The idea has been considered by regulators for years. It was unsuccessfully proposed by then-FDA Commissioner Scott Gottlieb under the Trump administration in 2018. Under the Biden administration, the plan was first announced by the FDA in 2021, but has repeatedly been pushed back since.

Many observers attribute the Biden administration’s latest postponement to political motives in an election year. They ask how Black voters, a core Democratic constituency, would respond to a ban, when Black people who smoke overwhelmingly smoke menthols.

The announcement of the delay has sparked contrasting reactions—from dismay among anti-smoking advocates who say the ban would save lives, to relief among advocates who say consequences of prohibition would include a transition to illicit sales and more law enforcement targeting of Black communities.

“It’s a matter of when, not if.”

But as far as the FDA is concerned, it is only a delay—not an abandonment. Dr. Brian King, director of the agency’s Center for Tobacco Products, emphasized this in remarks to the E-Cigarette Summit in Washington, DC, on May 14.

These policies (the proposal would also ban flavored cigars) “remain a priority for the FDA,” King said, and his agency is “committed to seeing this through.”

“It’s a matter of when, not if” the proposed rules “see the light of day,” he added.

In announcing the postponement, the White House noted feedback from civil rights groups and others opposed to the ban. Organizations that oppose it or have expressed deep concerns include the ACLU, the Drug Policy Alliance (DPA), the Law Enforcement Action Partnership (LEAP), the National Black Justice Collective and Students for Sensible Drug Policy, among many others.

“It is clear that there are still more conversations to have, and that will take significantly more time,” stated Health and Human Services Secretary Xavier Becerra on April 26.

Becerra, known as a supporter of the ban, naturally made no mention of the upcoming presidential election, but advisers have reportedly warned the administration of electoral consequences.

“In theory, regulations and rules are based in science, but everything in Washington, DC, revolves around politics,” tobacco harm reduction advocate Gregory Conley, director of legislative and external affairs for American Vapor Manufacturers, told Filter.

“With polling consistently showing a tight November 2024 presidential race, the Biden administration is by all accounts concerned about holding together the coalition of voters that tend to drive Democratic victories,” he added. “Top among this list is African Americans.”

“Pro-ban activists have always had polling data showing that most African American voters support menthol prohibition,” Conley said. But he also suggested that people who personally face losing legal access to their preferred cigarettes, or those close to them, would be more likely to change or withhold their votes over this decision than people who are not directly impacted.

“Such policy is not a public health approach, and dangerous to the very communities the ban is meant to protect.”

Art Way is a drug policy consultant who has written for Filter about how nicotine and tobacco prohibitions, like those of other drugs, harm marginalized communities through the growth of unregulated markets and increased police interactions.

“A blanket ban on already-popular products that thrive in gray/illicit markets is symbolic,” Way told Filter. “Such policy is not a public health approach, and dangerous to the very communities the ban is meant to protect.”

Diane Goldstein, executive director of LEAP, also welcomes the Biden administration’s second thoughts. She has written for Filter that Black and Latinx communities would bear the brunt of enforcement stemming from the policy.

“This ban, while seemingly race-neutral, would have targeted Black smokers, for whom menthol products make up over 80 percent of sales, while leaving the tobacco products favored by white smokers completely legal,” Goldstein told Filter.

“The menthol ban is just another extension of the War on Drugs, which has sent incarceration soaring, saddled millions with arrest records that make it difficult for them to find jobs and stabilize their lives, and decimated police-community relations,” she continued. “We should be doing all we can to end these sorts of laws rather than expand them.”

The Campaign for Tobacco-Free Kids, which seeks to restrict access to tobacco harm reduction products in the name of preventing youth vaping, is among many proponents of the ban.

“There is absolutely no reason to further delay a policy that has been studied for more than 12 years, is supported by overwhelming scientific evidence, and will save hundreds of thousands of lives,” said Yolonda C. Richardson, its president and CEO, and Derrick Johnson, president and CEO of the NAACP, in a joint statement in April, before the postponement was confirmed. “Make no mistake: Delays cost lives, especially Black lives.”

“Our work showed finalizing the ban could save 650,000 deaths by 2060 through greater smoking cessation.”

But the issue also divides the tobacco harm reduction community. For example, Global Action to End Smoking (previously the Foundation for a Smoke-Free World, it relaunched on May 13), supports both access to safer nicotine products for adults who smoke and a menthols ban.

The organization released a May 1 statement from CEO Cliff Douglas, describing the Biden administration’s postponement as “a setback for public health.”

“In the proposed ban, the [FDA] cited modeling it funded from me and other national tobacco control experts,” the statement read. “Our work showed finalizing the ban could save 650,000 deaths by 2060 through greater smoking cessation.” Referencing death and disease among Black people who smoke menthols, it called the ban “an imperative step for social justice and health equity.”

“This delay is atrocious,” said Dr. David Margolius, director of public health in Cleveland, Ohio. “The longer that we wait, the harder it’s going to be to end the sale of menthol cigarettes. Any delay will result in more people dying in this country.”

Menthol is the only cigarette flavor that hasn’t already been banned in the US. Ban proponents say it is particularly insidious as it conceals the harshness of smoking cigarettes, making them easier to smoke and harder to quit. Other experts, such as Dr. Ray Niaura, a tobacco researcher and professor at New York University’s School of Global Health, have noted research indicating that menthols are not more harmful or addictive than other cigarettes.

Ban proponents emphasize not only the historical role of tobacco companies in marketing menthols to Black communities, but tobacco company funding for some organizations and individuals that oppose the ban. Most opponents of the ban do not receive such funding, however.

“Decades of evidence show that drug prohibition doesn’t work. We urge the Biden administration to implement a harm reduction approach to tobacco use.”

“From the start, we warned that such a ban would drive people to the illicit market, putting people’s health at risk, and would lead to more negative interactions between communities of color and police, putting people’s lives at risk,” Martiza Perez Medina, director of the office of federal affairs for the Drug Policy Alliance, told Filter.

Rev. Al Sharpton is among other civil rights and social justice advocates to have spoken out about harmful repercussions of a ban for Black communities.

“Decades of evidence show that drug prohibition doesn’t work,” Perez Medina added. “We urge the Biden administration to implement a harm reduction approach to tobacco use.”

This is another area where the administration and FDA have received heavy criticism. Under its onerous PMTA (premarket tobacco product application) process for vapes, the FDA has rejected millions of applications, while authorizing just 23 tobacco-flavored vaping products—all now manufactured by tobacco companies—as “appropriate for the protection of public health.”

Most adults who switch from cigarettes to vapes prefer non-tobacco flavors, and some find these critical to switching. While many prefer not to revisit the taste of the cigarettes they left behind, it would seem logical that some people seeking to quit menthol cigarettes would find menthol vapes helpful. 

Global Action to End Smoking called for the FDA to authorize menthol vapes in its May 1 statement, saying that “the effectiveness of a menthol cigarette ban would be amplified significantly by the availability of less harmful mentholated nicotine products.”

Filter previously reported that in 2022, Brian King’s office at the FDA’s Center for Tobacco Products intervened to overrule CTP scientists’ recommendation to authorize some menthol vaping products.

On May 14, Dr. King insisted: “We do not have a de facto ban on flavored e-cigarettes … You can say it until you’re blue in the face.” 

