marketing denial orders to Logic for multiple other electronic nicotine-delivery systems (ENDS) products, mostly non-tobacco flavors.
“While Logic received marketing orders for its tobacco-flavored products, it is still awaiting a determination from the FDA on its menthol products. At the FDAs discretion, products like Logic’s menthol capsules can continue to be marketed while under review,” Logic stated in the release. “Additionally, Logic received marketing denial orders (MDOs) for flavored products that are not currently on retailers’ shelves. Logic is reviewing the FDAs determination and rationale before taking further action.”
The FDA also indicated that it was moving closer to issuing decisions on other applications that account for “a large part” of the marketplace, which based on Nielsen ratings, are mostly owned by large tobacco companies.
Logic is only the second company to have vaping products approved for marketing by the FDA. In Oct. of 2021, the agency authorized the marketing approval of three outdated vapor products to the RJ Reynolds (RJR) Vapor Company for its Vuse Solo device and two tobacco-flavored pods. The agency also denied Vuse PMTAs for flavored products other than tobacco.
Update: At 2:56 pm the House went into recess, to presumably make amendments to the bill. Media outlets have reported it is to remove some Covid-19 related measures (30 states at risk of losing Covid relief funding previously promised). Currently, the vote on the omnibus appropriations bill is expected to occur this evening or late tonight.
It is possible that the omnibus appropriations bill vote is delayed. In case Congress does not complete work on the omnibus by the end of the week, the House is also expected to vote on a CR through March 15 today to allow time for Senate passage and signing by the President.
If the synthetic nicotine language remains in the bill, the rule will become law 30 days after the bill’s passage date. Manufacturers of currently marketed synthetic products would have an additional 60 days to file a premarket tobacco product application (PMTA) without being subject to FDA enforcement—unless the FDA has already denied a non-synthetic version of the same product (meaning those manufacturers would be subject to enforcement 30 days after the passage of the bill).
The U.S. House of Representatives is expected today to vote on an omnibus appropriations bill (page 1,870) that includes language that would give the U.S. Food and Drug Administration the power to regulate synthetic nicotine . Lawmakers have said some add-ons have already been agreed to, such as a package of health care provisions including Medicare program extensions and eliminating the synthetic nicotine loophole.
The House is planning to vote sometime today before going to Philadelphia for its annual issues conference. The bill must clear the Senate before stopgap funding expires at midnight Friday. GOP objections to a unanimous consent agreement to speed consideration in the Senate could delay final passage into the weekend, lawmakers warned, but both sides expect the process to be complete in time to avoid a partial government shutdown when federal agencies open Monday.
House Appropriations Chair Rosa DeLauro was adamant after a private House Democratic Caucus meeting Tuesday morning the omnibus would be ready for the House to pass on Wednesday, according to RollCall.
“It’s not going to get delayed. We’re going to vote tomorrow,” she said.
If the spending bill currently under consideration passes, the language of the Tobacco Control Act would change to define a tobacco product as “any product made or derived from tobacco, or containing nicotinefrom any source, that is intended for human consumption.”
Amanda Wheeler, president of American Vapor Manufacturers association, said the of banning synthetic products is going to drive millions back to combustible cigarettes.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said. “It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Amanda Wheeler
Yaël Ossowski, deputy director of the Consumer Choice Center, said the legislation will actively harm adults who want to quit smoking. He says that the method of “fattening up continuing resolution bills with laws that benefit special interests, without broader democratic debate or analysis of the costs and benefits,” is shameful in a modern American Republic.
“The byzantine process of asking permission to sell harm reducing vaping products in the 21st century is asinine in itself. But using sleight of hand during an emergency government funding bill to castigate millions of vapers and the entrepreneurs who make and sell the products they rely on is the definition of active harm,” said Ossowski. “Only the largest and most powerful vaping and tobacco companies can afford the lawyers and the time necessary to complete the paperwork necessary to pass the FDA’s process, meaning thousands of hard-working American business owners will now be forced to close, depriving millions of adult consumers of harm reducing options. Many will be forced back to cigarettes.
“Synthetic nicotine is an innovative method of providing nicotine independent of tobacco, and millions of American adults now use these products as a less harmful method of consuming nicotine. A back door bureaucratic power move like this represents a sledgehammer to the men and women of our country who have sought out vaping devices to kick their cigarette habit.”
