As previously announced, JUUL Labs refrained from lobbying the Administration on its draft flavor guidance and pledged to support the final policy. We fully understand the urgent need to continue resetting the vapor category and earn trust as we combat underage use and convert adult smokers from combustible cigarettes.
In light of the studies released this week relating to the 2019 National Youth Tobacco Survey and Monitoring the Future survey, JUUL Labs’ CEO K.C. Crosthwaite announced that the company will immediately stop accepting orders from our retail partners for our Mint JUULpods in the U.S. and cease the sale of Mint JUULpods in the U.S. through our ecommerce site (JUUL.com).
In making the announcement, Crosthwaite said: “These results are unacceptable and that is why we must reset the vapor category in the U.S. and earn the trust of society by working cooperatively with regulators, Attorneys General, public health officials, and other stakeholders to combat underage use. We will support the upcoming FDA flavor policy and will follow the PMTA process.”
As part of Crosthwaite’s review of JUUL Labs’ policies and practices, the company has already:
- Refrained from lobbying the Administration on its draft flavor guidance.
- Suspended all broadcast, print, and digital product advertising in the U.S.
- Stopped the sale of Mango, Creme, Fruit, and Cucumber JUULpods online in the U.S., pending FDA review. In November 2018, JUUL Labs stopped the distribution of these JUULpods to all of our traditional retail store partners.
- Announced a restructuring plan aimed at aligning the company’s organization and resources behind key priorities: earning trust by reducing and preventing underage use, investing in scientific research to ensure the quality of its PMTA application in the U.S., and expanding its commitment to develop new technology.
- Ceased active support of Proposition C in San Francisco.
Crosthwaite and the leadership team will continue to review JUUL Labs’ policies and practices and will take appropriate actions as the company works to combat underage use and earn society’s trust.
As of today, JUUL Labs sells only Virginia Tobacco, Classic Tobacco, and Menthol JUULpods in the U.S. and it will not sell any others under any name unless they are first authorized by the FDA as part of the PMTA process.
In September, JUUL Labs announced that its new CEO, K.C. Crosthwaite, is leading a broad review of the company’s practices and policies. As part of that process, the company:
- Suspended all broadcast, print, and digital product advertising in the U.S.
- Ceased active support of Proposition C in San Francisco
- Is refraining from lobbying the Administration on its draft flavor guidance and will fully support and comply with the final policy when effective
Today, Crosthwaite announced another action resulting from the company’s review — the suspension of the sale of our non-tobacco, non-menthol-based flavors (Mango, Creme, Fruit, and Cucumber) in the U.S., pending FDA review.
Given the lack of trust in our industry, we believe the FDA’s PMTA process and its “appropriate for the protection of the public health” standard are the best ways to assess the role these products can play in helping adult smokers move away from combustible cigarettes while also being kept out of the hands of youth.
In making the announcement, Crosthwaite said, “We must reset the vapor category by earning the trust of society and working cooperatively with regulators, policymakers, and stakeholders to combat underage use while providing an alternative to adult smokers.”
Until today, our non-tobacco, non-menthol-based flavors (Mango, Creme, Fruit, and Cucumber) were made available by JUUL Labs in the U.S. only at JUUL.com, which has strict age-verification controls.
As we evaluate what products to submit for PMTA, we will continue to develop scientific evidence to support the use of these flavored products, coupled with strict measures to combat underage use, as we believe these products can play an important role in helping adult smokers move away from combustible cigarettes.
The company will continue to refrain from lobbying the Administration on its draft flavor guidance and will fully support and comply with the final policy when effective.
JUUL Labs recently announced a broad review of the company’s policies in order to responsibly lead the industry. When he was appointed CEO last week, K.C. Crosthwaite said: “We must strive to work with regulators, policymakers and other stakeholders, and earn the trust of the societies in which we operate. That includes inviting an open dialogue, listening to others and being responsive to their concerns.” As we continue that review, the company announced it will cease active support of Prop C in San Francisco.
In a statement today, K.C. Crosthwaite said:
“I am committed to seeing that JUUL engages productively with all stakeholders, including regulators, policymakers and our customers. This decision does not change the fact that as a San Francisco-founded and headquartered company we remain committed to the city. San Francisco is not only the home of our company’s founding but is also the home of many of our talented employees.”
JUUL Labs remains as committed as ever to our goal of improving the lives of the world’s one billion smokers while keeping our products out of the hands of youth through strong category-wide regulation.
CEO Kevin Burns announces decision to step down. K.C. Crosthwaite joins company as CEO effective immediately, bringing over two decades experience working with regulators and stakeholders, advancing alternative products to combustible cigarettes.
