On Dec. 23, the FDA authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products (MRTP). As part of the MRTP designation, 22nd Century may inform consumers that smoking VLN cigarettes will considerably reduce their exposure to nicotine.
According to Bates, the FDA decision is misguided because the cigarettes retain the tar that is responsible for smoking-related illness. “We have known for a long time that ‘people smoke for the nicotine but die from the tar,’” writes Bates on his blog.
“The only value these products have in public health terms is if smokers don’t use them because they are so unsatisfying, and switch to something with lower risk. If they do use them, they are still exposed to thousands of toxins from smoke,” writes Bates. “However, the purpose of the marketing communication is precisely to encourage people to buy these products.”
If smokers want to reduce their health risks, they are far better advised to switch to a non-combustible vaping or heated tobacco product, according to Bates.
“So for health-conscious smokers, this is a diversion from a strategy that would actually help them. Instead, the authorized claims falsely promote reduced nicotine exposure as a health benefit.”
When it comes to government regulation, it’s sometimes hard to get the details right, according to Steven Greenhut in an opinion hew wrote for InsideSources. He says that the Utah Department of Public Health’s proposed new rules that would reduce the amount of nicotine that sellers and manufacturers can include in their “closed-system” electronic cigarettes derail harm reduction efforts.
Two years ago, the agency adopted a compromise that capped the amount of nicotine in closed vaping products at 5 percent. That 2019 rule attempted to protect consumers from the over-consumption of nicotine. But the 5 percent cap still enabled vape users to consume a sufficient amount of nicotine to satisfy their cravings. However, the newly proposed regulation would reduce the nicotine cap to 3 percent.
Greenhut states that the proposed rules could make consumers vape more than they do now, switch to open systems that allow the use of higher-nicotine liquids or even mix their own e-liquid recipes, raising a host of troubling health concerns. Some might even return to cigarette smoking.
“Regulators, at the behest of anti-smoking activists, are missing the forest for the trees—or at least overlooking the 7,000 carcinogenic chemicals that make traditional cigarette smoking so detrimental while focusing on one highly addictive but not particularly dangerous substance,” he states. “Many public-health advocates take a zero-tolerance approach toward anything tobacco or nicotine-related. They seek to ban—or overly regulate—e-cigarettes as a means to reduce availability. Their goal is abstinence, although they often support the use of Food and Drug Administration (FDA)-approved smoking-cessation products, such as patches and gum, that contain some nicotine.”
In their zeal to quash the use of vape and other lower-risk nicotine products, health advocates are endangering public health, explains Greenhut. “One needn’t be a health expert to realize that if nicotine-addicted people can’t get enough nicotine to fulfill their needs, they will try alternatives,” he states. “Utah already adopted a defensible approach to nicotine regulation. Maybe now, the best approach is to leave well enough alone.”
Steven Greenhut is Western Region director for the R Street Institute.
In 2018, the U.S. Food and Drug Administration (FDA) and then-Surgeon General Jerome Adams declared a so-called youth vaping epidemic. Lawmakers across the country, from city council members, to state leaders, to Congress, have been attempting to reduce youth use of e-cigarettes and vaping products ever since, Lindsey Stroud wrote for Inside Sources. Addressing youth use of any age-restricted product is laudable, but it should not come at the expense of adult users of such products. And all policies introduced by well-intended lawmakers threaten adult access either through bans, arduous regulations, or unfair taxation.
A quick glance at existing data on youth e-cigarette use finds many of these “solutions” fail to address the real reason why youth use e-cigarettes. Officials completely disregard that youth smoking rates are at all-time lows. Such legislation threatens adult access to tobacco harm reduction products and is unlikely to reduce youth e-cigarette use.
Take, for example, the impending ban on mailing vapor products. Crammed into the 5000+ pages of the December 2020 COVID-19 relief bill was an amendment to include electronic cigarettes in the Prevent All Cigarette Trafficking (PACT) Act. Not only will the new regulation ban the shipment of e-cigarettes in USPS mail it will also require retailers to register with the Bureau of Alcohol, Tobacco, Firearms and Explosives, as well require sellers, to submit monthly reports to the state agency that handles tobacco taxes in all states where their products are sold.