Yaël Ossowski
Ossowski said he hopes elected representatives reject the synthetic nicotine inclusion and “go back to the drawing board” to offer a more permanent policy.
Congress has tried numerous times over the past year to give the FDA authority over synthetic products. The FDA said last year that synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the agency. Many states have already begun banning synthetic products.
Sens. Richard Burr, Dick Durbin and Patty Murray, along with Rep. Frank Pallone led the effort to get the language into the omnibus, according to two Senate sources familiar with the discussions. “This is an enormous win for public health and American consumers,” Pallone said in a statement. “I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus.”
This year’s Global Tobacco and Nicotine Forum (GTNF) focused on innovation and sustainability in the ENDS industry.
By Vapor Voice staff
The Global Tobacco and Nicotine Forum (GTNF) has been one of the most insightful conferences over the past decade, especially in its embracing of electronic nicotine-delivery systems (ENDS) and their potential for harm reduction. During this year’s event, held in London from Sept. 21-23, speakers were challenged to focus their insights on this year’s theme: Continuing Change: Innovation & Sustainability. Below, we have provided session overviews of the many keynote speeches and panel discussions that centered on ENDS products. Next year’s GTNF will be held in Seoul, Korea on Sept. 20-22.
GTNF Fireside Chat with Todd Cecil, FDA
The U.S. FDA insists its banning of all flavored e-liquids other than tobacco is not a de facto ban on the products.
By VV staff
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
Credit: Malcolm Griffiths
At least four companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on its handling of the regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those … scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”
GTNF Panel: The Fork in the Road: What is Next for Tobacco and Nicotine
Regulators must remember the vaping industry began with hobbyists and enthusiasts who built their own devices.
By VV staff
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
Credit: Malcolm Griffiths
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”
GTNF Panel: Consumers: The Key Stakeholders
Harm reduction should empower individuals to make their own choices about what products they consume.
By VV staff
For many people, the threats they face in day-to-day life are far more immediate than their long-term health. The mission of harm reduction should be to empower people to make their own choices about what products they consume and their own health decisions, even if those decisions don’t align with what public health experts would say is optimal. This was the general focus during a plenary panel discussion at the GTNF called Consumers: The Key Stakeholders.
Credit: Malcolm Griffiths
Most of the session centered consumers standing up and advocating for the industry, the global attacks on flavored e-liquids and growing threats from the World Health Organization (WHO), which remains suspicious of tobacco harm reduction. Panelists agreed that while some consumers prefer to remain on the sidelines, many others are willing to get organized and campaign for tobacco harm reduction and the vaping industry. “The consumer voice is very powerful,” a panelist said.
A major concern for the vaping industry is the concerted campaign against flavors. Flavors, according to one panelist, are used to by the industry’s enemies to redirect the conversation toward children. “They’ll say vaping flavors attracts children, and then they get us to play in their playground,” he said. “It’s very different. You [consumers] have got to keep asserting that adults use flavors.”
The WHO is a threat no matter what, the panel agreed. The global health body is now even talking about redefining smoke to include anything that’s heated and emits a vapor. “This means that any customizability of a product will be restricted and have limits on it, which basically means all the vape products will be the same,” explained one panelist. “These [recommendations] have to be resisted. The WHO doesn’t make laws, but it’s very influential, and these things can’t just be waved away.”
The scientific studies the WHO uses to justify its negative view toward next-generation products as tools for harm reduction are “fantasy and cherry-picked” studies, according to another speaker. “The people who are against harm reduction will never sleep. They’re always working, and they’re highly funded,” a panelist said. “[Consumers] have to stay alert, and they have to stay organized because, at the end of the day, there are more consumers than there are activists against harm reduction, and we’ll vote. So, consumers really have a big role to play.”
Consumers are the key stakeholders. However, when talking about consumers, regulators must acknowledge that not every smoker is the same, according to the panel. Many smokers don’t want to quit combustibles. “The important thing is to understand why and respect their choice,” a panelist said.
One speaker said that the industry also needs more responsible vape reviewers on YouTube because the current ones “are absolutely appalling.” The speaker urged consumers to make their voices heard in politics. “You’ve got to have somehow to get ahold of your Parliamentarians or your politicians in your country and get them to campaign on your behalf because there are many, many consumers, but you haven’t got great voice in government, and that’s what you really need to try and get,” he said.
