|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.
JUUL Labs is committed to improving the lives of the world’s one billion adult smokers by providing a true alternative to combustible cigarettes. We do not want youth using our product. It is antithetical to our mission.
In November 2018, we launched a comprehensive action plan to combat youth usage and said: “for us to successfully fulfill our mission of helping adult smokers, we must be trusted – and we must earn that trust. That starts with action, not words.”
Since then, we have taken aggressive action and have kept every single commitment we made.
Nothing is more important to us than solving the problem of underage use.
What we said we would do in November:
“We launched flavors like Mango, Fruit, Creme, and Cucumber as effective tools to help adult smokers switch from combustible cigarettes, and we do not sell flavors like Gummy Bear or Cotton Candy, which are clearly targeted to kids. However, we are sensitive to the concern articulated by Commissioner Gottlieb that ‘[f]lavors play an important role in driving the youth appeal,’ and understand that products that appeal to adults also may appeal to youth. As of this morning, we stopped accepting retail orders for our Mango, Fruit, Creme, and Cucumber JUUL pods to the over 90,000 retail stores that sell our product, including traditional tobacco retailers (e.g., convenience stores) and specialty vape shops.
“We will only restart accepting orders for Mango, Cucumber, Fruit, and Creme from retail stores that can legally sell flavors and comply with the criteria of our new 21+ Restricted Distribution System.”
What we did:
We stopped the distribution of Mango, Fruit, Creme, and Cucumber to our distributors (100+) and retailers (90,000+). These flavors are currently available only online at JUUL.com with our enhanced online controls that are compliant with our 21+ Restricted Distribution System.
Enhanced Online Controls at JUUL.com
What we said we would do in November:
“We are adding additional age-verification measures to an already industry-leading online sales system that is restricted to people 21+ and utilizes third party verification.”
What we did:
Since we submitted our action plan, we have strengthened our e-commerce platform to further restrict underage and bulk purchases:
- First, we revised our bulk-purchasing limits to restrict users from purchasing excess quantities of product and reselling to others, potentially youth.
- Third, we incorporated facial-recognition technology, requiring a potential purchaser to upload a selfie in addition to his or her government-issued identification if their personal information cannot be verified by publicly-available records.
Improving Retailer Compliance
What we said we would do in November:
“Only JUULpods that mirror what is currently available for combustible cigarettes – tobacco and menthol-based products (Menthol and Mint pods) – will be sold to retail stores, including traditional tobacco retailers (e.g., convenience stores) and specialty vape shops. To secure sales of these products, we are immediately increasing our secret shopper program, from 500 visits per month to roughly 2,000 per month, to verify that our standards are being followed by retailers. We will also impose financial consequences against retailers caught by FDA selling to minors or allowing bulk sales of our products. We will permanently cut off all sales to retail stores with multiple violations.”
What we did:
We have ramped up our secret shopper program as described above and now conduct compliance checks against our bulk-purchasing requirements (2 devices and 5 pod packages per transaction). The program grew from 549 visits in November 2018 to over 2,000 visits in January 2019.
We have also taken additional measures to strengthen retailer compliance. We have followed the FDA’s lead on Civil Monetary Penalties (CMPs) for age-verification non-compliance and initiated an escalating penalty structure. We have revised our reseller policy and notified retailers that we will penalize them for FDA CMP violations. We have also applied financial penalties retroactively to retailers that had received a CMP within the last twelve months as of October 2018, regardless of whether the retailer carried JUUL products at the time of the violation. A total of 731 retailers received notice that we would withhold commercial funding for the next promotional cycle, an estimated financial impact of $525,000 across retailers.
Unauthorized Online Sales
What we said we would do in November:
“In addition to monitoring retail locations, we will continue enforcement efforts against online marketplaces that sell JUUL products in violation of their terms-of-service.”
