Category: Regulation

  • The Wrong Lessons

    The Wrong Lessons

    The EU’s ban of snus provides a cautionary tale for U.S. regulators considering restricting consumer access to electronic nicotine-delivery systems.

    By Josh Church

    As the proverbial Armageddon for electronic nicotine-delivery systems (ENDS) in the United States draws closer, it has become apparent that the vapor industry as a whole has been found guilty without fair trial. Maybe it’s due to the constant presence of unsubstantiated science and fraudulent claims, or maybe it’s because public health and regulatory bodies both refuse to allocate resources to non-biased research.

    It’s almost as if these organizations are selectively blind to the research and science that is happening around the globe, especially if that research enforces the fact that ENDS can be of any benefit to the health of this nation. One thing is certain: The burden of truth is placed squarely on the shoulders of the vapor industry. It is now the job of the industry to prove that ENDS do not represent the decimation of public health, as much of the media and certain public health groups in the U.S. would have you believe.

    AS IT CURRENTLY STANDS

    Without the allocation of federal resources, the ENDS industry must fund and complete extensive research into combustible tobacco products. This includes but is not limited to the behavioral patterns in regard to users transitioning from combustible products to ENDS products as well as the potential health risks to a person using both products simultaneously.

    It’s important to remember in this context that most ENDS manufacturers have no connection to large tobacco companies and have no way to complete this robust amount of research into combustible products. The ENDS industry already has a massive burden in proving that it will not initiate new users of nicotine products, on top of developing methods to eliminate the usage of ENDS among minors.

    These two requirements on their own are difficult enough to substantiate without the addition of having to conduct research on combustible tobacco usage patterns. U.S. regulars will not accept any evidence for ENDS without the combustible tobacco research. If this requirement continues past the 2021–2022 deadlines, the U.S. is certain to see an entire product sector be all but eliminated as an option for American smokers.

    LOOKING AT OTHER NATIONS

    If we look at Europe’s approach to substantiating the public health benefit or threat of ENDS, we see a basis of sound science and a transparent reporting of findings. Studies both for and against ENDS have been available not only for the regulatory bodies and public health departments but also for the general public in many countries.

    Millions of dollars have been allocated throughout the EU with the purpose of understanding exactly what this new tobacco technology can mean for public health. While many of these studies highlight that more research needs to be done, a good portion of preliminary findings are showing that there is a positive effect for a person transitioning completely to an ENDS device and continuing to abstain from all use of combustible tobacco products. Cancer research in the U.K. has gone as far as producing informational packets for general practitioners to educate patients about the possible health benefits of transitioning completely to ENDS. This is a far cry from what we see happening in the U.S. It begs the question: “Are European lungs different than American lungs?

    New Zealand has set an aggressive goal of becoming a smoke-free country by 2025. While a good portion of this effort is being executed through higher taxation and stricter regulations on combustible tobacco products, ENDS have been given a role as well.

    New Zealand is the only country other than the U.S. that allows for the commercial advertisement of pharmaceuticals through public media outlets. While it is still a long way away from allowing ENDS manufacturers to advertise their products as approved smoking cessation devices, it allows the advertisement of ENDS as alternatives to traditional tobacco products.

    These advertisements occur not only through radio broadcasts but also on television and other visual outlets. Such actions allow the public to understand both the potential risks and benefits of transitioning to an alternative to the proven deadly combustible cigarette.

    PROHIBITION OF HARM REDUCTION

    EU regulators’ openness to ENDS is even more remarkable given their history of overreach in tobacco-related issues. In 1992, for example, the EU banned snus in all member states except Sweden. In 1980, Sweden’s smoking rate was 34 percent—in line with adult smoking rates throughout the rest of the EU at the time. Through societal influence and education, among other factors, smoking rates have since declined across the EU. However, in Sweden—where snus remained legal—smoking rates fell much faster. While snus manufacturers were not allowed to sell their product as a reduced-risk alternative, Swedish consumers were able to educate themselves and come to their own conclusion.

    Over the next three decades, EU smoking rates leveled off between 23 percent and 36 percent. In Sweden, by contrast, they plummeted to an unrivaled low rate of 5 percent. Many health officials consider a society with a smoking rate of 5 percent or lower smoke-free. You may question whether this transition from combustible cigarettes to snus was due to government marketing campaigns, but this was not the case.

    The product and the consumer were left to their own devices. With this reduction of combustible tobacco use, Sweden now boasts Europe’s lowest levels of lung cancer in males, cardiovascular disease and other tobacco-related illnesses.

    Some may speculate that the increase in oral tobacco use resulted in more incidences of oral cancer, but this was not the case. Studies across Sweden found that oral cancer rates in snus users were similar to those of never users. It is critical that global regulators, public health groups, and people who either use combustible tobacco products or know a person who does take note of this. Despite such evidence for harm reduction, many still believe abstinence of nicotine and tobacco is the only answer to the public health crisis.

    NOT MAKING THE SAME MISTAKES

    The U.S. risks learning the wrong lessons from the EU. Regulators should observe these examples and apply them to ENDS. U.S. regulators, health officials and public health groups must be extremely cautious about depriving combustible tobacco users of viable options to reduce their health risks.

    History has shown that traditional nicotine-replacement therapies and approaches promoting abstinence have little to no effect on consumers who enjoy or are addicted to nicotine. The example of snus regulations in the EU suggests that prohibition would be the worst option. Regulators and industry representatives need to work together to make sure that this will not be known as the era where perfect is the enemy of better.

    Picture of Josh Church

    Josh Church

    Josh Church is the chief regulatory and compliance officer of Joyetech Group, the largest vapor industry manufacturer in the world.

  • Policy Problems

    Policy Problems

    Three scientists at an e-liquid filling station
    Photo: NicVape

    Newly proposed rules regarding nontobacco-related flavored vapor products could crush the industry.

    By Timothy S. Donahue

    On March 13, the U.S. Food and Drug Administration (FDA) put the vapor industry on notice. The regulatory agency released its new draft guidance for vapor products titled, “Modifications to Compliance Policy for Certain Deemed Tobacco Products (March 2019),” and it wasn’t good news.

    The plan includes new restrictions on most flavored e-liquids and pods, a tighter deadline to review flavored nicotine products and the ability for the agency to pull all vapor products from the market if it deems the action is necessary to prevent the rise in youth vaping. If enacted, the new policy will likely remove some flavored vapor products from retail stores. Sales of flavored nicotine pods will be restricted to websites, vape shops and other retailers that impose strict age restrictions.

    The newly proposed final guidance provides additional clarity to vape shops on their responsibilities under federal law. Any changes in the compliance policy addressed in its new draft guidance will be implemented 30 days after a final version of the guidance is issued. The rule explains that retailers can continue to assist their adult customers with electronic nicotine-delivery systems (ENDS) by demonstrating or explaining how to properly use an e-cigarette or other type of ENDS.

    Sam Salaymeh, president and CEO of North America for AMV Holdings, which owns Madvapes, Alohma, Maxx and Select-A-Vapor stores, says the new FDA proposal appears to be based on the collective punishment principle—hurting good companies along with ones that violate the rules by marketing toward youth, for example.

    “I would prefer reasonable regulation,” Salaymeh says. “We have a crisis that is the result of a single product. It is creating undo pressure on the good stewards of this industry. If easily concealed, high-nicotine products are the problem, then easily concealed, high-nicotine products should be the target of harsher regulations.”

    One risk of the proposed FDA regulations is the growth of the black market, according to Salaymeh. He says that the push to make vapor products available only to adults over the age of 21 and limiting flavors are bad ideas.

    “Closed systems are demonizing [an industry that is probably] one of the most significant public health advancements in the last two decades. Anything that impacts an adult’s accessibility to these products will have a negative impact on the public health of this country,” he says. “The mission to ban some of these products could push consumers towards an unhealthy and unsafe black market.”

    AGING ISSUES

    The regulatory agency has said that, when it comes to enforcement, it will prioritize vapor products offered for sale in ways that make them more accessible and appealing to minors. For over a year, vapor products have been under scrutiny as the FDA has struggled to address what it calls an “epidemic” of youth vaping, especially with popular pod systems like the Juul vapor device.

    The rule states that vapor products with flavors other than tobacco, such as fruit and candy flavors, can still be sold online or at brick-and-mortar stores that use a third-party age verification system or that have age-restricted sections. Stores that allow minors to enter will be held to different standards if only tobacco, menthol and mint flavors are sold—provided those standards comply with local and national laws.