At the end of the session, an audience member asked the panel if it could see a situation where consumers would sue regulators over counterproductive rules, such as flavor bans. “I have mentioned the fact that it would be interesting if someone could do a test case, but I don’t know whether that someone could come from the consumer side and sue [over regulatory action],” the panelist said. “It’s also expensive, and someone will end up having to pay if you lose.”
GTNF Panel: Science Driving Innovation
The nicotine delivery of products and being conscience of the environment are key points in innovation.
By VV staff
Regulators globally are becoming more understanding of what they expect next-generation tobacco products to accomplish. Regulators want manufacturers to demonstrate, on a product-specific basis, whether the vaping products are a benefit to combustible cigarette smokers. More importantly, manufacturers must ensure that vulnerable populations such as youth are not using these products.
Credit: splitov27
During the lunchtime GTNF panel “Science Driving Innovation,” one speaker also mentioned that manufacturers must be more conscious about the environmental impacts of vaping products too. The environment is a big issue in the minds of governments, regulators and society as a whole. The panelists agreed that vaping manufacturers should produce products that are environmentally sustainable.
“Think about all the batteries that go to waste every time an e-cigarette is disposed of. What are we doing as an industry to address the fundamental questions that society and regulators are concerned about?” a panelist asked. “We need to start thinking about what views of science we need to really put our investments in [and start] focusing on going into the future.”
Another major industry concern that should be addressed through innovation is youth initiation. One panelist said this topic should be a primary focus of scientific efforts relating to vaping products. Reduced-risk products must exist for adult smokers, so it’s imperative that the industry proactively addresses the underage use issue. “If we don’t, others will try to do it for us, and then collectively, we will all compromise the potential that [we are focusing on during the conference] today,” one panelist said. “It’s a critical balance. It’s important that we offer adult smokers an alternative, and we can also combat underage use. We can do both, and we must because there’s too much at stake if we don’t.”
Another speaker discussed her company’s global retailer compliance monitoring program. The company sends thousands of “mystery shoppers” into U.S. retail outlets that sell its vaping products and collects data around whether the retailers are abiding by federal age verification laws and/or other local policies.
“What we found is that retailers need help. There’s a lot going on in this world. We help them by providing information on how they’re performing, education and training, and we can also assist in changing their existing point-of-sale technology,” she said. “It can actually prompt the clerks to check ID when they’re selling an interesting new product. And it alleviates the mental burden on their end.”
Another concern for the industry that can be addressed through innovation is improving nicotine delivery and satisfaction. That satisfaction delivered by products today is not enough to sustain the large number of people we want to see switching from cigarettes to electronic nicotine-delivery systems.
“To achieve meaningful harm reduction, we need these products to appeal to and be affordable to most adult cigarette smokers. Which means those consumers would need to like the product and be able to afford the product,” a speaker said. “They need to be able to trust these products, and it requires a significant investment in innovation if you want to do it properly.”
GTNF Plenary Panel: Innovation as the Path to Progress
The more freedom the industry has to innovate, the more likely smokers are to transition away from combustibles.
By VV staff
Innovation is grounded in regulation. Regulators can either embrace innovation as a tool to support harm reduction, or they can regulate them to the point that any innovation is impossible to bring to market. During the GTNF panel Innovation as the Path to Progress, one speaker explained that the U.S. Tobacco Control Act was written with the goal that the state of public health will change over time. The idea is that as smokers quit and product standards are implemented, many may migrate to products lower on the risk continuum. As a result, as the state of public health changes, the products that the U.S. Food and Drug Administration determines to be appropriate for the protection of the public health (APPH) will also change.
Credit: Urupong
“If you think about the significance of the innovation of the e-cigarette, today we have major companies that are in the tobacco space talking about eliminating combustion altogether,” a panelist noted. “We have companies giving up their entire combustible segments, and that would not have happened, in my opinion, had it not been for the innovators.”
Making innovative progress in the vapor industry is measured by transitioning adult smokers to noncombustible products, according to the panel. However, there are many avenues to accomplish this goal as well as numerous obstacles. One speaker offered the audience three focus areas that he described as the pillars of innovation. The first pillar is product innovation. “If the product is not satisfying, people are not going to switch,” the speaker said. “In order to get there, we will need a very disciplined, science-based approach in understanding some of the questions underlying satisfaction. As we think about innovation and product innovation, it’s important for smokers to have a range of products to choose from.”