Lindsey Stroud
The amendment was introduced by Sen. Dianne Feinstein (D-CA), who erroneously claimed “[b]uying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products.”
Several state-based youth surveys have shown youths are not relying on the internet to obtain e-cigarettes. For example, in 2019, in Vermont, among current e-cigarette users, only three percent of high school students under 18 years of age reported buying vapor products online. Conversely, 52 percent of minors reported borrowing e-cigarettes. In aggregate data of all students from five different state high school surveys including Arkansas, Maryland, Montana, New Hampshire, and Rhode Island, only 0.9 percent of high school students reported purchasing vapor products from online retailers. With very few youths using the internet and mail to obtain e-cigarettes, a ban on the shipment of such products is highly unlikely to reduce underage e-cigarette use.
The mail ban isn’t the only flawed “solution” proposed by lawmakers. Many localities and states have banned, or are attempting to ban, the sale of flavored vapor products. Yet again, the data overwhelmingly indicate youth use e-cigarettes because of “other” reasons and because friends and family members use them. For example, in the aforementioned Vermont survey, when asked about the “primary reason” for using e-cigarette products (among current users) only 10 percent reported “flavors,” compared to 51 percent who cited “other,” and 17 percent who cited friends and family. This data is similar to other states including Connecticut, Hawaii, Maryland, Montana, Rhode Island, and Virginia.
Again, banning flavors is unlikely to reduce youth use of e-cigarettes and it may also have adverse effects. In San Francisco, which banned the sale of flavored e-cigarettes in 2018, youth vaping still increased after the ban, but so did youth smoking rates. In fact, current combustible cigarette use among high school students increased from 4.7 percent of San Francisco high school students in 2017, to 6.5 percent in 2019.
In order to protect adult access, youth use of e-cigarettes and vapor products must be addressed, but bans are ineffective measures and ultimately punish adults. States do have one solution in place, borne by the pockets of the very smokers that are trying to quit by using flavor vapor products: the monies received from tobacco taxes and settlement payments.
Each year, states allocate a pitiful amount of existing tobacco dollars towards tobacco control measures, including cessation, education, and youth prevention. In 2019, states collected an estimated $16.7 billion in cigarette taxes and $6.2 billion in tobacco settlement payments, yet spent only $655 million in state funding on tobacco control programs. This is a paltry 3 percent.
Given the lack of funding dedicated towards programs to help smokers quit, policymakers should embrace e-cigarettes as they have been more effective at reducing smoking than the insufficiently-funded tobacco control programs.
As a tool that has helped millions of American adults quit smoking, lawmakers must avoid policies that preventing adult access to e-cigarettes and vapor products. They must also rely on existing data on why youth are using e-cigarettes when putting forth policies to limit youth e-cigarette use. To fail to do so harms millions of American adult smokers – and former smokers – and fails to reduce youth use.
Lindsey Stroud is the creator and manager of Tobacco Harm Reduction 101 (www.thr101.org), a website that provides analysis and insight on tobacco and vapor products.
As the Biden administration engages the COVID-19 pandemic, a public tug-of-war has emerged over who should be nominated to run the Food and Drug Administration, a pivotal participant in the effort, write Henry I. Miller and Jeff Stier for Issues & Insights. An analysis of the two perceived front-runners illustrates that neither would likely introduce the kinds of reform needed at the agency.
Jeff Stier / senior fellow at the Consumer Choice Center
One candidate is acting Commissioner Dr. Janet Woodcock, a long-serving top FDA official with widespread institutional respect, both inside and outside the agency.
To her (far) left is Dr. Joshua Sharfstein, who served briefly as deputy commissioner of the FDA in the Obama administration, and who formerly was the secretary of the Maryland Department of Health, as well as the health commissioner in Baltimore. Earlier in his career, Sharfstein was the health policy adviser to influential, liberal Congressman Henry Waxman, D-Calif. He is currently the vice dean for Public Health Practice and Community Engagement at the Johns Hopkins Bloomberg School of Public Health.