    “For online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records [a company would be in violation of FDA rules],” former FDA Commissioner Scott Gottlieb wrote in a press release.

    Representatives of Avail Vapor recently shared with FDA officials their customer insights, perspectives and best practices for combatting youth access. “Commissioner Gottlieb asked the industry to step up, and that’s exactly what we did,” said Maggie Gowen, Avail Vapor’s director of external relations. “In addition to current regulations, we have proactively taken additional measures to prevent youth access in-store and online.”

    Among other measures, Avail Vapor increased the minimum purchase age online to 21. Its website is age-gated, and the firm conducts third-party age-verifications prior to purchase. In its stores, the company IDs all customers regardless of ages and scans all IDs prior to purchase. “We have also implemented best practices regarding marketing and advertising practices,” says Gowen.

    AMV Holdings is doing its part, as well, scanning identification cards and working toward age-restricted entry, among other measures. “We don’t want issues like kids being left in cars in the heat or cold, so we may look at creating a foyer area with a waiting room,” says Salaymeh. “There are several possibilities, and we are striving to do what is best for our customers. It is great that the FDA is seeing that brick-and-mortar vape shops aren’t the root of the problem and the agency does see value in flavors helping adult smokers switch.”

    The FDA plans to air a television ad campaign explaining the risks of e-cigarette use in kids. If the 2019 National Youth Tobacco Survey indicates continuing high use of ENDS, the agency reserves the right to further strengthen policies and enforcement, possibly even banning all vapor products.

    What’s more, the FDA expects manufacturers of all flavored ENDS (other than those with tobacco, mint and menthol flavors) that remain on the market under these new conditions to submit premarket tobacco product applications (PMTAs) to the agency by Aug. 8, 2021—one year earlier than the agency had previously proposed. In addition, the FDA has requested comments on whether to adjust the premarket review compliance date to include tobacco-, mint- and menthol-flavored products.

    The FDA also requested comment on whether there are any technologies or other measures that could be useful in addressing youth access to ENDS. Gowen has asked the FDA to convene a working group comprising FDA staff and industry members to explore ways to strike a balance between providing adult smokers with options and preventing youth engagement.

    After Aug. 8, 2021, the FDA plans to step up its enforcement against flavored ENDS for which the manufacturer has not submitted a PMTA. Several other developments are set to impact the vapor industry. The White House’s March 11 budget proposal includes a user fee on vapor products to fund FDA oversight, for example.

    CHANGING PLACES

    When Gottlieb announced his retirement in early March (also see, “FDA in Transition,” page xx), many industry representatives hoped the change of guard would result in a less heavy-handed approach to vapor regulation. Gottlieb, however, was quick to douse those expectations.

    “Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump administration. Nobody wants to see children becoming addicted to nicotine,” Gottlieb stated prior to his departure from the FDA on April 5. “Our dedication to this effort will endure, and our commitment to advancing our comprehensive framework will continue …. We won’t tolerate a whole generation of kids becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.”

    The appointment of Ned Sharpless, director of the National Cancer Institute, as the acting head of the FDA seems to underscore that pledge. Anti-vapor groups have been quoted in news articles saying that the appointment of Sharpless should allay any concerns that Gottlieb’s departure would end the FDA’s crackdown on flavored electronic cigarettes and teen smoking.

    “There will be no letup in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes,” says Alex Azar, the U.S. Secretary of Health and Human Services.

    To support its public health objectives, the FDA has requested about half a billion dollars in additional funding for 2020.

    “Importantly, the budget also seeks $100 million in new tobacco fees, and includes manufacturers and importers of deemed tobacco products and [especially ENDS]. E-cigarettes … represent an increasing share of the tobacco marketplace,” the FDA stated in a press release. “The new resources will support the FDA in its continued efforts to create a modern regulatory framework for the appropriate oversight of e-cigarettes and in taking continued steps to reduce youth use of all tobacco products … and aggressively confront youth use of these products to make sure children don’t become addicted to nicotine.”

    Deferred Results

    The U.S. Food and Drug Administration (FDA) has extended the harmful and potentially harmful constituents (HPHC) reporting compliance date. The deadline was Nov. 8, 2019.

    The new deadline is six months for large manufacturers and nine months for smaller manufacturers after the FDA releases guidance for how the testing will be conducted. The agency defines “small-scale” as a company that generates less than $5 million in revenue and has fewer than than 150 employees.

    Some suspect the HPHC testing was extended only because the FDA has taken an unnecessarily long amount
    of time to complete a list of what constituents the vapor industry should be testing for, and few manufacturers want to pay for expensive testing that could possibly end up not meeting the standards. The FDA also waited until after many manufacturers began the testing process to extend the deadline to an unknown date.

    Sam Salaymeh, president and CEO of North America for AMV Holdings, says the rules needed to be changed
    because testing under the FDA’s current rules is so expensive that only companies with large cash flows and
    resources could survive.

    “Testing is nearly impossible under the current FDA policy,” he says. “There are no standard temperatures, coil
    variations or wattage settings, for example. Where do you draw the line? We are testing different approaches, but we don’t know what the FDA wants.”

    Currently, a manufacturer of vapor products can choose to perform many tests, guessing what the FDA will require. Ultimately, manufacturers are expecting to be asked to supplement their applications with more testing data for the FDA. However, this still leaves many questions. The FDA has stated its intent to clarify the rules.

    “In the deeming final rule, FDA stated its intention to issue guidance regarding HPHC reporting, and later a testing and reporting regulation, with enough time for manufacturers to report given the initial three-year compliance period (originally Aug. 8, 2019) …,” said FDA press officer Michael Felberbaum. “This additional time also will allow FDA to develop an appropriate policy for HPHC testing and reporting by deemed tobacco product manufacturers to account for the different types of deemed products.”

    Many vapor industry representatives want to know why it is so difficult for the FDA to give the industry a list of what to test for. “How can this take as long? Why is the science agency FDA lacking scientific guidance on its [HPHC] testing list?” asked one manufacturer who requested not to be named. “Since the development of these products has been unchanged for greater than two years, the data from these products is not changing. If the products aren’t changing, why has the FDA not yet given manufacturers a complete list of things to test for? What is the FDA’s role in helping the industry to conform to their regulations?”

    When asked by Vapor Voice for a response to these questions, the FDA reiterated that it is working on clearer guidelines for HPHC compliance. The agency did not explain what its role in helping companies conform is or why the process is taking so long. – T.S.D.

    Retail Clarity

    There isn’t much new to this one. The U.S. Food and Drug Administration (FDA) released its final guidance that interprets rules for vape shops. In the report, titled, “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops,” the regulatory agency has clarified several actions for vape shop owners.

    For example, under the Food, Drug, and Cosmetic Act, a tobacco product in package form is misbranded if its label “does not include an accurate statement of the percentage of tobacco used in the product that is foreign-grown and domestic-grown,” according to the FDA. However, the FDA states that it does not intend to enforce the rule for tobacco-derived liquid nicotine or e-liquids made or derived from tobacco on labeling.

    Additionally, for products that do not yet have marketing authorization orders, a vape shop’s modifying a product would generally result in a new tobacco product, for which the vape shop is required to seek premarket tobacco product authorization (PMTA). The FDA does not intend to enforce these requirements either if the vape shop modifies a product consistent within specifications provided by the original manufacturer.

    The FDA states that a vape shop cannot assemble a custom final product from components or parts sold individually or from multiple pre-built kits, however, Maggie Gowen, director of marketing at Avail Vapor, says that items such as different tanks and coils can be sold for hardware, but the vape shop cannot assemble them in-store for the customer.

    However, the FDA states that a vape shop can assemble a final product from the components that are packaged together in a pre-built ENDS kit or from parts sold individually that are also available packaged together. A vape shop can also explain how to charge a battery or fill a tank, as well as demonstrate how to turn on a device.

    “This guidance is just more concise than the previous guidance on the subject,” says Gowen. “We turned some
    of these rules into a positive educational experience at the store level because our customers walk out more confident having assembled their device on their own for the first time. They also are more likely to have continued success outside the store having already assembled it on their own.”

    Refilling open systems is also allowed if the vape shop does not make any further modifications to the product or any modifications to the e-liquid. However, a closed system cannot be refilled, and an atomizer may not be repaired or modified by the vape shop without violating FDA rules. The shop can replace the coils with identical coils from the same manufacturer.