The second pillar is scientific innovation. There must be a comprehensive assessment of science to demonstrate that a product is APPH, and while all novel products tobacco products must be held to this high standard, it is rigorous and takes time. There are innovations in scientific methodologies that must be made, the speaker explained.
The speaker cited dissolution methods to understand nicotine release profiles and computation of toxicology as examples of tools that can help accelerate this pathway for getting products in the market. “Along with that, I think that regulators have an opportunity to create some innovative processes,” the speaker said. “For example, establishing product standards that will hopefully help these products be reviewed in an expedited manner, and most importantly, get them in the hands of consumers.”
The third pillar is communication. The industry needs to make clear the benefit to smokers by switching to noncombustible products. The industry needs to address the misperceptions surrounding nicotine and the wrong assumption nicotine causes cancer. “This clouds the decision-making process of adult smokers,” the speaker said. “As manufacturers in the U.S., we have to seek FDA authorization before we can communicate a modified-risk or modified-exposure order. That, too, is important but time-consuming and resource intensive. This is a responsibility for everybody to explore innovative communication approaches that can address these misperceptions.”
Another area ripe for innovation in the electronic nicotine-delivery system industry is environmental sustainability. For example, e-cigarette batteries contain heavy metals. The industry must innovate battery technology that will reduce their products’ environmental impact. Responsible disposal of any product is important. Regulation can also impact environmental issues. In the U.K., for example, requiring 10 mL bottles instead of larger bottles creates more waste.
Finally, synthetic nicotine also offers innovative advancements for next-generation products. “I think that when we talk about moving away from combustion, that is one thing, but when we talk about moving away from tobacco—in other words, giving consumers a truly tobacco-free option—that’s where science comes in,” a panelist explained. “The promise that is involved with synthetic nicotine is significant. They need to research it closely and recognize that it does provide certain benefits that perhaps the tobacco-derived nicotine does not.”
GTNF Keynote: Frank Han
The leader of FEELM said that exciting innovations are happening every day in the vaping industry.
By VV staff
During a keynote address for GTNF, Frank Han, senior vice president of Shenzhen SMOORE Technology Co. and CEO of its FEELM business division, said that there are exciting innovations—big and small—happening every day in the vaping industry. Vaping products using FEELM atomization technology have now reached millions of users in more than 50 countries.
Credit: Malcolm Griffiths
“Vaporization technology is still just at the beginning; we could welcome the opportunity for innovation to create a better life together … Basic Science Innovation has been the cornerstone for sustainable growth; it is the science of atomization that we need to build as the foundation supporting the industry,” he said, speaking through an interpreter. “As a firm believer of innovation, SMOORE has integrated disciplines like engineering thermodynamics and biomedical sciences into our atomization research.”
SMOORE has been actively learning to understand and assess the long-term health effects of vaping, according to Han. The company currently has seven research centers between the U.S. and China, “bringing in global talents” from different backgrounds. In addition to in-house R&D resources and efforts, SMOORE is also focused on partnering with leading universities to transform the company’s scientific discoveries into applied technologies. “The way vape products are manufactured is also constantly evolving; more effectively and definitely more environmentally friendly,” said Han.
SMOORE had begun operations using the first fully automated pod production line in the world. Each new manufacturing (single) line can produce 7,200 standard vaporizers per hour, double the previous generation’s output. “We have been working with business partners to improve sustainable practices in all stages of product development, especially manufacturing with the common goal of reducing carbon footprint,” said Han.
SMOORE is currently evaluating the underlying technology of atomization for its potential applications in other fields. “With one direction of our R&D focus on the atomization application in healthcare, I am proud that SMOORE has made progress on the research of atomized medication, along with partners from different sectors,” Han said. “The initial results are all positive. We are hoping in the near future, more and more people might be able to inhale medicines or even vaccines with atomization devices.”
Looking ahead at the vaping industry overall, Han said that policymakers and NGOs must be inclusive. Regulation has been a heated topic recently in both the U.S. and China, and while institutional innovations to promote healthy industry development and more balanced regulations are needed, regulators must also embrace vaping as a strategy to improve public health while safeguarding against youth initiation, he said.