Company to restrict product-related advertising and will not lobby Administration on draft guidance.
JUUL Labs announced today that K.C. Crosthwaite will be joining the company as CEO effective immediately. The announcement from co-founders James Monsees, Adam Bowen and Kevin Burns follows Burns’ decision to step down.
Incoming CEO K.C. Crosthwaite brings over two decades of global operational, management, stakeholder and regulatory engagement experience. As Chief Growth Officer at Altria Group Inc., he oversaw the company’s expansion into alternatives to combustible cigarettes and played a key role in the commercial and regulatory efforts related to the U.S. launch of IQOS. He also served as an observer on JUUL Labs’ board of directors.
In his new role, Crosthwaite and the entire JUUL Labs leadership team will continue a broad review of the company’s practices and policies to ensure alignment with its aim of responsible leadership within the industry. Effective immediately, JUUL Labs announced the company is:
- Suspending all broadcast, print and digital product advertising in the U.S.
- Refraining from lobbying the Administration on its draft guidance and committing to fully support and comply with the final policy when effective
Commenting on the announcement, Crosthwaite said: “I have long believed in a future where adult smokers overwhelmingly choose alternative products like JUUL. That has been this company’s mission since it was founded, and it has taken great strides in that direction. Unfortunately, today that future is at risk due to unacceptable levels of youth usage and eroding public confidence in our industry. Against that backdrop, we must strive to work with regulators, policymakers and other stakeholders, and earn the trust of the societies in which we operate. That includes inviting an open dialogue, listening to others and being responsive to their concerns.”
Burns said: “Working at JUUL Labs has been an honor and I still believe the company’s mission of eliminating combustible cigarettes is vitally important. I am very proud of my team’s efforts to lead the industry toward much needed category-wide action to tackle underage usage of these products, which are intended for adult smokers only. Since joining JUUL Labs, I have worked non-stop, helping turn a small firm into a worldwide business, so a few weeks ago I decided that now was the right time for me to step down. I am grateful to be able to confidently hand the reins to someone with K.C.’s skill set, which is well-suited to the next phase of the company’s journey.”
Under Burns’ leadership, JUUL Labs helped provide an alternative to millions of adult smokers around the world and took aggressive actions to combat youth usage. Over the course of Burns’ tenure, JUUL Labs grew from a firm with fewer than 300 hundred employees operating in the U.S. to a company with thousands of employees and operations in 20 countries around the world. Burns implemented industry-leading manufacturing and quality control standards.
Burns also oversaw the implementation of industry-leading actions to combat underage use of vapor products. JUUL Labs has strongly advocated for Tobacco 21 (T21) laws, stopped the sale of non-tobacco and non-menthol-based flavored JUULpods to all of its traditional retail store partners, enhanced its online age verification, discontinued its U.S.-based Facebook and Instagram accounts and works to remove inappropriate social media content generated by others on those platforms. The company also intensified efforts to combat illegal and potentially dangerous counterfeit and compatible products. Most recently, JUUL Labs started deploying technology at retail stores that automatically restricts the sale of JUUL products until a government-issued ID is electronically scanned to verify age and ID validity, exceeding the standards in place for other tobacco products and alcohol.
Monsees and Bowen said: “Kevin transformed our start-up into a global business, and we are incredibly grateful for his commitment to and passion for our mission. K.C. has long understood the potential of alternatives to combustible cigarettes and the need to combat youth usage and we look forward to having him lead our team during this crucial phase.”
JUUL Labs, which exists to help adult smokers switch off of combustible cigarettes, has been monitoring the situation closely. To be clear, the ingredients of our products do not include THC, any compound derived from cannabis, or vitamin E compounds like those found in cannabis-related products. We appreciate the work of the CDC, FDA, and other public health authorities, and are confident that they will get to the bottom of this issue.
|We strongly agree with the need for aggressive category-wide action on flavored products. |
We will fully comply with the final FDA policy when effective.
At JUUL Labs product quality and safety are of paramount importance. As part of our commitment to improve the lives of adult smokers by eliminating cigarettes, we maintain robust quality controls and manufacturing standards. Our Regulatory and Quality executive leaders have decades of experience in the pharmaceutical and medical device industries, and they leverage their expertise to measure, manage and continuously improve JUUL Labs’ quality system. We are committed to meeting exacting quality standards for our products.
E-Liquid: Subject to High Product Quality Standards
We fill the e-liquid for all JUULpods in the United States. While our products are regulated in the United States as “tobacco products,” for which good manufacturing practice (GMP) requirements have not yet been established, our e-liquid production facilities are certified against international manufacturing standards (ISO 9001). We also perform chemical testing and chemical release on every lot of e-liquid.