Harm reduction advocates have been saying it—and also some judges.

With experiences from state-level menthol cigarette bans in California and Massachusetts indicating illicit markets, increased enforcement and mixed impacts on smoking, both supporters and opponents of a national ban point to different evidence and cite the imperative for racial justice.  

We have no timeline from the Biden Administration or the FDA on when the ban might be formally raised again, and the November election adds another layer of uncertainty. But this issue, and the divisions around it, will not be going away.

Photograph (cropped) by Wikimedia Commons/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from Global Action to End Smoking, from Reynolds American, Inc. and Altria (two companies which oppose the menthols ban), and (previously) from DPA. Art Way’s consulting clients have included Reynolds. Diane Goldstein is a member of the board of directors of The Influence Foundation, and LEAP was formerly The Influence Foundation’s fiscal sponsor. Filter’s Editorial Independence Policy applies. 

The post The Menthols Ban: Delayed, Divisive and Far From Dead appeared first on Filter.

New data suggest it’s pretty clear which way they went. And it should make sobering reading for the Food and Drug Administration, which presses on with its plan for a national menthol cigarettes ban while refusing to authorize any menthol (or flavored) vaping products.

A recent study analyzed discarded cigarette packs and vape packaging collected from streets and public trash cans in 10 Californian cities. The research was conducted by the WSPM Group, an independent firm that was commissioned by tobacco giant Altria.

These thousands of products cannot legally be bought from retailers in the state, yet their presence demonstrates that the ban has done little to reduce demand.

Between May 1 and June 28 of this year, the researchers collected 15,000 cigarette packs and more than 4,500 vaping product packages. They found that 21.1 percent of the cigarette packs were for either menthol or menthol work-around products (marketed to menthol users, with similar packaging but non-menthol descriptors). Meanwhile nearly all (97.9 percent) of the vaping products were flavored.

These thousands of products cannot legally be bought from retailers in the state, yet their presence demonstrates that the ban has done little to reduce demand. Prior to the ban, menthol cigarettes made up 24.5 percent of the state’s total cigarette sales. The discarded packs study showed a reduction in menthol prevalence of just 13.9 percent.

One key objection to the FDA’s proposed national ban is the inevitability of the criminalization of local suppliers, likely to be concentrated in communities of color that disproportionately smoke menthols. California’s experience confirms that menthols won’t go away, and that the threat is real.

There are implications for public finances, too. When people can’t legally buy flavored nicotine products in California but are obtaining them anyway, that hits tax revenues and public services in a state facing soaring budget deficits. Annual revenues will fall by over $300 million, according to one estimate.

In the study, of more than 11,000 packs for which tax origin could be determined, less than half (45 percent) were from California. And in a clear indication of the outcome of a national menthols ban, more than one-quarter (27.6 percent) were of non-domestic cigarettes, intended for sale in markets outside the United States.

What’s more, cigarette packs without the cellophane covers were not included among the tax-determinable packs. Researchers noted that smugglers often remove the cellophane “to hide the origin of the pack and avoid paying taxes.”

Of course, some people will dismiss this study on the basis that it was commissioned by Altria. But its findings match everything we know about drug prohibition, and the existence of huge illicit markets for cigarettes and vapes in the US is not in doubt.

Estimates of the proportion of national cigarette sales represented by the illicit market range as high as 21 percent—billions of packs annually. But it’s a great deal higher in California. For 2021, the Mackinac Center for Public Policy estimates that 44 percent of cigarette packs in California were not legally purchased in the state—second only to New York. How much higher might it be now, in the wake of the ban?

Back in 2017, the US Government Accountability Office reported numerous schemes in which cigarettes are purchased at duty-free stores along the southwest border and brought into the US, either directly or via Mexico, without being declared to Customs and Border Protection. And in 2022, before California’s ban, organized groups in Mexico normally concerned with trafficking other drugs were reportedly muscling into the illicit cigarette trade, and committing human rights abuses to control the market.

What is all this for? Californians are still smoking menthols in large numbers, and the state’s overall situation has worsened.

Enforcement follows, as we have seen over and over and over again with unregulated cigarettes in California, long before Prop. 31 made many more of them illegal.

States far away have meanwhile reported record-breaking seizures of illicit cigarettes this year. In early October, Arkansas state police seized over 3,200 cartons of untaxed cigarettes; the majority were mentholated.

And what is all this for? Californians are still smoking menthols in large numbers, and the state’s overall situation has worsened.

As many past lessons have taught us, banning substances doesn’t end demand. It simply shifts them from a regulated marketplace with oversight to one that doesn’t pay taxes, doesn’t impose product standards and doesn’t check ID.

This is all the more exasperating when in the nicotine field, we have an obvious, positive alternative to prohibition, using the carrot and not the stick.

Instead of banning anything, we could support the availability of a wide range of non-combustible harm reduction options: vapes, snus and heated tobacco products. We could allow the full range of flavors that are important to adults switching from cigarettes. We could use taxation to incentivize harm reduction purchases over the cigarettes that kill. And health authorities could promote these options as the lifesaving alternatives that they are, as happens in other countries.

But this is the United States, and banning things seems to be what we do.

Photograph by Helen Redmond

The Influence Foundation, which operates Filter, has received grants from Altria. Filter’s Editorial Independence Policy applies.

The post Trashed Cigarette Packs Highlight Failure of California’s Flavor Ban appeared first on Filter.

To date, the mere 23 vaping products authorized under the FDA’s Premarket Tobacco Product Applications (PMTA) pathway have all been manufactured by big companies with the resources to compile the substantial scientific submissions required—Reynolds included.

But what makes the latest rejections unsurprising is the fact that, years into its PMTA process, the FDA has still not authorized any non-tobacco flavored vapes.

Though flavored vapes remain on shelves in many parts of the US, sales occur in a legal gray area at best, with some calling for harder crackdowns.

The FDA’s stance on flavors seems clear, even if the agency denies imposing a de facto flavors ban.

Studies show that vape flavors are really important to people who switch from cigarettes. Yet public health bodies and public consciousness, if not the data, firmly associate the availability of flavors with youth-vaping uptake. And the FDA’s stance on flavors seems clear, even if the agency denies imposing a de facto flavors ban.

“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, PhD, director of the Office of Science at the FDA’s Center for Tobacco Products. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”

However, in 2022 Filter broke the story that leadership at the FDA’s Center for Tobacco Products (CTP) had pressured CTP scientists to reverse their initial recommendation to authorize menthol vaping products (manufactured, in that instance, by Logic, a company owned by Japan Tobacco International). This, together with the pattern of PMTA denials and authorizations, suggests a political agenda against flavored vapes at the FDA.

The role of menthol vapes as a harm reduction option would seem especially pertinent at a time when the FDA is expected to move forward with a deeply controversial plan to ban menthol cigarettes.

Meanwhile, evidence of the harm reduction value of vape flavors in general continues to build. A study published in the Harm Reduction Journal on October 14 considered the preferences of more than 69,000 US adults who vape, the largest ever survey of its kind. This research, its authors concluded, “identified the importance of non-tobacco flavors in e-cigarette use initiation and sustained use, and their potential contribution to smoking cessation and relapse prevention.”