    As expected, the FDA has reiterated its stance that vape shops will not be allowed to produce and fill e-liquids in-store without being considered a manufacturer and submitting a PMTA. Sam Salaymeh, president and CEO of North America of AMV Holdings, said that many of his stores add nicotine to some e-liquids in-store, but all his stores are registered as manufacturers with the FDA.

    “We will go through the PMTA process for all of our flavors, including those produced in-store,” he says. “It’s a single PMTA per SKU regardless of [the] number of locations it’s sold. We are dedicated to helping smokers switch; 69.3 percent of smokers that enter our stores have stopped smoking completely, and are nonsmokers after 12 months. We will continue to do whatever we can to help end the death and disease cause by combustible cigarettes.” -T.S.D.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Apples to Apples

    Apples to Apples

    A recently developed international standard for e-cigarettes allows scientists to make meaningful comparisons.

    By Marina A. Murphy

    In less than a decade, electronic cigarettes have captured the attention of the world’s press and become one of the most promising technologies in the field of tobacco harm reduction. But it is only now, after three years of painstakingly drafting, reviewing and voting, that the first international standard1 for e-cigarettes has been developed.

    Developed by the ISO (International Organization for Standardization), the standard pertains to the generation of e-cigarette aerosol in the lab for testing purposes. This standard specifies exactly how that should be done. Going forward, this means that when scientists compare research results, they can be sure they are comparing like with like (as they can be sure they have generated the aerosol tested in the same way).

    While there are already a number of national standards for e-cigarettes, this is the first international standard to be developed thus far.

    AN INTERNATIONAL STANDARD

    Not surprisingly, the development of this standard was watched with interest by many groups beyond the usual suspects. E-cigarette and e-liquid manufacturers were naturally interested in developing this standard. “But so too were consumer groups, public health bodies, lab equipment manufacturers and many others, all of whom provided experts for the technical working group responsible for developing the standard,” explains Derek Mariner, who chaired this group. “ISO has a philosophy of inclusiveness, and our working group had the broadest range of stakeholders I have experienced in 14 years working with ISO. It was an absolute pleasure to have worked with such a diverse group of interesting and engaged experts,” he said.

    This standard is now available (for a fee) for researchers and scientists around the world to use. It will enable consistency between studies and will support direct comparisons of studies and products. It will also benefit regulators in the enforcement of regulations and of course the manufacturers who need to ensure they are compliant with those regulations. For example, manufacturers in the European Union need to be able to show that the aerosols produced by their devices are produced in a consistent manner.

    The standard describes precisely how puffing machines in the lab are set up to puff on e-cigarettes to produce an aerosol for testing. The puffing regime used is not intended to represent real life, since its purpose is to enable comparison of products, but its development has been guided by how consumers use their products. The consumer behavioral data used was developed around cigalike products, which were very popular a few years ago. Consumers using these devices take aerosol into the mouth first and then inhale it into the lungs (“mouth-to-lung” vaping). But direct-to-lung devices are more popular these days, which is why there is a provision in the standard for modification as more relevant and reliable data becomes available. In fact, as a new standard, ISO procedures require that it is reviewed in three years’ time.

    This is just the first of a number of international standards being developed for e-cigarettes. A number of proposals have already been made to ISO regarding the development of additional standards, including for analytical methods for measuring levels of nicotine and other substances in e-liquids, and methods for measuring nicotine, metals and carbonyl compounds (e.g., formaldehyde) in e-cigarette aerosols.

    ISO—ALL THINGS BEING EQUAL!

    ISO was established in 1947 as an international standard-setting body, and even its name is standardized! ISO is not an acronym. The name “International Organization for Standardization” would have different acronyms in different languages, so the ISO founders decided on the name ISO from the Greek word “isos,” which means equal. The connection to standards is that if two things reach the same standard, they should be equal.

    ISO is a global network of the world’s leading experts in standardization, which it brings together via its members—the national standards bodies in 162 countries as well as more than 500 liaison organizations from the public and private sectors with a stake in one or more specific aspects of ISO’s work. It is usually at the behest of these members that ISO develops a standard.

    In the case of this first international standard for e-cigarettes, it was Coresta, a liaison member of ISO, that recognized the value of developing an international standard for generating e-cigarette aerosols and put forward a proposal that this be done by ISO using a Coresta Recommended Method (CRM 812) as the starting point.

    Once the need for a standard has been agreed on by the relevant ISO technical committee or subcommittee, a technical working group of experts is convened and a project leader appointed. In this case, the project leader was Mariner, a principal scientist at British American Tobacco with 14 years of experience developing standards with ISO.

    Since 1947, ISO has published 22,436 international standards.

    The international standards produced by ISO are all voluntary, which means that ISO is not a regulator in the traditional sense. However, when governments and industries choose to use ISO standards, this can help promote cooperation between countries and facilitate trade, creating facto rules and best practices at the international level, thereby promoting international regulatory cooperation.

    Picture of Marina A. Murphy

    Marina A. Murphy

    1. https://www.iso.org/contents/data/standard/06/90/69019.html [↩]
    2. https://www.coresta.org/routine-analytical-machine-e-cigarette-aerosolgeneration-and-collection-definitions-and-standard [↩]
  • Cherry Crush

    Cherry Crush

    Several bills at the local, state and federal levels of government aim to ban all flavors in vapor products.

    By Timothy S. Donahue

    The fight never ends. The fight for flavors in the vapor industry has battlegrounds at every level of government. Currently, at least five U.S. cities have proposed bans on flavors for vapor products: Sacramento; New York City; Chicago and Baltimore, according to the Vapor Technology Association (VTA), a vapor advocacy group. Suffolk County, New York, is also considering a ban.

    There are at least eight U.S. states that have or intend to propose vapor flavor bans: California, Massachusetts, North Dakota, New York, New Jersey, Connecticut, Hawaii and New Mexico. However, there is one bill currently in the U.S. House of Representatives that could eliminate all flavors in vapor products everywhere: the Youth Vaping Prevention Act of 2019 (H.R. 293).

    Introduced by Connecticut Rep. Rosa DeLauro on Jan. 8, H.R. 293 would ban the sale of all e-liquid flavors other than tobacco. The bill specifically references any constituent, additive, artificial or natural flavor (other than tobacco flavor), or an herb or spice “(including menthol, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry and coffee) that is a characterizing flavor of the tobacco product, tobacco smoke or aerosol emitted from the product.”

    The bill would also ban flavors in all vapor products even if the product does not contain nicotine. H.R. 293 defines e-cigarettes and electronic nicotine-delivery systems (ENDS) as “any electronic device that delivers nicotine, flavor or other substance via an aerosolized solution (including an electronic cigarette, cigar, pipe or hookah) to the user inhaling from the device (including any component, liquid, part or accessory of such a device, whether or not sold separately).”

    However, the bill would allow for flavors if an ENDS is “approved by the [U.S.] Food and Drug Administration (FDA) for sale as a tobacco cessation product or for another therapeutic purpose and is marketed and sold solely for a purpose approved as [just] described.”

    DeLauro serves in the Democratic leadership as co-chair of the Democratic Steering and Policy Committee, and she is a ranking member on the Labor, Health and Human Services, and Education Appropriations Subcommittee, where she oversees U.S. investments in education, health and employment, according to www.delauro.house.gov. Currently, H.R. 293 has no co-sponsors.

    “The New England Journal of Medicine just reported that e-cigarettes are twice as effective as FDA-approved products in helping smokers quit smoking,” said Tony Abboud, executive director of the VTA. “Banning flavored vapor products, which are both 95 percent safer than cigarettes and a more effective tool for quitting, simply cannot be the answer for anyone committed to ending the death and disease associated with combustible tobacco. Congress should allow [the] FDA to follow the science: Flavored vapor products help adults quit deadly cigarettes.”

    The VTA is also fighting the flavor ban bills in state and local governments. “Thanks to our growing network of state associations and VTA’s massive commitment of resources, our industry now has lobbying representation on the ground in almost 40 states,” says Abboud. “Our industry has dealt with an onslaught of legislation over the past two years. We’re taking on the most important issues, including those bills that present an existential threat to our industry, such as the over-taxation of vapor products and flavor bans, while we are focusing legislators on crafting responsible regulation to save our industry.”

