Chairperson Griffith and members of the committee:

My name is Michelle Minton, and I am a senior policy scholar at the Reason Foundation, a 501(c)(3) nonprofit, nonpartisan public policy research organization. As an expert in public policy, a Maryland resident, and former smoker, I am grateful for the opportunity to submit my testimony regarding the proposed prohibition of flavored tobacco products.

The aim of the proposed prohibition to reduce adult smoking and discourage youth initiation of any tobacco or nicotine product is a laudable one. However, based on science and historical evidence, we fear this proposal will not achieve its goal, but rather lead to greater health disparities and criminal justice inequities while radically increasing the size and danger of the illicit tobacco market.  

There is no question that smoking is deadly, but guilt by association is a poor foundation for government policy. Lumping everything under the definition of “tobacco” doesn’t change the scientific fact that noncombustible sources of nicotine (such as patches, gums, e-cigarettes, and snus) are vastly less harmful than the combustible cigarettes that will continue to be freely available throughout our state. Treating products that pose less than five percent of the risk of smoking the same as deadly combustible cigarettes, which kill half their users, is simply bad health policy.  

This proposal would prohibit the sale of any flavored tobacco product, including non-combustible, and, therefore, less harmful substitutes for cigarettes. This would include the flavored versions of products, like snus, on which many adults in Maryland rely to stay smoke-free and the availability of which the U.S. Food and Drug Administration (FDA) has deemed to be in the best interests of public health. If this proposal is enacted, Maryland would outlaw, under criminal penalty, the sale of safer products that exist now or will exist in the future.  

Youth

As with nearly all prohibitions, SB 259 is predicated mainly on the need to protect youth. While concern over youth experimentation with or the use of nicotine-containing products is worthy of attention, lawmakers should recognize that most youths do not use any form of tobacco at all.  Recent data from the Centers for Disease Control and Prevention (CDC) indicates that less than two percent of youth currently smoke, and just over 14 percent use e-cigarettes. 

In 2021, the Maryland Youth Risk Behavior Survey found that just 11 percent of Maryland high schoolers reported the use of electronic cigarettes, with the highest prevalence among white students (15 percent compared to 5 percent among black students), a significant decline from 2018  when 23 percent of high school students in Maryland reported any past-month e-cigarette use. 

Outlawing legal sales of flavored e-cigarettes and other products is unlikely to make more progress for several reasons. First, the research continues to indicate that youth do not initiate vaping because of flavors. CDC surveys show the main reason youth cite for vaping is “curiosity,” followed by peer influence or family members. The results are similar for Maryland, with 39 percent of youth citing “curiosity” as their reason for using electronic cigarettes, followed by 19 percent who said they used them because a friend or family member does. Flavor availability was cited by just 9 percent of Maryland youth as the reason they use them.

Second, most youths do not acquire the tobacco products they use from licensed retailers, but rather from friends, family, or illicit sources. For example, of the 23 percent of Maryland youth who indicated current e-cigarette use in 2018, nearly half said they got them by borrowing them from a friend.

Given the current size of the illicit tobacco market and the massive increase we expect to occur in the wake of a menthol cigarette ban, the current proposal may unintentionally provide youth with greater access to flavored tobacco products through illicit dealers who typically do not verify the ages of their customers. Moreover, youth who do avail themselves of the illicit market may have greater access not just to tobacco, but other substances as well. For example, when the Department of Justice arrested two brothers in Baltimore for conspiracy to traffic $6.6 million worth of contraband cigarettes, they were also found to be dealing in illicit oxycodone.

Illicit suppliers may also choose to make their own flavored tobacco products instead of buying them where they are legal and transporting them to Maryland. With regard to menthol cigarettes,  this task would be exceedingly simple, requiring nothing more than a would-be trafficker to legally purchase unflavored cigarettes and add menthol-flavoring with flavor beads, eucalyptus oil, sprays, and numerous other methods, the safety of which depend entirely on what is used as a flavoring agent. If this prohibition is enacted, Maryland lawmakers should probably be prepared for another outbreak of “vaping-related” lung injuries as we saw in the illicit market for cannabis oil vaping cartridges during the summer of 2019.

Lastly, laudable as the desire to prevent youth tobacco use may be, research suggests that banning flavored tobacco products may result in the perverse outcome of increasing youth smoking. For example, Yale University’s Abigail Friedman found that after the city of San Francisco enacted its ban on all flavored tobacco products in 2018, youth in San Francisco were twice as likely to smoke compared to adolescents in similar jurisdictions without such bans.

Illicit Sales  

Supporters of this and similar prohibition proposals argue that outlawing products for which there is significant demand, particularly among Marylanders of color, will not lead to increased illicit tobacco trafficking nor cause increased interactions with law enforcement. But the experiences of other jurisdictions which have attempted similar bans, as well as Maryland’s own experience with drug prohibition, make such assertions hard to believe.  

The harm or benefit of any prohibition largely depends on how those living under it respond.  With regard to this proposal, some current users of flavored tobacco may respond by quitting tobacco use altogether, eliminating the risks to those individuals. However, according to the Food and Drug Administration’s own analysis of its proposed national menthol cigarette ban,  around half will simply switch to equally non-menthol cigarettes, conferring zero health benefits. Moreover, the federal government estimated that roughly half of the public health benefits anticipated by outlawing combustible menthol cigarettes would come as a result of smokers switching to flavored non-combustible products, which Maryland’s proposed prohibition would also outlaw.

In Maryland, menthol cigarettes account for about half of all cigarettes sold in the state. Even without including all of the other flavored tobacco products, this represents a significantly-sized market which, if this proposal is enacted, would be pushed into the arms of the unlicensed tobacco dealers already operating in our state. Rather than encouraging healthier behaviors from  Maryland residents, this could increase risks to their welfare, increase enforcement costs, and divert millions in tax revenue to other states and criminal operations.  

Case Study: Massachusetts 

Massachusetts implemented the country’s first state-wide ban on flavored tobacco products in  June 2020. My colleague Jacob Rich, a policy researcher for both Reason Foundation and the  Center for Evidence-Based Care Research at the Cleveland Clinic, analyzed the ban’s impact by comparing cigarette sales in Massachusetts before and after its implementation. His analysis of national cigarette sales data shows that in the year following the prohibition, sales of menthol and non-menthol cigarettes declined in Massachusetts. However, sales in bordering counties increased, leading to a net overall increase in cigarette sales within the region of approximately 7.2 million packs. This indicates that the ban in Massachusetts merely diverted current menthol smokers to equally harmful non-menthol cigarettes and pushed sales of both menthol and non-menthol cigarettes to neighboring states.  

The result was no decrease in overall tobacco use and $125 million lost tobacco tax revenue for  Massachusetts. In Maryland, tobacco trafficking is likely to be significantly worse than in Massachusetts, given our residents’ proximity and access to neighboring states which do not yet outlaw flavored tobacco.  

Public Health 

The FDA acknowledges a “continuum of risk” for the variety of tobacco and nicotine products currently on the market, with cigarettes being the most dangerous and non-combustible alternatives,  such as snus, e-cigarettes, heated tobacco, and nicotine pouches, being the least dangerous. The FDA  has already authorized some of these products, deeming their availability to be in the best interest of public health, and allowed some to even be marketed as reduced-risk substitutes for smoking.  

The proposal before this committee would unnecessarily strip adults in Maryland of access to these  FDA-authorized and potentially life-saving alternatives, now and in the future.  

According to a 2020 study by Yale School of Public Health researchers, e-cigarette flavors are positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking. Moreover, the prestigious Cochrane Review concluded that e-cigarettes are more effective than traditional nicotine replacement therapies in helping smokers quit smoking cigarettes. Criminalizing the sale of flavored e-cigarettes in Maryland, which are overwhelmingly preferred by adult vapers, risks driving users of these alternatives back to smoking while also fueling illicit tobacco markets, causing net harm to our state’s public health, social welfare, and economic well-being.  

Nicotine is not risk-free and the interest in preventing youth uptake is understandable. We all want to see fewer people smoking and fewer youth experimenting with tobacco. But the desire to protect adolescents from all risks, even those that are relatively small, does not justify at-any-cost measures like the one currently under consideration. Regulators must show regard for the needs of other populations, including youth once they reach adulthood, and consider the harm such laws may have on their welfare.  

If Maryland’s state and local authorities are competent enough to regulate flavored alcohol and soon-to-be-legalized flavored cannabis in ways that preserve adults’ ability to purchase them safely and legally without encouraging youth use, they should be similarly capable of limiting the sale of flavored nicotine products to adults in Maryland, especially when they offer current and future smokers in the state a life-saving alternative to combustible cigarettes. 

The post Testimony: Maryland Senate Bill 259 would lead to greater health disparities and criminal justice inequities appeared first on Reason Foundation.

The ban has served as a test for what other states and municipalities might expect if they enact similar prohibitions on flavored tobacco products. Although officials often promote tobacco control policies as ways to protect public health, the unintended consequences of menthol cigarette bans on total cigarette sales have puzzled many public health officials and raised important questions about the effectiveness of the prohibitions.

In my analysis of the comprehensive flavored tobacco ban implemented in Massachusetts, the data show that the prohibition of menthol cigarettes was followed by millions of additional cigarette sales in the six-state region of Massachusetts and its bordering states. The year following the ban on menthol cigarette purchases saw 15 million fewer packs of menthol cigarettes sold than the year before the ban. However, approximately 22 million additional packs of nonmenthol cigarettes were sold in those states in the year after the flavor ban, leading to a net increase in cigarette sales.

In the 12-month period following the implementation of the comprehensive flavor ban in Massachusetts, the state sold 29.96 million fewer (22.24% less) cigarette packs compared to the prior year. However, a total of 33.3 million additional cigarette packs were sold during the same post-ban period in the counties that bordered Massachusetts in the states of Connecticut (3.05 million additional packs), New Hampshire (25.84 million), New York (1.04 million), Rhode Island (6.01 million), and Vermont (1.21 million). Thus, considering the change in cigarette sales in the entire six-state region, there was a net increase of 7.21 million additional cigarette packs sold in the 12 months after the menthol cigarette ban in Massachusetts, a 1.28% increase in cigarette sales compared to the prior 12-month period before the ban.

A paper by Samuel Asare et al. (2022) published in JAMA Internal Medicine publicized a reduction in cigarette sales in Massachusetts following the menthol cigarette ban but failed to include all but one of the bordering states in its analysis. Additionally, the paper analyzed Nielsen Retail Scanner data, which only represented approximately 30% of all US mass merchandiser sales volume that year. In contrast, the Management Science Associates Inc (MSAi) data in my analysis represents all cigarette distribution throughout the entire US.

In conclusion, policymakers must be careful about enacting prohibitions for a variety of reasons, including when the banned product is still available for sale in nearby municipalities. This is especially true when tax rates in neighboring states are relatively low. In 2020, the sales tax for cigarettes in New Hampshire ($1.78 per pack) was approximately half that of Massachusetts ($3.51 per pack), which further incentivized bulk purchases of cigarettes and allowed for a sizeable smuggling market for black market sellers after the flavored tobacco ban was implemented. 

With similar flavored tobacco prohibitions being proposed in states like Maryland, which currently has a cigarette sales tax of $3.75 a pack, policymakers should keep in mind that neighboring Virginia has a much-lower sales tax of $0.60 per pack and that the cross-border smuggling of cigarettes would inevitably follow a menthol cigarette prohibition in Maryland.

The data from Massachusetts and neighboring states show the menthol ban did not stop people from buying cigarettes, with sales increasing by seven million packs in the year after Massachusetts’ flavored tobacco ban. Massachusetts’ flavored tobacco ban primarily sent buyers to others states and illicit markets, so other cities and states should consider the real-world impacts of implementing similar prohibitions.

The post The effect of menthol bans on cigarette sales: Evidence from Massachusetts  appeared first on Reason Foundation.

New York already enjoys the dubious honor of having the highest rate of illegal cigarette smuggling in the country. More than half of all cigarettes smoked in New York come from smuggled sources. The black market sales cost New York an estimated $1 billion dollars a year in tax revenue, according to the Tax Foundation.

Banning menthol cigarettes would put rocket boosters under the illicit tobacco market and reduce the state’s tax revenues. That’s what happened when Massachusetts banned flavored tobacco. One year after Massachusetts’ 2020 ban on menthol cigarettes was implemented, nearly 30 million fewer packs of cigarettes were sold in the state, Reason Foundation’s Jacob James Rich found. But, as smokers sought their preferred products elsewhere, 33 million additional cigarette packs were sold in bordering states than were sold the year before Massachusetts’ ban.

There’s no doubt the governor has been sold on good intentions and the virtues of prohibition. Advocates claim that menthol cigarettes are more addictive, easier for kids to start using, and harder for smokers to quit. But none of these claims are true.

Research shows menthol smokers tend to start smoking later in life and smoke fewer cigarettes per day than non-menthol smokers. States that have higher rates of adult menthol smoking relative to non-menthol smoking actually have lower youth smoking rates. Research from Vanderbilt University Medical Center, published in the Journal of the National Cancer Institute, found no statistically significant difference in successful quit rates between menthol and non-menthol smokers. There was also no difference in the quit rates between Black and white smokers.