“The global media must also be inclusive. We must value the media that report from an unbiased perspective, involving more people in the public dialogue on vaping, discussing the pros and cons and discovering the truth,” said Han. “I’d like to share an old Chinese saying here: ‘Though the road ahead is dangerous and difficult, we can only achieve our goals with constant efforts.’ We must press ahead with a sense of perseverance to expect a better future.”
Amanda Wheeler: NO SURRENDER
Her dreams and business crushed by a marketing denial order, Amanda Wheeler vows to continue the fight for vaping.
By Timothy S. Donahue
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis at age 19, she was unable to quit smoking for another 11 years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
Credit: Malcolm Griffiths
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy. She joined several support organizations, including Arizona Smoke Free Business Alliance, Vaping Advocates of Oklahoma, Rocky Mountain Smoke Free Alliance, Smoke Free Alternatives Trade Association, American E-Liquid Manufacturing Standards Association and Vapor Technology Association.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
Wheeler and the AVM assisted 230 e-liquid manufacturers that submitted PMTAs for more than 1.7 million products following a plan she developed with Azim Chowdhury, a partner with the law firm Keller and Heckman and a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. The agency’s deadline to decide on all the applications was Sept. 9, 2021. When Wheeler’s application was accepted, she felt confident that her business could survive and that the industry had a future.
As the deadline approached, however, Wheeler became anxious. The FDA was slow to release information before the deadline. Then, on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the small company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
That’s how Wheeler found herself on the global stage, sharing her story with some of the largest players in the nicotine industry at the recent GTNF conference in London.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. “Their freedom as Americans no longer includes the right to use a product with none of the well-established, deadly effects of those other substances, and which has undoubtedly saved the lives of countless former smokers.”
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said. “In this malign effort, those activists had enthusiastic help from nearly the whole of the national news media. By focusing on the messaging of Bloomberg dark money NGOs [nongovernmental organizations] and beneficiaries of MSA funds, our media and political class have criminally neglected the harm reduction aspects of vaping under the guise of moral virtue. The years added to their lives by our products are never mentioned.”
The misinformation plaguing the vapor industry has been around since Hon Lik introduced e-cigarettes to a mass market in 2006. TheWall Street Journal, for example, recently ran a gushing story about a Truth Initiative advertising campaign that misleadingly asserts that vaping nicotine “can worsen symptoms of anxiety and depression.” There is no evidence to support the claim. According to Wheeler, the statement is also contradicted by studies on the Truth Initiative’s own website. The Journal article even quoted a Truth Initiative executive admitting that “it is unknown whether a causal link exists” between nicotine and those symptoms.
“Just last month, FDA records gathered by Freedom of Information Act laws revealed that America’s most preeminent news organization, the New York Times, would send its articles in their entirety and before publication, to FDA officials for review and feedback. Neither that reporter, Sabrina Tavernise, nor her editors have summoned the integrity to offer any explanation,” Wheeler said. “Remember, these are publications and outlets that routinely praised and awarded themselves for taking on Big Tobacco. And yet on a decision that has given Big Tobacco exactly what they wanted—a monopoly—they are silent. Marching arm in arm with the very businesses they once excoriated as merchants of death.”
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”
The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has been accused of falsely issuing warning letters, leaving companies off of its list of accepted PMTAs and of having issues with its PMTA filing software.
As of July 9, the FDA has issued 130 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, there is some confusion as some companies who have submitted PMTAs by the Sept. 9, 2020 deadline have received warning letters.
According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products that submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does show that the regulatory agency is overwhelmed by the number of submissions it is reviewing.
The FDA also had recently started listing closeout letters for companies that had responded to warning letters. Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. A court order requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021.
If a negative action is taken by the FDA on a PMTA application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
There are other issues with the FDA PMTA process, as well. The FDA released its list of products that are legal for sale in the U.S. A total of 360 companies (on the original list) filed PMTAs. However, at least five companies that filed PMTAs were erroneously left off the list, according to posts by Amanda Wheeler of the AVM.
In its own investigation, Vapor Voice found that Humble Juice Co. submitted a timely PMTA, received an acceptance letter and was subsequently misidentified on FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.
Other issues with PMTAs include errors in submitting them electronically. Several companies have complained that the FDA’s software that manufacturers must download in order to submit PMTA data has randomly left out some of files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.