Fruit and dessert flavors were among the most popular for people switching from cigarettes, and participants considered such options “particularly helpful” to them in avoiding a return to smoking. Just 15 percent were using tobacco-flavored vapes, which respondents considered less helpful in keeping them off cigarettes.

“Identifying the factors that can promote the transition to tar-free products and accelerate eradication of smoking among adults is of utmost significance,” Dr. Riccardo Polosa, professor of internal medicine at the University of Catania, Italy, and one of the study authors, told Filter. “One such factor is the inclusion of various flavors.” 

“Within this context,” he continued, “fruit as well as dessert/pastry/bakery and candy/chocolate/sweet flavors emerge as key elements that can aid adult smokers in their cessation efforts and contribute to reducing relapse rates.”

If the FDA presses ahead with a national menthol cigarettes ban, such rejections beg the question of what it expects the millions of people who smoke them to do.

Research and anecdotal reports indicate that many people who quit cigarettes with vapes don’t want to contend with the constant reminder of smoking that a tobacco-flavored product may present.

Three of the six Reynolds products that just received MDOs were menthol-flavored. And if the FDA presses ahead with its national menthol cigarettes ban, such rejections beg the question of what it expects the millions of people who smoke them to do—other than migrate to the booming illicit menthols market that opponents of the ban say it would create.

Dr. David T. Levy, professor of oncology at Georgetown University School of Medicine, has studied the potential public health impacts of a menthols ban, and was an author of research published in the Tobacco Control journal in April.

“My research indicates that, in the event of a menthol cigarette and a cigar flavor ban, a large portion of smokers will quit cigarette and cigar use, many of whom are likely to switch to e-cigarettes,” Levy told Filter.

However, “if non-tobacco-flavored e-cigarettes are not available,” he continued, “I expect that many of those who would have switched to e-cigarettes are likely to continue to smoke non-menthol cigarettes or non-flavored cigars.”

That makes the case for flavors in general. But in particular, wouldn’t it make sense to permit harm reduction products that most closely resemble the banned cigarettes? Even if some people preferred different options (perhaps for the same reason as those avoiding tobacco flavors), it seems logical that menthol vapes might help others in switching.

“The FDA’s denial of all menthol e-cigarette applications to date could backfire,” Dr. Michael Pesko, professor of health economics at the University of Missouri, told Filter.

Pesko is among the authors of another recent study, looking at the effect of vape-flavor restrictions on tobacco product sales (currently available online prior to peer review).

“Our findings from state and local e-cigarette flavor restrictions find that cigarette sales sizably increase when flavors are restricted from e-cigarettes, likely offsetting any public health gains,” Pesko continued. “A more rational policy from a public health perspective is to make menthol available in e-cigarettes while working to eliminate it from cigarettes.” 

“Given our findings linking flavor restrictions to increased cigarette sales, I am concerned about the path FDA is headed down.”

Dr. Abigail S. Friedman, associate professor at Yale School of Public Health and another author of that study, has similar worries.

“Given our findings linking flavor restrictions to increased cigarette sales, I am concerned about the path FDA is headed down,” she told Filter. 

“FDA is required to evaluate whether each individual product is ‘appropriate for the protection of public health,’ she continued. “But microeconomics tells us that an individual product’s effects on behavior depend not just on the product’s characteristics and costs, but also on the alternatives available in the market.”

These concerns add up to growing conviction that the FDA’s continued rejection of all flavored vapes, including menthols, cannot be considered “appropriate for the protection of public health.” 

Photograph (adapted) by Felton Davis via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from Reynolds American, Inc. Both The Influence Foundation and the Center of Excellence for the acceleration of Harm Reduction (CoEHAR), founded by Dr. Polosa, have received grants from the Foundation for a Smoke-Free World. Filter‘s Editorial Independence Policy applies.

The post FDA’s Rejections of Menthol Vapes Could “Backfire,” Scientists Say appeared first on Filter.

A public comment period last year saw 175,000 comments submitted on the proposed menthol cigarette ban, with another 71,000 for a similar restriction on cigars. Based on my review, a majority appear to be against the ban. But there’s no indication the FDA will listen. The agency says it’s “committed to completing the rulemaking process as quickly as possible,” but has yet to publish an analysis of scientific data, expert opinions or comments.

If the ban is enacted, make no mistake: Black and Latinx communities will bear the brunt of associated law enforcement.

We should be deeply troubled. Because street-level policing has never been under the control or influence of the FDA.

The FDA, of course, denies this. In repeated announcements of its plan since 2021, it has emphasized that people who smoke menthols—comprising less than 40 percent of the US cigarette market but preferred by 85 percent of Black Americans and 48 percent of Hispanic Americans who smoke—will not be targeted. In proposed rules released last year, the agency stated that “FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes. FDA’s enforcement will only address manufacturers, distributors, wholesalers, importers, and retailers.”  

If this is the extent of the assurance we have, we should be deeply troubled. Because street-level policing has never been under the control or influence of the FDA.

When Eric Garner was killed in 2015 by New York City police officers, who put him in a prohibited chokehold for selling untaxed cigarettes on the street, it was a case of local police enforcing a state law. If a menthol ban leads to a large illicit market—and everything we know about drug prohibition says it will—then it’s not the FDA, directly, that we need to worry about. 

All 50 states and many municipalities already treat illegal tobacco sales and distribution as a crime, with 44 classifying it as a felony and 37 carrying mandatory minimum sentences. These laws are designed to protect licensed business interests and governments’ tax revenues. An FDA decision to ban menthols would have a downstream effect on these jurisdictions, creating new avenues for enforcement.  

Do we really think that a market of millions of people who smoke menthols will just disappear, when it is easy to mentholate tobacco?  

We’re talking about a national menthol market worth tens of billions of dollars annually. And evidence suggests that many people who smoke menthols are resistant to non-mentholated substitutes if the option to continue smoking menthols exists. 

We should note, meanwhile, that the FDA has yet to authorize a single menthol vaping product, despite the recommendation of its own scientists—thereby suppressing a non-punitive way of encouraging many people who smoke menthols to switch to a far safer option.

Do we really think that a market of millions of people who smoke menthols will just disappear, when it is easy to mentholate tobacco? Of course not. Demand will persist and huge profits will be on the table.

This is illustrated by the fact that a giant illicit market for cigarettes, which are heavily taxed when sold legally, already exists in the US, and is predicted to grow. Wide-ranging estimates suggest that illicit sales comprise up to 21 percent of the country’s cigarette market. This market is particularly evident along national borders.

It is inevitable, too, that law enforcement in many places would interpret “supplying” menthols in the broadest terms.

Any insistence that enforcement of a menthol ban would only target people who operate illicit menthol markets carries little weight. As our existing illicit drug markets illustrate, the people operating the menthols market at the lower levels most susceptible to enforcement will predominantly be from the communities that market serves—overwhelmingly, in this case, Black and Latinx communities that are already disproportionately policed.

It is inevitable, too, that law enforcement in many places would interpret “supplying” menthols in the broadest terms. Take our experience with drug-induced homicide laws: A huge proportion of these prosecutions have been brought against people who were just using and sharing drugs with the person who died, often friends or family members. “Fewer than half of cases we analyzed involved a traditional buyer/seller relationship,” said Leo Beletsky, a researcher with Health in Justice and Northeastern University.