Supporters of prohibition claim a menthol ban is needed to tackle smoking in the Black community because the majority of Black smokers choose menthol products. But the Black youth smoking rate in New York is just 4.2%, while the white youth smoking rate is 4.4%. For adults, white New Yorkers are the most likely to smoke at 12.9% compared to the 11.3% of Black New Yorkers who smoke. Given menthol and nonmenthol cigarettes are equally toxic, it’s odd that one should be singled out over the other. Gov. Hochul isn’t advocating for banning products preferred by the largest group of smokers in the state — white New Yorkers.

It’s also a sad irony that Hochul is pursuing this policy when New York City was where Eric Garner was pointlessly killed by police during an arrest for selling untaxed cigarettes in 2014. Last year, the mothers of Garner and Trayvon Martin, and George Floyd’s brother pleaded with the Biden administration not to ban menthol cigarettes nationwide.

Yet supporters of menthol prohibition frequently cloak the ban in the language of equity. It’s an eccentric argument to claim that banning sales of cigarettes favored by Black smokers while the preferred choice of white smokers remains legal is the most equitable policy when they smoke at similar rates. There are uncomfortable tinges of the government’s unjust sentencing differential that hurt minority communities by mandating harsh sentences for crack cocaine and lighter sentences for powder cocaine, which had disparate use rates but similar risks, just like menthol and nonmenthol cigarettes.

Few issues unite conservatives like Grover Norquist of Americans for Tax Reform with progressives like the Rev. Al Sharpton and the American Civil Liberties Union, but opposition to menthol bans is one of them. Whether viewed through the lens of individual choice or social justice, Hochul’s proposed prohibitions can be relied upon to unite a diverse coalition of opponents.

Gov. Hochul should abandon the proposed ban. Youth smoking is at its lowest rate in decades and has almost disappeared in the state. With safer nicotine alternatives making traditional smoking increasingly obsolete, public health can continue to improve without a menthol ban that would surely bring negative racial justice implications and usher in criminal punishments that would disproportionately impact New York’s minority communities.

A version of this column first appeared in the New York Daily News.

The post New York shouldn’t ban flavored tobacco products appeared first on Reason Foundation.

Public polling indicates many American smokers say they want to quit using combustible cigarettes. Despite the existence of tobacco control policies and traditional cessation methods, 30.8 million adult smokers remain, many of whom have not tried to quit or have not quit successfully. For this population of smokers, a suite of safer nicotine alternatives such as e-cigarettes, nicotine pouches, snus, and heat-not-burn products may succeed in helping them quit where other policies have failed.

Traditional tobacco control strategies such as education, taxation, marketing restrictions, and bans on smoking in a growing list of public spaces have contributed to a gradual reduction in the smoking rate from its peak of around 40 percent in the mid-1960s to 12.5 percent today. Safer nicotine alternative products are a newer, yet crucial, component of a tobacco harm reduction strategy, giving those smokers who would not otherwise have quit a way to use nicotine without the smoke that may kill them. A substantial body of evidence demonstrates that these tools are more effective in helping smokers quit than traditional cessation methods, such as nicotine replacement therapies (NRTs), and are vastly less harmful to human health than combustible tobacco. 

To maximize these products’ potential to help improve public health while limiting youth access and uptake, Congress, the U.S. Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC) must ensure consumers have access to these products at reasonable prices and are accurately informed about their risk relative to cigarettes. 

Correcting misperceptions

Millions of Americans have successfully switched from combustible cigarettes to safer nicotine alternatives. While the overall smoking rate has declined to a generational low, smoking remains disproportionately high among low-income communities, people without college degrees, and those with mental health problems.

A substantial barrier preventing greater uptake of safer alternatives to cigarettes is the widespread misperception among a majority of the public and physicians that these products are just as dangerous or more dangerous than combustible cigarettes.

For example, though the spate of lung injuries and deaths that occurred in 2019 were quickly linked to the proliferation of adulterated cannabis vapor products, public polling suggests a majority of adults attribute the outbreak to nicotine vapor products.

In Dec. 2022, a group of public health experts urged the CDC to correct rampant misinformation regarding the dangers of e-cigarettes. Speaking to the Associated Press in 2022, the Director of FDA’s Center of Tobacco Products (CTP) Dr. Brian King said there were widespread misperceptions around the use of e-cigarettes.

“I’m fully aware of the misperceptions that are out there and aren’t consistent with the known science,” King said. “We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product.”

But, as of now, it appears the FDA has no plans to correct these misperceptions.

Congress can contribute to communicating clear and accurate information on the relative risks of noncombustible products and potential benefits for adult smokers who switch to these products. Unfortunately, the FDA and the CDC are currently falling short of this mission, and neither agency has outlined any plans to address the problem. It is the responsibility of Congress to hold both to account.

Reagan-Udall Foundation evaluation

After a series of missteps handling e-cigarette product applications, FDA Commissioner Robert Califf asked the Reagan-Udall Foundation (RUF) to evaluate the FDA’s tobacco program. RUF was established by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

In Dec. 2022, the Reagan-Udall panel delivered its verdict on FDA’s performance. The report found several failings at the FDA, including opacity and confusion regarding the agency’s refusal to authorize safer nicotine products. 

In 2009, Congress passed the Tobacco Control Act, which established a pathway for authorizing safer nicotine products, ensuring tobacco harm reduction could play some role in reducing smoking rates. But in practice, the process has created a functional barrier to entry for legitimate companies and products, costing vast sums of time and money per application and leaving applicants unsure of what materials they need to provide for a successful application. In the meantime, the vapor market, bereft of FDA-authorized options, has been flooded with illegitimate products in order to fill the vacuum.  

In particular, RUF’s report called on the FDA to define what is “appropriate for the protection of health,” a central factor in determining whether to authorize new products. The evaluation also called on the FDA to develop and implement a comprehensive plan for the Center of Tobacco Products’ goals and priorities, greater transparency, engagement with industry stakeholders, clarity on when FDA decisions prioritize public policy or political concerns rather than the strength of the underlying science, removing illicit products from the market, and simpler processes for authorizing certain novel products that may benefit individual and public health. Congress should closely monitor the FDA’s efforts to implement RUF’s recommendations and, if it refuses to do so, investigate why.   

Taxation

Research shows e-cigarettes are substitutes, not compliments to traditional cigarettes. There are good reasons to tax combustible cigarettes, such as recouping costs to the health care system attributable to smoking-related diseases and discouraging youth smoking. But since noncombustible nicotine products, like e-cigarettes and other reduced-risk products, present significantly less danger to consumers and offer a net benefit to public health if smokers switch from cigarettes, sound public policy dictates that these products should be taxed at a significantly lower rate than cigarettes, if at all. 

In the last Congress, there were attempts to introduce the first federal e-cigarette tax, which would’ve set the tax to be equivalent to the tax on cigarettes. According to modeling from Georgia State Univerity Professor Michael Pesko, the tax would have resulted in fewer adult e-cigarette users and an increase of 2.5 million more smokers than there would be otherwise. Taxing less harmful products at a level equal to or higher than the most deadly products provides a clear disincentive for smokers to switch, thus resulting in net harm to public health. Additional federal taxes on e-cigarettes and other harm reduction taxation tools would prevent a significant number of smokers from switching, harming public health, and should be resisted. 

Conclusion

Innovation presents promising opportunities to improve public health and support small businesses. While the economic benefits are secondary to the public health benefits, in 2019, The Washington Post reported that vape shops were the fastest-growing U.S. retail segment of the previous decade. Unfortunately, many of these stores have already been forced to shut their doors over the past three years in large part due to the flood of misinformation about these products and the byzantine regulatory process the FDA has yet to fix.

A sound regulatory framework for safer alternatives to cigarettes would ensure these harm reduction options are available to the consumers who need them at reasonable prices while still limiting the access young people have to them. Ensuring the FDA and the CDC are supporting, rather than hampering this public health objective is a sure way Congress can bear down on the public health toll of smoking. 

The post Tobacco harm reduction should be on Congress’ agenda appeared first on Reason Foundation.

The final report, which found FDA “struggled to function as a regulator in part due to some of its own policy choices,” likely made for uncomfortable reading at the agency.

Since 2009, all tobacco products have been regulated by the FDA. Products not on the market before Feb. 2007, like e-cigarettes, must undergo an expensive and time-consuming application process to be authorized for sale. Before they can be approved, each product must demonstrate to the FDA it is “appropriate for the protection of public health” for both users and non-users. For products that had already been on the market, the deadline to submit their applications was eventually set for Sept. 2020.

But the FDA denied the vast majority of e-cigarette applications, claiming they were of insufficient quality or failed to demonstrate a net public health benefit. As a result, most of the safer alternatives to cigarettes that were on the market prior to 2020 are now illegal in the United States. But the FDA’s lack of guidance to applicants, opacity in decision-making, and blanket denial of all products marketed using non-tobacco flavors left the agency exposed to litigation, with many suspecting the agency’s decisions are heavily influenced by anti-vaping politics rather than science.

Among the recommendations in the Reagan-Udall report was for the FDA to provide a clear definition and interpretation of “appropriate for the protection of public health” and transparency around political considerations and value judgments in the FDA’s decision-making.

During the evaluation, FDA staff complained to Reagan-Udall that decisions on product applications were prioritizing politics over science. The report also called for “more substantial engagement with stakeholders and the public.”

In this context, last week, the American Vapor Manufacturers Association (AVM), a trade organization representing the independent vapor industry, highlighted the FDA’s public calendar for last December. AVM found that FDA officials met with four organizations that are hostile to e-cigarettes as a tobacco harm reduction tool to discuss Reagan-Udall’s findings in the hours and days following its publication. These organizations include the Campaign for Tobacco-Free Kids, American Heart Association, American Lung Association, and the American Thoracic Society.

The FDA declined to comment on whether these meetings were held at its request. But Reason Foundation confirmed with the American Heart Association and the American Thoracic Society that these discussions were held at the agency’s request. The American Vapor Manufacturers’ Association announced that the head of the Center for Tobacco Products, Brian King, had agreed to meet with the FDA for a public dialogue on e-cigarettes, making it the sole group supportive of e-cigarettes as a harm reduction tool to have such a meeting to date.

“Dr. Califf’s rush to meet with four separate organizations dedicated to banning safer alternatives to smoking is emblematic of so many of the serious issues identified by the Reagan-Udall review,” said AVA’s Director of Legislative and Regulatory Gregory Conley. “Other centers at the FDA interact regularly and productively with the industries they regulate, but when it comes to nicotine products, FDA’s top priority is keeping activist groups happy.”

The select access granted to anti-vaping groups is particularly jarring given the FDA’s very different to another Reagan-Udall report—this one on its food program, which also found the agency to be woefully deficient. In that case, The New York Times reported:

The Food and Drug Administration’s food division has no clear leadership, avoids bold policy or enforcement actions, and fosters a culture that doesn’t adequately protect public health, according to a report issued on Tuesday by an agency-related group.

Experts with the group, the Reagan-Udall Foundation, which was asked to examine the food division after widespread criticism stemming from the infant formula crisis, concluded in the report that the division’s management structure and mission should be overhauled.

Dr. Robert Califf, the agency commissioner, released a statement Tuesday saying he would form a group to advise him on the findings and on how to put the recommendations in place. The infant formula crisis was the first major challenge that Dr. Califf confronted this year as commissioner, although the agency has also faced criticism over the regulation of vaping and tobacco products, which prompted a similar review of its tobacco division.

Immediately following the publication of the food report, the FDA held meetings with stakeholders, including campaign groups and the industry itself, notably food and beverage giant Nestlé.

Perhaps in response to AVM’s highlighting of the issue, Dr. Brian King, the director of FDA’s Center for Tobacco Products, agreed to a public discussion on Feb. 24, according to the American Vapor Manufacturers. While this engagement is welcome, the fact that the FDA’s first response to a critical report was to request private meetings with the chief supporters of the status quo inspires little confidence that the agency can adequately change and foster a marketplace conducive to the public health benefits that could come with a science-based tobacco harm reduction approach.

Sadly, it appears any positive changes in the FDA’s approach to safer alternatives to traditional cigarettes may need to come through the new Congress intervening and ensuring the agency takes heed of the very review the FDA commissioned itself.

The post FDA needs a new approach to e-cigarettes and other safer alternatives to traditional cigarettes appeared first on Reason Foundation.

I want to thank the expert panelists for including this public dialogue as part of their evaluation of the U.S. Food and Drug Administration (FDA). I would also like to make it clear that my interest in this conversation is not to advocate for or against any particular product or company. My interest is in people, the individual human beings whose lives can be drastically affected, for good or for bad, by the way government agencies approach regulation. It is people who are at the heart of the discussion about tobacco regulation and this investigation into how well the FDA is fulfilling its public mission. 

While there is no shortage of debate when it comes to how tobacco products should be regulated, there is widespread agreement that the current approach adopted by the FDA is not working. The enormous challenge facing the experts on the panel is to shed light on why that is the case and what can be done to fix it for the benefit of the public. To that end, I offer the following comments, and I hope they will bring some sober clarity to a controversial issue. 

