It was a historic victory to those who support access to a variety of safer nicotine products—including flavors, which research and experience have repeatedly shown to be key to many people’s ability to switch from cigarettes. Access is vital because combustible tobacco use is still the leading cause of preventable disease and death in the United States. Smoking kills more than 480,000 people each year.

“The amount the company had to spend was in the high double-digit millions of dollars … We had numerous meetings with the FDA, navigating the process through substantial scientific review.”

Sean Greenbaum, the founder and president of Glas, explained to Filter how the company got through the FDA’s expensive and legendarily arcane Premarket Tobacco Product Application (PMTA) process.

“We started working on our application in 2019,” he said. “The amount the company had to spend was in the high double-digit millions of dollars. It was a significant investment of time, resources and capital. We had numerous meetings with the FDA, navigating the process through substantial scientific review, various deficiency letters, and we responded to all the questions they had. We conducted scientific, clinical and age restriction studies.”

Not everyone celebrated that blueberry and mango vapes passed FDA muster. The Campaign for Tobacco-Free Kids (CTFK) and Parents Against Vaping Electronic Cigarettes (PAVE) were apoplectic.

CTFK trotted out the old, tired and false narrative that “kid-friendly” flavors’ purpose is to hook youth. “By authorizing fruit flavors and allowing e-cigarette makers to disguise them with names like Gold and Sapphire, the FDA is risking a resurgence of youth e-cigarette use,” President Yolanda C. Richardson said in a press release. “History can’t be allowed to repeat itself; mango was one of the most popular Juul flavors that contributed to a past surge in youth e-cigarette use before it was pulled off the market.”

Their fury flows from a sense of betrayal towards an agency that has generally caved to their demands.

On a PAVE webinar to discuss the FDA decision, cofounder Meredith Berkman was enraged: “It’s a catalytic moment where the FDA has failed us. Has failed American families. Has failed to live up to its regulatory authority to protect public health and the health of our children … It’s shameful that at this moment the FDA has been co-opted by the predatory tobacco industry.” Apparently the mango-hating Manhattanite doesn’t know that Glas is an independent vape business that’s never been affiliated with the tobacco industry.

The apocalyptic language over the sale of two fruit-flavored vapes is ridiculous. Surely CTFK and PAVE are aware that vapes in dozens of fruit flavors are easily purchased on the booming illicit market created by the FDA’s obstructionism? Despite this, there has been no increase in youth vaping for years—in fact, the number has dropped sharply.

Their evidence-free claims that the legal availability of flavored vapes will unleash another teen vaping “epidemic” are an attempt to create another drug panic and to bully the FDA into reversing its decision. Their fury flows from a sense of betrayal towards an agency that has generally caved to their demands.

FDA Commissioner and tobacco control lapdog Marty Makary was toeing that line in April when he issued a memo preventing the authorization of Glas menthol, mango and blueberry vapes, after FDA scientific reviewers green-lit them. Then the Trump Whitehouse got involved and suddenly they were authorized. Weeks later Makary resigned specifically over this issue. Don’t be surprised if he ends up working for CTFK. That’s where Brian King, the former Director of the FDA’s Center for Tobacco Products, is now employed.

PAVE initiated a letter-writing campaign demanding repeal of the authorization. Joining the attack are 21 state attorneys general who wrote a letter to the FDA urging it to “reverse guidance easing sales of flavored e-cigarettes.”

“DARS are an information-gathering device masquerading as a youth prevention.”

Tobacco control organizations and other groups have another bone to pick with Glas. They have denounced the “device access restrictions” (DARS) technology, arguing it won’t stop tech-savvy youth and deploys Big Brother spying software.

“DARS are an information-gathering device masquerading as a youth prevention,” stated Willow Najjar Anderson, an attorney at the Public Health Law Center. “They give the industry a socially responsible gloss while doing little to stop youth from seeing, wanting or accessing flavored vapes. Moreover, privacy concerns with DARS remain real, especially when access to an addictive product is conditioned on surveillance, biometric check-ins, and data collection.”

Anderson makes an important point about the monitoring features embedded in the Glas app. Where do the information and photos collected by the company go, and who has access to them? In an era of powerful hacking groups, rampant identity theft and massive data breaches, this might be a deal-breaker.

I asked Greenbaum why Glas did this. “We wanted to take a very conservative approach that presented zero risk in regards to any form of appealing to youth, and we combined that with our extensive and robust age-restrictive technology,” he said. “We conducted two age restriction studies. The first study didn’t expose youth to the brand or the physical product. We put the technology in their hands and provided them the opportunity to game the system. They couldn’t. Then the FDA told us to put the actual vape in the hands of young people, and we conducted the same set of tests where they tried to game or break the system. Zero youth were able to.”

That’s a lot of steps to puff on a vape. Compare that to how fast and easy it is for anyone—of any age—to pick up and smoke a cigarette.

Here are the steps to activate a Glas flavored vape. Before it can be unlocked, the device has to be paired with a smartphone app, so the first step is to download the app. The next step is uploading a government-issued ID and a real-time selfie, which the software analyzes to confirm legal age. Once verified, a digital certificate is sent to the vape, allowing the heating coil to be activated. Sensors in the vape actively monitor the connection to the smartphone, and if the phone is moved out of close range of the vape, or if it is turned off, the vape automatically deactivates.

That’s a lot of steps to puff on a vape. Compare that to how fast and easy it is for anyone—of any age—to pick up and smoke a cigarette. Or use an unauthorized, non-age-gated vape, for that matter.

“Every new technology product has a little bit of a hurdle in the beginning, but our process is seamless and efficient,” Greenbaum said. “From the perspective of thinking about all of the products that we use as consumers in today’s world, everything for the most part is connected and you have some form of a mobile app. The process that we have for verifying a user, it occurs in under three minutes. It’s similar to a mobile banking app. In our studies we pulled from a demographic of heavy smokers of all ages and demographics, and the ease of use on the technology side was not a concern for them.”  

To be sure, some people will be able to activate the device, but seriously, in under three minutes and nothing will ever go wrong?

It’s a feature that is the opposite of user-friendly—but this is where the FDA, and the manufactured outcry at “kid-friendly” flavors, have gotten us.

What Greenbaum isn’t taking into account is the digital divide that is a reality for low-income, vulnerable populations, especially in rural areas, that have the highest rates of smoking. People who are street-homeless often don’t have consistent access to wifi, often don’t have government-issued ID, and cell phones get lost, stolen or are shut off for nonpayment. People with serious mental health diagnoses might have cognitive or functional impairments that limit their ability to follow directions to activate the vape.

Another problem is that the pleasure of inhaling nicotine could be lost because the freedom to move around while vaping is compromised by the technology. I envision people forgetting that they have to keep their cell phone and vape in close proximity and the device abruptly deactivating. Annoying! It’s a feature that is the opposite of user-friendly—but this is where the FDA and the manufactured outcry at “kid-friendly” flavors have gotten us.

It was a seven-year battle to get FDA authorization of flavored vapes. But if age-gating surveillance technology becomes the norm and makes vapes too difficult, frustrating, time-consuming or invasive to use, then tobacco control zealots will have found yet another way to block the use of safer nicotine products. 