In addition to enforcing stringent manufacturing controls, we conduct extensive preclinical and toxicological testing of the ingredients and analytes in JUUL e-liquids and aerosols, including testing for harmful and potentially harmful constituents (HPHCs). Our testing is conducted through reputable, independent third-party laboratories and we provide the results of these tests to regulatory bodies.
JUUL is a closed system vapor product, designed to prevent someone from altering the product, including by refilling the cartridge with other substances (which would be an open system). We do not sell any products that contain THC, which is a Schedule 1 controlled substance.
Device and Pod Manufacturing: Rigorous Design Standards, Supplier Audits, and Extensive Product Testing
Both our devices and our manufacturing facilities are subject to numerous quality and certification standards. JUUL products are manufactured in China, Hungary, Mexico, and several locations in the United States. We require our global device manufacturing plants to have quality systems compliant with international medical device standards (ISO 13485), as verified by third-party auditors.
Additionally, all JUUL products have received a CE Mark, meaning they meet the health, safety, and environmental protection standards of the European market (a designation that is recognized worldwide). Our devices and JUULpods are inspected before leaving our manufacturing facilities, undergoing rigorous testing in a wide variety of scenarios, and are specifically designed with multiple protections, while charging and in use.
We conduct reliability tests to simulate the effects of stress under actual use over time, and also involve routine hardware tests for reliability and safety in real-world scenarios, such as impact and drop testing. Additionally, our contracts with suppliers contain stringent quality requirements and we regularly audit them to ensure compliance.
Battery Safety: Exacting Product Specifications and Rigorous Testing
Battery safety begins with the product specifications, so that the battery itself, its current requirements, and the circuitry design it works within, are designed with fail-safes to make it very unlikely that safety issues could ever occur. Our captive batteries cannot be removed or altered by the consumer and have limited charging capacity, which mitigates the risks associated with a removable battery. JUUL device batteries also store a fraction of the energy of common open-system vaporizers.
We test for reliability and operational consistency in both individual battery packs and at the system level — at each stage of the design process — including impact and drop testing as well as forced failure, all according to international safety standards. We put the actual batteries and finished devices through rigorous testing to confirm our specifications are met.
Industry-wide Regulation: Protecting Adult Smokers and Combating Underage Use
JUUL Labs strongly supports industry-wide regulation to establish uniform quality control and manufacturing standards for all vapor products. We believe the standards we have voluntarily implemented are industry-leading and are critical to pursuing our mission to improve the lives of adult smokers by eliminating cigarettes.
We also strongly support regulations aimed at combating underage use of all vapor products and we support FDA’s draft guidance modifying its compliance policy for certain deemed products, including vapor, to address this. Youth use of vapor products remains an urgent issue, and JUUL Labs shares public concerns over the reported increase in use among youth, which is why we have initiated meaningful measures to limit access and appeal of JUUL products to minors.
Any reports of incidents involving underage use of vapor products reaffirm the need to keep all tobacco products out of the hands of youth through significant regulation on access and enforcement. We must also ensure illegal products, such as counterfeit, copycat, and those that deliver controlled substances, stay out of the market. These products, often marketed in violation of FDA laws, regulations, and policies, represent a pressing public health threat: they may be made with unknown ingredients and under unknown manufacturing and quality standards.
Moreover, these products are marketed in overtly youth-appealing flavors and packaging and often sold online with little to no age verification. JUUL Labs is aggressively enforcing our intellectual property rights against manufacturers of counterfeit and pod-compatible vapor products who flood the market with unauthorized and unregulated items.
We are fully committed to the current PMTA process and are confident in the content and quality of the materials we will submit with our application by May 2020.
We are not appealing the recent federal court case in the District of Maryland and similarly do not support the recent lawsuit against FDA filed by the Vapor Technology Association in the Eastern District of Kentucky.
While we have appreciated the opportunity to collaborate with the VTA, we will not renew our membership when it expires later this month as we are not aligned on too many critical policy issues. For example, we support clean Tobacco 21 legislation and an outright ban on certain flavors.
JUUL Labs will continue to focus on combating youth usage of vapor products including JUUL while preserving the historic opportunity to switch adult smokers off of combustible cigarettes.
On June 25, the San Francisco Board of Supervisors voted to ban the sale of e-cigarettes within city limits, at both retail and online, until they go through the FDA regulatory process. Under current FDA policy, these products can stay on the market through August 2022, when manufacturers must submit a product application.