Woodcock’s strength is her extensive background in pharmaceutical regulation. However, some perceive her to be overly sympathetic to industry. Woodcock has been at the FDA for 35 years, and would be a sober, steady influence at a time that cries for stability at the agency.
But her institutionalism is also a weakness; all is not well at the FDA. As former Commissioner Frank E. Young quipped, “dogs bark, cows moo, and regulators regulate.” Consistent with that propensity, the FDA often exceeds its congressional mandate. Regulators have concocted additional criteria for marketing approval of a new drug beyond the statutory requirements for demonstrating safety and efficacy— requirements that sometimes inflict significant but obscure damage on both patients and pharmaceutical companies.
For example, regulators have arbitrarily demanded that a new drug be superior to existing therapies, although the Food, Drug and Cosmetic Act requires only a demonstration of safety and efficacy. And in a classic case of regulatory mission creep, Phase 4 (post-marketing) studies are now routine, whereas the FDA used to reserve them for rare situations, such as when there were subpopulations of patients for whom data were insufficient at the time of approval.
The effects of FDA regulators’ self-aggrandizing, excessively risk-averse actions range from the creation of disincentives to research and development (which inflates costs) to significant threats to public health, such as the years-long delay in approval of a much-needed meningitis B vaccine.
Another egregious example of the impact of excessive risk-aversion is the saga of a drug called pirfenidone, used to treat a pulmonary disorder called idiopathic pulmonary fibrosis (IPF), which used to kill tens of thousands of Americans annually. The FDA unnecessarily delayed approval of the drug for years, although it had already been judged to be safe and effective and marketed in Europe, Japan, Canada, and China. (This deadly delay occurred on the watches of both Woodcock and Sharfstein.) As a result, more than 150,000 patients died of IPF in the United States, many of whom could have benefited from the drug.
The agency’s handling of e-cigarettes over the last two administrations is a sorry illustration of how regulatory dilly-dallying undermines public health. The agency’s mealy-mouthed endorsement of vaping as only a “potential” tool for tobacco harm reduction for adult smokers failed to sufficiently encourage smokers to make the switch away from consuming nicotine in its deadliest form, the cigarette. As a result, not enough smokers have been using them, while too many kids have.
Contrast this with Public Health England’s clear endorsement of using e-cigarettes to quit smoking, which has led to a sharp reduction in smoking without an epidemic of youth vaping. Woodcock would be unlikely to break the FDA’s mold in this space, while Sharfstein’s blind opposition to private sector-driven innovative solutions would likely shift e-cigarettes from a highly regulated marketplace to an illicit market like the one that caused the outbreak of pulmonary illnesses related to THC-vaping in 2019.
The agency has become extremely top-heavy, with ever more boxes appearing at the top of the organizational chart, even though the vast majority of day-to-day oversight and regulatory actions are taken at the level of FDA’s various “centers” – Woodcock’s longtime perch, the Center for Drug Evaluation and Research, the Center for Food Safety and Nutrition, the relatively new Center for Tobacco Products, and so on. The FDA needs to be put on an organizational diet.
If Woodcock is the institutional pick, Sharfstein would be the Ralph Nader pick. In fact, Sharfstein’s affiliation with failed nanny-state presidential candidates is more current than that. His academic affiliation with the Bloomberg School of Public Health is no coincidence. An outspoken advocate for expanding the scope of the FDA, which already regulates 20 cents of every consumer dollar, Sharfstein would have been the obvious pick for FDA commissioner, or even secretary of the Department of Health and Human Services, if former New York Mayor Michael Bloomberg’s multi-million-dollar presidential campaign had prevailed. Far from putting the agency on a diet, Sharfstein would instigate a regulatory feeding frenzy.
What’s needed are structural, policy, management, and cultural changes that create incentives for the FDA to regulate in a way that is evidence-based and imposes the minimum burden possible. A number of possible approaches and remedies to accomplish that have been described, but neither Woodcock nor Sharfstein is likely to embrace any of them.