Photographs courtesy of Glas

Correction, July 24: A previous version of this article incorrectly stated that the FDA did not issue a press release about the Glas authorizations. In fact, the agency did issue a press release on May 5.

The Influence Foundation, which operates Filter, has received unrestricted grants from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.

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“In recent years, there has been growing interest in and active research on the therapeutic potential of psychedelic drugs, in particular for the treatment of serious mental health conditions,” the FDA stated. “In response, FDA has made significant advances in psychedelic drug development through the issuance of scientific guidance, engagement with federal partners and the public, and regulatory actions to support drug development.”

A four-hour public hearing has been set for September 14 at the FDA campus in Silver Spring, Maryland. Requests to attend, either virtually or in person, must be submitted by August 21. The public can submit comment electronically up through October 5. Confidential submissions can also be sent by mail, as long as they’re received by the same deadline.

It’s likely that the first approvals of Schedule I psychedelics would be followed by proposals for rescheduling.

The clinical guidance is the final version of draft guidance the FDA issued in June 2023.

“Drug development programs for psychedelic drugs are subject to the same regulations and same evidentiary standards for approval as other drug development programs,” the final guidance states. “However, designing clinical studies to evaluate the safety and effectiveness of these products presents a number of unique challenges.”

The agency went on to describe the potential for “intense perceptual disturbances and alterations in consciousness,” as well as “both rapid-onset and long-term benefits,” sometimes after only one dose.

“There is preliminary evidence that psychedelic therapies can rewire the brain and produce rapid improvements for people with serious mental illness or substance use disorders,” stated National Institutes of Health Director Dr. Jay Bhattacharya. “However, we still have much to learn about long-term benefits and risks, including the potential for misuse.”

A number of psychedelic substances have been heavily researched for their potential to treat conditions like SUD, post-traumatic stress disorder and major depressive disorder. These include psilocybin (the active compound in “magic mushrooms”) LSD, MDMA and ibogaine—all of which are banned under Schedule I of the Controlled Substances Act. Because the criteria for Schedule I are a “high potential for abuse” and no medical use approved by the FDA, it’s likely that the first INDA approvals would be followed by proposals to reschedule those psychedelics to a less-restrictive category, the same process by which medical marijuana was recently moved to Schedule III. The final clinical guidance states that in the event of a Schedule I psychedelic being approved for medical use, “the abuse potential assessment [from the INDA] would assist in determining an appropriate rescheduling action.”

HHS singled out ibogaine in particular.

The HHS announcement singled out ibogaine in particular. The plant-based psychedelic from Central West Africa appears to be in favor with the Trump administration, and the National Institute on Drug Abuse is currently funding research exploring it as a treatment for opioid use disorder.

On July 13, HHS also announced a new memorandum of understanding (MOU) with the VA. At publication time the VA was involved in 20 active clinical trials studying psychedelic treatments for mental health conditions.

“Under the agreement, HHS and VA will coordinate workforce training, develop evidence-based clinical protocols, support research and real-world evidence generation, and prepare the VA healthcare system to responsibly implement future FDA-approved rapid-acting psychiatric drug products as they become available,” the MOU states. 

It will be in effect through 2031. The partnership will aim to increase veteran participation in clinical trials, train the health care workers involved in such trials, create public awareness materials and facilitate data-sharing that could allow the FDA to issue INDA approvals more quickly.

The HHS announcement also referenced a “separate, complementary MOU” pertaining to mental health treatment more broadly, but this appeared to be the same one announced by the FDA. That MOU is the only one recently listed in the FDA’s Domestic MOU catalog, although there its expiration date is “Indefinite” rather than the five-year term described elsewhere. The FDA did not respond to Filter’s inquiry.

Image via Hillsboro, Oregon

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The newly authorized products are four G2 pods made by the vape company Glas: Classic Menthol, Fresh Menthol, Gold and Sapphire. The latter two are mango and blueberry flavors, making them the first non-tobacco, non-menthol vaping products the FDA has authorized. 

Youth use has always been the FDA’s reason for denying authorization for flavored vapes—which are important for harm reduction because many adults find them the best way of switching from cigarettes. But the agency determined that Glas’s device-access restriction technology—pairing a vape with an age-verified smartphone via Bluetooth—would, combined with marketing restrictions, effectively deter youth use. 

This is not a simple story of a product moving cleanly through a scientific review process, but one that has continually involved politics, pressure and public perceptions.

The story behind this authorization began in July 2021, when Glas submitted Premarket Tobacco Product  Applications (PMTA) for these products. By then, the PMTA process was already becoming a maze for flavored-vape applicants. 

Internal FDA memos later showed how the agency handled many such applications through what became known as the “Fatal Flaw” review. Instead of fully evaluating each application on its merits, the review looked for the presence of certain types of studies in applications for non-tobacco-flavored products—a systematically different approach from that used with other applications. 

That helped fuel criticism that the PMTA process was chaotic, opaque, stacked against smaller companies and amounted to a de facto flavor ban.  

By then, starting in August 2021, the FDA had already begun issuing waves of marketing denial orders for flavored vaping products. Those decisions helped set the pattern: FDA would repeatedly say flavored products had not shown enough adult benefit to offset youth risk, while many adults who had switched insisted that flavors were helpful—if not critical—to making the switch.

For years, the public was told that the FDA’s tobacco decisions were based on science. They should be. But the science office’s recommendation has not always been the final word.

In 2022, internal FDA memos involving Logic’s menthol vaping products showed that the CTP’s Office of Science had recommended authorization, but CTP leadership pushed back. The documents revealed substantial disagreement inside CTP, with FDA scientists on one side and the agency’s bureaucratic and political leadership on the other. 

In December 2025, tobacco harm reduction advocate Gregory Conley noticed a Google Alert showed a PDF indicating the FDA had added the Glas G2 device and multiple Glas pods to its authorized list. In an unusual twist, the update to the authorized list later that day no longer included the Gas products. The FDA attributed the weekend changes to a glitch.

In March, the FDA authorized the Glas G2 device and one Blonde Tobacco pod. There was no press release, but that authorization represented the first of a vaping product with age-gating technology that must be activated before use. Glas also stood apart from most companies with authorizations because it has never been owned by or previously tied to a tobacco company. 

Combustible cigarettes, we should remember, do not require Bluetooth pairing. Age-gating vapes makes the safer option much harder to access than the more dangerous one.

But the flavors that had drawn attention in December were still missing. Had the FDA reviewed them and said no? Or had something else happened?

By April, internal FDA records suggested that the story was not so simple. Scientific staff had recommended marketing orders for flavored Glas products, but senior leadership halted them. Because those records became public through Glas, they should be read carefully. But they were not hard to believe, because the Logic case had already shown a similar pattern: FDA scientists saw a path to authorization, and higher-level officials intervened.

This difference was evidently resolved in favor of authorization. And this happened at a time when the pressure around the FDA has visibly shifted. 

For years, health and parents’ groups have pushed the agency not to authorize flavors, and that’s still the case. After the Glas announcement, the Campaign for Tobacco-Free Kids called the decision a “big step backward,” warning that fruit flavors appeal to youth. 