“We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out the FDA, got a basic response … we’re aware of this, we’ll get back to you type of thing. We believe it’s a bug in the agency’s eSubmitter program.”
Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.
Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer. The FDA has not said if it intends to ask for an extension on the deadline, however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.
The FDA often only lists a few products that a company is selling as illegal in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
A more in-depth analysis of these issues will be in the next issue of Vapor Voice.
After submitting its premarket tobacco product application (PMTA) application to the U.S. Food and Drug Administration (FDA) on or before Sept. 9, 2020, Arizona-based JVapes announced that it had received a PMTA acceptance letter from the regulatory agency. The company submitted PMTAs for 992 SKUs of its JVapes e-liquids.
Credit: JVapes
The company now waits for a filing letter from the FDA. Following acceptance, applications undergo a more thorough review to determine if they include the data outlined in Section 910(b)(1) of the Tobacco Control Act (TCA). A filing status will only be received by brands that have submitted an application that contains all the necessary components with enough data included to justify a complete scientific review.
Filing is a critical milestone for a brand because once this status is reached, it is legal for products to remain on market till September 2021 while FDA completes its review.
During the substantive review phase of the PMTA process, FDA performs a detailed inspection of the documents and research that a brand has provided. This review considers whether or not an applicant product is safe for consumers and if it will be manufactured and marketed to FDA standards, with the ultimate goal of determining if a product is appropriate for the protection of public health.
Substantive review typically takes 90 days from notification of entering the review phase to receiving the first set of questions and comments from the FDA, according to the FDA. The majority of applications will receive follow-up questions and/or requests for additional data that may extend the timeline of the review phase.
A new advocacy group has form to small vapor industry manufacturers navigate the U.S. Food and Drug Administartion’s (FDA) premarket tobacco product appliucation (PMTA) process.
The American Vapor Manufacturers Association (AVM) was founded by two vapor business owners, Amanda Wheeler and Char Owen. Both have been longtime advocates for the vaping industry and have helped hundreds of other vapor business owners submit PMTAs. Wheeler will serve as president of the new organization, and Owen vice president.
Amanda Wheeler / Credit: RMSFA
“The founders of AVM have demonstrated a long standing commitment to our industry and have a proven track record of working hard for small business. Our President, Amanda Wheeler, has represented our industry at the federal regulatory level since June of 2019. At that time, Amanda began her journey by preparing a request to HHS and FDA to develop a small business PMTA pathway that was signed by 1,453 businesses,” the AVM website reads. “Amanda also collaborated with esteemed industry attorney Azim Chowdhury to develop a small business PMTA proposal. Since that time, Amanda has worked tirelessly to engage with HHS, FDA, the Trump Administration, and members of Congress to advocate for the small business proposal and the work that our co-founder, Char Owen has done to get over 200 businesses to the point they were able to submit pre-market tobacco applications for over 1.7 million products.”
Owen also began advocating for the vapor industry’s ability to participate in the PMTA process in June of 2019. “Char was motivated by the desire to honor her father’s memory, since he passed away from lung cancer due to a lifetime of smoking. Char had a conviction that there could be a viable path forward for small businesses to participate in the PMTA process,” the site states. “She set about her work to bring crowdsourced tools to small businesses that needed assistance preparing the documents necessary for successful PMTA submission. Over 200 businesses came together under Char’s leadership to successfully complete the requirements necessary to have PMTA’s successfully submitted and accepted.”
Other media outlets have reported that the AVM intends to create a vapor product testing lab specifically for small manufacturers. Labs have been overburdened since the PMTA guidelines were announced and a Maryland judge set Sept. 9 as the deadline to submit applications to the FDA.
The Trump Administration recognized an opportunity to save thousands of small businesses across Colorado. The president issued an executive order requiring federal agencies to identify burdensome regulations hindering economic recovery and propose modifications or waivers “for the purpose of promoting job creation and economic growth.” One Food and Drug Administration (FDA) regulation that must be on the list to alter per this executive order is the pre-market tobacco application (PMTA) that would destroy approximately 125 small vapor businesses, like mine, across Colorado.
We can all acknowledge that over-regulation can be the death knell for many small businesses. At no time in our history is that more evident than right now.