This effective prohibition will drive former adult smokers who successfully transitioned to vapor products back to combustible cigarettes, deny current adult smokers the opportunity to move off combustible use altogether, and create a thriving black market instead of addressing the actual causes of underage access and use.
Many have come out with the same reaction to this misguided policy, noting the significant negative impact for adult smokers.
Dr. Michael Siegel, Professor in the Department of Community Health Sciences, Boston University School of Public Health
“San Francisco Board of Supervisors poised to deliver huge gift to Philip Morris” (Dr. Michael Siegel: “San Francisco Board of Supervisors Poised to Deliver Huge Gift to Philip Morris,” The Rest of the Story: Tobacco and Alcohol News Analysis and Commentary, 6/22/19)
“Earlier today, the Board approved an ordinance that will ban the sale of all electronic cigarettes in the city, including both brick-and-mortar and online sales. Before it becomes law, the ordinance is subject to a final vote, which is expected to take place next week. … Absurdly, the San Francisco Board of Supervisors is allowing the continued, unfettered sale of real cigarettes — the ones that kill more than 400,000 Americans (including more than 40,000 Californians) each year” (Dr. Michael Siegel: “San Francisco Board of Supervisors Poised to Deliver Huge Gift to Philip Morris,” The Rest of the Story: Tobacco and Alcohol News Analysis and Commentary, 6/22/19)
“This has to be one of the most insane public health proposals I have ever seen. This legislation basically says: ‘We care so much about the health of our kids that we can’t allow e-cigarettes to remain on the market until they have a complete safety review. However, we are perfectly happy allowing cigarettes—which have had extensive safety reviews and been found to be killing hundreds of thousands of Americans each year—to remain on the market” (Michael Siegel, “Why Is SF Considering Banning Fake Cigarettes But Allowing The Real Ones To Stay On The Market?” San Francisco Examiner, 3/26/19)
David J. Johns, Executive Director of The National Black Justice Coalition
“There are several potential negative impacts this ban would have on the black community. First, a ban that removes all vapor products risks folks who have stopped smoking cigarettes reverting back. Simply put, prohibition does not work. Lawmakers have the responsibility to enforce reasonable expectations. With that, let’s do this responsibly, we should focus on regulation, responsible marketing and accountability for companies that violate policies.”
“Adults should have the opportunity to make adult decisions while we continue to find ways to reduce the number of adults using both cigarettes and e-cigarette alternatives. Beyond restricting the rights of responsible adults making informed decisions, an unintended consequence includes increasing the use and purchase of cigarettes.” (David J. Johns, Op-Ed, “San Francisco Vaping Ban Will Disproportionately Impact The Black Community,” San Francisco Examiner, 6/30/19)
San Francisco Chronicle Editorial Board
“But the crusade needs a reality check. It’s not as if reasonable steps are not being taken to study vaping and restrict its appeal to youth. The city cracked down on flavored e-cigarettes through a ballot measure last year. The federal Food and Drug Administration is entering the picture with its own limitations aimed at curbing sales. Vaping is a tempting public villain. Manufacturers should be treated with skepticism about claims that vaping is a benign habit. What vaping doesn’t deserve is a dose of shortsighted demonizing that does little to change the bigger picture of tobacco abuse and other health dangers the city is loath to confront” (San Francisco Chronicle Editorial Board, “Editorial: San Francisco Vaping Ban Is Purely Political Grandstanding,” San Francisco Chronicle, 6/21/19)
Josh Barro, Columnist
“Instead of Juul, San Francisco should have banned cigarettes” (Josh Barro, “Instead Of Juul, San Francisco Should Have Banned Cigarettes,” New York Magazine, 6/26/19)
“Ideally, you should want a public policy that encourages smokers to switch to vaping; that discourages non-users of nicotine products, especially minors, from taking up any nicotine product; and that discourages vape users from switching to combustible cigarettes. San Francisco’s proposed policy (a second vote by the Board of Supervisors is required before it becomes law) fails to meet the third test because it makes traditional cigarettes easier to obtain than vapes” (Josh Barro, “Instead Of Juul, San Francisco Should Have Banned Cigarettes,” New York Magazine, 6/26/19)
“Adult smokers who are thinking about switching to vaping, or who have already done so, might continue buying cigarettes because the city will make that the more convenient option” (Josh Barro, “Instead Of Juul, San Francisco Should Have Banned Cigarettes,” New York Magazine, 6/26/19)
Los Angeles Times Editorial Board
“The San Francisco Board of Supervisors gave a tentative thumbs-up to the ban last week, and the supervisors are expected to reaffirm their support in a final vote Tuesday. We hope the supervisors will see the light before then. Not only is it bad public policy to outlaw a legal product that’s widely available just outside the city’s borders, but it’s bad public health policy to come down harder on the lesser of two tobacco evils” (Los Angeles Times Editorial Board, “San Francisco’s E-Cigarette Ban Isn’t Just Bad Policy, It’s Bad For Public Health,” Los Angeles Times 6/24/19)