But pressure is now coming from the other direction, too. Earlier on May 5, news broke that President Donald Trump had rebuked FDA Commissioner Marty Makary for not moving quickly enough to approve flavored vapes and nicotine products. Advisers described Makary as blocking Trump’s pledge to “save” vaping. Hours later, the FDA announced the Glas authorizations.

So this is not a simple story of a product moving cleanly through a scientific review process, but one that has continually involved politics, pressure and public perceptions.

The age-gating technology may well be what finally made the authorization politically viable, which suggests the FDA is not opening the door to many other flavored vapes. The Glas G2 requires users to download an app, upload a selfie and driver’s license images, and use the device while near the paired phone. That may be a path through FDA’s maze, but it is a narrow one.

Combustible cigarettes, we should remember, do not require Bluetooth pairing or any of the other elements of this digital lock; anyone who obtains them, including youth, can use them. So age-gating vapes makes the safer option much harder to access than the more dangerous one.  

People who smoke deserve more than a regulatory system that offers them cigarettes quickly and harm reduction alternatives slowly.

That does not make the Glas authorization bad news. It is good and historic news. But it also shows how many hoops a company had to jump through before the FDA could say yes.

The evidence on flavors makes this story bigger than one company. Fruit and sweet flavors are positively related to moving away from cigarettes, and helping people select a flavor can improve the chance of switching. It took until 2024 for the FDA to authorize any non-tobacco flavored vape, in the form of menthol.

For adults who smoke, the practical question has never been whether a product fits neatly into a regulatory debate. The question is whether there is a regulated, accessible option that helps them move away from cigarettes. Glas may be an answer for some people. It will not be the answer for everyone.

The authorization does not solve the larger problem. It does not suddenly create a broad legal market of smoke-free products that reflect the mostly unregulated variety adults already use. It does not erase the damage done by years of uncertainty, denials and misinformation about safer options.

It does mark a change, but the next step should not be to declare victory. It should be to ask why it took this long, how many adults were left without acceptable legal options along the way, and whether the FDA will apply this lesson more broadly.

People who smoke deserve more than a regulatory system that offers them cigarettes quickly and harm reduction alternatives slowly.  

Photograph (cropped) by Global State of Tobacco Harm Reduction via Flickr/Public Domain

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Though not a strict requirement, two well-controlled studies demonstrating safety and efficacy has long been the FDA’s default position. The agency did not announce the new policy on its website, but in a February 18 New England Journal of Medicine article by Commissioner Dr. Marty Makary and Chief Medical and Scientific Officer Dr. Vinay Prasad, who also directs the FDA’s Center for Biologics Evaluation and Research.

“The FDA’s historical reliance on two clinical trials rather than one was intended to provide credible causal evidence that a therapy could improve clinical outcomes with acceptable safety in a world where biologic understanding was more limited than it is today,” the authors wrote. “Two trials should be seen as just one of many interlocking facets of clinical credibility, and in 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

Makary and Prasad argued that the approval process will not become less rigorous since the two-trial standard was never foolproof to begin with, and greater scrutiny will now be placed on each trial that is submitted. They also noted that many drugs are already approved based on a single trial, and that the FDA retains the authority to request a second trial.

The new standard is intended to “substantially” cut costs for sponsors, with the paper citing estimates that the cost of a pivotal study can range from $30 million to $150 million.

“Lowering capital costs for drug developers may remove a persistent argument in justification of lofty and rising drug prices for everyday Americans—the onerous cost of research and development,” the authors wrote. “The FDA expects a surge in drug development in response to our initiative.”

“Who was consulted? Was anyone consulted? What were the data that drove the decision?” Center for Medicine in the Public Interest President Peter Pitts, a former FDA associate commissioner, told Regulatory Focus. “Was there industry input? Was there patient input? Was there input of any kind from anybody other than Drs. Makary and Prasad?”

In May 2025, shortly after his appointment to FDA commissioner, Makary began an “aggressive” internal rollout of artificial intelligence tools that purportedly “allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process.” These include a generative chatbot called Elsa that reads, writes and summarizes scientific documents, and a more recent agentic AI tool ​​used for “more complex tasks” including review validation.

Makary has also established the Commissioner’s National Priority Voucher pilot program, a new expedited approval process that will see certain drugs cleared to go to market after just one to two months of review. The standard has been six months for priority drugs, and 10 months for most drugs. Makary had initially planned to give a voucher to a psychedelic treatment for depression developed by Compass Pathways, but it was cut at the last minute. 

President Donald Trump’s second term has seen sweeping rollbacks of economic and environmental safeguards that have often attracted less media attention—from the Department of the Interior opening federal lands to development under expedited permits to the Federal Communications Commission forcing anti-consumer policies past the public during the 2025 government shutdown. Earlier in February, the EPA revoked its 2009 finding that greenhouse gas emissions are a public health threat, the legal basis of their regulation under the Clean Air Act. 

In December 2025 the White House announced that the administration had so far completed 646 deregulatory actions, and only five regulatory actions. Deregulation is expected to be the de facto theme of Trump’s 2026 State of the Union Address on February 24.

“Deregulation is the unsung hero of this entire economic turnaround,” state Trump’s prepared remarks. “We are cutting costs through deregulation faster than anybody ever thought possible.”

Top image (cropped) and inset graphics via Food and Drug Administration

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As part of appropriations legislation that President Donald Trump signed in 2025, many hemp products that were legalized during his first term under the 2018 Farm Bill will be prohibited once again, starting in November. The spending measure included separate provisions, however, to have the FDA and other relevant agencies study the cannabinoid marketplace and develop lists of cannabis components.

After the bill was signed, the FDA was given 90 days to publish: 1) a list of  “all cannabinoids known to FDA to be capable of being naturally produced” by cannabis; 2) a list of “all tetrahydrocannabinol class cannabinoids known to the agency to be naturally occurring in the plant;” and 3) a list of “all other know cannabinoids with similar effects to, or marketed to have similar effects to, tetrahyrocannabinol class cannabinoids.”

The purpose of the FDA directive appears to be related to how federal law will distinguish between legal hemp products under a new, narrower definition, and marijuana.

Further, the agency was tasked with providing “additional information and specificity about the term ‘container’” with respect to hemp product THC serving sizes. In the bill, the term is defined as “the innermost wrapping, packaging, or vessel in direct contact with a final hemp-derived cannabinoid product in which the final hemp-derived cannabinoid product is enclosed for retail sale to consumers, such as a jar, bottle, bag, box, packet, can, carton, or cartridge.”

The lists and information are due by February 10. Whether the FDA makes the deadline is yet to be seen, however, as there are multiple examples of federal agencies failing to meet congressionally mandated timelines, including when it comes to marijuana-related policy issues.

The purpose of the FDA directive appears to be related to how federal law will distinguish between legal hemp products under a new, narrower definition in the recently enacted legislation and marijuana, which remains illegal under US law.

Since 2018, cannabis products have been considered legal hemp if they contain less than 0.3 percent delta-9 THC on a dry weight basis.