The overarching message I would like to communicate is this: Unless there is a viable pathway for safer products to enter the market legally, there will be no innovation toward safer products, and we will continue to condemn the millions of current and future adults who enjoy the non-medical use of nicotine to one of two undesirable options—illicit market products or deadly combustible cigarettes. 

Challenge #1: A comprehensive approach to tobacco and nicotine regulation that is principles-based, reasonable, and implemented consistently across all programs

For nearly every other risky or potentially harmful behavior, we recognize that incentives matter. It is generally acknowledged that regulation cannot prevent risk, but it can encourage markets and people to be as safe as possible. Seatbelts, helmets, electric vehicles, contraception, pre- and post-exposure prophylaxis, ridesharing, opioid maintenance therapy, and Narcan are just a few examples of how the market, unhindered by regulation, has provided means to reduce the potential harm of risk-taking behaviors, both for the individuals engaging in that behavior and for those around them. 

Yet, when it comes to tobacco, the FDA, whether accidentally or not, has adopted an approach that maximizes, rather than minimizes, harm. Instead of promoting public health through a regulatory process that champions innovation, the agency has made it all but impossible for such innovation to occur or, at least, for the products of innovation to make it into consumers’ hands.

The result is that, unlike all other areas of our lives, FDA regulation has preserved and protected the most dangerous form of nicotine use, smoking combustible cigarettes, from extinction. 

This is, in part, because the regulatory framework was structured around cigarettes with the goal of suppression. Unfortunately and unsurprisingly, this framework has made it impossible for truly novel products to enter the market. Many see this blockade of new nicotine products as a positive outcome, but the perverse unintended effect is that it is still easier for combustible cigarettes to gain FDA authorization than the safer products that could displace them. Worse, it leaves consumers who already rely on less harmful forms of nicotine use frustrated and most of the public confused about the relative risks and benefits of various products.  

It doesn’t have to be this way and, for a moment in 2017, it seemed the FDA recognized the need to modernize its approach in response to the market’s rapid shift toward tobacco harm reduction. In that year, the agency announced its comprehensive plan for tobacco and nicotine regulation which recognized that tobacco products exist on a continuum of risk, that nicotine, while not risk-free, is not the main source of tobacco-related mortality or morbidity, and acknowledged that in the best interest of public health, the agency’s approach to reducing the harms caused by smoking required an equal effort to promote less harmful alternatives.  

This plan, had it been implemented, would have likely addressed many of the challenges the FDA now must address. Unfortunately, while the agency has taken steps to reduce the appeal of combustible cigarettes, it has apparently abandoned its promise to promote the development of and consumer access to safer nicotine alternatives. And the continued failure of the FDA to adhere to any sort of comprehensive approach could have disastrous consequences. Take, for example, the FDA’s proposed prohibition on menthol as a characterizing flavor in combustible cigarettes and cigars. 

The goal of the proposed menthol ban is to reduce the appeal of combustible cigarettes, used disproportionately by people of color. According to the FDA’s calculations, the ban would result in less initiation of cigarettes by youth, increase smoking cessation among adults, and lead to better health outcomes in many populations.

Those calculations, however, were based on certain assumptions about how consumers might respond to such a ban, given the other options available to them. Surprisingly, a great amount of the health benefits the FDA expects a menthol ban to produce, upwards of half, come from consumers replacing combustible menthol cigarettes with mentholated versions of noncombustible e-cigarettes. The problem with this is that few menthol smokers will have this option as the FDA has so far not authorized a single mentholated e-cigarette and has given little reason to believe they ever intend to do so. 

Recommendations for FDA: 

• Issue an updated comprehensive approach to tobacco and nicotine that is principles-based, reasonable, and implemented consistently across FDA programs to guide regulation and research. In addition to the 2017 plan, we suggest they refer to the Institute of Medicine’s 2001 Clearing the Smoke report. 

Challenge #2: Compliance standards that are clear, transparent, and predictable

In the first public meeting the Reagan-Udall Foundation held on this topic, one of the stakeholders expressed his belief that tobacco manufacturers, including those of lower-risk nicotine products, have no interest in being regulated and have intentionally submitted deficient pre-market tobacco applications in order to slow down enforcement by the agency. 

But within the nicotine alternatives market are thousands of small businesses who desperately want to understand what the FDA wants from them in order to approve their products for legal sale and reasonable regulations that would protect their companies, as well as the entire market, from bad actors. 

The problem is not that the industry doesn’t want to comply with FDA regulations, the problem is that they cannot. By constructing an opaque and seemingly arbitrary pre-market authorization process and by failing to set reasonable standards, the FDA has created regulatory hurdles too high for all but the largest tobacco makers to surmount. 

Recommendations for FDA: 

• Set clear and consistent standards, requirements, and thresholds.
• Provide detailed definitions for critical terms like “appropriate for the protection of public health” and disclose how those definitions are calculated or determined.
• Be more transparent, cooperative, and flexible; convening meetings for public discourse, workshops, and unbiased explanations for its decisions and conclusions.

Challenge #3: A more appropriate balance between innovation, risk, and the needs of various populations

The FDA’s interest in preventing potentially harmful products from entering the market is understandable. However, aversion to this risk must not come at the expense of squashing innovation that could have a positive net benefit to public health. Nor should the agency’s aversion to the small potential risks presented by new products blind the FDA to the potential risks caused by a market that is too tightly regulated that it spurs the proliferation of illicit markets or denies consumers potentially life-saving alternatives.

Similarly, the FDA’s concern about youth experimentation and initiation with novel nicotine products is reasonable. But that concern should not lead to decisions made at the expense of current and future adult smokers. The FDA certainly has a role to play in addressing the population-level risks associated with novel tobacco products, but unlike matters such as those relating to product safety, these concerns do not justify the existing bottleneck created by the FDA’s onerous pre-market approval regime.

Challenge #4: More efficient pathways to the authorization of lower-risk products

Many of the challenges faced by the FDA’s Center for Tobacco Products (CTP) in recent years stem less from resource limitations than they do from choices regarding implementation and priority-setting.

The FDA has thus far given marketing orders to just a handful of noncombustible products, the vast majority of which are owned by large tobacco firms. This will continue to be the case so long as the approval process remains onerous, slow, and wasteful. Other nations have structured regulations based on standards and thresholds, which make compliance and, more importantly for the FDA, verification a far easier and less resource-intensive task.

The results of this standards-based approval regime are vibrant markets, with devices and flavors that meet consumers’ needs, without the problems of youth experimentation that have so vexed U.S. health authorities. Adopting a similar standards-based approach, with streamlined pathways, categories for products and components, and a substantial equivalence for novel lower-risk products would allow companies (as well as the FDA staff) to conduct more efficient reviews, ensuring that the rules encourage compliance, protect the public, and leave nobody behind. 

Recommendations for FDA

• Use rulemaking power to establish streamlined Premarket Tobacco Product Application (PMTA) pathways for non-combustible products rather than forcing those products likely to be significantly less harmful than smoking to an outdated pathway even more onerous than for combustible cigarettes.
• Create a standards-based regime, with a small number of reasonable criteria for products the FDA would approve, similar to how regulation occurs in France and the United Kingdom.
• Create a substantial equivalence pathway for novel lower-risk products. This could be accomplished by “deeming” all those products which have or will receive marketing orders by the FDA as “predicate” on a rolling basis.
• Create a definition for “minor” changes as opposed to “significant” changes and created a streamlined approval process for minor changes (such as those relating to packaging, container size, and other modifications not expected to increase the potential risk of the product).
• Conduct periodic performance reviews to assess how well FDA regulation is working for consumers of reduced-risk products, based on turnaround for applicants, number of approvals for sufficient applications, and market dynamism.
• Hold public meetings with small industry participants to inform such performance reviews.

The post Testimony: FDA regulation has preserved and protected the most dangerous form of nicotine use—smoking combustible cigarettes appeared first on Reason Foundation.

Reason Foundation’s policy analysts are examining statewide ballot initiatives on issues related to consumer freedom, including, sports gambling, flavored tobacco and e-cigarettes, wine and alcohol sales, and more.

California Proposition 26 (2022): In-person sports betting regulation and tribal gaming expansion

California Proposition 27 (2022): Legalizes online sports betting, funds homelessness and mental health programs

California Proposition 31 (2022): Banning flavored tobacco products

Colorado Initiative 96 (2022): Concerning liquor licenses

Colorado Initiative 121 (2022): Sales of wine in grocery stores

Colorado Initiative 122 (2022): Third-party delivery of alcoholic beverages

Maryland Question 4 (2022): Marijuana legalization amendment

Voters’ guides for other states and policy issues can be found here.

The post The 2022 ballot initiatives about consumer freedom issues appeared first on Reason Foundation.

On August 28, 2020, California Gov. Gavin Newsom signed into law a ban on the sale of flavored tobacco products. California Senate Bill 793 bans menthol cigarettes, e-cigarettes in flavors other than tobacco, as well as oral tobacco products. Exceptions were made for hookah, premium cigars, and pipe tobacco. Retailers selling flavored tobacco products may be subject to a $250 fine for each sale. Proposition 31 on California’s November 2022 statewide ballot seeks to overturn that law, SB 793, so that the sale of flavored tobacco would remain legal in the state. 

Fiscal Impact

“Proposition 31 likely would reduce state tobacco tax revenues by an amount ranging from tens of millions of dollars per year to around $100 million annually,” according to the Legislative Analyst’s Office (LAO).

If a substantial number of smokers quit because of the ban, it could engender some savings to the state’s health care system. On the other hand, the LAO points out that if these smokers quit and live longer, it could increase the government’s health care costs. “Given the possibility of both savings and costs, the resulting long-term net impact on government health care costs is uncertain,” LAO concludes.

Arguments in Favor

Supporters of a ‘yes’ vote to uphold the law passed by the state legislature and signed by the governor include California Gov. Gavin Newsom, Campaign for Tobacco-Free Kids, American Cancer Society Action Network, California Teachers’ Association, and many others.

Proponents of prohibition argue flavors such as menthol in combustible cigarettes, sweet and fruit flavors in e-cigarettes, oral tobacco, and little cigars are targeted to and disproportionately impact young people and minorities.

In the case of menthol cigarettes, supporters of the law observe that around 85 percent of black smokers use a menthol cigarette, compared to a little more than a third of white smokers, with the tobacco industry gearing its marketing of menthol cigarettes toward black Americans. It’s also alleged that menthol cigarettes are especially appealing to young people because menthol acts as a cooling agent masking the harsh taste of burnt tobacco allowing new smokers to become hooked easier than they would if they tried a regular cigarette.

Regarding flavored e-cigarettes, the sweet flavors and fruit e-liquids are claimed to be responsible for the upswing in youth vaping that California and the rest of the country experienced beginning in 2017. Supporters of prohibition argue these flavors are hooking a new generation of kids on nicotine. Banning flavors, proponents claim, would help reduce the number of young people trying tobacco products and cause a substantial portion of adult smokers and vapers to quit nicotine for good.  

Arguments Opposed

The groups arguing for a ‘no’ vote on Prop. 31 include companies in the tobacco industry, the Howard Jarvis Taxpayers Association, and the Republican Party of California.

Opponents of the bans argue that the increase in the tobacco age to 21 in 2020 has already substantially reduced youth access to tobacco products. While the desire to protect youth may be well-intentioned, opponents say the laws would primarily affect adult tobacco users who enjoy flavors and argue that adults should have the right to choose whether to use these products just like with alcohol and marijuana.

They also say there is an unfairness to the legislation since hookah, pipe tobacco, and premium cigars are exempted.

The opponents warn that prohibition would have a negative financial impact on small businesses operating on tight margins. The ban would transfer flavored tobacco sales to the black market, which would mean not just a loss of tax revenue for California.

A ban would also entail criminal enforcement, which brings with it the possibility of increased targeting of minorities by law enforcement, opponents note. The ban on flavored e-cigarettes is also problematic from a health care standpoint because e-cigarettes are safer than combustible cigarettes and limiting access to these products could cause many vapers to relapse to smoking and prevent some smokers who would otherwise have switched from doing so, limiting tobacco harm reduction. 

Discussion

The claims made against menthol cigarettes in California mirror the arguments that were made to the Massachusetts legislature when it was considering a ban on flavored tobacco in 2019. To date, Massachusetts is the only state in the country to have implemented a comprehensive flavored tobacco ban.

According to a pre-print (not yet peer-reviewed) analysis by Reason Foundation Policy Analyst Jacob Rich, one year after the ban, menthol sales within Massachusetts did decline dramatically. But the sales of non-menthol cigarettes within Massachusetts increased substantially. There was also a dramatic rise in cigarette sales in the states bordering Massachusetts. The entire six-state region near Massachusetts reported a net increase in cigarette sales of 7.21 million packs compared to the year before the state ban came into effect. According to the Tax Foundation, the ban also cost Massachusetts $125 million in tax revenue in its first year.

When adult products are relegated to the illegal market consumers often respond by seeking out these products or substitutes on the black market, presenting opportunities for criminals to supply these goods as we’ve seen with alcohol and illegal drugs and sex work.