“There are more reasonable ways to attack teen vaping than criminalizing electronic cigarettes for everyone. The state is already trying one: Two years ago it raised the legal age for all tobacco products from 18 to 21, which cut off legal access to those products for teens who may still be in high school and might purchase electronic cigarettes for their younger school friends. San Francisco adopted another last year: banning fruit and candy flavorings that appeal to teens. The city hasn’t given this narrower ban much of a chance to show results, however. A third possibility would be to restrict e-cigarette sales more tightly, such as by permitting only retail outlets that use point-of-sale ID readers and restricting how many electronic cigarettes can be purchased at one time” (Los Angeles Times Editorial Board, “San Francisco’s E-Cigarette Ban Isn’t Just Bad Policy, It’s Bad For Public Health,” Los Angeles Times 6/24/19)
It’s no secret that smoking kills a lot of people every year. According to the Center for Disease Control, “cigarette smoking is responsible for more than 480,000 deaths per year in the United States, including more than 41,000 deaths resulting from secondhand smoke exposure. This is about one in five deaths annually, or 1,300 deaths every day.”
Knowing this, I asked myself: why do adult smokers still smoke?
As a designer, my job is to create experiences that are meaningful and add value to and impact people’s lives. I do this by being empathetic to the audience of whatever product I’m designing. Because I don’t smoke, and never have, I have to rely on published facts and the experiences of those who do. The CDC lays out an abundance of striking data around cigarette-smoking, very openly and clearly. How I respond to these facts determines what kind of designer I am, and what kind of designer I want to be.
Finding empathy for adult smokers
Most adult smokers are trying, but have not yet found a way to meaningfully change their relationship with nicotine. Shouldn’t we be finding solutions to help these people and those around them? Don’t these millions of people deserve a better alternative?
It’s easy to fall into the trap of blaming adult smokers for their plight. Not only is this cruel, but it’s also unhelpful.
Behind every smoker is a complicated personal journey into smoking. Knowing and respecting that journey — and designing an alternative path forward — is designing a new life. I, myself, have loved ones who still struggle with a 35+ year history with cigarettes. I’m doing this for them.
Adult smokers deserve an alternative to combustible cigarettes.
Like many other designers, I want to make an impact. I want to design based on empathy. I want to design based on data. The design problems that we tackle for adult smokers, through technological innovations, have the potential to be profoundly impactful worldwide, and that’s exciting. As a designer at JUUL Labs, my ultimate intentions when designing our future products are:
● To design an intuitive experience that gives nicotine users insight into their usage;
● To create a pathway to provide users with greater control and visibility into their usage;
● To build on this technology in a way that helps adult smokers and prevents unauthorized use, including underage use.
“If a consumer wants to quit our product, they can,” said James Monsees, co-founder of JUUL Labs in TechCrunch. “We will give them the toolset to do that in the smoothest possible way.”
What resonated with me about this quote, discussing a potential future state of JUUL Labs products, was the clear focus on giving the user control over their experience.
“I’ll probably smoke until I die,” was a phrase I heard in one of our research interviews, said with an air of nonchalance. I realized that this was the voice of someone who felt that they had lost control over their relationship to nicotine.
The crux of our approach has to be the empathy we show our core demographic — the adult smoker. We have to practice what we preach, design products that give our customers greater control and visibility , and empower them with innovative features.
We have to give them a path towards control that works for them.
As part of the design process, we evaluated a lot of existing apps that help you track and measure behavior. Many of those apps require you to do chore-like maintenance; regularly inputting data without helping the individual reach the goals they set forth. This in-turn has an adverse effect on the individual, and can present more opportunities for them to feel like they are failing.
While I don’t know what the perfect solution looks like yet, I certainly know what I don’t want – I don’t want users to feel like this is yet another chore on their to-do list; I don’t want to ask for any information without offering the user something in return; I don’t want to shame users or set them up for failure; and I don’t want them to feel alone in their struggle. I want any experience I design to feel as seamless as our physical product does — no buttons, no maintenance, simple, and unobtrusive.
Digital behavioral change that works with minimal effort.
What does it look like and when will we get there? I don’t know, we have the privilege to “think big” — one of JUUL Labs’ company values.