However, the law that is set to take effect in November specifies that, within one year of enactment, the weight would apply to total THC—including delta-8 and other isomers. It would also include “any other cannabinoids that have similar effects (or are marketed to have similar effects) on humans or animals as a tetrahydrocannabinol (as determined by the Secretary of Health and Human Services).”

The new definition of legal hemp would additionally ban “any intermediate hemp-derived cannabinoid products which are marketed or sold as a final product or directly to an end consumer for personal or household use” as well as products containing cannabinoids that are synthesized or manufactured outside of the cannabis plant or not capable of being naturally produced by it.

Legal hemp products would be limited to a per-container total of 0.4 milligrams of total THC or any other cannabinoids with similar effects.

“If it remains unclear exactly which cannabinoids are outlawed, then the McConnell hemp ban will just cause more confusion and chaos.”

Hemp stakeholders are paying particularly close attention to the “container” definition for cannabinoid products.

“No matter what they come up with, it won’t solve the intermediate issue,” Adam Terry, CEO of the hemp beverage company Cantrip, told Marijuana Moment on February 5. “It may allow something like individually wrapped gummies with 0.4mg THC per piece, but the liquid used to pour into molds will still break that container rule, which under statute applies to intermediates.”

“So the gummies would be illegal to make in the US. Full-spectrum CBD needs a more comprehensive reform as the president said” in his recent executive order, Terry said, adding that a bill introduced by Representatives Morgan Griffith (R-VA) and Marc Veasey (D-TX) in January is “the best proposal for that.”

Jim Higdon, the co-founder and chief communications officer at Cornbread Hemp, said he is “eager for the FDA to finally provide some guidance on hemp, which they have withheld since the passage of the 2018 Farm Bill.”

“If it remains unclear exactly which cannabinoids are outlawed, then the McConnell hemp ban will just cause more confusion and chaos,” he said, referring to Senator Mitch McConnell (R-KY), who led the charge to both initially legalize hemp in 2018 and the more recent push to recriminalize hemp THC products.

The Hemp Enforcement, Modernization, and Protection (HEMP) Act represents a potential alternative to the outright THC ban that was included in the spending bill Trump signed, affirmatively allowing the sale of consumable hemp products to adults 21 and older. That includes edibles, beverages and inhalable items.

If the legislation is enacted, there would be various regulatory restrictions for the market. For example, packaging couldn’t appeal to youth and would need to be tamper-proof. It would also need to list all cannabinoids present and include a QR code linking to a certificate of analysis.

Hemp product makers would be prohibited from adding substances like alcohol, caffeine, tobacco, nicotine, melatonin or others “with effects that could interact with cannabinoids or enhance or alter their effects.”

For what it’s worth, four in five marijuana consumers say they oppose the recriminalization of hemp THC products.

There would also be manufacturing and testing requirements, and hemp businesses would need to register their facilities.

Additionally, there are provisions mandating the establishment of a total cannabinoid cap on hemp products. The US. Department of Health and Human Services (HHS) would be charged with proposing cannabinoid limits within 60 days of enactment.

Meanwhile, alcohol retailers recently came together to encourage Congress to delay the enactment of the law Trump signed to federally recriminalize hemp-derived THC beverages and other products.

The coalition is calling on lawmakers to pass recently introduced legislation, the Hemp Planting Predictability Act, that would give the hemp industry two more years before a federal ban on THC products would take effect—which stakeholders hope will better position them to negotiate a broader regulatory compromise.

House Oversight and Government Reform Committee Chairman James Comer (R-KY), who is cosponsoring the proposal, appeared at a January press conference alongside farmers who are concerned about the looming federal hemp ban’s impact on their businesses.

For what it’s worth, four in five marijuana consumers say they oppose the recriminalization of hemp THC products under the spending bill Trump signed in November. However, it should be noted that that poll was conducted weeks before he issued a cannabis rescheduling order and took steps to protect access to full-spectrum CBD.

Trump signed an executive order in January directing the attorney general to complete the process of moving marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA).

Part of that announcement also holds implications for the forthcoming hemp law. The president’s order urged Congress to examine updating the definition of hemp to ensure that full-spectrum CBD is accessible to patients.

A further redefinition of hemp would be part of a novel proposal to allow Medicare recipients to access non-intoxicating CBD that’d be covered under the federal health care plan.

To effectuate that, the Centers for Medicare & Medicaid Services (CMS) will be announcing “a model that will allow a number of CMS beneficiaries to benefit from receiving CBD under doctor recommendation at no cost,” a White House official said during a briefing from which Marijuana Moment first reported leaked details ahead of the signing event.

Trump seemed to endorse a more flexible CBD policy when in summer 2025 he shared a video calling for that specific reform while promoting the health benefits of cannabidiol, particularly for seniors.

A White House spokesperson said prior to the bill signing that Trump specifically supported the prohibition language.

Meanwhile, a separate recently filed Republican-led congressional bill would stop the implementation of the hemp ban under the enacted appropriations legislation.

Hemp businesses and industry groups have warned about the potential ramifications of the ban, but despite his support for states’ rights for cannabis and a recent social media post touting the benefits of CBD, Trump signed the underlying spending measure into law without acknowledging the hemp provisions.

GOP political operative Roger Stone said recently that Trump was effectively “forced” by Republican lawmakers to sign the spending bill with the hemp THC ban language.

However, a White House spokesperson said prior to the bill signing that Trump specifically supported the prohibition language.

The Democratic governor of Kentucky said that the hemp industry is an “important” part of the economy that deserves to be regulated at the state level—rather than federally prohibited, as Congress has moved to do.

Also, a leading veterans organization is warning congressional leaders that the newly approved blanket ban on consumable hemp products could inadvertently “slam the door shut” on critical research.

Image via New Jersey Cannabis Regulatory Commission

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on X and Facebook, and sign up for its newsletter.

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To THR advocates, it’s too little and long overdue. The FDA has been guilty of spreading misinformation about safer nicotine products that can help people quit smoking. It has been notorious for a sluggish, punishing and politicized vape authorization process that obstructs regulated access—sending applicants for flavored vapes, in particular, on a “wild goose chase,” according to one appeals court, and moving the goalposts to “arbitrarily and capriciously” deny them (even if the Supreme Court didn’t see it that way in April). 

The agency has been blamed for making a “gigantic, chaotic mess” of the US vapes market, ceding the space to the unregulated products that now dominate, and generally dissuading people who smoke from switching with a relentless, grossly exaggerated emphasis on youth vaping harms.

In January, however, the FDA authorized some nicotine pouches for the first time under its Premarket Tobacco Products Applications (PMTA) process—acknowledging that they “offer greater benefits to population health than risks.” 

April saw the removal of the director of the FDA’s Center for Tobacco Products (CTP), Dr. Brian King, who’d unapologetically prioritized youth prevention more than the needs of adults who smoke (he soon found a new job at the Bloomberg-funded, anti-THR Campaign for Tobacco-Free Kids). And in July, the FDA authorized Juul vapes after a years-long legal battle—a move heavy with symbolism, when the company once served as chief scapegoat for youth use.

“This pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose,” the FDA stated.