Supporters of a ‘yes’ vote on Prop. 31 are correct that black smokers, young people and adults, disproportionately use menthol cigarettes. But this obscures some important facts. According to the most recent data from the Youth Risk Behavior Surveillance System in 2017, California’s black youth have the lowest smoking rates of any group, while black adults have the highest. If menthol cigarettes are as appealing to youth as has been suggested it is unclear why youth who are most exposed to menthol have the lowest smoking rates. The data is however in accordance with a Reason Foundation study published in 2020 showing that states with higher menthol sales, such as California, have some of the lowest youth smoking rates in the country. According to the Centers for Disease Control and Prevention (CDC) most of the young people who do smoke, 61 percent, use nonmenthol cigarettes. While we do not have recent data for youth smoking rates in California, nationally, they’re at a record low of 1.5 percent. Considering California’s smoking rate historically underperforms the national average we should expect the state’s smoking rate to be even lower. 

While the ban purports to target only retailers, the reality is that prohibition creates a significant potential for menthol cigarette smuggling and black market activity. Given that menthol products are disproportionately popular among black smokers it’s reasonable to assume black communities could suffer from further unnecessary contact with law enforcement if menthols are banned. The American Civil Liberties Union (ACLU) and law enforcement organizations such as the National Organization of Black Law Enforcement Executives (NOBLE) are among the groups that have voiced concerns as it relates to a proposed national menthol ban by the Food and Drug Administration. Similar concerns would exist in California.

The other major target of the flavored tobacco ban is e-cigarettes. As the use of vaping products by young people rose from 2017 to 2019, it’s unsurprising that some legislators saw prohibition as an easy answer to the problem. But it is important to note that e-cigarettes are a much safer form of nicotine consumption than traditional combustible cigarettes and have helped many Americans quit smoking. Because e-cigarettes heat a liquid solution containing nicotine instead of burning tobacco the number and levels of harmful and potentially chemicals are substantially reduced.

The Royal College of Physicians reports that the risks of vaping are unlikely to exceed five percent of those of smoking. There’s also a growing body of evidence showing that e-cigarettes are more effective than traditional nicotine replacement therapies at helping smokers quit. While e-cigarette flavors are portrayed as being targeted at youth, most adult vapers trying to quit smoking use non-tobacco flavors. According to research conducted by Yale University’s Abigail Friedman, vapers using non-tobacco flavors are more likely to successfully quit smoking than those who don’t.

Banning e-cigarette flavors may have the unintended consequence of not just damaging the state’s vape stores, but could push some vapers back to smoking cigarettes. It could also reduce the number of smokers looking to transition to a safer alternative to cigarettes.

While there is limited evidence on the effects of e-cigarette flavor bans thus far, a recent study published in the journal Nicotine and Tobacco Research examining seven California cities that implemented flavored tobacco bans found no significant effect on the likelihood that youth would vape.  An earlier study published in 2018 concluded that a comprehensive tobacco flavor ban would reduce overall tobacco use, but there would be more cigarette smoking than the status quo. Fortunately, youth vaping has fallen by 60 percent since 2019, despite there being no federal prohibition of e-cigarette flavors. 

California’s voters have to decide whether banning flavored tobacco products is likely to achieve the intended public health benefits at minimal cost to taxpayers and social justice, or whether a path of using e-cigarettes and flavors as a harm reduction tool to reduce smoking in a regulated market can achieve similar outcomes without the unintended negative consequences we’ve witnessed with previous experiments in prohibition.

Voters’ guides for other propositions on California’s 2022 ballot.

The post California Proposition 31 (2022): Banning flavored tobacco products appeared first on Reason Foundation.

Based on its own number crunching, the FDA claims the move will save around half a million lives over the next 40 years and reduce health disparities. Supporters of the ban argue that this can be accomplished without triggering the devastating consequences caused by every other drug prohibition in history. The problem, however, is that the FDA’s math is wrong. For millions of adults, communities around the nation, and public health at large, this could prove a deadly miscalculation. 

Like all federal agencies, the FDA is required to provide some justification for major rules, showing why it expects the benefits of that rule to outweigh its costs to society. In the case of banning menthol cigarettes, that justification centers primarily on the lives it is expected to save, which the FDA estimates at between 324,000 to 654,000 by the year 2060. To come up with that number, the agency relied on a series of studies that used predictive modeling to guess how menthol cigarette smokers, now and in the future, might behave in the wake of such a ban.  

These models predict that, while around 56 percent of current and future menthol smokers would respond in ways that do not improve health (such as switching to equally-harmful non-menthol cigarettes or relying on illicit markets), a significant portion—45 percent—would alter their behavior in ways that promote better health. According to these models, however, nearly half of the public health benefits would come from smokers switching to mentholated versions of lower-risk nicotine products, like e-cigarettes. The issue with this in the real world is that smokers may not have that option thanks to the FDA’s own irrational policies. 

Nicotine, though a habit-forming substance, is not what makes smoking dangerous. The danger comes from combustion; the chemicals created by burning tobacco and paper. Despite nearly all evidence indicating that non-combustible sources of nicotine, like e-cigarettes, are safe and effective substitutes for smoking, the FDA continues to do everything in its power (and arguably beyond it) to eliminate the e-cigarette market. Only a handful of options have been approved for sale and the FDA has refused to approve any in menthol flavor (indicating it never will). Smokers already have limited access to any sort of FDA-sanctioned e-cigarette, let alone the type and flavor they might find an acceptable replacement for their cigarettes. As the FDA continues to pull e-cigarettes off the market, including the most popular and effective brands, and as cities and states implement their own e-cigarette bans, issues with limited access will grow. 

If nearly half of the public health benefits the FDA expects from a menthol cigarette ban come from the expectation that many smokers will switch to e-cigarettes, what will happen when the agency’s own policies prevent this from happening? It is possible that more smokers will choose to quit tobacco and nicotine use altogether, making a menthol cigarette ban even more beneficial for public health than the FDA currently predicts. But, evidence suggests smokers will instead choose to switch to non-menthol cigarettes, gaining zero health benefits, or turn to illicit markets, where their risks might actually be increased.

To make matters worse, the FDA’s math also suffers from incorrect assumptions about how illicit markets would respond to a menthol cigarette ban. Though menthol cigarettes make up over a third of all cigarette sales, generate more than $21 billion in revenue, and are used by an estimated 19 million Americans, the FDA claims a ban won’t lead to increases in illicit cigarette sales. But this is yet another miscalculation. 

The already-booming illegal cigarette market in America has traditionally operated via domestic bootlegging, with primarily “mom and pop” enterprises legally purchasing cigarettes in low-tax jurisdictions, such as Virginia, and selling them in high-tax jurisdictions, like New York. Since the scheme involves a product that is legal everywhere in the country, the risks illicit operators face for this sort of smuggling are relatively low. For the same reason, the potential profits smugglers can make are also relatively low, since illicit cigarette dealers must keep the prices they charge for smuggled cigarettes lower than what their customers would pay for legal cigarettes where they live. Because a nationwide ban on menthol cigarettes would prevent would-be menthol cigarette dealers from simply hopping state lines to supply their trade, the FDA assumes they would not even bother. But this is a dangerous underestimation of the resourcefulness of illicit supply chains. 

A national prohibition, whether for menthol cigarettes or anything else, certainly increases the risks for those hoping to profit by selling illicit goods. But, it also vastly increases the rewards for those who do so successfully. Unlike the current market for illicit tobacco which hinges on offering customers cheaper cigarettes, a national prohibition would make illicit sources the only option for menthol smokers. As such, those customers might be willing to pay as much or even more for illicitly supplied menthols as they would have paid when they were legal. By increasing both the demand for and the profitability of illicit menthol cigarettes, a ban may have the unintended effect of attracting international drug cartels into the racket. And given the skill with which these cartels continue to evade authorities, it is not clear why the FDA thinks a cigarette ban would be more successful than any other drug prohibition.

Even if U.S. authorities could stop the flow of illicit cigarettes over our national borders, there is little they could do to stop domestic producers from supplying the market with counterfeit menthols. This task would involve little more than purchasing still-legal non-menthol cigarettes and adding menthol flavoring. The government could do even less about individuals who might make their own supply of menthol cigarettes the same way. 

Far from making menthol cigarettes unavailable, as the FDA assumes, a menthol ban could have the perverse effect of making them far more available, particularly for minors, since illegal dealers aren’t exactly sticklers for age verification. Even more perversely, the ban could harm the very group—people of color—it supposedly seeks to help most. 

While there is no credible evidence that menthol cigarettes are more toxic, harder to quit, or more attractive to youth than non-menthol cigarettes, it is true that they are overwhelmingly preferred by people of color with around 85 percent of black smokers choosing menthols compared to just 30 percent of white smokers. The FDA claims this means that black people would benefit most from a menthol cigarette ban since they will be more motivated to quit smoking. But, it also means that many of the smokers who do not quit and instead turn to illicit markets to get the menthol cigarettes they prefer will be people of color. And, as it is with any drug war, it will be people and communities of color that bear the brunt when local authorities attempt to crack down on illicit activity. 

If the FDA is truly interested in promoting smoking cessation and saving lives, there are more effective and certainly less destructive ways to do this than a prohibition. Another approach would be for the FDA to adopt policies grounded in harm reduction, to encourage smokers who cannot or will not quit using nicotine to switch to less harmful options, such as the already FDA-endorsed (but largely ineffective) nicotine patch, gum, and lozenge, as well as e-cigarettes, snus, and heated tobacco. But, for this to work those products must be at least as accessible, affordable, and palatable to smokers as the cigarettes they are used to. Whether the FDA wants to admit it or not, that means allowing them in flavors smokers want, including menthol. 

In other countries, like the United Kingdom and Japan, tobacco harm reduction has been widely embraced and hugely successful. America has already adopted a similar approach to other substance use issues, such as legalizing cannabis, offering clean needles to people who use intravenous drugs, opioid replacement therapy, and naloxone for overdose prevention. There is no reason that tobacco harm reduction would not be similarly successful if the FDA abandoned its unscientific opposition to nicotine and got out of the way of innovation. Such a harm reduction approach may anger prohibitionists in the anti-tobacco industry and Congress, but unlike the current approach, it might actually save lives. 

The post The FDA’s deadly menthol miscalculation appeared first on Reason Foundation.

Thank you for allowing me the opportunity to submit testimony on House Bill 7870. 

My name is Guy Bentley, and I am the director of consumer freedom at the Reason Foundation, a 501(c)3 nonprofit think tank. The consumer freedom project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice.

The intention behind this bill to limit tobacco use, especially among youth, is to be applauded. However, the evidence of the success of such prohibitions should raise significant concerns that the ban would promote further inequalities in the criminal justice system, push sales and tax revenue to other states, increase the illicit tobacco trade, and fail to improve public health in Rhode Island.

Case Studies: Massachusetts, Canadian Provinces, and the European Union

Massachusetts’ ban on flavored tobacco products went into effect in June of 2020. The Reason Foundation has conducted a yet-to-be-published, preliminary analysis of the ban’s impact which compared cigarette sales in and around Massachusetts the year prior to the ban and the year following the ban’s implementation. We found that there was a net increase in cigarette sales of 7.2 million packs sold within Massachusetts and in its bordering states. 

These figures likely underestimate cross-border trade because they do not also account for lost sales of flavored e-cigarettes, smokeless tobacco, or cigars. Massachusetts also saw a 15.6 million pack increase in non-menthol cigarette sales as consumers switched brands.

According to the Tax Foundation, Massachusetts lost $125 million in tobacco revenue for the fiscal year 2021.

Furthermore, according to a study published by the Journal of Law and Economics, Canadian provinces’ menthol prohibition significantly increased non-menthol cigarette smoking among young people, resulting in no overall net change in youth smoking. As for adult smokers, provincial menthol bans simply shifted smokers’ cigarette purchases away from grocery stores and gas stations. 

The world’s largest experiment in menthol prohibition is the European Union, which includes 27 countries and has a population of 447 million people. The EU ban became effective in May of 2020. Prior to the ban, Poland had the largest menthol cigarette market in the EU, making up 28 percent of total sales. An analysis funded by the Norwegian Cancer Society in partnership with the Polish Ministry of Health found there was no statistically significant decline in cigarette sales after the ban.

These results are important not just because they demonstrate an immediate economic impact on jurisdictions that introduce prohibition but, thanks to cross-border trade and the substitution of non-menthol cigarettes, any predicted public health benefits are likely to be severely limited. In other words, the loss in tax revenue is unlikely to be offset by lower health care costs or improved public health.

Public Health and Disparate Impacts

Advocates for the prohibition of menthol cigarettes correctly observe that a disproportionate number of black smokers choose menthol products. In Rhode Island, some hope the ban would dramatically reduce the state’s smoking rate. While these populations are more likely to use a menthol product while white smokers are more likely to use a non-menthol product, smoking prevalence is, in fact, lower among black youth and adults.

Black non-Hispanic young people are less likely to smoke than their white peers. In Rhode Island, 4.1 percent of white high schoolers smoked in 2019. For black Rhode Island high schoolers, the number was 3.4 percent. These data conform to Reason Foundation’s study published in 2020 showing that states with higher menthol cigarette use tend to have lower, not higher, youth smoking rates.