Our mission to eliminate cigarettes is ambitious, and requires insight into how adult smokers rely on combustible cigarettes in their daily lives. Accessibility is an incredibly important part of the conversation as we, as a company, approach our design challenges, because it dictates whether or not our product is useful to people who need or want to consume nicotine.
I’m excited to come to work everyday because I get to be a part of a myriad of projects that, together, could present a holistic, realistic approach to switching off of cigarettes, managing nicotine use, and preventing youth access to vapor products. Prior to working at JUUL Labs, I worked on consumer-facing health management app that began to pivot into tackling problems like cigarette-smoking. Now that I’m at JUUL Labs, the scale of possibilities for positive impact is so much bigger.
If you’re reading this and still think, “I still just can’t get behind nicotine in any shape or form,” that’s completely understandable. I know this touches a deeply emotional vein for people who have seen their loved ones suffer at the hands of cigarette addiction, or any addiction.
Because, for me, it hasn’t been enough to tell them, “please stop smoking cigarettes.” I want to work on a viable alternative, and designing at JUUL Labs allows me to do exactly that.
P.S. We’re hiring!
JUUL Labs is pleased to announce our purchase of the 123 Mission Street building in San Francisco, which will serve as additional office space to accommodate our rapidly growing team. We have always been a proud San Francisco-based company, and remain committed to serving the community as we focus on helping adult smokers switch from combustible cigarettes — the leading cause of preventable death — and combating underage use.
We applaud Governor Greg Abbott, Senator Joan Huffman and Representative John Zerwas for their successful efforts to raise the purchasing age for all tobacco products, including vapor products, to 21.
We won’t succeed in providing the world’s one billion adult smokers with a true alternative to combustible cigarettes, the number one cause of preventable death in this country, if youth-use continues unabated. Tobacco 21 laws fight one of the largest contributors to this problem – sharing by legal-age peers – and they have been shown to dramatically reduce youth-use rates. That is why we are committed to working with lawmakers to enact these effective policies and hope more jurisdictions follow in Texas’ example.
We’re pleased to support Meharry Medical College’s launch of the Meharry Center for the Study of Social Determinants of Health. Dedicated to examining social factors that influence public health and well being, the Center’s first initiative will be research and community outreach programs related to the emerging prevalence of e-cigarettes, as well as tobacco and other nicotine-delivery products, particularly in minority communities. Meharry Medical College is the nation’s largest private, independent historically black academic health sciences center. You can read more about this initiative here.
As we’ve long said, there are many questions about the health impact of vapor products, and JUUL products in particular, that only a robust body of public health research can start to answer. We are committed to contributing to and supporting independent and peer-reviewed scientific research programs that assess the harm-reduction potential of JUUL products, including their impact on the individual user, their ability to switch adult smokers from combustible cigarettes, and the net-population impact on public health.
As we work to fulfill our mission to help adult smokers switch from combustible cigarettes, JUUL Labs is committed to both conducting and supporting durably designed, painstakingly executed preclinical, clinical, and behavioral research examining the public health impact of our products. We occupy a unique space in this industry as we seek to completely eliminate combustible cigarettes by providing smokers an alternative nicotine delivery system.
We understand that there are many questions about the health impact of vapor products, and JUUL products in particular, and we are committed to contributing to the body of global public health research on these topics. To that end, JUUL Labs has built a robust scientific research program to assess the harm-reduction potential of JUUL products, including their impact on the individual user, their ability to switch adult smokers from combustible cigarettes, and the net-population impact on public health.
Our research portfolio is comprised of three principal fields of work:
Preclinical and toxicological research encompasses ingredient and analyte testing of JUUL e-liquids and product aerosols for a variety of substances, including harmful and potentially harmful constituents (HPHCs) commonly found in combustible cigarettes and other tobacco products. This research also involves testing the impact of JUUL products on cytotoxicity (cell death) and genotoxicity (cell mutation). Our testing is conducted through reputable, independent third-party laboratories and we provide the results of these tests to regulatory bodies as required for market entry.
Our clinical program involves human subjects and examines how people use the product, how much and how often they use it, how biomarkers of exposure and potential harm change over time compared to cigarettes, the environmental impact to others, and the potential physiological impact to the individual. Our clinical trials are reviewed and approved by Institutional Review Boards (IRBs) and follow the highest ethical standards for human clinical research.