Then in September, the FDA launched a pilot program to streamline its PMTA review process for nicotine pouches. Its announcement acknowledged—as the agency has done previously, if not very loudly, using “continuum of risk” language—that non-combustible nicotine products are safer than cigarettes. It also pointed to evidence that nicotine pouches can be valuable smoking-cessation aids.

The FDA said that to increase efficiency in its case-by-case reviews of pouches, it will focus “on the most critical elements for this product category,” in assessing “appropriate for the protection of public health”—aiming for better communication with applicants and “shorter review timeframes.” 

“For adults who smoke and want to switch to a nicotine pouch product, this pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose,” the agency stated.

Whether the promise is kept remains to be seen. If it is, it could be a huge win for US public health. Uptake of low-risk oral nicotine products has reduced Sweden’s smoking rate to 5.3 percent—verging on world-first “smoke-free” status. 

Experts have long called for the FDA to start authorizing a much wider range of safer nicotine products. People have individual preferences, and often find completely different products helpful or unhelpful. So offering them lots of options, with the confidence of knowing they’re authorized, would give the US the best chance to accelerate smoking cessation like Sweden or New Zealand. 

The promised streamlining of pouch authorizations sounds like a start. It also suggests that the FDA has the ability to make changes swiftly—particularly if pushed. But the agency could be using many other tools, too, if it really wants THR to take off.

The paper sets out 15 practical recommendations that the FDA has the power to adopt. 

In September, just days after the FDA pilot announcement, a group of researchers in the field published a paper with the American Enterprise Institute (AEI)—“Regulating the Tobacco and Nicotine Market in the American Public Interest: A Reform Agenda for the FDA.” It sets out 15 practical recommendations that the FDA has the power to adopt. 

When pressed by THR proponents, FDA officials such as King have pleaded that they’re merely implementing the law under the Tobacco Control Act, and that their hands are therefore tied. But as the paper states, “These reforms do not require a change in the law but rather a pragmatic interpretation of the process governing the PMTA and the ‘appropriate for the protection of public health’ test.”

The recommendations include: applying the “least-burdensome principle” to regulation; establishing “soft standards” to speed up authorizations in a given product category, using “category-wide findings” rather than endlessly demanding individual findings for every single product; not always requiring manufacturers to produce human studies, when studying a product’s emissions is a “reasonable proxy;” and using “real-world outcomes” of products already on the market to evaluate public health impacts.

The authors also want authorized manufacturers to be allowed to communicate more clearly to the public about the reduced-risk nature of their products. And they call on the FDA to “Educate health professionals and the public” about the “differential risks between smoking and smoke-free products.”

“These reforms are necessary and urgent,” Dr. Brad Rodu, professor of medicine at the University of Louisville and one of the authors of the paper, told Filter. When around 480,000 people die of smoking-related illnesses each year in the US, guaranteeing access to more non-combustible alternatives is paramount. 

“Crowd out the illicit market by authorizing at least 4,000 products that smokers desire, reduce review time to the statutory maximum 180 days and lower application costs.”

To date, Rodu pointed out, the FDA has authorized just 39 mostly unpopular vaping products, with a handful of menthol options the only non-tobacco flavors. This just isn’t enough to outcompete the vast array of cigarettes and other combustible tobacco products available. But even partial prohibition is enough to boost unregulated markets.

“The demand for safer cigarette substitutes is now being met by illegal vaping products,” Rodu said. People who use these products instead of smoking are still practicing harm reduction, but without the safeguards of product standards and consumer protections. This, Rodu said, could be solved by the paper’s recommendations.

“Crowd out the illicit market by authorizing at least 4,000 products that smokers desire,” he urged, “reduce agency review time from several years to the statutory maximum 180 days, and lower product application costs from tens of millions, to tens of thousands of dollars.” 

And if the full benefit of authorizing far more safer nicotine products is to be realized, the FDA has a responsibility to make sure people who smoke know about them.

“The FDA must invest heavily in honest consumer education on the differential risks of combustible and smoke-free tobacco,” Rodu said.

“The FDA and HHS leaders can correct course, but doing so will require genuine leadership.”

“Currently, the general public and health professionals are grossly misinformed about the significant risk-benefit ratio of nicotine itself, and the large difference in health risks between smoked tobacco and use of smoke-free delivery systems,” he pointed out. “[Health and Human Services] Secretary Kennedy knows these basic facts: So should all Americans.”

Gregory Conley, a longtime THR advocate and former legislative director of the American Vapor Manufacturers Association, sees the AEI paper as a “major opportunity” for the FDA to reset, by building an authorization pathway to a functioning regulated market. 

“Despite a campaign trail commitment from President Trump to ‘save’ flavored vaping, companies still face an opaque and impractical process,” Conley told Filter. “The FDA and HHS leaders can correct course, but doing so will require genuine leadership and a break from the missteps of prior administrations.”

There have been signals that new FDA leadership might be more receptive to these signals than their predecessors were. In October, acting CTP Director Dr. Bret Koplow voiced support for THR, including potentially increasing the range of authorized flavored vapes, as a way to reduce use of lethal cigarettes. 

“I agree with the proposals. Millions of lives are waiting for the CTP, and all of us, to get this right.”

“After hearing Bret Koplow speak at the FDLI Tobacco and Nicotine Conference, I feel more hopeful than I have in a long time,” Skip Murray, a THR advocate who herself quit smoking with vapes, told Filter. 

Murray strongly agrees with the paper’s authors that the PMTA process “needs a do-over.” For her, the long-term obstruction has been personal. Murray’s husband has COPD after years of smoking, as she recently wrote for Filter, and she has lost many loved ones from smoking-related illnesses. 

“Streamlining the PMTA process would free up funds available to the CTP to put towards educating the public on the continuum of risk,” Murray pointed out. “I agree with the proposals in the AEI. Millions of lives are waiting for the CTP, and all of us, to get this right.”

Photograph via Freerange Stock/Public Domain

The Influence Foundation, which operates Filter, formerly received donations from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.

The post The FDA Might Be Thawing to THR: Here’s How It Could Move Faster appeared first on Filter.

“People need different doses for different reasons,” Dr. Raymond Niaura, a psychologist and professor of social and behavioral sciences at New York University’s School of Global Public Health, told Filter. “They may metabolize nicotine more quickly, it might be their neurological make-up, maybe they’re more or less sensitive to the effects of nicotine or have developed a tolerance to it.” 

A broad range of nicotine pouch strengths, allowing people who smoked to go for higher nicotine levels if needed, is therefore crucial to maximize harm reduction, he said.

A new study, published in the Scientific Reports journal, underlines this point. The researchers set out to understand how much nicotine higher-strength modern pouches delivered to a person’s bloodstream, and how quickly. Most prior studies of this kind had only looked at products with lower nicotine levels.

The study was conducted in Sweden, where mass switching to snus and pouches has dramatically reduced smoking rates.

Twenty-seven adults who already used snus or pouches were randomly assigned to use one of three higher-nicotine pouches, which are currently not available in the United States, or a tobacco snus comparator. The nicotine doses of the pouches used were 14 mg, 16 mg and 20 mg, while for the snus product it was a comparably high 16.6mg.