What are the implications for people who casually offer an illicit menthol cigarette to friends, or give a pack to a family member? After Massachusetts implemented a menthol ban in 2020, its Illegal Tobacco Task Force recommended creating new criminal statutes allowing for prison sentences—including for the mere possession of unstamped cigarettes.

In proposing its ban, the FDA rightly points to severe health disparities faced by Black communities. But a ban will fail to solve this when people are sure to continue smoking menthols or switch to other cigarettes, as we saw in Massachusetts. And it will inflict further harms. 

It is in tobacco harm reduction—not the legality of menthol cigarettes—where the FDA should adopt radical policy change.

The FDA’s promises of limits to enforcement amount to misinformation, when it will have zero ability to oversee the nation’s 18,000 local law enforcement agencies. Its apparent benevolence will be little comfort to people subjected to arrest and prosecution.

Tobacco harm reduction is a strongly evidenced way to reduce health disparities suffered by the predominantly marginalized populations who smoke cigarettes. The FDA, with its remit to regulate all nicotine products, has a powerful role to play here. 

Yet instead of ensuring that a wide range of devices and flavors are available, instead of unequivocally promoting far safer alternatives to smoking as other countries have done, the agency has spread misinformation and seemingly sought to strangle availability.

It is in this area—not the legality of menthol cigarettes—where the FDA should adopt radical policy change.

The scenario seems inevitable: people in communities of color selling illicit menthol cigarettes. Enter the police. History has shown us how this ends.

In pursuing the prohibition of a class of omnipresent, entrenched consumer products, the FDA is going against a national tide to decriminalize and legalize other substances. It is repeating past mistakes that have had devastating consequences, above all for Black and Latinx Americans. 

It is for this reason that organizations like the ACLU, the Drug Policy Alliance, Students for Sensible Drug Policy, the National Black Justice Coalition and my own Law Enforcement Action Partnership, among many others—together with Eric Garner’s mother, Gwendolyn Carr—have questioned or opposed the idea of banning menthols.

The scenario seems inevitable: people in communities of color selling illicit menthol cigarettes, and local businesses and officials objecting. Enter the police. History has shown us how this ends.

Photograph by Wil540 via Wikimedia Commons/Creative Commons 4.0

The Drug Policy Alliance previously provided a restricted grant to The Influence Foundation, which operates Filter, to support a Drug-War Journalism Diversity Fellowship. The Law Enforcement Action Partnership was previously the fiscal sponsor of The Influence Foundation.

The post FDA’s Approaching Menthol Cigarette Ban Would Expand the Drug War appeared first on Filter.

Almost three years into the Massachusetts ban, some apparently contradictory things are unfolding. One study found that sales of all cigarettes by licensed retailers declined by almost 33 percent. Proponents of the ban believe this is proof that it works.

But the inconvenient truth is, people who want menthol cigarettes can buy them in the bordering states of Connecticut, New Hampshire, New York, Rhode Island and Vermont. “In the 12-month period following the comprehensive flavor ban in Massachusetts, the state sold 29.96 million fewer cigarette packs compared to the prior period,” reported a preliminary study on this question. “However, a total of 33.36 million additional cigarette packs were sold during the same post-ban period in the counties that bordered Massachusetts.”

And if travel to another state isn’t an option, “sophisticated tobacco smuggling operations” are now serving Massachusetts, according to a new report by the state’s Multi-Agency Illegal Tobacco Task Force. The expanding “tobacco diversion” law enforcement bureaucracy has ramped up its operations. State police and the Department of Revenue’s Criminal Investigations Bureau (CIB) are increasing inspections and seizing more illegal, untaxed products.

The underground, cross-border market is thriving, just as opponents of prohibition predicted.

In one example cited by the report, “The CIB executed an administrative search warrant and conducted an inspection of an unlicensed tobacco distributor…and seized a large quantity of untaxed ENDS [electronic nicotine delivery system] products, OTP [other tobacco products] and Newport Menthol cigarettes affixed with New Hampshire excise tax stamps.” It appears that the Task Force—so far—is targeting distributors, retailers and organized smugglers, rather than individuals in possession.

The underground, cross-border market for flavored vapes and menthol cigarettes is thriving, just as opponents of prohibition predicted. Law enforcement has confiscated huge amounts of illegal products, “resulting in a strain on the Task Force’s storage capacity.”  The Task Force is also trying to figure out how to “safely and lawfully dispose of ENDS products.” In an ironic twist, it will destroy large quantities of vastly safer vapes while combustible cigarettes remain legal and on sale everywhere.

People arrested by State Police detectives are being indicted for violating the flavor ban and charged with felonies or misdemeanors related to trafficking unstamped cigarettes, tax evasion, conspiracy to traffic in contraband smokeless tobacco, and money laundering. Currently, people convicted face “imprisonment for not more than five years.” The nicotine warriors call for increased penalties for tobacco trafficking “based on the amount of tobacco sold or possessed with intent to sell serving as the basis for a misdemeanor or felony charge.” This language is reminiscent of the war on crack in the 1990s.

Welcome to the War on Nicotine in Massachusetts, circa 2023.

“It shows that bans do not impact everyone the same.”

When it comes to smoking rates, a new study published in JAMA Internal Medicine had mixed findings. The study estimated the association between the menthol ban and current cigarette smoking in Massachusetts. It found an overall decline in self-reported smoking—although people smoking illicitly obtained products might be less likely to report their use. But within that were wide demographic variations.

A large decrease in smoking among Black men was reported, together with significant decreases among Hispanic men and women. But there was a large increase among Black women, and rates also substantially increased among Asian-American and Indigenous women. The authors stress that the research shouldn’t be taken to indicate causation. But this confusing picture nonetheless shows startlingly unequal outcomes.

“It’s a cross-sectional study, so it’s limited in the conclusions we can draw,” Dr. Annie Kleykamp, a research analyst and science writer at BAK and Associates, told Filter. “It shows that bans do not impact everyone the same. There can be simultaneous harms and benefits and it is critical to not hyper-focus on one or the other, or on some populations and miss the combined net harms or benefits of policies.”

A powerful rationale for the prohibition on menthol cigarettes is the targeting of the Black community by tobacco companies. Nearly 85 percent of Black Americans who smoke, smoke menthols. Smoking-related diseases are the leading cause of death in this population, and Black Americans who smoke are more likely to die of smoking-related causes than their white counterparts.

Public health organizations, the Campaign for Tobacco Free Kids and the African American Tobacco Control Leadership Council have fought to ban menthols, arguing it would save Black lives. They contend that making these products illegal and unavailable would force adults to quit smoking and also dissuade young people from starting. The Food and Drug Administration is on board. Last year, FDA Commissioner Robert Califf presented a plan for banning menthol products to a congressional subcommittee.

Tobacco control authorities in Massachusetts are on a dangerous trajectory to expand the scope of policing the growing illicit tobacco market.

But this approach ignores the potential further criminalization of Black communities that are already targeted by the drug war. And the demonstrated futility of prohibition, when supply will inevitably follow demand, only less safe when regulation is removed—think opioids and fentanyl. For these reasons, dozens of drug policy and human rights organizations, including the ACLU, have spoken out against a federal menthols ban.