The gist of the regulation lumps small businesses in with big tobacco. Their incongruous approach falls under tobacco regulation although nearly no vapor products actually contain tobacco. Most, if not all, small vapor businesses view themselves as a safer alternative to big combustible tobacco. We are dedicated to getting adults off combustible tobacco and stopping youth access.
It is one thing for our industry to believe our products are safer, but we are not alone. First on the list is the FDA, the very government regulatory agency that lumps small vapor businesses in with big tobacco. They want to regulate vaping like tobacco but think vaping is a safer alternative for adults.
The FDA said they view “products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less harmful alternative for currently addicted individual adult smokers” than combustible tobacco. The list of organizations echoing this notion includes the American Cancer Society, National Academy of Science, American Association of Public Health Physicians, Royal College of Physicians, British Medical Association, British Lung Foundation, and more.
Despite the FDA’s position, it still plans to enforce PMTA this fall. Unfortunately, the inconsistent and arbitrary regulation of PMTA compels vapor and e-liquid manufacturers to submit a new application for every nicotine product they want to continue selling. If any product does not submit a PMTA by the September deadline, it must be pulled from the market.
While vapor manufacturers are required and actually do adhere to the highest safety standards, we also want to provide the safest and best products possible for our customers. Regrettably, PMTA applications cost, on average, $2,000,000 in legal and other fees. For my business, which has over 1,800 products, the cost to comply with this regulation would surely put all of us out of business. The FDA is asking small businesses to foot the bill again, in spite of the fact that they have endorsed the safety of a master list of the products and their ingredients. Talk about over regulation; the FDA is merely saving big tobacco because it can afford multiple tests. Small businesses lose.
My business, with two stores in Colorado, is no different than the 125 vapor owners, who employ 1,100 people throughout the state. But the very regulation meant to control tobacco or vapor use, regardless of how you feel about it, merely puts the small guys out of business while strengthening big tobacco. One-size PMTA is an effective ban on small businesses and their employees as big tobacco will not replace those jobs or businesses. But this is about more than just dollars, it’s about our health.
This obstacle that small businesses in the vapor industry face with this regulation makes David and Goliath look like a comparatively fair fight, wiping out roughly $50 million in annual economic activity.
It seems counterintuitive, however, nearly 350,000 Coloradans have found vaping products critical to reducing and stopping combustible cigarette use. It is working as cigarette use continues to plummet across nearly every American demographic. Effectively banning vapor products by destroying the industry through regulation would only drive adults back to smoking cigarettes.
Ours is an industry worth saving and, now, there is an easy way to do so. It is highly unlikely that my two little vape shops in Colorado will put the big guys out of business, but the regulation the FDA is considering only goes one way; it saves big tobacco and kills small business. I believe this runs counter to the president’s recent executive order. Our industry is asking President Trump and his administration to acknowledge that one size does not fit all when it comes to the PMTA. Our families, our businesses, our employees and our customers are looking for certainty and solutions as we are one answer to continued harm reduction, tax revenue and better health.
“Although we are not surprised to learn that Japan Tobacco Inc., brand owner of Logic, is now among the Big Tobacco companies with FDA market authorization, we certainly aren’t pleased with FDA’s consistent rejection of flavored products and will continue to apply pressure in that regard, as well as in the enforcement discretion arena – particularly for the manufacturers with products still in review that participate in our Responsible Industry Network program,” said April Meyers, CEO of the Smoke-Free Alternatives Trade Association (SFATA). “As the nation’s leading regulatory body, the agency appears to be cherry-picking what science it utilizes for decision making. That FDA cited the recent NYTS data but failed to acknowledge the steep decline in youth use while coining the low rates an “epidemic”, makes its rejection of flavored products today seem more an act of fear over what might happen than a decision based on scientific evidence. This is disappointing, at best, but again, not surprising.”
“People forget that in the story, Dr. Jekyll was a benevolent physician in a lab coat who only wanted to help people. But tomorrow morning, (FDA Commissioner) Robert Califf and (director of the FDA’s Center of Tobacco Products) Mitch Zeller will transform back into their Mr. Hyde alter-egos and resume their hellbent mission to sabotage the single-most effective smoking cessation device ever devised,” said Wheeler. “Well, the American people are watching and I for one am not going to stand by and let them get away with it. So, here’s my own announcement for today: FDA and CDC have my approval to stop deceiving the American public about the safety and efficacy of nicotine vaping.”