From a public health standpoint, as black adults and young people smoke at lower rates than non-Hispanic whites, it’s hard to ascertain why non-menthol cigarettes, which are equally dangerous, would not be subjected to prohibition while menthol products would be. 

Because menthol cigarettes are overwhelmingly the choice of minority smokers, prohibition will necessarily lead to a concentration of the illicit tobacco market in minority communities. The American Civil Liberties Union and other civil rights groups warn that the prohibition of menthols could disproportionately negatively impact people of color, trigger criminal penalties, and prioritize criminalization over public health and harm reduction. The National Organization of Black Law Enforcement Executives (NOBLE), Grand Council of Guardians (GCGNY), National Association of Black Law Enforcement Officers (NABLEO), and Law Enforcement Action Partnership (LEAP) have argued that prohibitions of all kinds disproportionately affect communities of color, and this is especially the case when it comes to banning menthol cigarettes.

Food and Drug Administration Review and Tobacco Harm Reduction

Last year, the Food and Drug Administration authorized an e-cigarette as “appropriate for the protection of public health” for the first time. The FDA is also currently reviewing e-cigarette product applications that contain reams of data on safety, efficacy, and potential threats to youth. If the FDA finds that any product is a net harm to public health, it will be removed from the market. But if the product is deemed to be net beneficial, it will be authorized for sale as appropriate for the protection of public health. 

If Rhode Island chooses to ban these products prior to the FDA concluding its review, it would limit consumer access to products the FDA may deem as a positive for public health. According to a survey conducted by the International Tobacco Control Policy Evaluation Project, 57 percent of vapers said they would continue vaping if flavors were banned and half said they would find a way to get their preferred flavor. Of most concern was the finding that close to one in five vapers said they would stop vaping and smoke instead. 

While prohibiting e-cigarette flavors other than tobacco may seem an attractive solution to the problem of youth vaping, policymakers should recognize that, according to the 2021 National Youth Tobacco Survey (NYTS), 89 percent of high schoolers are not using e-cigarettes at all and 95 percent are not using them frequently. Youth vaping has also fallen to its lowest point in seven years.

Furthermore, data released by the Centers for Disease Control and Prevention (CDC) shows flavors are not the leading reason why youth initiate vaping. According to the CDC, the primary reason youth initiate vaping is curiosity, followed by use by a friend or family member. Availability in flavors, such as mint, candy, fruit, or chocolate comes as a very distant third. Banning flavored tobacco products may also induce perverse outcomes contrary to the promotion of public health among adolescents. 

In 2018, San Francisco banned the sale of all flavored tobacco products, including e-cigarettes with flavors other than tobacco. Yale University’s Abigail Friedman found that after the ban was enacted, San Francisco area youth had double the odds of smoking compared to similar jurisdictions with no tobacco flavor ban.

“While neither smoking cigarettes nor vaping nicotine are safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health,” said Friedman. 

According to a 2020 study by researchers at Yale School of Public Health, the use of e-cigarette flavors is positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking. The prestigious Cochrane Review concluded e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit.

Prohibition of flavored e-cigarettes, which are overwhelmingly the choice of adult vapers, risks driving vapers back to smoking, fueling illicit markets, and forcing the closure of Rhode Island vape shops. 

The post Testimony: Rhode Island e-cigarette prohibition could create unintended consequences appeared first on Reason Foundation.

Chair Lontine, members of the committee, thank you for allowing me the opportunity to submit testimony on HB22-1064. 

My name is Guy Bentley, and I’m the director of consumer freedom at the Reason Foundation, a 501(c)3 nonprofit think tank. The consumer freedom project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice.

The intention behind HB22-1064 to limit tobacco use, especially among youth, is to be applauded. However, the evidence on the success of such prohibitions should raise significant concern that the ban will promote further inequalities in the criminal justice system, push sales and tax revenue to other states, increase the illicit tobacco trade, and fail to improve public health in Colorado. 

Case Studies: Massachusetts, Canadian Provinces, and the European Union

Massachusetts’ ban on flavored tobacco products went into effect in June of 2020. A preliminary analysis awaiting publication conducted by Reason Foundation which compared cigarette sales in Massachusetts the year prior to the ban and the year following the ban’s implementation found that, in total, there was a net increase in cigarette sales of 7.2 million packs for Massachusetts and its bordering states. These figures underestimate cross-border trade because they do not account for lost sales of flavored e-cigarettes, smokeless tobacco, or cigars. There was also an increase of non-menthol cigarette sales in Massachusetts of 15.6 million packs as consumers switched brands.

Furthermore, according to a study published by the Journal of Law and Economics, Canadian provinces’ menthol prohibition has significantly increased non-menthol cigarette smoking among youths, resulting in no overall net change in youth smoking rates. As for adult smokers, the study discovered, provincial menthol bans shifted smokers’ cigarette purchases away from grocery stores and gas stations to First Nations reserves (where the menthol bans do not apply). 

The world’s largest experiment in menthol prohibition is the European Union, which includes 27 countries and a population of 447 million people. The EU ban became effective in May of 2020. Prior to the ban, Poland had the largest menthol cigarette market in the EU, making up 28 percent of total sales. An analysis funded by the Norwegian Cancer Society in partnership with the Polish Ministry of Health found there was no statistically significant decline in cigarette sales. These results are important not just because they demonstrate an immediate economic impact on jurisdictions that introduce prohibition but, thanks to cross-border trade and the substitution of non-menthol cigarettes, any health benefits are severely limited. In other words, the loss in tax revenue is unlikely to be made up of lower healthcare costs.

Public Health and Disparate Impacts

Advocates for the prohibition of menthol cigarettes correctly observe that a disproportionate number of Black smokers choose menthol products. In Colorado, some hope the ban will dramatically reduce the state’s smoking rate. While these populations are more likely to use a menthol product while White smokers are more likely to use a non-menthol product, smoking prevalence is, in fact, lower among Black youth and adults.

Black non-Hispanic youth are less likely to smoke than their White peers. In Colorado, 4.3 percent of White high schoolers smoked in 2019. For Black Coloradan high schoolers, the numbers were so low as to not be statistically significant. These data conform to Reason Foundation’s study published in 2020 showing that states with higher menthol cigarette use tend to have lower, not higher, youth smoking rates. From a public health standpoint, as Black adults and youth smoke at lower rates than non-Hispanic Whites, it’s hard to ascertain why non-menthol cigarettes, which are equally dangerous, will not be subjected to prohibition and menthol products will be. 

Because menthol cigarettes are overwhelmingly the choice of minority smokers, prohibition will necessarily lead to a concentration of the illicit tobacco market in minority communities. The American Civil Liberties Union and other civil rights groups warn prohibition could disproportionately impact people of color, trigger criminal penalties, and prioritize criminalization over public health and harm reduction. The National Organization of Black Law Enforcement Executives (NOBLE), Grand Council of Guardians (GCGNY), National Association of Black Law Enforcement Officers (NABLEO), and Law Enforcement Action Partnership (LEAP) have argued that prohibitions of all kinds disproportionately affect communities of color, and this is especially the case when it comes to banning menthol cigarettes.

Food and Drug Administration Review and Tobacco Harm Reduction

Last year, the Food and Drug Administration authorized an e-cigarette as “appropriate for the protection of public health” for the first time. The FDA is also currently reviewing e-cigarette product applications that contain reams of data on safety, efficacy, and potential threats to youth. If the FDA finds that any product is a net harm to public health, it will be removed from the market. But if the product is deemed to be net beneficial, it will be authorized for sale as appropriate for the protection of public health. 

If Colorado chooses to ban these products prior to the FDA concluding its review, it would limit consumer access to products the FDA may deem as a positive for public health. According to a survey conducted by the International Tobacco Control Policy Evaluation Project, 57 percent of vapers said they would continue vaping if flavors were banned, but half said they would find a way to get their preferred flavor. Of most concern was the finding that close to one in five vapers said they would stop vaping and smoke instead.

While prohibiting e-cigarette flavors other than tobacco may seem an attractive solution to the problem of youth vaping, policymakers should recognize that, according to the 2021 National Youth Tobacco Survey (NYTS), 89 percent of high schoolers are not using e-cigarettes at all and 95 percent are not using them frequently. Youth vaping has also fallen to its lowest point in seven years. Furthermore, data released by the Centers for Disease Control and Prevention (CDC) shows flavors are not the leading reason why youth initiate vaping. According to the CDC, the primary reason youth initiate vaping is curiosity, followed by use by a friend or family member. Availability in flavors, such as mint, candy, fruit, or chocolate comes as a very distant third. Banning flavored tobacco products may also induce perverse outcomes contrary to the promotion of public health among adolescents. 

In 2018, San Francisco banned the sale of all flavored tobacco products, including e-cigarettes with flavors other than tobacco. Yale University’s Abigail Friedman found that after the ban was enacted, San Francisco area youth had double the odds of smoking compared to similar jurisdictions with no tobacco flavor ban. “While neither smoking cigarettes nor vaping nicotine are safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health,” said Friedman. 

According to a 2020 study by researchers at Yale School of Public Health, the use of e-cigarette flavors is positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking. The prestigious Cochrane Review concluded e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit. Prohibition of flavored e-cigarettes, which are overwhelmingly the choice of adult vapers, risks fueling illicit markets, forcing the closure of Colorado vape shops, and driving vapers back to smoking.

The post Colorado should rethink potential tobacco prohibitions appeared first on Reason Foundation.

Chairman David Gowan and members of the committee, thank you for allowing me the opportunity to submit testimony on Senate Bill 1245.  My name is Guy Bentley, and I’m the director of consumer freedom at Reason Foundation, a 501(c)3 nonprofit think tank. Reason’s consumer freedom project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice.

The intention behind Senate Bill 1245 to limit tobacco use, especially among youth, is to be applauded. The principle of local control is crucial for a well-functioning government. Allowing Arizona towns and cities to regulate tobacco sales and use in the way that best fits their citizens’ needs has a number of advantages. But reserving the power to prohibit entire categories of tobacco products to the state legislature avoids the unintended consequences of inconsistent local prohibitions which can severely disrupt the state’s public health goals and distort the wider economy, through increases in the illicit tobacco trade and the reallocation of legal transactions such as groceries and alcohol to other jurisdictions.

Protecting youth from tobacco use

The last time Arizona’s youth smoking and vaping rates were recorded was in 2019 when the state ranked below the national average in both categories. Since 2019, youth vaping nationally has fallen to its lowest point in seven years. According to the 2021 National Youth Tobacco Survey (NYTS), 89 percent of high schoolers are not using e-cigarettes at all and 95 percent are not using them frequently. 

These declines have all been enjoyed in the absence of prohibition of flavored tobacco products, with the exception of Massachusetts, which banned the sale of such products in June 2020. But thanks to cross-border trade, Reason Foundation analysis shows Massachusetts and its bordering states experienced a net increase in cigarette sales of seven million packs instead of the sharp decline that was hoped for. Furthermore, data released by the Centers for Disease Control and Prevention (CDC) shows flavors are not the leading reason why youth initiate vaping. According to the CDC, the primary reason youth initiate vaping is “curiosity,” followed by “friend or family member used them,” with “they are available in flavors, such as mint, candy, fruit, or chocolate” coming a very distant third. 

Nevertheless, it’s vital that youth access to tobacco products is further restricted by bringing Arizona’s minimum age of sale in line with the federal age of 21, which may assist in limiting the social sourcing of tobacco products to minors. Furthermore, if Arizona fails to update its minimum age of purchase it risks losing 10 percent of the federal government’s Substance Abuse Prevention and Treatment Block Grant. 

Senate Bill 1245’s proposal for the Department of Liquor Licenses and Control to take responsibility for the licensing aspect of tobacco outlets has significant efficiency advantages which can be utilized to prevent sales to youth. Currently, Arizona’s municipalities are responsible for policing tobacco retails. This can be a costly burden for many jurisdictions and may be inefficient.  Because there is significant overlap between tobacco and alcohol retailers, the Department of Liquor Licenses and Control can bring enforcement uniformity, which stands a greater chance of finding businesses selling tobacco products to youth. Combined with harsh penalties for violations, the new regulatory environment presented by SB 1245 raises a significant opportunity to accelerate the already diminishing rates of youth tobacco across the state of Arizona.  

Case Studies of local tobacco prohibitions: San Francisco and Canadian Provinces

When localities seek to prohibit tobacco, nicotine, or alcohol they expose themselves to cross-border trade and illicit markets.  Such bans can also be detrimental to the state’s public health goals and distort economic activity across the region. 

In 2018, San Francisco banned the sale of all flavored tobacco products, including e-cigarettes. Yale University’s Abigail Friedman found that after the ban was enacted, San Francisco area youth had double the odds of smoking compared to similar jurisdictions with no tobacco flavor ban. “While neither smoking cigarettes nor vaping nicotine is safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health,” said Friedman. 