Tobacco control authorities in Massachusetts are on a dangerous trajectory to expand the scope and budget of policing the growing illicit tobacco market. As history has shown, that will create yet more “net harms.”

The policy that would create “net benefits” is tobacco harm reduction, and making menthol vapes and other safer nicotine products widely available and affordable. 

Update, March 15: This piece has been edited to add Dr. Kleykamp’s affiliation.

Photograph by Helen Redmond

The Influence Foundation, which operates Filter, has received grants from Reynolds American, Inc, which manufactures Newports. Filter‘s Editorial Independence Policy applies.

The post Massachusetts Post-Menthols Ban: Mixed Smoking Impacts, More Policing appeared first on Filter.

Two memos reviewed by Filter indicate that the office of Brian King, director of the FDA’s Center for Tobacco Products (CTP), intervened to push back against the CTP Office of Science’s recommendation to authorize menthol vaping products for the first time. These documents appear to reveal substantial disagreement within CTP, one that could be framed as the agency’s scientists battling against its bureaucratic upper ranks, who have the FDA commissioner, and ultimately Congress, to answer to.

It can all be viewed, in other words, as a fight between science and politics. The news has angered tobacco harm reduction proponents, who point out that most adults who switch from cigarettes to vapes find flavors, in general, helpful—and sometimes even critical—to their doing so. No non-tobacco flavored vapes have yet been authorized.

At the end of October, the CTP denied the PMTAs for Logic’s menthol-flavored e-cigarettes. On December 6, Logic, which is owned by Japan Tobacco International (JTI), filed a petition for a review in a federal court of appeals, which granted a temporary stay—meaning the manufacturer could continue selling those products while the court weighed a motion for a full stay of its marketing denial order (MDO).

Documents show that CTP’s Office of Science had recommended authorizing the menthol-flavored e-cigarettes—but eventually reversed course after pressure from the office of CTP Director Brian King.

In March, the FDA had authorized Logic’s tobacco-flavored vaping products, finding that they were “appropriate for the protection of public health” (APPH)—a threshold that has come to be understood as a product’s deemed likelihood of transitioning adults from cigarettes without introducing a new generation to nicotine.

Now, documents made available to Logic after it had filed the stay motion show that CTP’s Office of Science (OS) had recommended authorizing Logic’s menthol-flavored e-cigarettes—but eventually reversed course after pressure from the office of CTP Director Brian King (OCD).

“These memoranda further support Logic’s argument that FDA denied Logic’s PMTAs for its menthol ENDS [electronic nicotine delivery systems] pursuant to an unpromulgated policy against the product category, not an evaluation of Logic’s product-specific evidence,” Logic’s December 12 supplemental filing with the appeals court states.

“That is, under new leadership, OCD overruled OS’s initial recommendations to approve Logic’s products—recommendations that OS had based upon its science-based evaluation of Logic’s submission—because OCD concluded that all menthol-flavored ENDS should be treated disfavorably, as a category,” it continued. “As Logic has explained, basing product-specific decisions on unpromulgated, across-the-board policies that were never subject to notice-and-comment rulemaking is arbitrary and capricious.”

A Logic spokesperson declined to comment on the ongoing litigation. The FDA is currently trying to prohibit menthol combustible cigarettes as well—an action that could make the availability of menthol-flavored vapes all the more important to people.

“The suggested narrative in these legal filings relates to pending litigation, and FDA does not comment on pending litigation,” an FDA spokesperson told Filter. “As was noted in FDA’s press release issued in October 2022, the FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”

But the two unearthed memos from October reviewed by Filter tell a rather different story.

“OS concluded that the existing literature supports that menthol-flavored cigarette smokers show a preference for menthol-flavored ENDS relative to tobacco-flavored ENDS,” an OS memo from October 25 reads. “But OS did not find that the current literature supports that use of menthol-flavored ENDS by adult smokers is associated with greater likelihood of complete switching or significant cigarette reduction relative to tobacco-flavored ENDS. OS considered these findings from the literature together with product-specific evidence to assess the public health impact of particular menthol-flavored ENDS products.”

As Logic’s PMTAs were among those “furthest along” in the review process, as the OS memo puts it, OS briefed the OCD “in the latter half of 2021” that it was offering a “preliminary recommendation to authorize the marketing of the products.” (Mitch Zeller, now retired, was still the CTP director at this point. He declined to comment, too.)

“From a policy perspective, OS believed at the time that as long as menthol-flavored e-cigarettes remain on the market, menthol-flavored ENDS could be a direct substitute for them, providing a less harmful alternative for menthol-flavored cigarette smokers, who are less likely to successfully quit smoking than smokers of non-menthol flavored cigarettes,” the memo continues, adding that while menthol could appeal to youth, “it may not be at the same level as other flavors” and that documented preferences for menthol vapes among people who smoke menthol cigarettes “suggest a potential benefit.” 

“OS considered that this suggested potential benefit, in the form of increased opportunity for use and transition, coupled with product-specific evidence of some benefit to smokers (even if not greater than that of tobacco-flavored ENDS products), amounted to a likelihood of greater cessation or significant reduction in smoking that would outweigh the known risks to youth from the marketing of the products, sufficient to meet the legal standard for authorization,” it continued.

But according to the OS memo, OCD had some questions about “the role and sufficiency of the general scientific literature” that the preference of people who smoke menthols for menthol vapes could result in “behavioral change” (switching from cigarettes to the safer alternative). It also raised concerns about youth’s (perceived) attraction to menthol. (The second memo from King went into further detail about these preoccupations.)

Discussions remained ongoing until July 2022, when Brian King assumed the role of CTP director following Zeller’s retirement. Right up until a mid-July meeting between OS and OCD.

“This astonishing revelation demonstrates what many of us have been saying for over a year: The PMTA authorization process is a rigged political experiment where science has limited-to-no bearing.”

After that meeting, OCD determined that “in light of the substantial risk to youth and the lack of robust evidence of actual differential use to quit or significantly reduce cigarettes per day, the approach to menthol-flavored ENDS should be the same as for other flavored ENDS, i.e. the products could be found to be APPH only if the evidence showed that that benefits of the menthol-flavored ENDS were greater than tobacco-flavored ENDS, which pose lower risk to youth.”

OS then changed its opinion, based on this approach.

“This astonishing revelation demonstrates what many of us have been saying for over a year: the PMTA authorization process is a rigged political experiment where science has limited-to-no bearing on the likelihood of success for an applicant,” an industry insider, who requested anonymity so as not to affect his company’s PMTAs, told Filter. “It is the best example to date of political interference in what should be, but clearly is not, a science-based series of decisions by CTP and the FDA. It’s beyond time for Congress to step in and hold Brian King and CTP to account for their refusal to authorize life-saving products despite the recommendations from the experts within the agency to do just that.”

It was also in July 2022 that Matthew Holman, the OS director, quit the FDA to take a job at Philip Morris International (PMI). Holman had recused himself from agency work since before King’s tenure. There is no direct evidence to suggest that his departure was related to the internal menthol debate.

But both Robert Califf, the FDA commissioner, and King have come under political fire for not denying menthol vaping products: In September, King left early from a nicotine conference to meet with Senator Dick Durbin (D-IL), who called on him to remove flavored all e-cigarettes from the market; Durbin has similarly demanded that Califf do the same.