    As of this writing, H.R. 293 has been referred to the Committee on Ways and Means in addition to the Committee on the Judiciary, as well as the Committee on Energy and Commerce, for a period to be subsequently determined by the speaker of the house to be sent to the House floor for a vote. It would then have to pass the U.S. Senate before being signed into law by President Donald Trump.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Dear Mr. President

    Dear Mr. President

    Nineteen advocacy organizations ask the U.S. President to halt the FDA’s attack on vapor products.

    By Timothy S. Donahue

    It was necessary. On Feb. 4, a letter signed by representatives from 19 advocacy groups was sent to U.S. President Donald Trump urging him to immediately end the U.S. Food and Drug Administration’s (FDA) “aggressive regulatory assault” on the vapor industry.

    “From inaction on pending product approvals to threatening letters sent to American manufacturers and promises to begin new rulemaking that would make illegal certain consumer products, this FDA is currently pursuing several policies that are more extreme than those contemplated by the Obama administration,” the letter reads. “FDA Commissioner Scott Gottlieb’s effort to curb the $6.6 billion electronic cigarette industry and an even larger reduced-risk tobacco alternatives market is inconsistent with your clearly articulated deregulatory objectives and will destroy jobs, limit consumer freedoms and harm public health.”

    The signatories were: Grover Norquist, president of Americans for Tax Reform (ATR); Lisa Nelson, CEO of ALEC Action; Norm Singleton, president of the Campaign for Liberty; Tom Schatz, president of Citizens Against Government Waste; Michelle Minton, senior fellow for the Competitive Enterprise Institute; Jeff Stier, senior fellow for the Consumer Choice Center; Kenneth T. Cuccinelli II, director of Regulatory Action Center for FreedomWorks and former Attorney General of Virginia; Henry I. Miller, former director of the Office of Biotechnology at the FDA; Naomi Lopez Bauman, director of Healthcare Policy at the Goldwater Institute; Mario H. Lopez, president of the Hispanic Leadership Fund; Julie Gunlock, director of the Center for Progress and Innovation for the Independent Women’s Forum; Bob McClure, president and CEO of The James Madison Institute; Seton Motley, president of Less Government; Pete Sepp, president of the National Taxpayers Union; Douglas Kellogg, director of Ohioans for Tax Reform; Carrie L. Wade, director of Harm Reduction Policy at the R Street Institute; Paul Gessing, president of the Rio Grande Foundation; and Tim Andrews, executive director for the Taxpayers Protection Alliance.

    The letter explains that vapor products do not contain tobacco and that they deliver nicotine without the combustion or tar that is found in traditional cigarettes. There are also numerous studies that have found that vapor products are at least 95 percent less harmful than combustible cigarettes. The letter also states that Gottlieb, the FDA Center for Tobacco Products’ director, Mitch Zeller, and Surgeon General Jerome Adams have acknowledged the harm reduction potential of e-cigarettes.

    “Unfortunately, a spike in the use of these products by teens has resulted in regulatory panic and significant government overreach,” the letter reads. “Commissioner Gottlieb has already pressured major manufacturers of e-cigarettes to remove many products from convenience store shelves, suggested that more than 100,000 retailers limit adult access to these products and threatened to use agency power to remove thousands of legal products from the market. We do not write you today urging your administration to ignore the concerns about the use of e-cigarettes by teens. We do, however, urge your administration to subject the FDA’s response and actions to much closer scrutiny and examine it within the context of your broader deregulatory and pro-jobs agenda.”

    When President Trump signed executive order 13771, “Reducing Regulation and Controlling Regulatory Costs,” he directed departments and agencies to not only eliminate at least two regulations for every new one created but to sensibly manage costs. The deregulatory efforts led to over $33 billion in savings through October 2018, according to the letter. Nearly every department and agency identified harmful regulations and worked to untangle and repeal them. One glaring exception has been the FDA.

    “It’s important that we hold the president accountable for the promises he made in the 2016 campaign and initial days of his administration,” said Paul Blair, director of strategic initiatives for ATR. “Regardless of one’s politics, it’s clear that across every department and agency, the deregulatory agenda is being fully implemented. That’s just not happening at the FDA, and we want the president to know that conservatives are fed up.”

    Blair goes on to say that vapers are passionate consumers, and, more importantly, they represent millions of voters, adding that they believe they’ve made a personal decision to improve their health. “There is a broad coalition in support of our efforts here; it’s not just [ATR’s] discontent at the FDA,” he says. “I want the president to understand that even though ATR has been out in front of this issue for years, we’re not alone in recognizing the importance of getting regulations for the tobacco and vapor industry right.”

    It is likely that the impact of the FDA’s proposed, pending, and possible new guidance and rules for vapor products will amount to billions of dollars in lost economic activity and costs, according to the letter. Blair says it’s inexcusable. “At this point, a Hillary Clinton presidency would have been no different for the industry than Trump’s, all thanks to Scott Gottlieb’s misguided crusade.”

    STUDY TIME

    They keep coming. Another positive study concerning vaping has been completed. On. Jan. 30, the New
    England Journal of Medicine published a predominantly U.K.-based study that finds that “e-cigarettes [are]
    more effective for smoking cessation than nicotine-replacement therapy when both products [are] accompanied by behavioral support.”

    For the study, scientists randomly assigned adults attending the U.K. National Health Service stop-smoking
    services to either nicotine-replacement therapy (NRT) products of their choice, including product combinations, or an electronic nicotine-delivery system (ENDS) starter pack, with a recommendation to buy
    their own flavors and strengths of e-liquids. The treatment plans also included weekly behavioral support for a
    minimum of four weeks.

    The researchers wanted test subjects to have sustained abstinence for one year, which was validated biochemically during the patient’s final visit. A total of 886 participants were involved. The one-year abstinence rate was 18 percent in the ENDS group, according to the study, as compared with 9.9 percent in the NRT group.

    Among subjects with one-year abstinence, those in the ENDS group were more likely than those in the NRT group to use their assigned product at 52 weeks (80 percent [63 of 79 participants] vs. 9 percent [four of 44 participants]), according to the study. Overall, throat or mouth irritation was reported more frequently in the e-cigarette group (65.3 percent vs. 51.2 percent in the NRT group) and nausea more frequently in the nicotine-replacement group (37.9 percent vs. 31.3 percent in the e-cigarette group).

    The researchers hail from Queen Mary University of London; King’s College London; London South Bank University, London; the University of York, York; Leicester City Council, Leicester; and the Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. –T.S.D.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • Angle of Attack

    Angle of Attack

    Billed as a public hearing on eliminating youth use of vapor products, the FDA’s free forum failed to deliver.

    By Timothy S. Donahue

    It was bad. The U.S. Food and Drug Administration’s (FDA) attempt at an unbiased hearing to discuss cessation methods for youth addicted to e-cigarettes and other tobacco products did not accomplish its goal. The Jan. 18 meeting, called the Public Hearing on Eliminating Youth Use of Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies, was little more than an attack on the vapor industry that continued to propagate misconceptions.

    The meeting opened with a speech by FDA Commissioner Scott Gottlieb, who told attendees that the focus of the gathering was the potential role that drug therapies may play in the broader effort to eliminate e-cigarette and other tobacco product use among young people as well as the appropriate methods for evaluating such therapies.

    Gottlieb said the hearing was in response to statistics from the National Youth Tobacco Survey (NYTS) released by the FDA and U.S. Centers for Disease Control and Prevention (CDC) showing that more than 3.6 million middle school and high school students were current (past 30 days) e-cigarette users in 2018—an increase of more than 1.5 million students since 2017. He also said that the survey showed youth who use e-cigarettes are also using flavored products more often than last year.

    “This past November, the [CDC] reported that smoking rates among adults reached an all-time low in 2017; 14 percent of adults reported cigarette smoking ‘every day’ or ‘some days,’ marking a 67 percent decrease since 1965,” he said. “Sadly, this progress is being undercut—even eclipsed—by the recent dramatic rise in youth vaping. A few years ago, it would have been incredible to me that we’d be here discussing the potential for drug therapy to help addicted youth vapers quit nicotine.”

    There is a large body of research on adult smoking cessation; however, the methods to treat adolescents and teens who are addicted to vaping are not well understood, according to Gottlieb. “There is little information about how drug or behavioral interventions might support youth e-cigarette cessation as well as youth tobacco use more generally,” he said. “The data and other information presented at today’s hearing will be vitally important to helping the FDA and other stakeholders begin to address these information gaps.” The data never came.