We need significant legislative changes, or just conscientious congressional oversight, to disrupt the agency’s built-in bias for overregulation, but political realities make that unlikely anytime soon.
Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. A 15-year veteran of the FDA, he was the founding director of the agency’s Office of Biotechnology. Jeff Stier is a senior fellow at the Consumer Choice Center. Please follow them on Twitter at @henryimiller and @JeffAStier.
If Health Canada has its way, this year vaping will be dealt three knockout blows that will see, not just the end of the business as we know it, but an increase in smoking-related deaths nation-wide, says Ian Irvine, a professor of economics at Concordia University.
Ottawa is recalibrating the delicate equilibrium between harm reduction and youth use of nicotine. It plans to introduce a mandatory limit on nicotine concentration in e-cigarettes and to ban most flavours. Maximum permissible content is currently at 66 milligrams per millilitre; the new limit will be 20. Eventually, we will see strike three: excise taxes.
Ian Irvine, courtesy Concordia University
Harm reduction tries to induce smokers to switch to nicotine products with greatly reduced toxins, particularly if they are habituated or even addicted to nicotine. Public Health England has repeatedly stated that the toxins in e-cigs are at most five per cent of those in regular cigarettes. The toxins that cause cancer come from the burning of tobacco at 700 degrees Celsius. But vaping devices heat rather than burn. Nicotine is not the health demon. It does cause habituation. But it’s the burning that shortens lives.
In an article for the Regina Leader-Post, Irvin explains that e-cigarettes are not harmless. The health problem vaping poses is that between five and 10 per cent of teens are regular vapers and nicotine is bad for the developing brain. But while a pack-a-day smoker will on average lose 10 years of life, an equally indulgent vaper might lose just one. Most adults who drink moderately, gamble, like sugar too much, or exercise insufficiently might think one year off a normal lifespan a reasonable price to pay to indulge a passion or need.
As for adult smokers, people considering a transition from smoking to vaping require a product yielding enough nicotine to satisfy their craving. Many potential switchers will not make the transition — and will end up dying prematurely — if they cannot get a strong enough nicotine substitute for their cigarettes. Canada has about 40,000 smoking-related deaths per year, so if even a small percentage of smokers don’t transition because of insufficient nicotine, that will mean thousands more deaths annually.
If Health Canada succeeds in introducing both a nicotine cap and a flavour ban on vaping, smoking rates will continue to be higher than necessary and many thousands of unnecessary deaths will folllow.
On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
A new year and new resolutions. In 2021, many Americans will attempt to lose the weight gained after weeks – and months – of stay-at-home orders. Some may have been inclined to reduce their Zoom time, but for many smokers the beginning of a new year marks a resolution to quit smoking.
Credit: Marko Tomic
This particular resolution is difficult. A 2016 study from the UK’s Royal Society for Public Health (RSPH) reported that “quitting smoking is the most difficult resolution to keep,” and that among Brits who reported making a resolution to quit smoking, “41% kept this for a month, [and] 13% [stuck] with it after a year.” A study from the University of Scranton found “only 8 percent of people who make resolutions [to quit smoking] meet their goal.”
Regardless if one is choosing to quit smoking as a New Year’s resolution, giving up cigarettes is difficult any time of the year. According to the Centers for Disease Control and Prevention, less “than one in 10 adult cigarette smokers succeed in quitting each year,” and in 2018, only 7.5 percent of smokers had successfully quit smoking.
There are many options for smokers to use to help aid their smoke-free journey, including traditional nicotine replacement therapies (NRT) like gum and patches, medication, and switching to electronic cigarettes and vapor products. In the aforementioned RSPH report, the agency noted vapor products “are becoming increasingly popular, and RSPH [recognizes] the growing body of evidence that for many they can be an effective smoking cessation tool.”