“This is yet more evidence that the FDA Center for Tobacco Products is willing to ignore science if it allows career bureaucrats to avoid making politically difficult decisions,” Greg Conley, the director of legislative and external affairs at American Vapor Manufacturers, told Filter of the revelation. “Not only is this injurious to employee morale, but it is a bright and clear signal that the only paths to reform at CTP involve federal judges or a new administration in the White House.”

Copies of Logic’s filing and the two October CTP memos are embedded below:

Update, December 14: This article has been updated to include comment from the FDA received after publication.

Photograph by Felton Davis via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from PMI. Filter‘s Editorial Independence Policy applies.

The post Memos Show FDA Overruled Science-Office Call to OK Menthol Vapes appeared first on Filter.

Explicitly, the proposed law would prohibit “menthol as a characterizing flavor in cigarettes”—meaning that “a cigarette or any of its components or parts (including the tobacco, filter, wrapper, or paper, as applicable) shall not contain, as a constituent (including a smoke constituent) or additive, menthol that is a characterizing flavor of the tobacco product or tobacco smoke.” Nobody would be able to manufacture, distribute, sell or offer for the distribution of sale any such cigarette or its components and parts.

Many civil rights groups oppose the prohibition as a continuation of the War on Drugs, saying it is likely to increase interactions between Black people and the police.

The plan has been embraced by the Biden administration and much of mainstream tobacco control as a means to reduce cancer rates and youth experimentation—and as something of a corrective to the tobacco industry’s marketing of menthol toward Black communities. A large majority of Black smokers smoke menthols.

But many drug policy and civil rights groups—including the Drug Policy Alliance and American Civil Liberties Union (ACLU)—oppose the prohibition as a continuation of the War on Drugs, saying it is likely to increase interactions between Black people and the police.

Like it has in the past, the FDA emphasized in a press release that it would not—and could not—target people who use or possess menthol flavored cigarettes for enforcement. The agency would instead only focus on manufacturers and distributors, it said. The FDA acknowledged that state and local law authorities could not take enforcement action on the agency’s behalf, but said it would seek input on “how it can best make clear the respective roles of the agency and state and local law enforcement, as well as policy considerations related to the potential racial and social justice implications of the proposed product standards.”

Yet advocates note that prohibiting products used in communities that have already borne the brunt of drug-war enforcement will create illicit markets within those communities, leading to further criminalization as lines between consumers and sellers blur.

“One need only review the history of criminal law enforcement with crack cocaine, cannabis, opioids, or other drugs, and alcohol in the 1920s, to know that law enforcement is the wrong tool here, especially when there are other, far more helpful interventions the federal government could be emphasizing,” stated a recent letter to the administration from dozens of human rights and drug policy organizations that oppose the menthol ban. “Any proposal to effectively criminalize the sale and distribution of a product used by 18 million adults, particularly a product preferred by black and brown citizens, must take these issues with the utmost seriousness and undertake genuine efforts to find better policy solutions.”

“Time and time again, we see encounters with police over minor offenses—for Daunte Wright it was expired tags, for George Floyd it was using a counterfeit bill, for Eric Garner it was selling loose cigarettes—result in a killing,” read an ACLU statement in response to the April 28 announcement. “There are serious concerns that the ban implemented by the Biden administration will eventually foster an underground market that is sure to trigger criminal penalties which will disproportionately impact people of color and prioritize criminalization over public health and harm reduction.”

Menthol prohibition is rolling forward, but will not happen quickly: Many forecast it won’t go into effect until 2024.

Menthol prohibition is rolling forward, but will not happen quickly: The FDA now intends to invite public comments on the proposed rules through July 5, 2022, and many forecast the ban won’t go into effect until 2024—perhaps even later if the tobacco industry sues the agency. As the Wall Street Journal reported, the plan “could sweep from the market more than a third of all cigarettes sold in the US,” which represent “more than $20 billion in annual sales.”

The menthol debate has been a contentious one since as early as June 2009, when President Barack Obama signed a law giving the FDA the power to regulate tobacco products. The agency then stripped flavored cigarettes—except menthol—from the market. But the FDA has since faced a court deadline to act on the menthol-ban question, which was triggered from a citizen petition in 2013 signed by advocacy groups like the American Heart Association, the Campaign for Tobacco-Free Kids (CTFK), and the American Lung Association. As part of his comprehensive tobacco control plan, former FDA Commissioner Scott Gottlieb began plans to ban menthol cigarettes in 2017. That eventually stalled, and Gottlieb resigned in 2019.

As with vaping, harm reduction and drug policy reform advocates find themselves in the precarious position of making similar arguments to the tobacco industry—which, cynically or not, has adopted the language of harm reduction and racial justice to support e-cigarettes and the continued sale of menthol combustibles. To some degree, the planned ban has divided both the Black community—the NAACP, for example, supports it as a way to promote health—and the tobacco harm reduction community.

“Prohibition is not the answer. Harm reduction is.”

The ban would not cover menthol e-cigarettes; however, the FDA has yet to authorize a single menthol-flavored vaping product through its premarket tobacco product application (PMTA) process. The agency has also stated that it would consider making some exemptions on a case-by-case basis, which include heat-not-burn devices and cigarettes with very low nicotine levels.

“Prohibition is not the answer,” stated the letter from the anti-ban coalition. “Harm reduction is. Rather than criminalizing this product, FDA and the Administration should be massively investing in community-based health care solutions.”

Photograph by Officer via Wikimedia/Creative Commons 2.0

The Influence Foundation, which operates Filter, previously received a restricted grant from the Drug Policy Alliance to support a Drug War Journalism Diversity Fellowship.

The post FDA Announces Proposed Rules for National Menthol Cigarette Ban appeared first on Filter.

Nearly a week later, on March 3, Dr. Robert Califf, the new commissioner of the FDA, announced on Twitter that the public should expect to see the specifics of a federal menthol cigarette and flavored cigar ban by spring. The agency had indicated last April that it intended to publish the rules “within the next year,” appearing to honor a commitment amid months of pushing deadlines to decide vaping’s future. President Barack Obama first floated menthol prohibition in 2009, and it’s stalled ever since, becoming a contentious debate for more than a decade.

In a series of tweets, Califf noted that the American Heart Association recently “pointed out that tobacco product use is the leading cause of years of life lost in the US,” and said that “specific groups of people have been targeted, leading to disproportionate deaths from tobacco use, especially from flavors that entice them to start and keep smoking.”

“As these proposed rules are advanced through the system, we expect that by spring the public will see the specifics of the proposed product standards and will be able to comment,” Califf wrote. “Such comments to proposed rule dockets are helpful in determining what changes, if any, might be made to produce a final rule.”

Still, just because the rules have been moved into OMB’s system, does not mean things will happen quickly, if at all. Tobacco control experts of every stripe—from anti-nicotine prohibitionists to tobacco harm reduction advocates—largely agree that the process could take years.

Supporting the menthol ban are a collection of organizations that are usually opposed to one another.

“In administrations past, OMB is where regulations go to die,” Matt Myers, the president of the Campaign for Tobacco-Free Kids (CTFK), told Stat. “This administration has made a commitment to move forward on this specific rule, and what OMB does will be a critical test of their commitment.”