Our behavioral research examines what smokers do in the real world when exposed to JUUL products. We seek to answer the following questions: What are their switch and recidivism rates; who are the smokers that are most successfully able to switch and who are not; and what attributes drive switching? We collect this information through IRB-approved research surveys of JUUL users, and we currently have over 70,000 participants enrolled in behavioral studies around the world. We believe this is the largest behavioral research program in the world dedicated to the study of vapor products and we plan to further grow the program with tens of thousands of more participants by year end. Results from our most recent studies are promising and find that approximately half of all smokers demonstrate 30-day abstinence from combustible cigarettes at follow-up assessments after just three months of JUUL use.
One principle unites the three fields of our research program: transparency
We are conducting this research in order to share it with the scientific and public health community and our regulators. We do this by submitting our research to the peer-reviewed publication process, presenting at conferences, and publishing scientific papers. We are committed to asking the right and relevant questions – and we take direction on what to research from FDA’s public and policy statements, including its draft guidance on PMTAs for vapor products, as well as issues identified by leading public health researchers.
While we have built a robust, reliable, and transparent research program, we also know that we cannot answer these questions alone. There are simply too many pressing issues, and we need independent researchers from around the world to contribute to the public understanding of vapor products. In order to promote further study, JUUL Labs has established an Investigator Sponsored Research (ISR) program to fund independent research examining the public health impact of JUUL products. ISR studies are executed independent of JUUL Labs, and researchers retain control over the analysis and public disclosure of their results, including the publication process. We have funded a number of ISR studies to date and are in active discussions with a number of other interested researchers and institutions.
We understand the common distrust of historical tobacco companies around scientific research and how they have misled the public with false claims and cherry-picked data, leading to warranted skepticism of newcomers to the nicotine delivery space. But JUUL Labs is a next generation company dedicated to transparency and information sharing. We embrace nonpartisan science that informs and advances public health.
JUUL Labs is committed to earning the trust of the scientific community by conducting and funding research over the long-term, and continuing to openly share that research through peer-reviewed publications, conference presentations, and regulatory submissions.
JUUL Labs today announced plans to invest more than $125 million in a new assembly facility in Lexington County. This investment is expected to help create more than 500 new jobs to support the assembly operations.
Today, The Washington Post published an editorial from Kevin Burns, chief executive officer of JUUL Labs, discussing our comprehensive initiatives to address youth use of JUUL products, while preserving access to our products for adult smokers looking for a true alternative to combustible cigarettes.
In the piece, Kevin explains that as the vapor category continues to evolve, we want to take the chance to reintroduce ourselves, the work we are doing, and how it is helping adult smokers make the switch. We took the lead in our industry responding to the FDA’s call to action last year, submitting an action plan in November 2018 to address youth access, appeal, and use of JUUL products and overhauling how we run our business, but we all must work together to fight against underage use of vapor products.
Key points from Kevin:
Health and Human Services Secretary Alex M. Azar and Food and Drug Administration Commissioner Scott Gottlieb were right when they argued in The Post on March 21 that vapor products present an opportunity to move adult smokers off combustible cigarettes, the leading cause of preventable death.
They are right that use by minors of vapor products, including Juul products, is a serious problem that threatens the opportunity our industry offers.
They are right also that companies such as ours must step up with meaningful measures to limit access and appeal of vapor products to young people.
And that’s exactly what we’ve done, and we will do more to combat teen use in order to save the harm-reduction opportunity for the 34 million adult smokers in the United States.Kevin Burns, JUUL Labs CEO
We support the FDA’s draft guidance restricting the sale of certain flavored products, including Juul pods, at retail outlets and online. There is no place for kid-appealing flavors in the marketplace. That is why we would also support an outright ban on such flavors, including those that mimic candies or childrens’ foods. We also support the FDA’s swift enforcement against any manufacturer that packages or markets its vapor products in a way intended to promote use by minors.Kevin Burns, JUUL Labs CEO
We’ve led our industry in support of raising the minimum-purchasing age for all tobacco products, including vapor products, to 21. Tobacco 21 laws fight one of the largest contributors to this problem — social sourcing by legal-age peers — and they have been shown to dramatically reduce teen-use rates. We applaud California, Hawaii, Maine, Massachusetts, New Jersey, Oregon and Virginia, which have passed “T21” legislation, and urge the federal government and every state to pass legislation to raise the minimum-purchasing age to 21.Kevin Burns, JUUL Labs CEO
We also need government agencies to take their own actions against counterfeit, knockoff and other illegal vapor products, which are often made with unknown ingredients, with unknown quality standards, and with youth-appealing flavors and packaging. Many of these products are offered for sale online without age-verification or in violation of FDA rules, which prohibit new products from entering the market without FDA approval.