The products “provide satisfactory levels of nicotine delivery for adult smokers with no intention to quit smoking, and with positive subjective outcomes.”

Participants exclusively used their assigned product over a period of four days spent in a clinic setting. A “single-blind” protocol meant they didn’t know which of the products in question they were using, but the investigators did. Blood samples were taken to assess nicotine concentrations, and the participants answered questions about cravings, satisfaction and other aspects of their experiences.

“Overall, this study has demonstrated that the three zoneX MOND [modern oral nicotine delivery] products tested provide satisfactory levels of nicotine delivery for adult smokers with no intention to quit smoking, reducing urge to use nicotine following use, and with positive subjective outcomes,” the authors concluded.

The researchers are all employees of the tobacco company Imperial Brands, which manufactures the pouches used. Though some would see that as discrediting their findings, the study was peer-reviewed before publication. Moreover, the basic finding that higher nicotine dosage has harm reduction value matches what independent research has shown about other types of safer nicotine products, with many people who smoked heavily saying that higher-nicotine vapes were the only reason they were able to quit.

“Higher nicotine strength products deliver higher levels of nicotine to participants’ bloodstreams,” Matthew Stevenson, one of the co-authors, told Filter. “Our tobacco-free products generally scored more favorably than the snus comparator for satisfaction, psychological reward, aversion and relief.”  

Acknowledging that all the products, including snus, “exhibited similar reductions in urge to use nicotine both during, and following usage,” he said that overall, the research “adds to the existing scientific weight of evidence that MOND products offer encouraging THR potential for adult smokers.”  

“One size does not fit all,” and someone who smokes heavily is likely to need a higher-strength safer alternative.

Dr. Niaura of NYU, who was not involved in the study, said that it further solidifies the idea of a “dose-response relationship.” 

He added that the research reminded him of the history of NRT, because a large part of the history of patches and gums has revolved around the question of dosage. “The same logic applies here,” he said. “One size does not fit all,” and someone who smokes heavily is likely to need a higher-strength safer alternative.

If we accept the importance of higher-nicotine pouches, the next question concerns their availability. And as Stevenson noted, the study findings “pertain to products sold in Europe and are not indicative of any product currently authorized or marketed in the US.”  

In January, tobacco harm reduction advocates celebrated when the United States Food and Drugs Administration (FDA) authorized the marketing of certain modern nicotine pouches for the first time. 

Another big development came in September, when the FDA—known for its onerous, chaotic and bitterly contentious authorization process for vapes—resolved to “drop a requirement that [pouch] manufacturers submit product-specific studies in several areas,” under a pilot program. By relying instead on available research about nicotine pouches in general, this has the potential to streamline future pouch authorizations.

Yet right now, the 20 Zyn products authorized in the US have nicotine levels no higher than 6 mg. 

“The FDA is maybe a bit squeamish about higher doses … It’s a start. It’s not game over.”

“The FDA is maybe a bit squeamish about higher doses, they’re just being cautious,” Niaura said, adding that, “any regulatory agency is going to be conservative.” 

“They only recently authorized them,” he continued. “Once everyone has more experience of them in the real world, there will be opportunities to do follow-up studies.”

“It’s a start,” he summarized. “It’s not game over.”

From a Swedish perspective, this looks like unjustified foot-dragging.

“Regulation should reflect [that] higher nicotine content is closer in its delivery to cigarettes and that, for some people, this is what is needed for them to make the switch and avoid relapse,” Suely Castro, founder of the nonprofit Quit Like Sweden, told Filter. 

But many authorities in Europe, too, are failing to get the message.  Luxembourg, for instance, has drafted a law to restrict dosage to an incredibly low 0.048 mg of nicotine per pouch. Advocates have described it as a de facto pouch ban, and fear it will jeopardize smoking cessation.

Castro said Luxembourg only has to look to Sweden to see how easy access to snus and pouches has resulted in far fewer smoking-related deaths per capita than the rest of Europe. Sweden’s smoking rate is on the verge of dropping below the 5 percent “smoke free” threshold. Luxembourg’s rate is estimated at 21.7 percent.    

“Sweden’s model works precisely because it’s not based on prohibition or limiting products’ functionality to the point that it is unsuitable as a quitting aid,” Castro said.

It’s a lesson lawmakers and regulators need to learn fast, if they’re serious about preventing death and disease from smoking.

Photograph (adapted) by Global State of Tobacco Harm Reduction via Flickr/Creative Commons 2.0

Zyn pouches are manufactured by a subsidiary of Philip Morris International (PMI). The Influence Foundation, which operates Filter, has received unrestricted grants from PMI. Filter‘s Editorial Independence Policy applies.

The post High-Nicotine Pouches Help People Stay Off Cigarettes—If Available appeared first on Filter.

The petition was submitted by Harmed Americans for Reform in Medical-Device Safety (HARMS), a nonprofit organization founded by three experts at Northeastern Law and Tufts Medical Center. HARMS isn’t exclusively focused on cannabis issues, but the organization said an FDA-approved cannabinoid hair-testing device created by the Psychemedics Corporation raises serious concerns that the agency should address.

“Our petition requests that the FDA require clearer labeling to specify that the device can be used to detect only the presence of cannabinoid metabolites in hair and cannot be used for ‘identifying marijuana use,’” as the label implies,” HARMS’s Hooman Noorchashm said in an October 17 press release. “If firms use this 510(k) device for the express purpose of ‘identifying marijuana use,’ they are not using the device properly.”

Unlike conventional saliva, urine and blood tests for THC metabolites, determining whether a person used cannabis based on hair samples is uniquely complicated because secondhand smoke exposure could be enough to lead to a positive result. HARMS is advising the FDA to exercise its authority to revise the device’s labeling requirements to clarify that point.

“The Psychemedics Device is marketed for identifying marijuana use in employment and insurance contexts, including by federal, state, and municipal law enforcement agencies.”

Making that labeling change is “particularly important,” the experts said, because “the Psychemedics Device is marketed for identifying marijuana use in employment and insurance contexts, including by federal, state, and municipal law enforcement agencies.”

Cannabinoid metabolites “are detectable in hair in both purposeful use and in the case of inadvertent exposure,” says the petition, which the FDA has acknowledged it received. “So while hair testing can detect cannabinoids, it cannot definitively confirm marijuana use because ‘external contamination’ is always possible.”

While other standard THC tests can more definitively demonstrate past usage of cannabis, it continues, “hair testing of the kind used in the Psychemedic’s Device detects THC-COOH over a longer period (months) and faces additional challenges, including false positives from passive exposure (e.g., inadvertent inhalation of marijuana smoke), as well as variability in cannabinoid incorporation due to hair type, hair treatments, and growth rates.”

“Given the unreliability of hair testing to accurately identify marijuana use, the FDA should evaluate the Psychemedics label or labeling of hair testing for cannabinoids,” it says. “These concerns have real-world impact. For example, the Psychemedics Device is used in employment settings, particularly for law enforcement officers.”

“Employers may erroneously believe a positive result proves marijuana use when it showed only exposure. This kind of misunderstanding can cause significant harm.”