As of 2018, 13.7 percent of adults (34.2 million) in the US smoked, according to the Centers for Disease Control and Prevention. And about 18.6 million of those current smokers use menthol cigarettes, according to the FDA, though others estimate the number is closer to 11 million. Of Black Americans who smoke, a large majority smoke menthols.

Supporting the menthol ban are a collection of organizations that are usually opposed to one another, like CTFK and the pro harm-reduction Foundation for a Smoke-Free World, which is funded by grants from Philip Morris International (PMI). They argue that tobacco companies explicitly targeted Black communities with menthols marketing in the past, causing suffering into the present.

On the other side of the issue, another diverse group of harm reductionists and racial justice advocates worries that a menthol ban will increase interactions between Black people and the police, a blatant and legitimate fear. In 2014, a cop arrested and then killed Eric Garner, for example, because he was selling loose cigarettes; Garner’s mother, Gwendolyn Carr, soon became a vocal opponent of a proposed menthol ban in New York City that never materialized.

Those in favor of the ban repeat that only manufacturers and retailers would be targeted, not smokers themselves. But given the history of prohibition, as critics note, smokers will inevitably become those very sellers. It’s not difficult to bootleg menthol cigarettes, for one thing.

“The War on Drugs should make it clear that the consequences of criminalizing substances, particularly those preferred by marginalized groups, are often far more devastating than the substance itself.”

“The desire to address health disparities is laudable,” Michelle Minton, a tobacco harm reduction expert and senior fellow at the Competitive Enterprise Institute (CEI), told Filter. “But, while a ban might seem like an easy fix, our experience with the War on Drugs should make it clear by now that the consequences of criminalizing substances, particularly those preferred by marginalized groups, are often far more devastating than the substance itself. While some smokers might quit in response to a ban, many will switch to non-mentholated cigarettes and many more will simply turn to the already-thriving illicit cigarette market, offering zero health benefit.

“Califf should reject the prohibitionist approach,” she continued, “and instead look toward harm reduction strategies that encourage smokers who cannot or will not quit nicotine to switch to safer alternatives.”

As many tobacco harm reduction proponents have noted, too, the FDA has long promised a “comprehensive” tobacco control agenda, including “a continuum of risk.” If the agency were to ban menthol cigarettes, it should also authorize menthol-flavored e-cigarettes and other safer nicotine alternatives, like pouches, they argue, to give adult smokers an option to switch.

“It’s all a preliminary step in a very long process,” David Sweanor, an industry expert and chair of the advisory board for the Centre for Health Law, Policy and Ethics at the University of Ottawa, told Filter. “One that would take years. It is odd that anti-tobacco groups push for a measure that cannot come into force for years, if ever—but oppose, or are silent, on significant measures that could happen immediately: such as accurately informing people who smoke cigarettes about the relative risks of alternatives.”

Photograph by North Carolina Department of Public Safety via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from both the Foundation for a Smoke-Free World and Philip Morris International. Filter’s Editorial Independence Policy applies.

The post The Federal Menthol Cigarette Ban Is Slowly Moving Forward appeared first on Filter.

Bidi believes that particular decision to be a mistake on the FDA’s part, and is currently exploring next steps to address the situation.

“It looks like FDA is making a mistake in many, many cases,” said Azim Chowdhury, a partner at the law firm Keller and Heckman, where he advises Bidi and other clients on nicotine regulations. “I have a number of companies that have received MDOs, but those MDOs are also identifying their menthol products. It seems like FDA, in their rush to get all these out, they’re not doing a very thorough job.”

Like all other vape companies, Bidi has had to undergo an expensive and onerous premarket tobacco product application process (PMTA) in which the FDA reviews whether submissions are “appropriate for the protection health”—a definition that has recently been understood to mean a given product’s likelihood of helping adult smokers transition to safer alternatives while not introducing teenagers to potential nicotine dependence. Vapor companies had until September 9, 2020 to submit their applications; the FDA, which has already sent out hundreds of MDOs, then had until that same date in 2021 to review an avalanche of PMTAs, numbering in the millions.

The FDA recently stated that it would not complete its review by that date. Most of the largest players now sit in limbo, awaiting decisions, as the agency continues to send out MDOs to smaller manufacturers without the means or resources to finish the applications, let alone in a tight time frame.

Bidi received an MDO for its flavored products, and the company had recently taken “the initiative of adopting one-word, non-characterizing terms to identify” its products in an attempt to follow FDA’s enforcement priorities (so as not to remotely appeal to youth). “Fruity Mango” became “Gold”; “Dragon Venom” became “Regal”; “Berry Blast” became “Solar.” In the process, it changed “Mint Freeze”—its menthol flavor—to “Arctic.”

“I want to be careful how we characterize the challenge or the defiance. Because FDA might have been confused.”

So there’s a likely scenario in which the FDA issued Bidi an MDO for its flavored products and included “Arctic” because the agency believed it to be a flavor other than menthol, since it was not literally called “menthol.”

When asked if that was the situation, an FDA spokesperson told Filter that the agency “is aware of the company’s public statements and is looking into it.”

“I want to be careful how we characterize the challenge or the defiance,” Chowdhury emphasized to Filter. “Because FDA might have been confused, trying to get these out before the deadline. If they had looked at the ingredients or the actual substance, they may have seen that this is in fact a menthol product.”

“It’s not just Bidi, though,” he added. “I want to be clear. It’s a ton of folks.”

Bidi is now arguing, essentially, that the wording in press releases from the FDA’s Center for Tobacco Products (CTP) allows the company to keep selling menthol flavors for its ENDS (electronic nicotine delivery system) devices despite the MDO: “Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA,” one such document reads. (Emphasis my own.)

Niraj Patel, the CEO of Bidi, acknowledged that some of the company’s product studies were incomplete yet ongoing, like those of so many other vape manufacturers, and that the FDA had not granted sufficient time to complete studies that could take up to six or even nine months. The FDA had issued a draft document on tobacco product perception and intention (TPPI) studies to be included in a PMTA application at least one month after the September 2020 deadline.

As a result, Bidi’s applications, like those from so many other companies, were incomplete and consequently denied.

“We are doing all of those studies, and we’ve constantly updated the FDA about the company we hired and this is the timeline in which we will get you a result,” Patel told Filter.

Continued denials, of course, would be catastrophic, as they have already been for much of the industry.

In a press release, Bidi, which saw its most recent quarterly revenue fall from $32.4 million to $3.4 million in 2021 when compared to the equivalent quarter last year, largely faulted the FDA’s regulatory procedure for the significant drop. Bidi also mentioned manufacturing delays of its tobacco-derived nicotine pouch, citing COVID-related reasons. (Kaival Brands Innovations Group, a publicly traded company that distributes Bidi Vapor, has seen its stock price sink.)

“We are willing to work within the regulatory framework. We have to be.”

Bidi also stated in the press release that a removal of synthetic nicotine—that is, nicotine made in a lab and not derived from tobacco—from the marketplace would be “a positive event.” Many small- and medium-sized manufacturers are now transitioning to synthetic nicotine, viewing it as a legal gray area outside the FDA’s regulatory authority.

Puff Bar, the number one disposable vape company according to Nielsen data reviewed by Filter, is likely Bidi’s biggest competitor. The company, which has been castigated for its mysterious ownership and attracting youth, has already made the switch to synthetic nicotine.