A landmark October 2020 review published in the Cochrane Library Database of Systematic Reviews examined 50 completed studies on e-cigarette use, which represented more than 12,400 e-cigarette users. The authors found that there was “moderate-certainty evidence, limited by imprecision, that quit rates were higher in people randomized to nicotine [e-cigarettes] than in those randomized to nicotine replacement therapy.” Indeed, the authors found that of “every 100 people using nicotine e-cigarettes to stop smoking, 10 might successfully stop, compared with only six of 100 people” using NRT or “nicotine-free e-cigarettes.”
Despite the science presented, many lawmakers are disregarding the evidence and seeking to limit and/or prohibit adult access to vapor products. Currently, New Jersey, New York and Rhode Island have banned the sale of flavored vapor products. Massachusetts has a current ban on both flavored combustible cigarettes and e-cigarettes, and California’s own flavored tobacco and vapor ban is currently delayed as officials verify signatures for a referendum that would create a ballot measure to repeal the flavor ban in 2022.
Worse, politicians have used the novel coronavirus to push through legislation that bans the United States Postal Service (USPS) from delivering vapor products. Literally “buried” in the thousands of pages in the December COVID-19 relief package is the “Preventing Online Sales of E-Cigarettes to Children Act” which orders the USPS to “promulgate regulations” to apply the Jenkins Act – which currently forbids the shipment of cigarettes by the USPS – to vapor products. The legislation also imposes greater tax reporting requirements on business sales of vapor products that are shipped by the USPS.
Although addressing youth use of e-cigarettes is laudable, essentially preventing online sales of vapor products will harm consumers of those products as retailers are forced to rely on an even limited number of delivery services to ship their products. FedEx recently announced that beginning on March 1, 2021 the delivery service “will begin prohibiting electronic cigarettes, vaping liquids, and other vaping products in the FedEx global network.”
New Year’s resolutions shouldn’t be broken because of government regulations. Former smokers should not be fearful of a possible return to cigarettes because policymakers are preventing access to tobacco harm reduction products. Perhaps the only good thing is that this year, unlike other New Year’s resolutions, smokers can blame the government on their broken resolution to quit smoking.
The views expressed in the above opinion are those of the authors’ and do not necessarily represent or reflect the views of Vapor Voice or its parent organization.
Lindsey Stroud is the creator and manager of Tobacco Harm Reduction 101 (www.thr101.org), a website that provides analysis and insight on tobacco and vapor products. She wrote this for InsideSources.com.
New Year resolutions always include commitments to quit smoking. Most people fail not for want of trying but for want of options that can help them. Our interventions to date are not good enough. Will the World Health Organization’s (WHO) campaign to help 100 million people quit tobacco (WHO News Release Dec 8, 2020) make a difference? Is the WHO willing to embrace new methods and emerging scientific data to course correct and in the process save millions of lives?
Credit: Martin Budenbender
The WHO depends upon “new contributions from partners” to help smokers quit (WHO News Release Dec 8, 2020), Derek Yach and Chitra Subramaniam write in an opinion for Business Insider. They are as diverse as Amazon Web Services, Facebook, and Google. These digital giants are not known for their solutions to help people quit. Worse, WHO has turned to Allen Carr’s Easyway that has published studies of dubious quality and has a strong opposition to the use of nicotine even in nicotine replacement therapy (NRT Allen Carr, BMJ 2006).
Unfortunately, most of the countries listed as priorities for this campaign have yet to include NRTs in their national drug formularies despite WHO having included it in the Essential Drug list way back (Application for Inclusion of Nicotine Replacement Therapy (NRT) in the WHO Model List of Essential Medicines, WHO, 2009).
WHO should conduct an independent review of the evidence of each partners’ interventions in the very diverse set of countries where they will be tested. Such a review is a basic requirement for making global recommendations. It must be as rigorous and science-based as the processes that were put into action to approve COVID 19 vaccines. (WHO News Release Dec 31, 2020)
Florence, WHO’s robotic digital health worker was launched with this campaign to help smokers quit. Dr. Yach tried it (see Speak to Florence) but found Florence true to its name – robotic and unable to answer simple questions and clearly out of depth when asked real world questions outside of the algorithm. A gimmick of this nature is disrespectful as it mocks those seeking to quit.