“Because positive test results may reflect only passive exposure rather than intentional marijuana use, consumers (employers) may erroneously believe that a positive result definitively proves marijuana use when it showed only marijuana exposure. This kind of misunderstanding can cause significant harm to individuals who are deemed marijuana users, and may result in inappropriate medical care or adverse employment decisions. To ensure consumers and users understand the limitations of the Device, the FDA should undertake the requested actions.”

HARMS’s David Simon said that the “labeling and instructions for use are a crucial component of a device that is supposed to provide accurate information to consumers and users.”

HARMS filed a citizen’s petition to require the FDA to ensure clear labeling on a device that detects the presence of cannabinoids in hairhttps://t.co/ezJCmA1T5a

— David A. Simon (@david__simon) October 17, 2025

“The current instructions for use are confusingly worded, and do not achieve this goal,” he said. “Most worryingly, people’s livelihoods may be on the line if the test is not used properly.”

The petition asks the FDA to recommend or order Psychemedics to revise the device’s instructions for use to read: “The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoid metabolites in hair using a 11-nor-9-Carboxy- Δ9-THC calibrator at a cut off of 10 pg/10 mg hair.”

As an alternative, it suggests that FDA could order the company to “provide a disclaimer on the Device that it does not identify whether any test subject used marijuana but only detects the presence or absence of cannabinoid metabolites in hair, which could have occurred without the subject using marijuana.”

Marijuana Moment reached out to Psychemedics for comment, but a representative was not immediately available.

As the state legalization movement has continued to expand, the complications around cannabis drug testing policies have also gained increased attention.

As acknowledged by a Department of Justice researcher, it’s unclear whether a person’s THC levels are even a reliable indicator of impairment.

In July, for example, a Rutgers University law professor published a commentary investigating how roadside tests for marijuana impairment that are widely used by police departments across the U.S. are “inadequate.” He urged policymakers to take a more scientifically robust approach to transportation safety while relying less on law enforcement’s ostensible expertise.

There’s another wrinkle to the cannabis testing debate: As acknowledged by a Department of Justice researcher, it’s unclear whether a person’s THC levels are even a reliable indicator of impairment.

In October 2024, a study preprint posted on The Lancet, by an eight-author team representing Canada’s Centre for Addiction and Mental Health, Health Canada and Thomas Jefferson University in Philadelphia, identified and assessed a dozen peer-reviewed studies measuring “the strength of the linear relationship between driving outcomes and blood THC” published through September 2023.

The issue was also examined in a federally funded 2024 study that identified two different methods of more accurately testing for recent THC use, accounting for the fact that metabolites of the cannabinoid can stay present in a person’s system for weeks or months after consumption.

Photograph by Daniele Levis Pelusi via Unsplash

This story was originally published by Marijuana Moment, which tracks the politics and policy of cannabis and drugs. Follow Marijuana Moment on X and Facebook, and sign up for its newsletter.

The post Marijuana Hair-Test Device Doesn’t Prove Use, Warns Petition to FDA appeared first on Filter.

On September 9, President Donald Trump signed a memorandum ordering the Food and Drug Administration (FDA) to increase enforcement of restrictions on DTC drug advertising, with an emphasis on TV ads. The FDA announced a crackdown on “deceptive” DTC ads that same day.

“For far too long these ads have distorted the doctor-patient relationship and have created artificial demand for induction regardless of their clinical appropriateness,” FDA Commissioner Marty Makary stated on social media. “In recent years the FDA has increasingly been lax in its enforcement approach … Well, it’s a new day.”

The FDA has already issued approximately 100 cease-and-desist letters, and thousands of additional warning letters. These actions are being heavily promoted by the administration, and framed as a corrective to the dwindling number of letters the FDA has been issuing in recent years. However, it doesn’t appear that the agency actually sent companies individualized letters describing specific violations identified in their advertising. The letter authored by Makary and shared by the FDA begins “Dear Pharmaceutical Company,” and includes the line “We are issuing this letter to provide notice to all application holders.” Cease-and-desist letters are not typically issued in this generic fashion.

The FDA has a certain amount of enforcement authority under the Federal Food Drug and Cosmetic Act, which requires that all prescription drug advertising balance information about potential benefits with information about potential risks, so as to not be misleading. But the administration is not banning DTC ads outright—something Health and Human Services Secretary Robert F. Kennedy Jr. has pushed for, but which federal courts have historically viewed as a violation of the First Amendment, and which the FDA has stated it doesn’t have the authority to do.

 

Let’s get President Trump back in the White House and me to DC so we can ban pharmaceutical advertising. pic.twitter.com/Qp7fj9xskU

— Robert F. Kennedy Jr (@RobertKennedyJr) November 3, 2024

TV ads hawking pharmaceuticals to potential patients is essentially an American phenomenon; only New Zealand has comparably permissive regulations.

Up until the 1980s, pharma companies would pitch their products to health care providers, who were the sole source of information for patients. Then companies realized they could bypass the medical professionals, and advertise to the public directly. 

In 1985 the FDA issued guidelines that restricted pharmaceutical ads, including by banning them from naming specific conditions that a drug could treat, unless they also included the complete list of side effects. Newspapers and magazines were able to accommodate this requirement, but the concept of “fine print” doesn’t translate as well to TV and radio. Many companies didn’t bother. 

Then, in 1997, the FDA issued new guidelines. Rather than list all the side effects, ads only needed to include a brief summary. Or, instead of the brief summary, a URL or toll-free number viewers could use to find the information. This became known as the “adequate provision” loophole. The pharmaceutical industry now spends over $5 billion a year on TV advertising, and over $10 billion a year on DTC ads in total.

“The Trump administration is taking action to return to the pre-1997 status quo by engaging in FDA rule-making to close the ‘adequate provision’ loophole to ensure risk disclosure,” HHS stated, ”and stepping up enforcement action of DTC pharmaceutical ads.”

RFK Jr. has suggested the changes might result in ads that swell to four minutes long, in order to include all the side effects and required risk information. The likelihood of this is unclear, but what seems more certain is that pharma companies will file legal challenges to the new restrictions.

“Pharmaceutical ads hooked this country on prescription drugs,” RFK Jr. stated. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

In 2019 during his first presidential term, Trump attempted to force pharma companies to include drug prices in their DTC commercials, if the price would be more than $35 per month. A federal judge blocked it in the final hours before it would have taken effect, ruling that the administration doesn’t have the legal authority to compel private companies to disclose their prices.

Image (cropped) via United States Food and Drug Administration/YouTube

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The backstory to this long battle is the power, money and influence of a uniquely dangerous Tobacco Control cult, to which the 480,000 people who die from smoking in the United States each year are invisible. Without it, far fewer would die. FDA officials, politicians, “public health” groups and much of the medical community and mainstream media are among its bought-and-paid-for members.  

It’s no longer smoking; instead, cult followers want to hasten the end of nicotine use. A nicotine-free world will never happen, but they need a drug to vilify and prohibit in order to remain relevant. And critically, to keep the spigot of money flowing—from billionaire Michael Bloomberg, the cult’s overlord, and from Master Tobacco Settlement payouts, funded by cigarette sales.  