    The first speaker, Bonnie Halpern-Felsher, a professor of pediatrics at Stanford University, was one of the only speakers to even mention nicotine-replacement therapies (NRTs) for youth. She said that there are currently no approved NRTs for youth. “Therefore, there is no evidence of their effectiveness when used off label,” she said. “Clearly, we need much more research … we need some evidence, so that’s the first thing we need to consider.”

    She then added that there are additional “pharmacological events” to consider, going as far as calling on the FDA to ban all flavors in vapor products and claiming there is no evidence that flavored vapor products help adult smokers quit. Speaking to a five-member panel, as well as attendees, Halpern-Felsher also said the FDA needed to stop companies from saying vapor products in general help adults quit smoking combustible cigarettes when “there is no clear evidence that is the case, and, instead, it’s just attracting young people.” Of course, the FDA already bans vapor companies from making cessation claims.

    The claims made by Halpern-Felsher contradicted the statements made by Gottlieb moments earlier. Gottlieb told attendees that he believes e-cigarettes present an important opportunity for adult smokers to transition off of combustible products and onto nicotine-delivery products that may not have the same level of risk associated with them.

    “The FDA’s plan was founded on the principle that what primarily causes the death and disease from tobacco use isn’t the nicotine in these products but rather the harmful chemicals associated with cigarette combustion,” he said. “But we also know that nicotine isn’t a benign substance. We know that initiation to and addiction to nicotine by neversmokers—predominantly youth and young adults—raises its own set of public health concerns.”

    Halpern-Felsher also asked the FDA to eliminate all ads for all flavors and ban companies from saying e-cigarettes are safe or safer (also banned by the FDA). “We all hoped that to be true [that e-cigarettes help adult smokers quit smoking combustible cigarettes], but the evidence isn’t playing out …. In most of the [cases] when adults were using electronic cigarettes, they tend to not be able to quit smoking and, if anything, tend to use both cigarettes and e-cigarettes, therefore increasing the amount of nicotine they are using,” said Halpern-Felsher, who provided no evidence to support her claims.

    Susan Tanski, speaking for the American Academy of Pediatrics, reiterated that there is no data available for NRTs for youth use. She called on the FDA to quickly fund studies to better understand adolescent e-cigarette addiction, while also quickly identifying effective interventions for this population of e-cigarette users. “Indeed, the very issue of nicotine dependence and adolescent e-cigarette use is also likely to be a challenge, and researchers may need support in measuring dependency in a consistent way,” she said. “There have not been any trials for e-cigarette cessation with NRTs.”

    Oddly, Tanski also stated that improvements to current NRT products, “such as changes to flavors that make them more palatable to youth, may help improve” compliance and effectiveness. Ironically, she also supported a ban on flavors in vapor products.

    Another speaker explained how it was wrong for Gottlieb to say things, such as vaping is safer than smoking, while vapor companies could not make the claim. Lauren Lempert, a researcher with the University of California San Francisco’s Center for Tobacco Control Research and Education, said that “the FDA’s own statements characterizing e-cigarettes as less harmful nicotine-delivery devices have been misunderstood by kids to suggest that e-cigarettes” would help them stop smoking combustible cigarettes.

    “The less harmful claims made [by] the FDA have not been substantiated. In fact, if e-cigarette companies made these very same claims, they would be illegal,” she said. “The problem is these companies have been repeating them in their ads … messages that say something is for adults only actually have the reverse effect of attracting youth and do more harm than good.”

    Lempert called for the removal of all e-cigarettes from the market that have not survived the premarket tobacco product application (PMTA) process (which would mean all e-cigarettes), a ban of all flavors of e-liquids, the prohibition of all internet sales (because “evidence has shown there is no age-verification scheme that is effective”), a ban of cessation claims from all companies and the prohibition of all ads that target youth. Jennifer Folkenroth, speaking for the American Lung Association, made nearly the same statements as Lempert.

    Points raised by vapor industry supporters seemed to fall on deaf ears. Spike Babain, technical analysis director for the New York State Vapor Association, drew attention to how the NYTS doesn’t specify whether a vape pen is used for nicotine or marijuana—it notes only that a vaporizer has been used. She also noted that the NYTS asked whether youth used a hookah pen and lumped the non-nicotine product in with nicotine use. She was asked a question about data but didn’t answer the question.

    Bill Godshall, founder of Smokefree Pennsylvania, stated that most youth who vape are not using nicotine. He also noted that most youth who vape are 18 years old and can legally purchase vapor products in most states. He pointed out that the FDA and CDC have been characterizing all vapor use as nicotine consumption whereas a significant share of that figure may have in fact been marijuana use, given that nine of 10 states with the highest reported e-cigarette use among teens have legalized marijuana in some form. Godshall presented a plethora of data, such as that the 2017 NYTS found that 49.8 percent of sixth-graders to 12th graders who ever used an e-cigarette reported using an e-cigarette containing THC, marijuana, wax or hash oil, up from 38 percent in 2016.

    “Scott Gottlieb and the FDA rely upon NYTS data on marijuana vaping, experimental and occasional e-cigarette use, and vaping by smokers, former smokers, and 18 and over adults to falsely claim youth nicotine vaping is an epidemic and threatens to ban/restrict more vapor product sales to adults,” he said. “Marijuana vaping has skyrocketed among teens—as with adults—in recent years.”

    Some speakers appeared unaware of how the tobacco industry is regulated. Daniel Hussar, a professor at the Philadelphia College of Pharmacy at the University of the Sciences, suggested that vapor products should be available only by prescription. “Nicotine is a drug. The FDA recognizes that,” he said. “Yet nicotine-containing products are routinely available even to the youth [to whom] they are not supposed to be sold.”

    Hussar said nicotine is no different when delivered through an electronic-delivery system. “Why has the FDA not made these devices available only by prescription?” he asked. “If the FDA does not comply with its own regulations and policies, why should anyone else feel they should need to comply?” However, in 2007, Njoy won a lawsuit against the FDA that prevented the agency from regulating e-cigarettes as a drug. The decision requires the agency to regulate vapor products in the same way it does other tobacco-derived products.

    Other speakers took the opportunity to highlight products that could help address the FDA’s concerns. Jack O’Toole, president of FreshAir Sensor, for example, explained how his smoke detector-like device could be placed in a teen’s bedroom and would sound an alarm when someone in the bedroom was vaping. Two other presenters discussed the “SKY Bio-Psycho-Social Program for Youth Empowerment,” which teaches those addicted to nicotine other methods of stress relief, such as taking deep breaths.

    Don Seibert, founder of Smokenders, discussed his web-based quit-smoking program that boasts a 60 percent success rate. “We do it now by a video class each week and daily action steps the student uses,” said Seibert. “We guarantee they quit smoking, or they get their money back.” The company is soon starting a Vapenders program to address teen vaping. Seibert added that he had no data on whether his program would work with youth vapers. Another speaker said that she put her teen in a 30-day, in-house drug treatment program to help him stop vaping. She then stated that “he no longer vapes because he knows he will have to go back to the treatment facility.”

    Gottlieb closed his speech by saying that he had met with senior executives from the five largest e-cigarette manufacturers, and he would be calling some of them back to meet again. Those companies had previously given the FDA written commitments about the steps they would take to stop youth use of their products.

    “Are they living up to what were very modest promises? We all need to ask ourselves that question,” Gottlieb said. “But the major marketers of these products don’t seem to fully understand the scope of this challenge, or they don’t seem to be fully committed to their own stated commitments to curtail this youth use …. It matters if the e-cig makers can’t honor even modest, voluntary commitments that they made to the FDA. It informs how we shape our regulatory policies and our enforcement activities.”

    The FDA is not dependent on voluntary action. Gottlieb said that unless youth use is lowered, the debate will change to one of whether flavored products should continue to be marketed at all without going through the PMTA process. “It could be ‘game over’ for some [of] these products until they can successfully traverse the regulatory process,” he said. “I think the stakes are that high. And [it] would be a blow for all of the currently addicted adult smokers who, I believe, could potentially benefit from these products.”

    As for learning more about the potential role that drug therapies may play in helping youth addicted to nicotine, the FDA is still where it was before the start of this hearing.

    Picture of Timothy S. Donahue

    Timothy S. Donahue

  • The Flying Circus

    The Flying Circus

    America’s tobacco-control policy brings to mind a sketch from Monty Python—with potentially unfunny consequences.