It seems that WHO is far more interested in ending the use of tobacco harm reduction products than in saving lives.
The latest Global State of Tobacco Harm reduction (GSTHR) report (GSTHR, Burning Issues 2020) indicates that almost 100 million people are now using a range of such products with most completely off combustible cigarettes and toxic smokeless tobacco products. This report provides convincing evidence that harm reduction products, including snus, e-cigarettes and heated tobacco products, are more effective means of quitting than the use of NRTs, and substantially lower exposure to harmful products of combustion seen in cigarettes and bidis.
In contrast, WHO’s latest report from their expert committee on Tobacco Product Regulation, released December 23rd, recommends banning and prohibiting e-cigarettes and heated tobacco products. This echoes a call by the Union, a Bloomberg Philanthropy financed NGO, to all low and middle income countries (LMICs) to ban such products to “avoid being distracted” by them (WHO Expert Committee Meeting Report, Dec 23, 2020).
Distraction from what one may ask?
This “expert” report did not address snus. That may be because WHO accepts the EC ban as being the basis for its policies despite the recent USFDA decision that led to it being the first class of tobacco harm reductions products to pass its rigorous evaluation process (FDA News Release, Jul 2020).
Before the FCTC negotiations began 20 years ago under Dr. Yach’s leadership of the Tobacco Free Initiative (TFI) WHO invited tobacco industry scientists to present to the fledgling Tobacco Products Regulation Expert Committee on their progress in developing safer tobacco products. The presentations were not useable then for any specific harm reduction recommendations to be made. The hope remained that in time scientific progress would follow. For that reason – and in good faith – harm reduction found its way into the very definition of tobacco control used in the FCTC (WHO FCTC 2004).
Decades have passed and tobacco consumption continues to kill people mainly in LMICs. Science and innovation have permeated every sector of society. Dirty legacy industries are now leaders in driving sustainable development. This is underway in the oil and gas, transport, mining and food sectors. And as the GSTHR and our Tobacco Transformation Index (https://tobaccotransformationindex.org/) bears out, such transformation is underway in the tobacco sector as well. This transformation should be embraced by the WHO not shunned.
Instead of looking into the future and enabling global leadership, the United Nation’s (UN) top health agency is digging into its past with a ferocity that is difficult to comprehend. Ignoring decisions by the United States Food and Drug Administration (FDA), Cochrane Collaborating Centers and other regulatory and science oversight groups indicating the power of THR to increase quit rates more effectively than NRTs for example, or the potential to sharply reduce risks associated with combustible cigarettes or toxic smokeless products.
One hopes that as 2021 unfolds, WHO will take a fresh look at the power of THR to accelerate an end to smoking. A good way to start would be to summon the leading scientists from tobacco and e-cigarette companies to present to the WHO Tobacco Product Regulations Expert Committee in a series of open sessions. The aim could be simple: to assess whether industry has made material progress in developing products able to end smoking in order to truly judge whether the unilateral bans and prohibitions are warranted.
From what we know, the answer is yes. WHO’s unambitious aim of helping 100 million of the 1.1 billion tobacco users quit could be revised upwards dramatically if they were to open up to rapid progress underway in the very companies we rightfully condemned 20 years ago.
Knowledge that ignores science cannot help public health. We are seeing it with the COVID 19 crisis. We are seeing it differently in tobacco control. Time is not on our side.
The views expressed in the above opinion are those of the authors’ and do not necessarily represent or reflect the views of Vapor Voice or its parent organization.
Derek Yach is president of the Smoke Free Foundation, USA. He has spent four decades advancing global public health especially chronic diseases. He was a key architect of the WHO’s FCTC.
Chitra Subramaniam is the founder of CSD consulting Switzerland. A journalist by training and a media entrepreneur she writes on public health, development and trade
The COVID-19 pandemic has changed the conventional wisdom about many things, and upended the world and our economy in ways we could not have imagined in January. The proliferation of misleading, conflicting and sometimes outright false information, coupled with the constantly changing norms brought on by the pandemic, have hit business owners particularly hard.