Furthermore, according to a study published by the Journal of Law and Economics, Canadian provinces’ prohibition on menthol-flavored cigarettes has significantly increased non-menthol cigarette smoking among youths, resulting in no overall net change in youth smoking rates. As for adult smokers, the study discovered, provincial menthol bans shifted smokers’ cigarette purchases away from grocery stores and gas stations to First Nations reserves (where the menthol bans do not apply). These results are important not just because they demonstrate an immediate economic impact on jurisdictions that introduce prohibition but thanks to cross-border trade and the substitution of non-menthol cigarettes, any health benefits are severely limited. In other words, the loss in tax revenue is unlikely to be made up of lower healthcare costs. 

Arizona’s cigarette tax is higher than four of its neighbor states and no state bordering Arizona has implemented a ban on flavored tobacco products. The emergence of prohibition potholes throughout the state will leave Arizona vulnerable to cross-border trade from other states as well as increased exposure to illicit market activity. 

Food and Drug Administration review and tobacco harm reduction

Last year, the Food and Drug Administration authorized an e-cigarette as “appropriate for the protection of public health” for the first time. The FDA is also currently reviewing e-cigarette product applications that contain reams of data on safety, efficacy, and potential threats to youth. If the FDA finds that any vaping product is a net harm to public health, it will be removed from the market. But if the product is deemed to be a net benefit, it will be authorized for sale as appropriate for the protection of public health. 

If Arizona municipalities choose to ban these products prior to the FDA concluding its review it would limit consumer access to products the FDA may deem as a positive for public health. According to a survey conducted by the International Tobacco Control Policy Evaluation Project, 57 percent of vapers said they would continue vaping if flavors were banned, but half said they would find a way to get their preferred flavor. Of most concern for public health, was the finding that close to one-in-five vapers said they would stop vaping and smoke traditional cigarettes instead.

According to a 2020 study by researchers at Yale School of Public Health, the use of e-cigarette flavors is positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking. The prestigious Cochrane Review also concluded e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit. 

More than 8,000 Arizonans die each year from smoking-related diseases. Smoking is responsible for 28.7 percent of the state’s cancer deaths. The prohibition of products that are helping to reduce this burden would have grave consequences. If Arizona wishes to continue to reduce the number of deaths from smoking each year, the power to regulate the legal sale of safer nicotine products should be reserved for the state legislature itself. 

Thank you for your time. I’d be happy to answer any questions.

Guy Bentley

Director of Consumer Freedom, Reason Foundation

Correction 2/14: The previous version of this testimony stated that 87 percent of high schoolers are not using e-cigarettes at all and 92 percent are not using vaping devices frequently. This has been updated to 89 and 95 percent, respectively.

The post Testimony: Arizona should examine the negative impacts that additional nicotine and licensing regulation would bring appeared first on Reason Foundation.

Chairman Ned Claxton and members of the committee, thank you for allowing me the opportunity to submit testimony on LD 1693. 

My name is Guy Bentley, and I’m the director of consumer freedom at the Reason Foundation, a 501(c)3 nonprofit think tank. The consumer freedom project analyzes and promotes policy solutions that improve public health while avoiding unintended consequences and protecting consumer choice.

The intention behind Legislative Document (LD) 1693 to limit tobacco use, especially among young people, is to be applauded. However, the evidence on the success of such prohibitions should raise significant concern that the ban would promote further inequalities in the criminal justice system, push sales and tax revenue to other states, increase the illicit tobacco trade, and fail to improve public health in Maine. 

Case Studies: Massachusetts and Canadian Provinces

Massachusetts’s ban on flavored tobacco products went into effect in June 2020. A preliminary analysis conducted by Reason Foundation compared cigarette sales in Massachusetts the year prior to that state’s ban and the year following the ban’s implementation found there was a net increase in cigarette sales of 7.2 million packs for Massachusetts and its bordering states. These figures underestimate cross-border trade because they do not account for lost sales of flavored e-cigarettes, smokeless tobacco, or cigars.

Furthermore, according to a study published by the Journal of Law and Economics,  Canadian provinces’ menthol prohibition has significantly increased non-menthol cigarette smoking among youths, resulting in no overall net change in youth smoking rates. As for adult smokers, the study discovered, provincial menthol bans shifted smokers’ cigarette purchases away from grocery stores and gas stations to First Nations reserves (where the menthol bans do not apply).

These results are important, not just because they demonstrate an immediate economic impact on jurisdictions that introduce prohibitions, but thanks to cross-border trade and the substitution of non-menthol cigarettes any health benefits of the bans are severely limited. In other words, the loss in tax revenue is unlikely to be made up of lower health care costs.

Public Health and Disparate Impacts

Advocates for the prohibition of menthol cigarettes correctly observe a disproportionate number of black smokers choose a menthol product, with around 85 percent using menthol. In Maine, some hope the ban will dramatically reduce the state’s black smoking rate. While black smokers are more likely to use a menthol product and white smokers use a non-menthol product, smoking prevalence is, in fact, lower among black youth and adults.

Black non-Hispanic youth are less likely to smoke than their white peers, at 2.5 percent and 3.7 percent, respectively. These data conform to Reason Foundation’s study published in 2021, showing that states with higher menthol cigarette use, such as Maryland, tend to have lower, not higher, youth smoking rates. From a public health standpoint, as black adults and youth smoke at lower rates than non-Hispanic whites, it’s hard to ascertain why non-menthol cigarettes, which are equally dangerous, will not be subjected to prohibition and menthol products will be. 

Because menthol cigarettes are overwhelmingly the choice of black smokers, prohibition will likely lead to a concentration of the illicit tobacco market in black communities. The American Civil Liberties Union and other civil rights groups warn prohibition could disproportionately impact people of color, trigger criminal penalties, and prioritize criminalization over public health and harm reduction. The National Organization of Black Law Enforcement Executives (NOBLE), Grand Council of Guardians (GCGNY), National Association of Black Law Enforcement Officers (NABLEO), and Law Enforcement Action Partnership (LEAP) have argued that prohibitions of all kinds disproportionately affect communities of color and this is especially the case when it comes to banning menthol cigarettes.

Food and Drug Administration Review and Tobacco Harm Reduction

Last year, the Food and Drug Administration authorized an e-cigarette as “appropriate for the protection of public health” for the first time. The FDA is also currently reviewing e-cigarette product applications that contain reams of data on safety, efficacy, and potential threats to youth.

If the FDA finds that any e-cigarette product is a net harm to public health, it will be removed from the market. But if the product is deemed to be net beneficial, it will be authorized for sale as appropriate for the protection of public health. 

If Maine chose to ban these e-cigarette products prior to the FDA concluding its review, it would limit consumer access to products the FDA may deem as a positive for public health. According to a survey conducted by the International Tobacco Control Policy Evaluation Project, 57 percent of vapers said they would continue vaping if flavors were banned, but half said they would find a way to get their preferred flavor. Of the most concern for public health was the finding that close to one-in-five five vapers said they would stop vaping and smoke traditional cigarettes instead.

While prohibiting e-cigarette and tobacco flavors may seem an attractive solution to the problem of youth vaping, policymakers should recognize that according to the 2021 National Youth Tobacco Survey (NYTS), 89 percent of high schoolers are not using e-cigarettes at all and 95 percent are not using them frequently. Youth vaping has also fallen to its lowest point in seven years. Furthermore, data released by the Centers for Disease Control and Prevention (CDC) shows flavors are not the leading reason why youth initiate vaping. According to the CDC, the primary reason youth initiate vaping is “curiosity,” followed by “friend or family member used them,” with “they are available in flavors, such as mint, candy, fruit, or chocolate” coming a very distant third. Banning flavored tobacco products may also induce perverse outcomes contrary to the promotion of public health among adolescents. 

In 2018, San Francisco banned the sale of all flavored tobacco products, including e-cigarettes with flavors other than tobacco. Yale University’s Abigail Friedman found that after the ban was enacted, San Francisco area youth had double the odds of smoking compared to similar jurisdictions with no tobacco flavor ban. “While neither smoking cigarettes nor vaping nicotine is safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health,” said Friedman. 

According to a 2020 study by researchers at Yale School of Public Health, the use of e-cigarette flavors is positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking. The prestigious Cochrane Review concluded e-cigarettes are more effective than traditional nicotine replacement therapies for helping smokers quit. Prohibition of flavored e-cigarettes, which are overwhelmingly the choice of adult vapers, risks fueling illicit markets, forcing the closure of Maine’s vape shops, and driving vapers back to smoking.

Thank you for your time. I’d be happy to answer any questions.

Guy Bentley

Director of Consumer Freedom, Reason Foundation

guy.bentley@reason.org

The post Testimony: Why Maine shouldn’t prohibit e-cigarettes appeared first on Reason Foundation.

A possible wrinkle for this line of reasoning comes from a focus group conducted by Democratic strategist Danny Barefoot. A group of suburban women was asked, “If Democrats had passed the bipartisan infrastructure package before the election would you have considered changing your vote?”

In the focus group, 91% answered “no,” and one woman laughed and asked, “What does that have to do with anything?”

As Congress struggles to pass some of its spending plans, there are obvious lessons to take away from Virginia’s fiercely fought gubernatorial race. Parsing through the Virginia results, a familiar pattern comes into view. Democrats are losing working-class, non-college-educated voters to Republicans. This group appears increasingly happy to turn out in off-year elections and without Donald Trump on the ballot.

If Virginia Democrats are to retain any chance of retaking the governor’s mansion or keeping control of Congress, Democrats need to up their game with this group of voters.

In the rash of revisions to the Build Back Better plan, House Budget Chair Rep. John Yarmouth (D-KY) added a nicotine tax to raise extra funds for the spending plan. The proposed tax wouldn’t affect regular smokers, but it would massively hike the taxes on e-cigarettes.

The tax would be highly regressive and break President Joe Biden’s campaign promise not to raise taxes on those earning less than $400,000 a year. According to Gallup, vapers are primarily concentrated in households earning less than $40,000. Those without a college degree are twice as likely to use an e-cigarette as those with a college degree. More than 320,000 Virginia adults vape and there are more than 15 million vapers across the United States.

In 2019, McLaughlin & Associates conducted polling of vapers in several battleground states, including Virginia. Four in five vapers said they were likely to decide their vote based solely on a candidate’s position on vaping, and half were “very” likely to be single-issue voters.

An e-cigarette tax is nearly perfectly calibrated to target working-class voters without a college degree. Such a tax plays into the worst stereotypes of Democrats, as out-of-touch paternalistic elites imposing taxes and policies for your own good. But what makes the proposed e-cigarette tax especially egregious is that it’s not just regressive; it’s terrible for public health.

In effect, e-cigarettes would be taxed more than regular cigarettes. Michael Pesko of Georgia State University estimates the new tax on safer nicotine alternatives, like e-cigarettes, would cause 2.7 million more daily adult smokers.

The biggest irony is that while House Democrats could hike taxes on more than 300,000 mostly lower-income Virginians, other proposed changes to the State and Local Tax Deduction (SALT) would slash taxes for millionaires and billionaires in high-tax blue states such as New Jersey and New York. The nicotine tax would be bad for Virginia and break President Biden’s promise to a state he won by 10 percentage points.

As they try to ensure the popularity of their agenda in Virginia and across the country, Democrats should focus on passing policies to help, rather than harm, public health and the people whose votes they are counting on.

A version of this column previously appeared in The Virginia Pilot.

The post The vaping tax in the Build Back Better plan is a threat to public health appeared first on Reason Foundation.

In 2018, San Francisco began enforcing its flavored tobacco ban. To investigate the subsequent impact on public health, Yale University’s Abigail Friedman conducted a study evaluating the policy. Friedman’s research showed young people in the San Francisco area had double the odds of smoking compared to young people in similar nearby jurisdictions where there was not a tobacco flavor ban. Friedman stated:

“While neither smoking cigarettes nor vaping nicotine are safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is responsible for nearly one in five adult deaths annually. Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health.”

There’s a widespread misperception that the main reason young people experiment with vaping is that e-cigarette products come in sweet or fruity flavors. But according to data from the Centers for Disease Control and Prevention (CDC), the principal reasons young people say they start vaping is “curiosity,” followed by “friend or family member used them,” and then “they are available in flavors, such as mint, candy, fruit, or chocolate” comes in a very distant third. 

The minority of youth who vape use non-tobacco flavors, but the same is true for adult smokers who switch to e-cigarettes to quit smoking. According to a 2020 study by researchers at the Yale School of Public Health, the use of e-cigarette flavors is positively associated with smoking cessation outcomes for adults but not associated with increased youth smoking.

Fortunately, youth vaping has been declining since before the COVID-19 pandemic and has plummeted by 60% in the last two years.

Blanket bans on the most popular reduced-risk alternatives to traditional cigarettes would also preempt the Food and Drug Administration’s (FDA) process for evaluating whether these products are a net benefit to public health. In October, the FDA authorized an e-cigarette as appropriate for the protection of public health for the first time. In fact, Denver’s ban, as constructed, would ban Swedish Match’s mint and wintergreen smokeless products, both of which have been authorized as appropriate for the protection of public health by the FDA and are permitted to make marketing claims informing consumers of their safety relative to cigarettes. 

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption,” said Mitch Zeller, head of the FDA’s Center for Tobacco Products.