    By George Gay

    If you were told that it had been proved that people smoke tobacco for the enjoyment they derive from nicotine, which is basically harmless, but die from the result of inhaling tar, it would be rational to postulate that reducing the tar produced during smoking could have a positive health outcome. Indeed, previous attempts have been made in the U.S. and Europe to do just that while keeping the nicotine level stable or even increasing it.

    What you wouldn’t suggest, I think, is lowering the amount of nicotine while retaining the tar. I mean, that would be laughable. Unless, of course, you were the U.S. Food and Drug Administration (FDA)—in which case it would make perfect sense.

    This isn’t quite as straightforwardly daft as it seems, of course. The argument for lowering the tar but not the nicotine is based on the idea that because cigarettes are—according to the FDA and just about everybody else—addictive, smokers cannot stop smoking this side of death, so the only thing to do is reduce the harmful component of this habit as far as possible. The reason that this has not been made to work is that, for reasons of taste, it is not possible to reduce tar levels far enough. This is a good example of the maxim, sometimes attributed to Albert Einstein, that, in theory, theory and practice are the same, but in practice they are not.

    The argument for lowering the level of nicotine, meanwhile, is based on the idea that this is the addictive component of cigarette smoke, and that reducing it to nonsatisfying levels would cause people to quit because they would no longer be getting their addictive fix. To my way of thinking, such an idea might be worth trying if it involved gradually reducing the nicotine deliveries of all cigarettes on a particular market over time, perhaps 10 years or so. But this is not what the FDA is looking at, or is being urged to undertake, as I understand it. The idea is that you go to near zero nicotine in one hit. In this case, to my mind, the idea doesn’t work even as a theory because it relies on your being able to keep two opposing ideas in your head at once, which is a trick usually confined only to artists. You must be able to believe at one and the same time that nicotine is and isn’t addictive. That is, the theory comes hard up against one of the basic tenets of rational thought: that P cannot be both Q and not Q simultaneously.

    HOW DID WE GET HERE?

    How has the U.S. tobacco products environment reached this strange place? I think the answer has to do with ideology. If you’ve followed the FDA since it was granted regulatory powers over tobacco products through the Family Smoking Prevention and Tobacco Control Act that was signed into law in 2009, you might have noticed that it resembles the monks in Monty Python and the Holy Grail, hooded to protect their senses from external ideas and beating themselves about the head with pieces of wood to keep on-message.

    OK, some will retort that this is unfair—that, a year or so ago the FDA came up with its comprehensive plan for tobacco and nicotine regulation that places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. And they will say that the FDA has been seeking public comment. This is true, but every utterance the FDA makes seems to indicate that it has already made up its mind.

    Basically, there are two arms to its plan, one of which involves lowering nicotine levels in combustible cigarettes to nonaddictive levels, the other of which involves encouraging innovation in respect to nicotine products. But the tragedy is that, in reality, the FDA, while hurrying ahead with the first arm of its plan, is dawdling or even backsliding in respect to the second.

    Writing at blog.heartland.org in July 2018, Jeff Stier, senior fellow at the Consumer Choice Center and policy advisor to The Heartland Institute, said in part that last July’s extension of timelines for manufacturers to submit electronic cigarette review applications had given the FDA the chance to develop product standards and offer companies guidance on what a successful application must include. “On that front, the FDA has been eerily silent, even as the previously extended deadline looms,” he said. “Instead, it issued a second ANPRM [Advance Notice of Proposed Rulemaking], a precursor to a possible ban on certain e-cigarette flavors, as the agency seeks to better understand how flavors may appeal to youth as well as the crucial role they play in helping adult smokers quit. Instead of keeping its promise to foster harm-reducing innovation, the agency is contemplating a crushing blow to the most significant competitive threat to the cigarette industry in history.”

    Like the Python monks, the FDA is wandering, hooded, beating itself with pieces of wood and presumably chanting obsequies to the e-cigarette category: Pie Iesu domine, dona eis requiem, thwack. Pie Iesu domine, dona eis requiem, thwack ….

    Or could it be that the FDA is simply taking its time over the issue of e-cigarettes? Its latest initiative is referred to as a multiyear plan, which when translated from agency speak probably means multi-decade plan, except that is in the case of reducing nicotine levels in combustible cigarettes.

    Even the National Tobacco Reform Initiative (NTRI), which is generally supportive of the FDA’s plan, in July 2018 tried to encourage a sense of urgency in carrying out all aspects of the plan. In a letter to the FDA commissioner, Scott Gottlieb, on the one-year anniversary of his announcement of the plan, the public health leaders who are part of NTRI said that while they had seen progress during the past 50-plus years in respect to declining smoking prevalence, an estimated 32 million U.S. adults still smoked cigarettes. “Cigarette smoking remains this nation’s leading cause of preventable disease and death, responsible for about 480,000 deaths each year and costing this country approximately $300 billion in healthcare costs and lost productivity,” the NTRI said in a press note that accompanied the letter. “With so many lives on the line each year, there must be an urgency to take bold, visionary actions immediately to reduce the disease burden that smoking addiction inflicts on the health of Americans.

    “While the NTRI fully supports the FDA’s announced visionary initiatives, we are concerned that the FDA is/will become mired in overly bureaucratic processes that will delay taking necessary and obvious steps to protect the public’s health. While some attention is being focused on the priority to consider reducing nicotine levels in cigarettes, the other equally important priority to establish a more workable and flexible regulatory framework to regulate all tobacco and nicotine products based on their risks and relative risks (continuum of risk) is nowhere to be seen.”

    HERD INSTINCT

    Why has the agency’s attitude toward e-cigarettes reached such a pass? It’s down to an ideology that afflicts a large section of tobacco control. In a piece published at the beginning of May, Alex Berezow, senior fellow of biomedical science with the American Council on Smoking and Health, made the point that, not long ago, if a company had invented a far safer way to deliver nicotine to addicted smokers, politicians would have been celebrating. But today, partisanship had ruined just about everything.

    “I knew something was amiss when I spotted an advertisement in a Seattle light rail car,” Berezow said. “The ad warned potential vapers not to be ‘fooled’ by e-cigarettes, which it said were toxic, addictive and unsafe. Yes, they are addictive (because they contain nicotine), but calling them toxic and unsafe is absurd. Compared to regular cigarettes, vaping devices are 95 percent safer, according to the U.K.’s NHS [National Health Service]. In other words, if Seattle smokers follow their own public health department’s advice, they are likelier to die. Why on earth would a public health department give such terrible advice? Because the debate over vaping isn’t about science; it’s about ideology.”

    As I was about to finish this piece, Gottlieb and Mitch Zeller, director of the FDA’s Center for Tobacco Products, issued a note in which they outlined updates and new initiatives from the FDA on the anniversary of the Tobacco Control Act and the FDA’s Comprehensive Plan for Nicotine. But, according to my reading, what they said would have done little to relieve the concerns expressed above.

    Berezow is surely right about the agenda’s being driven by ideology. But it is also being driven by the herd instinct and panic. The fuss in the U.S. over e-cigarettes and, especially, the Juul beggars belief. Some tobacco control advocates in the U.S. have put it about, on no evidence as far as I can see, that e-cigarettes constitute a gateway product. That is, those who use these products move zombie-like toward combustible cigarettes and, therefore, a wasted life of utter degradation. These messages have been picked up by the press and, on reading the press reports, the tobacco control advocates point to them and say, “We told you so.” In the U.S., which I always saw as the place where the market was king, the Juul, a hugely successful product with the potential to shift many smokers from combustible cigarettes to vaping, has been demonized. Anyone reading reports about it would believe that teenagers who use vapor products are immediately sold into slavery.

    In a country where 7-year-olds can work on tobacco farms, Gottlieb and Zeller could hardly contain themselves in expressing their zeal to keep nicotine products out of the hands of what they like to refer to as kids, children, youth … until you’re not sure how old some of these youngsters are. “We’ll use every tool available to protect our nation’s kids,” they boldly declared. In fact, this goal is so important to them that part of the heading of their update is: Advancing Tobacco Regulation to Protect Children and Families. That is, they take the children out of the families and set them apart.

    I’m certain that these two men are sincere, and I accept that they’re under tremendous pressure from those who live at the butt end of the quit-or-die rainbow, but the emphasis on e-cigarettes is simply over the top. Google “child poverty in the U.S.” and what you will read is really disturbing. If even half of what is described is true, it is shameful in such a rich country.