Dimitris Agrafiotis Credit: TSFA
The Tennessee Smoke Free Association is an advocacy group and trade organization with a focus on tobacco harm reduction through the use of personal vaporizers (electronic cigarettes) and other smokeless tobacco products shown to reduce the morbidity and mortality associated with smoking. While our primary focus is the prevention of tobacco harm, we are also a group of small business owners trying to stay afloat in these uncertain times.
In the summer and fall of 2019, mysterious lung injuries were making headlines in the United States. By October, the Centers for Disease Control and Prevention had taken notice and given it a name: EVALI, which stands for e-cigarette, or vaping, product use-associated lung injury. They began issuing warnings about vaping devices, and guidelines were issued on treating it. And then, in early November 2019, the CDC reversed course and issued a report naming the actual culprit as tainted vitamin E acetate cartridges in illicit marijuana vaporizers — not the vaporizers themselves.
However, the damage to our industry was already done, and stigma of the original incorrect conclusions persists. Standard vaporizers contain varying levels of nicotine (which can be controlled by the user) but don’t have many of the harmful carcinogens found in cigarettes. We are still fighting the battle of misinformation and working to get our message out that e-cigarettes and vape devices can be used by adults addicted to cigarettes in a responsible way that improves their health.
And then, in the wake of the confusion and misinformation surrounding EVALI, the pandemic hit. Cities and counties began shutting the economy down, separating businesses into categories of “essential” and “non-essential.” In many places, vape shops were designated non-essential and forced to close, while gas stations, grocery stores and convenience stores — all of which sell cigarettes — were permitted to stay open.
We were able to advocate for ourselves, and many cities and counties reversed course and allowed us to reopen with curbside services, which almost all of our members did, following strict safety protocols. We continue to be grateful to the elected officials who responded to our hardship and worked with us so we could operate in a responsible manner.
Prior to discovering vaping, I was a longtime heavy smoker with a family history of poor health and even death because of smoking cigarettes. I feel that e-cigarettes saved my life, and many members of the TSFA have had similar experiences. We are knowledgeable and honest about our products and are small-businesses owners who contribute to our communities.
However, as small-business owners, though, we are still struggling with the aftereffects of the EVALI fallout, which were compounded by the pandemic. At the Tennessee Smoke Free Association, we will continue our work to put out critical scientific information and bust myths surrounding the use of e-cigarettes.
Dimitris Agrafiotis is the executive director of the Tennessee Smoke Free Association.This article first appeared on Knoxnews.com.
Buried in the enormous spending/COVID-19 relief package that Congress approved this week is a bill that imposes new restrictions on the distribution of all vaping equipment, parts, and supplies, including a ban on mailing them. The provision illustrates not only how utterly irrelevant legislation can be slipped into unread, must-pass bills but also how Congress warps reality through legal fictions and uses save-the-children rhetoric to justify restricting adults’ choices, writes Jason Sullum in an opinion piece for Reason, a libertarian think tank.
Jacob Sullum / Credit: Reason
Title VI of the 2021 Consolidated Appropriations Act, which appears on page 5,136 of the 5,593-page bill, is called the Preventing Online Sales of E-Cigarettes to Children Act. The bill was introduced last April by Sen. Dianne Feinstein (D–Calif.), joined by seven original cosponsors: six Democrats plus Sen. John Cornyn (R–Texas). It includes two changes aimed at complicating and obstructing online sales of vapes and e-liquid.
Feinstein’s bill amends the Jenkins Act of 1949, which requires that vendors who sell cigarettes to customers in other states register with the tax administrators in those states and notify them of all such sales so they can collect the taxes that the buyers are officially obligated to pay. In 2002, the General Accounting Office (now the Government Accountability Office) found that online cigarette sellers routinely flouted the Jenkins Act and that the federal government had done virtually nothing to enforce it. Nine years later, Congress amended the law, beefing up its reporting requirements and extending it to cover roll-your-own tobacco.