No longer can it be claimed that the public-health agency doesn’t recognize the basic science that vaping is safer than smoking. Many flavored e-cigarettes are currently under FDA review. If they are found to be a public health risk, they will be removed from the market. But banning e-cigarette flavors regardless of the FDA’s decision would be to ignore the extensive scientific evaluation to which these products are subjected.

The prohibition of menthol cigarettes presents a different problem. As of now, the evidence suggests menthol bans are largely ineffective thanks to cross-border shopping and substitution for regular cigarettes. According to a study published by the National Bureau of Economic Research on menthol prohibition in Canadian provinces, the ban significantly increased non-menthol cigarette smoking among youths, resulting in no overall net change in youth smoking rates. As for adult smokers, the study found provincial menthol bans shifted smokers away from grocery stores and gas stations to First Nations reserves (where the menthol bans do not apply). 

In the first year of banning flavored tobacco, Massachusetts lost more than $140 million in tax revenue due to the decrease in sales. However, those sales didn’t stop entirely. Menthol cigarettes sales skyrocketed in the neighboring states of New Hampshire and Rhode Island.

Just as, or more important are concerns over the disparate impact that bans on menthol products may have on black communities. Advocates for the prohibition of menthol cigarettes correctly observe a disproportionate number of black smokers choose menthol products, with around 85% using menthol. From a public health standpoint, it’s hard to ascertain why non-menthol cigarettes, which are equally dangerous, would not be subjected to prohibition while menthol products would be. 

The American Civil Liberties Union and other civil rights groups have warned that the prohibition of menthols could disproportionately impact people of color, trigger criminal penalties, and prioritize criminalization over public health and harm reduction by penalizing those who become involved in the illicit trade for menthol cigarettes. In New York City, Eric Garner was killed in a police confrontation sparked by selling loose cigarettes. 

With smoking currently at a historic low among youth and adults, there are methods to further reduce the burden of smoking-related disease without risking discriminatory law enforcement action or criminalizing the preferences of one ethnic group while allowing those of others to remain legal. 

The post Denver shouldn’t ban flavored tobacco products appeared first on Reason Foundation.

A 6 milligram (nicotine)/30 milliliter bottle of e-liquid, for example, would be taxed at a rate of $5.01 under the proposal. A typical pack of e-liquid pods would be taxed at $4.59. The federal tax on cigarettes is $1.01 per pack. Thus, e-cigarettes would be taxed more than regular cigarettes, and dramatically more so in states that already levy their own high e-cigarette taxes. 

Michael Pesko of Georgia State University, one of the country’s leading economists when it comes to analyzing the effect of e-cigarette taxes, estimates the new tax on nicotine alternatives would cause 2.7 million more daily adult smokers, 530,000 more teen smokers, and 29,000 more prenatal smokers.

This is because e-cigarettes are substitutes, not complements to combustible cigarettes, and millions of American ex-smokers have used these products to get off smoking traditional cigarettes. 

“I think it makes sense to raise taxes on the most lethal forms of tobacco,” Pesko told Reason Foundation. “Unfortunately, this bill doesn’t do that. Instead, it raises taxes on one of the safer forms of tobacco and so the net public health impact of the tax is likely to be negative by pushing people toward more harmful combustible tobacco use.”

The Cochrane Review, the gold standard of evidence-based medicine, recently concluded e-cigarettes are probably more effective than traditional nicotine replacement therapies in helping smokers quit. “We are moderately confident that nicotine e-cigarettes help more people to stop smoking than nicotine replacement therapy or nicotine-free e-cigarettes,” they found.

From a public health perspective, rather than encourage traditional cigarette smokers to switch to nicotine alternatives that could improve their health, if implemented, this proposed tax seems certain to contribute to a greater incidence of lung diseases going forward.

As well as having a devastating impact on public health, the tax is highly regressive and would violate President Biden’s campaign promise not to raise taxes on people earning less than $400,000 a year. According to a recent Gallup poll, Americans with an annual household income of less than $40,000 are significantly more likely to vape than higher-income groups. Americans without a college degree are twice as likely to vape as college graduates. Those groups would be paying this tax increase.

With more than 15 million adult vapers now in America, many of whom attribute their ability to quit or reduce smoking traditional cigarettes to their use of e-cigarettes, it’s baffling House Democrats would consider targeting this group with a huge tax increase that could push many of them back to smoking and worsen public health.

The proposed tax increase won’t be worth causing 2.75 million more Americans to smoke and won’t generate much of the funding required to pay for the $2 trillion proposal. As the Tax Foundation’s Ulrik Boesen points out, a similar tax proposal from 2019 was estimated to raise less than $10 billion over 10 years. “The nicotine tax proposal in the Build Back Better Act neglects sound excise tax policy design and by doing so risks harming public health. Lawmakers should reconsider this approach to nicotine taxation,” Boesen concluded.

It is very difficult to understand why this proposed nicotine tax was included in the spending plan since it will have such negative consequences for public health, hurt low- and middle-income Americans, and break one of the president’s key campaign promises.

Sen. Joe Manchin (D, WV) opposes the tax and may be enough to ensure that it never becomes law. I second what Sen. Manchin said earlier this week, “A tax on nicotine? That doesn’t make any sense to me whatsoever.”

The post House Democrats’ tax on e-cigarettes would lead to millions more smokers appeared first on Reason Foundation.

The FDA’s decision to approve the Vuse Solo e-cigarette last month is a historic one: It marks the first time that America’s leading public-health agency officially recognized the potential of e-cigarettes to help smokers quit.

“The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption,” said Mitch Zeller, head of the FDA’s Center for Tobacco Products.

The FDA’s decision is both welcome and overdue. Indeed, it’s been clear for many years that e-cigarettes are dramatically safer than combustible cigarettes; the evidence base that supports it is overwhelming to boot. The U.S. has nevertheless consistently lagged behind other countries — such as the U.K., France, and New Zealand — in recognizing the science of tobacco harm reduction.

Yet rather than heed the FDA’s guidance — and listen to the science on the potentially lifesaving benefits of e-cigarette products — anti-vaping advocates have charged that the agency has made a terrible choice.

For years, the media have pushed scare stories about e-cigarettes; anti-vaping activists have done likewise, sowing doubt in the minds of voters and lawmakers as to whether these products truly are safer than smoking. The FDA’s approval of Vuse should end the fear-mongering and misinformation that has plagued this topic.

Sadly, it won’t. Take vaping opponents in Congress, who appear to be rejecting the evidence altogether.

“While I am pleased that FDA denied requests by the manufacturer to market certain flavors, I remain concerned given this product’s popularity with youth,” said Represenative Frank Pallone (D., N.J.), a co-sponsor of the 2009 Tobacco Control Act (TCA), which gave the FDA the responsibility for approving vaping products.

Another booster for the TCA was Senate majority whip Dick Durbin (D., Ill.), who is now concerned about “how the agency is applying its risk framework.”

The most brazen denouncement since the FDA’s decision came from Representative Raja Krishnamoorthi (D., Ill.). “FDA has turned its back on the public health by approving a high-nicotine e-cigarette,” the congressman stated in a press release. “[The agency] has ignored the data and missed another opportunity to address the youth vaping epidemic.”

Preventing tobacco use among minors is, of course, a worthy goal. But what the congressman and others neglect to mention is that youth vaping had been trending down before the pandemic and has declined by 60 percent in the last two years. Furthermore, youth use of the newly approved Vuse Solo products is so low that it can’t be reliably measured. A recent FDA survey showed that a little more than 1 percent of all high-school students used Vuse products in the past 30 days.

Anti-vaping campaigners increasingly appear to be fighting yesterday’s war.

The public should ignore the hysterical claims of those who have made political capital out of demonizing products that have effectively helped millions to quit smoking. Instead of fighting against a safer smoking alternative that has little appeal to youth, anti-vaping campaigners should ask a more fundamental question: Why has only one product been approved while others have been rejected?

In short, such products have been rejected because their firms lack the requisite legal and financial support to make it through a years-long regulatory process and because the FDA has adopted a narrow standard for approval. That arduous approval process is thanks to those who supported the TCA.

The FDA’s process for approving e-cigarettes is unlike any other public-health approval process in the world. Every single e-cigarette product, of which there are millions, must be reviewed to investigate how it will affect the health of smokers and that of the entire population.

R.J. Reynolds, which manufacturers the Vuse Solo products, is a multibillion-dollar company and can afford to comply with the FDA’s current regulatory regime. But the agency has rejected millions of other e-cigarette applications from smaller manufacturers. It would be wrong to assume that these products are inherently more dangerous than Reynolds’s.

To be sure, the FDA’s decision on Vuse Solo should be applauded. No longer can it be claimed that the public-health agency doesn’t recognize the basic science that vaping is safer than smoking. But the FDA’s process remains in desperate need of reform. If vaping is to replace smoking, the status quo in which only the largest companies with the deepest pockets can bring their products to market must change.

A version of this column previously appeared in National Review Capital Matters.

The post Even the FDA can’t convince anti-vaping advocates e-cigarettes present public health benefits appeared first on Reason Foundation.

The proposed tax increase attempts to equalize the taxes on all nicotine products—regardless of their risk, use patterns, or approval by the Food and Drug Administration. Taxes on combustible cigarettes would double to $2 per pack under the bill’s current form. The tax on dipping tobacco, roll-your-own tobacco, and pipe tobacco would rise by 2,023 percent, 100 percent, and 1,651 percent, respectively.

Vapor products, which are not currently taxed at the federal level, would be taxed at a rate of $100.66 per 1,810 mg of nicotine to align them with taxes on traditional cigarettes. Thus, the tax on a typical pack of e-cigarette pods would be around $9, and a 30-milliliter bottle of 12-milligram e-liquid would be taxed at $20.02. Federal taxes on small cigars would increase by 100 percent under the proposal, but larger and premium cigars could see up to a 1,000 percent tax increase. 

Two already products approved as “appropriate for the protection of public health” by the FDA would also see tax increases. The tax on heated tobacco products would increase 100 percent and the smokeless tobacco, snus, would incur a 2,892 percent tax increase on a can of 24 pouches.

These sweeping tax hikes would break the Biden administration’s campaign pledge that it would not raise taxes on low and middle-income Americans. The tax increases also contradict the FDA’s smoking reduction strategy, would undermine public health efforts, and cause job losses across the country.

Tobacco Tax Hikes Are Regressive

On the 2020 campaign trail, now-President Joe Biden frequently pledged to not raise taxes on individuals earning below $400,000 a year. However, cigarette taxes are acknowledged to be one of the most regressive taxes at both the state and federal levels. Almost three-quarters of America’s 34 million smokers are from low-income communities. According to the Joint Committee on Taxation, 94.3 percent of consumers who would be paying more in tobacco taxes make under $200,000 a year.

If the congressional tobacco tax proposal were to pass, a pack-a-day smoker in New York state making $15,000 a year would pay almost 20 percent of their yearly income to tobacco taxes, according to the Tax Foundation. In West Virginia, the state with the highest smoking rate in the nation, that figure would be more than 10 percent.

Smoking is concentrated among blue-collar workers without college degrees. For example, about 35 percent of those with only a GED smoke while only four percent of individuals with a graduate degree smoke. It would not be an understatement to say that the dramatic tobacco tax increase is strongly supported by high-income Americans with advanced educations but would be paid for by low- and middle-income Americans who didn’t go to or graduate from college. 

Under even the most optimistic assumptions by public health groups, 97 percent of smokers would continue smoking despite the proposed increased tax. However, these assumptions don’t account for those currently using safer nicotine alternatives switching back to smoking because the price advantage of using e-cigarettes and other devices would have been eliminated. The revenue raised from these taxes would be a fraction of the cost of the president’s Build Back Better agenda but would significantly impact the pocketbooks of tens of millions of Americans. 

Congress’ Proposal Contradicts the FDA’s Strategy for Tobacco Harm Reduction

Equalizing taxes across all nicotine products, regardless of their risk to users, runs counter the FDA’s strategy to reducing tobacco-related public health harms. The FDA’s plan to reduce smoking is based on the “continuum of risk,” which recognizes that not all nicotine products are created equal. Cigarettes are the most dangerous nicotine product, not because of the presence of nicotine but because of the smoke that results from combustion. Nicotine replacement therapies like gums are some of the safest.

Writing in the journal Tobacco & Nicotine Research, the head of the Center for Tobacco Products Mitch Zeller said:

“FDA’s new strategy promises to save millions of lives by accelerating declines in smoking among those currently addicted, while preventing future generations from becoming addicted to cigarettes in the first place. Primary objectives include helping people move away from the tobacco product that causes the most harm—cigarettes—and encouraging industry resourcefulness in developing potentially less harmful products for adults who seek nicotine.” 

Zeller told Congress, “If we could get all those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health.”

The FDA has already authorized two such products; IQOS, and general snus, both of which are allowed to inform consumers of their benefits relative to cigarettes. E-cigarettes are currently under FDA review. Increasing taxes on e-cigarettes so dramatically before the FDA has completed this process risks severe consequences for the roughly 15 million adult vapers in the U.S. 

Further, a study conducted by health economists at Georgia State University estimated that equalizing taxes on e-cigarettes and combustible cigarettes could deter 2.75 million Americans from quitting smoking. 