“We are willing to work within the regulatory framework,” Patel told Filter. “We have to be. It is important for public health that the products distributed in America have to be safe.”

Update, September 16: This article was updated to add the FDA’s comment.

Photograph by Vaping360 via Flickr/Creative Commons 2.0

The post Major Disposable Vape Maker Disputes FDA’s Marketing Denial Order appeared first on Filter.

In the US drug policy space, we are currently witnessing the decriminalization of drugs like heroin and cocaine and the ongoing legalization of marijuana. Despite many obstacles left to overcome, there is a gathering consensus that the criminalization of drug use is inherently wrong, that it produces negative public health outcomes like the overdose crisis, and that it fosters racial and other inequities. 

But in one major area of drug policy, we see the opposite direction of travel.

We now see attempts across the country to ban all legal access to flavored nicotine and tobacco products. This blanket prohibition will fail in two ways. First, it will not achieve the advertised substantive gains for public health through reduced use. Second, it will simultaneously create new problems—through the harms of new forms of criminalization, through the inherent risks of new illicit markets, and through incentivizing people to use riskier products by switching, for example, from vapes to cigarettes. 

But that seems not to trouble the architects of these policies. Because their purpose is essentially symbolic—to send a message to the public about youth prevention, regardless of the consequences for adults who use nicotine.

The unintended consequences of such symbolic policies are deeply troubling.

This has recently been illustrated where I live, in Denver. Councilor Amanda Sawyer and at-large Council Rep. Debbie Ortega have put forth a proposal to ban the sale of all flavored “tobacco products”—including menthol cigarettes, flavored oral products, hookah flavors and vape flavors.

This blanket ban would impose suspensions of up to a year on vendors who violate the flavor ban. The proposal doesn’t include criminal charges against users; but for reasons we’ll discuss, that shouldn’t negate our concerns. Other councilors have expressed worries about “jurisdictional shopping,” but have since decided to support the local ban. A hearing is now scheduled for October 6.

Given the councilors’ overwhelming membership of the Democratic party (despite their offices being officially non-partisan) one can’t help but wonder about the impact of Michael Bloomberg—the primary funder of both the Democrats and campaigns for flavor bans nationwide. It should be no surprise that Democratic strongholds such as California, Massachusetts, Minnesota, New York and now Colorado are taking the lead for Bloomberg on nicotine policy. 

The unintended consequences of such symbolic policies—both those that have occurred and those that will likely follow—are deeply troubling. For example, in places like San Francisco where vaping products are banned, we see an increase in tobacco use among young people.

Bans also strengthen underground economies based on products “smuggled” from other jurisdictions or those manufactured illicitly. What does it mean for consumer safety when people can no longer buy regulated products from their local vape shops? The “EVALI” scare of 2019—lung injuries initially and wrongly attributed to nicotine vapes, but actually concerning vitamin E acetate within illicitly manufactured THC vaping products—aptly illustrated the dangers of strengthening the illicit and gray markets.

For many people of color, prohibitions and the illicit markets they encourage lead to familiar and damaging interactions with police.

Data, past experience and common sense also suggest that it is members of marginalized communities, experiencing poverty and in need of supplemental income, who will disproportionately fill the void of prohibition by engaging in the illicit activity required to continue the supply of banned products. The consequences of this could be deadly—and all for the sake of bans that fail to achieve their stated purposes.

For many people of color in marginalized communities, prohibitions and the illicit markets they encourage lead to familiar and damaging interactions with police. Eric Garner, Michael Brown, George Floyd and Alton Sterling were all killed by police in circumstances where tobacco policy, drug policy or broader illicit activity under current laws played a role. The video of the young Black man being tasered and assaulted by police in Ocean Park, Maryland this summer as they enforced a vaping ban reflects the fuel such policies provide for police abuse in communities of color.

Science has always been sidelined in the pursuit of drug prohibitions, and this is especially so regarding vaping. E-cigarettes first hit the US market around 15 years ago, and have greatly evolved in the intervening years. Study after study has shown these products to be first, vastly safer than combustible cigarettes, and second, viable smoking cessation tools that are more effective than options like NRT. 

But as with other drugs, arguments about “the kids” have been leveraged to push for prohibition—”If we can stop our kids from smoking to begin with,” said Councilor Sawyer of her Denver proposal, “then hopefully they won’t turn into adult smokers.” And in the case of nicotine, a longstanding public health beef with the tobacco industry has also played into prohibitionists’ hands. 

The Consequences of Banning Menthol Cigarettes

There has therefore been a concerted effort to put the vaping genie back in the bottle. But this phenomenon is even starker with the attempts to prohibit menthol cigarettes—which people have been using for far longer and which are lumped in with the general push against flavored products.  

The menthol market is over a third of the US cigarette market. Menthols are disproportionately preferred by Black and other communities of color—the communities a ban would purportedly protect. 

No one is minimizing the harms that menthols, like other combustible cigarettes, cause. And although Black smoking rates are similar to whites’ overall, it is ludicrous to think that the substantial demand for menthols will disappear simply because a local, state or even federal government decides to prevent legal access. As with prohibitions on vaping products, menthol bans will produce harms related to criminalization and illicit markets—but they’ll likely be targeted even more at marginalized communities of color, because these are the communities where menthol supply and demand are already concentrated. 

A non-punitive approach to menthol cigarette-related health issues would involve a combination of public education and provision of resources—including vaping products—to aid quitting.

The menthol issue highlights the typically punitive nature of our drug policies. Nicotine and tobacco blanket bans are aimed at hurting the seller due to their promotional and advertising tactics—behavior which was rubber-stamped by our federal government. Yet despite the understandable knee-jerk reaction to hurt the seller, drug policy should always be focused on what’s best for people who use drugs. We’ve seen throughout the drug war how the harsh criminalization of sellers ramped up mass incarceration amid blurred distinctions between “seller” and “user,” while worsening drug-related risks and prohibition-related violence. 

In contrast, a non-punitive approach to the problem of menthol cigarette-related health issues would involve a combination of public education and provision of resources—including vaping products—to aid quitting. I would suggest that the money and effort put forth by the likes of Bloomberg to hurt the tobacco and nicotine industries would be far better employed in efforts like these—tailored to the marginalized communities that suffer the most smoking-related harms.

Proponents of bans, especially where vaping is concerned, say they are out to save youth from a lifetime of poor health and nicotine addiction. It sounds a worthy objective. But prohibition produces all kinds of new problems, without solving the old ones. 

Vaping began as a harm reduction tool, and that is what it principally remains. We must not pursue blanket bans in the name of curbing teen use, when these policies abandon adult smokers practicing harm reduction—and drive more teens to smoke.

We must not allow symbolic political gestures to disrupt the long-term progress we have seen in reducing smoking rates. There are 33 million fewer tobacco users in the US than there were 50 years ago, despite our population doubling in that time. And for millions of Americans who were unable to quit smoking, vapes proved to be the innovation that enabled them to do it.   

Photograph by Lindsay Fox via Flickr/EcigaretteReviewed.com /Creative Commons 2.0

The post Nicotine Flavor Bans: Symbolic Politics With Real-World Harms appeared first on Filter.