The Feinstein bill further expands the Jenkins Act, redefining cigarette to include “electronic nicotine delivery systems,” which are not cigarettes. It also counterintuitively defines electronic nicotine delivery system to include products that do not deliver nicotine: “any electronic device that, through an aerosolized solution, delivers nicotine, flavor, or any other substance to the user inhaling from the device” (emphasis added). That category includes e-cigarettes, e-hookahs, e-cigars, electronic pipes, vape pens, and refillable vaporizers, plus “any component, liquid, part, or accessory” used with those devices, whether shipped together with them or sold separately.
In other words, every product related to vaping, whether of nicotine, THC, CBD, lavender, or anything else, will now be subject to the Jenkins Act’s burdensome requirements. According to Feinstein, a bottle of e-liquid is a cigarette; so is a bottle of herbal essential oil if you plan to vape it. A coil or pod cartridge for a nicotine vaporizer is now also a cigarette; so is a vaporizer designed for THC or CBD oil.
Feinstein’s bill also requires the U.S. Postal Service to “clarify” that the ban on mailing cigarettes covers all of those products, which are not actually cigarettes and may not even have anything to do with nicotine. The new ban, disingenuously presented as a clarification of the existing ban, will take effect within 120 days of the law’s passage.
These reality-defying redefinitions ostensibly are aimed at preventing the sale of e-cigarettes to anyone younger than 21, the minimum age set by federal law. “Buying e-cigarettes online is one of the easiest ways for children and teens to get their hands on these harmful products,” Feinstein said when she introduced the bill. But the new burdens and restrictions go far beyond what is necessary to enforce the minimum purchase age. Requiring robust age verification for orders or an adult signature for deliveries, for example, would prevent sales to consumers younger than 21 without the expensive disruptions this law will cause.
“While there is no shortage of talk in Congress about the importance of small businesses and social distancing, the decision to shove this ban in the middle of a pandemic relief package reveals how hollow that rhetoric is,” says Gregory Conley, president of the American Vaping Association, an advocacy group that supports vaping as a harm-reducing alternative to smoking. “Many Americans at risk of COVID-19 complications have been staying home and ordering their supplies online, but Congress just decided they should either pay much more for shipping or go to a retail store that may not stock the product they use to stay off deadly cigarettes.”
Conley notes that shipping vaping products to minors is already illegal, and “the Food and Drug Administration has repeatedly enforced this law against bad actors in the industry.” While law-abiding vendors for years have been using the postal service’s ID-at-delivery option to comply with the age limit, “this will no longer be permitted.”
In short, a bill presented as a commonsensical effort to enforce the minimum purchase age is actually an assault on the vaping industry and its adult customers. “If the increase in shipping costs wasn’t enough, the bill also imposes huge paperwork burdens on small retailers, and backs it up with threats of imprisonment for even innocent mistakes,” Conley notes. “This is not a law designed to regulate the mail-order sale of vaping products to adults; it’s an attempt to eliminate it.”
Thanks to Feinstein’s sweeping and arbitrary definition of electronic nicotine delivery systems, the impact extends far beyond nicotine vaping. On its face, the law requires companies that sell cannabis vaping devices to comply with the Jenkins Act. It also prohibits them from mailing their products to customers. Although that is already arguably prohibited by federal law, the issue hinges on whether vaping equipment sold without any reference to cannabis nevertheless qualifies as “drug paraphernalia.” As written, the Feinstein bill also imposes these burdens on federally legal products such as CBD oil and herbal extracts used for aromatherapy.
“This could have a significant effect on cannabis vaping products, even if the intent is clearly to curb nicotine products,” Aaron Smith, CEO of the National Cannabis Industry Association, told Marijuana Moment. “We’re making sure that Congress and the incoming administration understand that it would be a misguided waste of resources to apply this to the already heavily regulated cannabis industry. In the long run, it’s important that cannabis is descheduled so it can be appropriately regulated at the federal level, clearing up ambiguities like this.”