    According to the Feeding America website, “[F]or the nearly 13 million kids in the U.S. facing hunger, getting the energy they need to learn and grow can be a day-in, day-out challenge. Although food insecurity is harmful to any individual, it can be particularly devastating among children due to their increased vulnerability and the potential for long-term consequences.” And Feeding America went on to say that such disadvantaged children were more prone to illnesses, performed badly at school and were less likely to do well in the job market. “Studies have also shown time and time again that even mildly undernourished children may potentially suffer abnormal brain, cognitive and psychological impairment that, if not corrected, can be irreversible,” the note said.

    Where is the alarm, the anger and the indignation over this situation? Where are the lofty declarations that every tool will be used to end this situation? The irony is that the word “food” is in the FDA’s title, whereas the word “e-cigarette” is not. Sure, the FDA’s remit is probably about food safety. But surely food safety should involve food security—making sure every child has nourishing meals every day. There’s no point in spending money making sure food is unadulterated if it doesn’t get eaten. As can be seen by the Gottlieb and Zeller statement, the FDA expends a lot of resources trying to keep e-cigarettes out of the hands of youngsters. Those resources would be better spent making sure that nourishing food gets into the hands of youngsters.

    The FDA seems to be worried about the better-off children who can afford e-cigarettes, and I would agree that they shouldn’t be ignored. But everything points to the fact that these youngsters are at little risk except in the minds of the Janus heads who believe that young people are attracted to e-cigarettes by their sweet flavors and then to cigarettes, presumably by their not-sweet flavors.

    But what are the facts? Well, according to Robert Goldberg, vice president at the Center for Medicine in the Public Interest, a recent survey found that 2 percent of respondents who hadn’t previously smoked cigarettes began doing so after using e-cigarettes.

    In an opinion piece published at the end of July on www.insidesources.com, Goldberg said that a new survey of e-cigarette users conducted by the independent Center for Substance Use Research in Glasgow had added to a growing body of evidence suggesting that the negative association between e-cigarettes and smoking was causative, not merely correlative. “The center surveyed nearly 19,000 users of Juul e-cigarettes, which command about half the U.S. market share,” he said. “Nearly two-thirds of respondents who were current smokers at the time they began using e-cigarettes quit smoking as a result. Compare this quit rate to other nicotine-replacement therapies, including gums and patches, of less than 7 percent. More than half of cigarette smokers in the survey who weren’t able to quit were nevertheless able to cut their cigarette consumption by 50 percent to 99 percent after they began using e-cigarettes.

    “Meanwhile, just 2 percent of respondents who hadn’t previously smoked cigarettes began doing so after using e-cigarettes. This suggests the gateway effect that e-cigarette critics fear is minimal to nonexistent. For every one respondent who started smoking after using an e-cigarette, 137 quit. Many more significantly reduced their consumption.”

    These results were in line with other research, Goldberg said.

    Picture of George Gay

    George Gay

  • Worlds Apart

    Worlds Apart

    Despite a shared culture and heritage, the U.K. and the U.S. find themselves at polar opposites of the spectrum in their attitudes toward vaping.

    By Maria Verven

    While there are more vapers in the U.S. than there are in the U.K., vaping is more prevalent in the U.K. when calculated as a percentage of the overall population.

    The reason? In the U.K., vaping is far less stigmatized socially, and it has been heartily endorsed by key public health organizations for “preventing almost all the harm from smoking.”

    Let’s find out the other reasons why these two countries are worlds apart.

    THE U.K.: ACKNOWLEDGING WHERE E-CIGARETTES ARE ON THE RISK CONTINUUM

    While the U.K. has imposed very strict regulations on e-cigarettes and e-liquids, key organizations including Public Health England (PHE) and the Royal College of Physicians (RCP) agree that vaping is far less harmful than smoking traditional tobacco products.

    The EU Tobacco Products Directive (TPD) provides the framework and regulations for all e-cigarettes and e-liquids containing nicotine. The TPD’s regulations outline minimum standards of safety and quality for anyone who manufactures, imports, or rebrands e-cigarettes and e-liquids.

    Among the guidelines are limits on the capacity of vapor tanks and e-liquid bottle sizes as well as restrictions on certain ingredients and coloring agents. There is a six-month approval period for new e-liquids and hardware. The TPD also regulates the allowable level of nicotine, so portable vapor devices such as the Juul that contained higher nicotine levels were not allowed (Juul Labs recently developed reduced-nicotine pods that meet the guidelines).

    Consumers and healthcare professionals can report adverse events and safety concerns to the U.K.’s Medicine and Healthcare products Regulatory Agency (MHRA) through a “Yellow Card” reporting system.

    But compared with the U.S., the U.K. sees much less disruption, thanks in part to the huge increase in e-cigarette use and a regulatory environment that appears to be informed on how e-cigarettes factor into the risk continuum. In fact, e-cigarette campaigners have even been assured by the Department of Health and Social Care and the designated approval agency that they will turn a blind eye toward any advertising promoting vaping as a safer alternative.

    MEANWHILE IN THE U.S.: BANS AND INCREASING RESTRICTIONS

    The Tobacco Control Act gave the U.S. Food and Drug Administration (FDA) authority over all tobacco products, and in May 2016, the FDA extended this authority over all electronic nicotine-delivery systems (ENDS), including e-cigarettes and vape pens.

    Manufacturers and importers selling vapor products and e-liquids made on or before Aug. 8, 2016, were required to submit a list of all ingredients to the FDA by November 2017; small-scale tobacco product manufacturers were given another six months.

    Submission of premarket tobacco product applications (PMTAs) for all noncombustible products, including e-cigarettes, is due on or before Aug. 8, 2022, when manufacturers must demonstrate that marketing the new tobacco products “would be appropriate to protect public health.” The FDA claims it will consider the risks and benefits to both users and nonusers when reviewing each product’s components, ingredients, additives and health risks in addition to how the product is manufactured, packaged and labeled.

    Ironically, the FDA’s deeming regulations don’t impose the same types of specific manufacturing guidelines as the TPD. They don’t outright prohibit any particular ingredients, set maximum nicotine levels or even require the use of child-resistant packaging. Since many e-liquid manufacturers also sell across the pond, they have been engineering their products and packaging to comply with the TPD’s guidelines. In fact, many bolstered their quality-assurance measures by implementing good manufacturing practices (GMPs) and building ISO 7 state-of-the-art cleanrooms in an effort to build public confidence and to stay one step ahead of potential FDA requirements.

    Despite this, many U.S. legislators continue to express concerns about e-cigarettes and who’s using them—particularly teens—siding with the popular stance that these products are “bad.” Coupled with a huge increase in the popularity of vapor devices such as the Juul, regulators and legislators have tried to outdo each other by proposing even more forceful actions to “stem this dangerous trend, including revisiting our policy that extended the compliance dates for e-cigarette manufacturers, including flavored e-cigarettes, to submit applications for premarket authorization,” according to FDA Commissioner Scott Gottlieb.

    So it came as no surprise when in November 2018 the FDA announced new restrictions on the sales of flavored e-cigarettes, except those flavored with menthol and mint. They have yet to specify a timeline for implementing the new proposal, which also requires stores to have secure areas that are restricted to adults over the age of 18. Ironically, this keeps e-cigarettes off the shelves of most convenience stores and gas stations, where traditional cigarettes continue to be sold. They also proposed new age-verification standards for online retailers selling e-cigarettes.

    THE U.K.: ENDORSEMENT BY THE HEALTH COMMUNITY

    London’s Royal College of Physicians (RCP) not only endorsed the use of e-cigarettes as smoking cessation aids; it also concluded that e-cigarettes can “prevent almost all the harm from smoking.”

    “Large-scale substitution of e-cigarettes for tobacco smoking has the potential to prevent almost all the harm from smoking in society,” the RCP states. “Promoting e-cigarettes and other nontobacco nicotine products as widely as possible as a substitute for smoking is therefore likely to generate significant health gains in the U.K.”

    In fact, in the U.K., the health community is launching a new campaign to convince smokers that vaping is not only less harmful than smoking combustible cigarettes; it’s also a good way to quit. In one short video, an experiment was conducted to collect the sticky black tar that accumulates in the lungs of a heavy smoker in a jar, while showing that vaping the same amount of nicotine collects only a trace of residue.

    And last year, PHE, the world’s oldest public health commission, even recommended that e-cigarettes be made available by prescription because of how successful they were in helping thousands of U.K. citizens quit smoking. PHE even recommended that the devices be made available for purchase in U.K. hospitals.