Lost in the stench of disinformation and moral panic is the revolutionary contribution of Adam Bowen and James Monsees to ending smoking. As students at Stanford they smoked cigarettes, and hated that they did. Both knew the risks, but enjoyed the benefits of nicotine. So they posed the question: “Why wasn’t there a way to enjoy nicotine without combustion that could save the lives of millions of smokers?” 

The two men went on a decade-long quest to design a user-friendly tech solution. The result: Juul, a sleek, slim vape pen that was deliberately designed not to look like a cigarette, but was as easy to use. Because of their lived experience, Bowen and Monsees understood the key roles that nicotine strength and flavors play in making the switch.

Juul was the victim of a massive attack that is without precedent in its senselessness and hostility.

To date, Juul has helped over 2 million adults stop smoking in the US. That number comes from Juul, but it’s credible when independent evidence shows over a million US adults using vapes to quit smoking per year. The figure would be much higher if the Tobacco Control cult hadn’t mobilized to block access, ban flavors and try to bankrupt the company. 

Juul was the victim of a massive attack that is without precedent in its senselessness and hostility. No other company making products that can save lives has been so successfully and publicly punished, humiliated and driven to the edge. Even coal and oil companies, health insurance corporations or Big Tobacco have largely avoided being so hammered in the media and the courts, despite campaigners’ efforts. State Attorneys General filed thousands of lawsuits against Juul. By the end of 2023, the company had paid out nearly $3 billion in legal settlements across the US.  

The attack started after Juul’s “Vaporized” campaign launched in 2015. Colorful images and videos featured young people with a Juul, looking cool. The device was pitched as a fun, cutting-edge commodity that came in flavors like mango and cucumber and could help people stop smoking. The idea was it’s cool to Juul, not smoke. 

In an era of social media, brand ambassadors and influencers, the campaign went viral—and was accused of targeting teens with flavors and then hooking them on nicotine salts. Monsees and Bowen heard the complaints and shut it down. Monsees said, “It [underage use] is an issue we desperately want to resolve. It doesn’t do us any favors. Any underage consumers using this product are absolutely a negative for our business. We don’t want them. We will never market to them. We never have. And they are stealing life years from adult cigarette consumers at this moment, and that’s a shame.”

Is a misguided product launch a reason to tear down a company that sells a lifesaving nicotine delivery device that millions depend on? No! 

With youth smoking at an all-time low following the introduction of vapes, Tobacco Control organizations’ existence has come to depend on finding new enemies.

The follow-up marketing campaign, “Make the Switch,” featured powerful testimonials from people who smoked and transitioned to Juul. It didn’t matter; the attacks intensified. The truth is, no matter how Juul advertised its device, it would have been broadsided. 

Tobacco Control organizations—like the Campaign for Tobacco-Free Kids and the Truth Initiative (new tagline: “Freedom from nicotine addiction”)—would have found a way to spin any promotion efforts and argue it encouraged youth vaping. With youth smoking at an all-time low following the introduction of vapes, their existence has come to depend on finding new enemies and launching a drug war against nicotine. Their disinformation crusade has continued even after a dramatic decline in teen vaping! 

The Vaporized campaign set off a frenzy across the US and around the world that continues today. A key reason it was ignited has to do with race and class. The teen demographic that initially bought Juul skewed white and wealthy. Many lived in affluent communities in California and New York. The price of a starter kit could run $45, and a four-pack of pods $25. Which teens could afford that? Their stories were always going to be amplified over those of lower-income communities with high smoking rates. 

Enter the entitled moms of Manhattan who founded PAVE (Parents Against Vaping E-cigarettes) in 2018. They were able to use their privilege to hire lawyers, utilize media connections, lobby state and federal lawmakers relentlessly to ban flavors, end vape sales in some cities and defame Juul. 

The New York Times and other corporate media outlets took their cues from PAVE and Bloomberg, and dusted off the Reefer Madness playbook to unleash a drug panic. “Teen vaping epidemic” and “nicotine-addicted adolescent brain” stories were evidence-free clickbait. In one biased article after another, Times journalists became stenographers for the Tobacco Control cult. They abandoned both-sidesism, almost never quoted adult vapers, and ignored studies demonstrating the efficacy and safety of vaping nicotine.

Then “the paper of record” whipped up yet more alarmism during the misnamed E-cigarette or Vaping-Associated Lung Injury (EVALI) outbreak. About 68 people died from using THC vape cartridges adulterated with vitamin E acetate—not from nicotine vapes. The CDC willfully failed to make this critical distinction, and faced with this onslaught of misinformation, many people blamed Juul and other nicotine vape companies for the deaths.     

The immense power of the Juul-triggered fenzy over teen vaping frenzy had a host of catastrophic knock-on effects, creating an Orwellian world of disinformation and doublethink.    

It made it illegal to buy flavored vapes in most states and entire countries—and in some nations, illegal to buy any vapes at all—as the cigarette trade remained lucrative and legal. It drove mom-and-pop vape shops and e-liquid companies, many owned by people who’d smoked, out of business. Small neighborhood stores—staffed by experts in vaping and nicotine, vigilant about age verification and helping thousands of adults—were tragically wiped out.  

Juul had a tagline, Smoking Evolved. But the landscape has now devolved in ways the founders could never have imagined.  

It created a cesspool of junk science, spreading lies about nicotine and vaping with a veneer of authority. One study found that 82 percent of physicians in the US believe nicotine causes cancer. Dr. Stanton Glantz, a leading purveyor of junk science whose study linking vaping to heart attacks was retracted, denies evidence from the highly respected Cochrane Review showing vapes increase smoking quit rates.  

It allowed the FDA to fuck with Juul for five years under its glacial Premarket Tobacco Product Applications process. In 2022, the agency banned Juul vapes from the market, issuing a marketing denial order asserting there wasn’t enough evidence regarding the products’ toxicological profile. It was a lie. Juul successfully appealed the ban in court, and the FDA had to reinstate its application for scientific review.  

Juul had a tagline, Smoking Evolved. But the landscape has now devolved in ways the founders could never have imagined.  

The juggernaut of the Juul teen-vaping frenzy changed the trajectory of the market. Instead of regulating, promoting, and making them legally available in a national network of community-based vape shops or other outlets, the US is filled with unregulated, disposable, flavored vapes, as consumers circumvent bans. It’s estimated that the illicit market sells 60 percent of all vapes in the US.

Geek Bar, Lost Mary and Raz have replaced Juul, which at its peak had a US vape market share of over 70 percent. The brands are wildly popular, the devices are easy to use, and berry bliss, rocket popsicle and Miami mint are among the flavors. But those who buy and sell these products are potentially criminalized.  

The good news is millions of people have ignored the bans and switched to vaping. They are courageously practicing tobacco harm reduction in the midst of prohibition, to save their lives.    

Without the Juul panic, far more people would have stopped smoking in the past five years. For the Tobacco Control cult, the lives of 480,000 Americans who die each year from smoking seem as disposable as the vapes. 

Image by Helen Redmond

The Influence Foundation, which operates Filter, formerly received donations from Juul Labs, Inc. Filter‘s Editorial Independence Policy applies.

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