To continue to have success in our mission to eliminate cigarette use among adult smokers, we must work together to fight against teen use of e-cigarettes.Kevin Burns, JUUL Labs CEO
Our mission is simple: to improve the lives of the world’s one billion adult smokers by providing the first true alternative to combustible cigarettes.
JUUL Labs’ cofounders, Adam Bowen and James Monsees, first began developing alternative technology to combusted cigarettes as graduate students together in the product design program at Stanford University. Smokers themselves, they first conceived of the idea for disrupting the worldwide cigarette industry during shared smoke breaks for their masters thesis project. As they continued to go outside for smoke breaks, they wondered why, in an age of incredible technological progress, there had yet to be a product that could offer an alternative to combustible cigarettes.
Even a decade ago, when Adam and James first presented their graduate thesis, they were steadfast in their mission to improve the lives of the world’s one billion smokers. “Adam and I were interested in working on design for social change, and we acknowledged right away that smoking was probably an easy target,” James says in the recording of their thesis presentation from June, 2005.
The clarity of purpose has been a constant for James and Adam — from the inception of their first prototypes to their leadership at JUUL Labs as Chief Product Officer and Chief Technology Officer.
Applying their backgrounds in product design to the challenge of finding a satisfying alternative to smoking, Adam and James labored for years over dozens of product iterations before landing on the design and features of the JUUL device.
Their work eventually evolved into the product JUUL Labs offers today, which has helped adult smokers make the switch off combustible cigarettes. Studies have shown that 40 to 55 percent of adult smokers who purchased and used the JUUL product fully switch from combustible cigarettes within 90 days of use.
Almost four years after the launch of JUUL, the cigarette industry is now facing unprecedented declines in sales volume, with year-over-year losses that have not been seen in the past 5 years of available data. Multiple factors have driven the long-term trend in cigarette declines, but the company believes the largest recent contributor, particularly over the past several months, has been the growth of JUUL products as a true alternative for smokers.
JUUL Labs’ mission is to help improve the lives of the world’s one billion adult smokers by providing them with a true alternative to combustible cigarettes. To accomplish our mission, we must restrict youth usage. That’s why, among many reasons, counterfeit and infringing products pose such a problem.
A key part of our youth prevention plan includes aggressively enforcing our intellectual property rights against counterfeiters and other infringers, operators who flood the market with unauthorized, and unregulated products, about which often little is known. These products tend to feature flavors and marketing that clearly target youth users and are often sold without any, let alone proper, age verification.
In our continued efforts to combat these violations, JUUL Labs filed a complaint in the U.S. District Court for the District of New Jersey against 4 entities, their owners, and other individuals for trademark infringement, cybersquatting, unfair competition, unjust enrichment, and fraudulent misrepresentation, among other charges. The defendants employed a marketing strategy seemingly designed to create a false association with JUUL Labs, while simultaneously targeting a youth demographic.
The named entities are Juul Monster, K & R Products, Status Distribution, and Status Vapes, and their owners are Kristen Vanorski, Ryan Doka, Craig Doka, James Doka, and Jaclyn Quinto. They are alleged to have sold/resold JUUL products, third-party vapor products, and counterfeit JUUL products under the misleading and infringing business and trade names “JUUL MONSTER” and “JUUL MEGA STORE,” and marketed using the cartoonish Juul Monster logo, which is clearly depicted using a JUUL device.
The defendants, who attempted to register their cartoon Juul Monster logo with the U.S. Patent and Trademark Office, appear to irresponsibly target children with their marketing strategy, using JUUL Labs’ own branding. They promote JUUL-compatible brands in kid-appealing flavors like “green apple hard candy,” which are pushed through affiliated social media accounts such as Juul Monster and HotPodz, undermining JUUL Labs’ ongoing youth prevention efforts.
This recent filing is another step to protect public health and JUUL Labs’ brand and innovations. We will continue to take forceful actions and do what we can to stop these counterfeit and infringing products from flooding the markets. We will work with regulators, law enforcement and other key stakeholders to protect public health and combat youth access.
From Kevin Burns, JUUL Labs Chief Executive Officer
We applaud the Commonwealth of Virginia for raising the purchasing age for all tobacco products, including vapor products, to 21 and we hope more lawmakers follow its example at all levels of government across the country.
We cannot fulfill our mission to provide the world’s one billion adult smokers with a true alternative to combustible cigarettes if youth-use continues unabated. Tobacco 21 laws fight one of the largest contributors to this problem – sharing by legal-age peers – and they have been shown to dramatically reduce youth-use rates. That is why we are committed to working with lawmakers to enact these effective policies to prevent youth access of JUUL and other vapor products.