    PHE says that although e-cigarette use did rise among young people in England, the numbers have flattened off since 2015. “There are no studies that show vaping increases tobacco use among young people in the U.K.,” said Martin Dockrell, head of the tobacco control program at PHE.

    PHE says that e-cigarettes could help many more people quit smoking. Data from its smoking cessation program showed that 65 percent to 68 percent of people who used e-cigarettes as well as nicotine-replacement therapies succeeded in quitting.

    “It would be tragic if thousands of smokers who could quit with the help of an e-cigarette are being put off due to false fears about safety,” said John Newton, PHE’s director of health improvement. “We need to reassure smokers that switching to an e-cigarette would be much less harmful than smoking.”

    MEANWHILE IN THE U.S.: FEARMONGERING PERSISTS

    Despite all of the e-cigarette studies that have been conducted, including the Drexel University study that concluded, “It’s about as harmless as you can get,” the U.S. public health community continues to fuel concern and controversy.

    Myths persist around what’s in e-liquids, despite the rigorous testing and numerous studies that have been conducted not just on e-liquids but also the resulting vapor that is produced. Undocumented, unsubstantiated reports of diacetyl, formaldehyde and other aldehydes stoke fear and spread the gross misperception that e-cigarettes are as harmful as traditional combustible cigarettes.

    Follow the money, and you’ll find that health organizations receive millions of dollars from pharmaceutical companies. So it’s no surprise that they demonized vaping and lobbied for bans, according to Bill Godshall, the founder and executive director of Smokefree Pennsylvania and a passionate advocate of vaping.

    “If you want to keep money flowing in from Big Pharma, you’ll keep hawking their products. That’s not public health information,” Godshall said.

    But by far the greatest hurdle to the industry is the FDA, according to Godshall, Gregory Conley of the American Vaping Association and other vaping advocates. Recent moves by the FDA to restrict or ban the sale of flavored nicotine pods will only serve to make it harder for adult smokers to switch to a far less harmful alternative, Conley said.

    “For many smokers, it will be much easier to pick up a pack of Marlboros or Camels—or even an unrestricted cherry-flavored cigar at a local convenience store—than it will be to make the switch to a vaping product that truly helps him or her break their desire for cigarettes,” said Conley.

    “Cigarette smokers have a human right to truthful health information and legal access to less hazardous alternatives,” Godshall said. “The FDA and public health agencies have an ethical duty to inform smokers that e-cigarettes are far less hazardous alternatives to cigarettes and to keep these alternatives on the market as long as highly addictive, lethal cigarettes remain legal.”

    In summary, the burdens being imposed on the U.S. vapor community by federal, state and local legislators raise serious ethical questions. Taken altogether, the bans and restrictions on vaping, scare tactics and misinformation campaigns, as well as egregiously high taxes on vapor products can potentially doom millions of people—particularly those crippled by poverty and mental illness—to a lifetime of smoking.

    All Americans have to do is look across the ocean to see how another country is providing the facts and endorsing a product that could save millions of lives.

    Picture of Maria Verven

    Maria Verven

    The original “Vaping Vamp,” Maria Verven owns Verve Communications,
    a PR and marketing firm specializing in the vapor industry.

  • Monkey business

    Monkey business

    Seven quick questions—and answers—about retailing vapor products

    By Timothy S. Donahue

    After smoking combustible cigarettes for more than 18 years, Kris Zarate wanted nothing more than to quit. After discovering e-cigarettes, he realized that they truly did help people stop smoking. If vapor worked for him, he figured, then these new products could work for anybody looking for an alternative to cigarettes.

    This is a story told time and time again in the industry. Ask vape shop owners why they opened their businesses and the most common answer will be to help people quit smoking cigarettes. In early 2016, the business ratings website Yelp listed 10,591 U.S. companies that identified as vape shops. That amounts to nearly 2.7 vape shops for every bowling alley in the nation and about four for every comic book store. That’s a lot of ex-smokers helping current smokers find a less risky way to consume nicotine.

    Zarate is now the owner of Vape Monkeys, with two locations in Chicago, Illinois, USA. He says that taxation is as much a threat to his business as are the U.S. Food and Drug Administration’s (FDA) new regulations. In Pennsylvania, for example, a recently passed revenue package would put a 40 percent wholesale tax on e-cigarettes, liquid cartridges and vapor devices. In Chicago, vape shops must apply not only a 10.25 percent sales tax to vapor products but also an additional $0.80 per “product unit” and $0.55 per milliliter of vape-able liquid. This means a $10 10 mL bottle of e-liquid costs $17.33 after taxes.

    “These tax policies are forcing shop owners to sell vapor products for more than it costs for someone to just keep smoking cigarettes,” says Zarate. “We need to incentivize quitting cigarettes; making cigarettes less expensive than e-cigarettes goes against improving overall public health, which is the stated goal of the FDA.”

    It is essential that vape shop owners be realistic in a post-FDA regulatory environment, according to Zarate. “Businesses need to focus on continuing their mission and stay true to their goals,” he says. “This will help define your business as the industry moves forward.” Vapor Voice recently sat down with Zarate so he could answer seven quick questions on the possible future of Vape Monkeys and share his outlook on the future of the vapor industry overall.

    Vapor Voice: What motivated you to get involved in the vapor industry?

    Zarate: Vapor products were the only method that worked for me. I quit after being a cigarette smoker for over 18 years. I was working a trade show with my previous job, and I saw people walking around and coming by my booth vaping. I was very curious, so I visited a company that was selling vapor products to get more information. I instantly realized this was a great industry to be in to help smokers kick the habit.

    What is the Vape Monkeys philosophy? How do you approach current smokers looking to switch or the newcomer just learning to vape?

    The Vape Monkeys philosophy is simple: Help people quit smoking cigarettes and introduce them to what we see as a better option. How we teach our employees to approach newcomers to the industry is to first explain the benefits of vaping compared to traditional cigarettes by comparing what you’re actually inhaling into your body. With all of our customers we take the time to explain the proper and safe way to use the products they purchase. If they ever have any questions, we are here for them.

    Have you noticed any change in business since the deeming regulations deadline, August 8?

    Yes, I have. I’ve noticed a huge drop in sales and customers coming into the stores. This can be attributed to the new FDA regulations, false information by writers paid by big tobacco companies and a forced tobacco tax in our county. These changes were only put out to scare current vapers and those looking to quit smoking, and to raise the taxes on nontobacco products and e-liquids. States are losing money as more people quit smoking, and they want to make sure they don’t lose that revenue stream.

    What needed to be done to get ready for the FDA’s deadline, and how do you anticipate moving forward?

    There were a lot of changes that needed to be done at the stores to get ready for the FDA’s deadline. I had to remodel all of my locations to meet the regulations the FDA is enforcing for shop owners. All I can really hope for moving forward is to keep my business alive and try my very best to give newcomers and experienced vapers quality products, and help them keep vaping. We have to be proactive in helping end the deaths caused by cigarettes and get the word out that vaping saves lives.

    How do you seek out products for your shop, where do you source information on the latest hardware and e-liquids?

    Every shop owner has their own methods of picking products to bring into their shops. With hundreds and thousands of hardware and e-liquids on the market, it does get overwhelming sometimes. With hardware, I do a lot of research, reading reviews and asking people what they think about the product before I make any purchases. I strongly believe in giving my customers quality products first. As for e-liquids, I am very picky about what I actually sell to my customers. I might use social media to check out the latest products, and customers request some products as well. Once I get samples from e-liquid companies, I personally try them first. Then my employees and customers try them out so we can get some feedback. I also try to not stock flavors that taste similar to what we already have available. This gives everyone a wide variety. Customer input is very important because everyone has a different palate when it comes to taste.

    Where do you see the future of the vapor industry?

    In my opinion, the future of the vaping industry is all about growth. This year, the vape industry has hit a lot bumps in the road, from the FDA and state regulations, taxation. However, vaping is still much safer than smoking cigarettes. All that vapers, shop owners, e-liquid and hardware manufactures can hope for is improving the industry by educating consumers and continue research that produces hard evidence that vaping is a safer alternative to smoking.

    Any advice for fellow vape shop owners stressing over the future of their businesses?

    My only advice to fellow shop owners is to just hang in there, be positive and don’t give up too soon. If this is your first and only business, remember that every business faces challenges. The vape industry isn’t going anywhere and will continue to grow. Stay strong in your mission to save lives.