In August, 15 past presidents of the Society for Research on Nicotine and Tobacco (SRNT) led by the University of Michigan School of Public Health’s Kenneth Warner took to the pages of the American Journal of Public Health (AJPH) to warn that the potential of e-cigarettes to save lives was being lost and that nicotine products should be taxed “proportionate to risk.”

Increased Tobacco Smuggling Could Threaten Community Safety

The illicit cigarette trade currently represents about a fifth of the entire market and deprives states and localities of between $3 and $7 billion in tax losses annually. Doubling the federal excise tax will undoubtedly increase the illicit market for tobacco products. One of the main concerns with increased illegal activity is national security and domestic organized crime. Because tobacco trafficking is a low-risk, high-reward activity, it’s especially attractive to criminal syndicates and terrorist networks. 

In 2015, a State Department report warned of the increasing danger such a lucrative criminal enterprise posed to U.S. security: 

“Internationally, it fuels transnational crime, corruption, and terrorism. As it converges with other criminal activities it undermines the rule of law and the licit market economy and creates greater insecurity and instability in many of today’s security “hot spots” around the world. Illicit tobacco provides a significant revenue stream to illicit actors without the high risks and punishments associated with trafficking in narcotics or humans.”  

Border states such as California, Arizona, New Mexico, and Texas are particularly vulnerable to the illicit tobacco trade. Tobacco taxes are significantly lower in Central and South America, and established pathways for narcotics trafficking can be utilized to smuggle cigarettes.

Tax Increases Hurt Small Businesses and Can Lead to Job Loss

Because of varying patterns of use and price elasticities between different tobacco products, the economic impact of the proposed tobacco tax will have diverse effects. For example, analysis by Chmura Economics & Analytics shows cigarette volumes will fall 6.4 percent. But cigar volumes will decline 55.9 percent, and vapor volumes will decline by 34.4 percent. Such declines represent a significant threat for the thousands of cigar and vape shops across the country as well as all-purpose tobacco retailers. 

According to Chmura, the Tobacco Tax Equity Act would cost 14,030 jobs. The states that would be hit hardest in terms of job losses are Florida, California, Georgia, North Carolina, Texas, and Ohio. 

Conclusion 

If one of the goals of the proposed reconciliation bill is to help low and middle-income Americans, large increases in tobacco and nicotine taxes will undermine this objective. As the Institute on Taxation and Economic Policy outlined in its modeling of the Build Back Better Bill “…tax increases on tobacco and nicotine would clearly fall most heavily on low-income smokers.”

Unfortunately, the Tobacco Tax Equity has not been subjected to sufficient analysis or scrutiny to determine whether the potential benefits outweigh the costs. From a public health standpoint, equalizing or, indeed, taxing lower-risk nicotine products more than combustible cigarettes disincentivizes switching away from more harmful products. As such, the status quo federal excise tax on tobacco products, despite a number of flaws, still remains preferable to the tax increases proposed in the Tobacco Tax Equity Act.

The post Four reasons to reject a federal tobacco tax increase appeared first on Reason Foundation.

But legislation recently released by the House the Ways and Means committee flies in the face of Biden’s cast-iron guarantee with an eye-watering increase to the federal tobacco tax. Cigarette taxes would double to more than $2 per pack under the House proposal. In addition, all other nicotine products, regardless of whether the Food and Drug Administration has approved them as “appropriate for the protection of public health,” would be taxed at the same rate as cigarettes. 

So far, the White House has refused to commit to the legislation.

Around 34 million Americans currently smoke, and three-quarters of smokers are from low-income communities. Smokers are significantly less likely to have a college degree and more likely to work a blue-collar job. The smoking rate in the LGBTQ community is 20 percent, compared to the national average of 14 percent. And there’s no question that a hike in the tobacco tax would be regressive, with almost all smokers making less than $400,000 per year.

For some, the regressivity of cigarette taxes is their biggest selling point. Speaking about so-called sin taxes in 2018, former New York City Mayor Michael Bloomberg said, “Some people say, well, taxes are regressive. But in this case, yes they are. That’s the good thing about them because the problem is in people that don’t have a lot of money.” 

There is no doubt high cigarette taxes can reduce some cigarette consumption, as proponents of the taxes hope. But even high taxes don’t push most smokers to quit. Thus, even under the most optimistic scenarios about how many smokers would quit smoking in response to the tax increase, millions of low-income Americans would pay higher taxes if the proposed legislation goes into effect. 

The constituents of Sen. Joe Manchin (D-WV) would be particularly hard hit by the tax. So, like so many other Democratic priorities in Congress right now, the fate of the House bill could ultimately rest in Manchin’s hands if it reaches the Senate. The poverty rate in Manchin’s state of West Virginia is above the national average at 16 percent. There are 15 states with lower cigarette taxes than West Virginia, yet it still has the highest smoking rate in the nation. The proposed federal cigarette tax would see a pack-a-day smoker in West Virginia pay almost $400 more in taxes a year, for a total of $1,593 per year. That’s 10.6 percent of the annual income of a low-income smoker making $15,000 a year.

Some may be tempted to cheer for the tax increase if, in the end, it prevents more deaths from smoking. But what’s especially disturbing about the new proposal is that it would also tax safer alternatives to traditional cigarettes, like e-cigarettes and heated tobacco products, at the same rate as cigarettes. For example, the federal tax on a pack of 5 percent nicotine Juul pods would be $9.18. 

Extensive research shows e-cigarettes are dramatically safer substitutes for traditional cigarettes and effective in helping smokers quit. According to researchers at the City University of New York and Bentley University, taxing e-cigarettes at the same rate as cigarettes would deter 2.75 million people from quitting smoking. E-cigarettes are currently under review by the Food and Drug Administration and some could soon be approved as “appropriate for the protection of public health.”

The FDA has already approved two tobacco products as being net beneficial for public health because they are less toxic than cigarettes and a pathway out of smoking. But the tax proposal from the House Ways and Means would treat these products the same as combustible cigarettes. The policy turns the logic of sin taxes on its head by penalizing consumers who are consuming a less dangerous product. 

Hiking cigarette taxes on an unpopular minority may be welcome among a large group of taxpayers—the wealthier, college-educated, non-smoking, non-vaping part of the electorate. Still, the proposed cigarette tax increase is almost uniquely targeted at some of the very people Democrats in Congress said they would protect from tax increases.

The post Congress considers tobacco tax increase appeared first on Reason Foundation.

Sept. 9 was the court-imposed deadline for the Food and Drug Administration (FDA) to decide which e-cigarettes, if any, would be allowed to remain on the market and which would be banned. In the end, the FDA failed to authorize a single e-cigarette for sale and gave more than a million products outright denials upon the deadline. The agency says it needs more time to decide on the remaining products it hasn’t yet rejected.

Because of this, all e-cigarettes are now subject to FDA enforcement action. The consequences of this decision will be devastating for a once-thriving industry and a tragedy for the health of millions of Americans. Less than a week after the FDA’s deadline expired, the Cochrane Review, recognized as the gold standard for evidence-based medicine, concluded e-cigarettes were more effective in helping smokers quit than traditional nicotine replacement therapies. Moreover, the evidence that e-cigarettes are safer than cigarettes, a pathway out of smoking, and fail to act as a gateway to tobacco has only strengthened since FDA took charge of regulating e-cigarettes back in 2016.

Over the past few years, public concern and government action in relation to e-cigarettes have mainly focused on youth vaping. If that is the motivation for banning most of the e-cigarettes on the market in America, then it is a highly misguided one. For one thing, the bans will likely have little effect on youth vaping. Even before lockdowns and school closures, FDA surveys suggest the number of youth vapers had fallen by around 30 percent since 2019. E-cigarettes were still available in all kinds of flavors and various nicotine strengths, but fewer kids were interested in using them. Moreover, even amongst the small minority of youth who do vape, most will never have heard of, let alone tried the products now banned by the FDA.

The FDA bans on e-cigarettes are likely to lead to an increase in smoking. Many of the now-banned e-cigarette products were used by adults who have either quit smoking are trying to do so. Indeed, the vast majority of vapers are adult smokers and ex-smokers, and the overwhelming evidence shows that by providing smokers with a far less harmful substitute that nonetheless provides much of the same satisfaction as smoking, e-cigarettes are dramatically cutting disease risk for a vulnerable population.

FDA’s decision-makers appear to have ignored arguably the most important premise of the legislation under which their ban has been affected. Section 3 of the Tobacco Control Act outlines its purpose, which crucially includes, “to promote cessation to reduce disease risk and the social costs associated with tobacco-related diseases.” That is precisely what e-cigarettes do. So there should be no need for individual applicants, many of whom are mom-and-pop operations, to demonstrate to the FDA that their specific product has the propensity to reduce smoking and tobacco-related diseases. But that is exactly what was required of each submission. And, to nobody’s great surprise, we then witnessed a tsunami of rejections, largely due to incomplete paperwork or companies failing to provide specific evidence showing their products would benefit adult smokers more than the risk they pose to youth. As The Verge reported:

After a year-long review of millions of e-cigarette–related products, the Food and Drug Administration says it has rejected 946,000 flavored products, prohibiting them from being marketed or sold. It also said that the applications for 4.5 million products were missing materials that the agency required to make a decision. All of those products must also be removed from the market. The FDA said in a statement Thursday that it has reviewed 93 percent of the applications submitted, which included 6.5 million products.

For years, vape companies asked FDA for clear guidance on what would be required to achieve authorization. Eventually, in June 2019, the FDA provided a 55-page guidance document that contained the following helpful advice on how to demonstrate that a product is “appropriate for the protection of public health (APPH)”:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) states that the finding of whether permitting the marketing of a product would be APPH will be determined, when appropriate, on the basis of well-controlled investigations (section 910(c)(5)(A)). However, section 910(c)(5)(B) of the FD&C Act also allows the agency to consider other “valid scientific evidence” if found sufficient to evaluate the tobacco product. Given the relatively new entrance of ENDS on the U.S. market, FDA understands that limited data may exist from scientific studies and analyses. If an application includes, for example, information on other products (e.g., published literature, marketing information) with appropriate bridging studies, FDA intends to review that information to determine whether it is valid scientific evidence sufficient to demonstrate that the marketing of a product would be APPH. Nonclinical studies alone are generally not sufficient to support a determination that permitting the marketing of a tobacco product would be appropriate for the protection of the public health.

Aside from the clear-as-mud bureaucrat-speak (ENDS are “electronic nicotine delivery systems” – i.e. e-cigarettes), the assertion that every producer of vape products must submit clinical studies evaluating the public health risks specific to their products is ludicrous.  

That’s the trouble: FDA’s demands were both vague and absurd. Most “e-cigarette” producers actually just made a few kinds of “juice” by mixing a nicotine solution with food flavorings and diluting with propylene glycol (the stuff used in theatrical smoke machines for decades without harm) and/or vegetable glycerin. Why on earth would FDA ask all these folks to submit clinical studies? It’s bonkers.

Meanwhile, the few larger e-cigarette producers that have been able to afford armies of scientists and lawyers to prepare their submissions have produced dossiers that would not be out of place in an application for approval for a new pharmaceutical that actually is highly toxic even when used as directed. One of the largest e-cigarettes companies, Juul, filed an application stretching to over 125,000 pages with data from more than 100 studies. So far, the FDA hasn’t rejected that submission. It is still reading it.

But even that approach apparently may not be enough. One larger company, Turning Point Brands, was issued a marketing denial order (MDO) in relation to some of its vapor products even though according to the company, “The PMTA [Premarket Tobacco Product Application] denied by this MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use.”

The depressing fact is that this entire mess could have easily been avoided by starting from the premise that the category of e-cigarettes prima facie meets the public health test as set out in the Tobacco Control Act—which clearly it does—and then addressing specific issues regarding the safety of individual products by setting clear standards and requiring that producers demonstrate that they meet those standards.

If regulators are concerned about the possibility that the juice contains too much diacetyl and acetyl propionyl (the chemicals that in large enough quantities can cause “popcorn lung”), or nitrosamines (among the nastiest cancer-causing chemicals that are found in tobacco products), or other chemicals that when heated to the normal temperatures of a vape device form nasty substances (such as formaldehyde) the FDA could and should set limits on them.

If FDA is concerned about the potential for an e-cigarette device to blow up, it should require devices to conform to the ANSI/UL standard. (Yes, there is already an ANSI/UL standard for e-cigarettes.)

Most all mom-and-pop vape stores could afford to buy United States Pharmacopeia-grade nicotine and other similarly pure ingredients. They could also afford to send samples of their juice to an approved chemistry lab for evaluation to ensure that they met the standards. And they surely would have done so gladly, knowing that they would be ensuring not only compliance with FDA rules but also the safety of their customers.

The current regulatory framework for approving e-cigarettes isn’t so much a pathway, as advertised, but a mountain accessible only to a few. The consequence of the FDA’s rejection of e-cigarette products is that many businesses will now close and smokers will lose an incredibly effective alternative to traditional cigarettes that has helped millions of people quit smoking. If fewer people switch from cigarettes to e-cigarettes, it means more Americans will die from smoking-related diseases.

The post The FDA has decimated the e-cigarette market appeared first on Reason Foundation.