What we did:
We believe strongly that to prevent our products from making their way into the wrong hands, JUUL.com should be the only e-commerce platform for the sale of JUUL products. That being said, other online resellers remain active, often without any age-verification, so we have undertaken significant actions to address this challenge. First, in November 2018, we identified 116 direct retailers selling JUUL products online in violation of our reseller policy, and we took immediate action. This resulted in pulling over 100 product listings. Continued actions will include penalties up to permanent bans for non-compliance. Second, we provided our 100+ distributors with “no sales lists” and revised their contracts to penalize them for future sales to these entities. Third, with third-party support we are currently deploying data analytics tools, on a monthly cadence, to monitor and identify online resellers of JUUL products, and will take action accordingly.
What we said we would do in November:
“We are addressing the presence of JUUL Labs on social media in two ways – exiting our own social media accounts and continuing to monitor and remove inappropriate material from third-party accounts.”
What we did:
We discontinued our Facebook and Instagram accounts. We continue to maintain a Twitter account, but only for non-promotional communications such as study results, executive hires, potential safety notices, and other corporate announcements. We are continuously working to remove inappropriate third-party social media content in partnership with major social media companies. Third-party users generate more than 99 percent of all social media content related to JUUL.
Technology-Based Solutions and Next Generation Product
What we said we would do in November:
“We are a technology company and will continue to use the latest breakthroughs to bolster user protections on our device. We are developing end-to-end traceability to track where a specific JUUL device or JUULpod was purchased to focus enforcement efforts on bad actors.
“JUUL Labs has also invested tens of millions of dollars and spent over a year working on our next-generation, Bluetooth-enabled device, which will break new ground on access restrictions at the user level.”
What we did:
We have committed to full-system traceability for JUUL products, which will mean the ability to track our products through the distribution chain by using unique product identifiers. This capability is in addition to the tracking mechanism we already have in place to ensure quality and control over our product. Borrowing concepts from the pharmaceutical and other industries, we have started the process to build a robust platform, and we will pilot some of the capabilities in the coming months. Ultimately, we will be able to trace a device confiscated from an underage user back through the distribution chain, potentially identifying the retailer that sold the product, and take appropriate action. Building an end-to-end traceability program is both complex and ambitious, and many teams are working to bring it to fruition as quickly as we can.
Additionally, we are moving full steam ahead with development of our Bluetooth-connected device that will incorporate user-level access restrictions. We will have more to say on this front in the near future.
We have seen the data that we are contributing to a continued, and in some ways, unprecedented level of success with driving smoking rates and consumption of cigarettes downward in the US. 2018 showed an over 5% YoY decline in cigarette consumption – the largest single-year decline since 2009.
However, we won’t be successful in our mission to serve adult smokers if we don’t curb youth usage. We will continue to be a transparent, engaged, and committed partner in this effort with FDA, state Attorneys General, local municipalities, and community organizations.
In November 2018, JUUL Labs announced our action plan to combat underage use. As part of our plan, we stopped shipping our non-tobacco and non- menthol-based flavors (Cucumber, Creme, Mango, and Fruit) to retail stores.
Since the announcement, we have been aggressively examining the landscape through thousands of secret-shopping visits to stores and online-monitoring and are dismayed that other companies are aggressively selling counterfeit JUUL devices and JUUL-compatible nicotine cartridges illegally. These products, which are sold both online and in physical stores, are unlawful, made with unknown and potentially hazardous chemicals, and with unregulated quality standards. These products often target youth with flavors such as Strawberry Milk, Lucky Charm, Bubble Bubble, Sour Gummy, Rainbow Drops, Taffy Burst, Cotton Candy, and Lemonade.
Illegal manufacturers and distributors focus on several types of potentially harmful products: counterfeits, which mimic actual JUUL products; and plug-compatible infringers (see representative samples above), who offer illicit pods, often falsely implying authorization by JUUL Labs.
These products could undermine public health and the efforts of all of us who are trying to keep nicotine delivery systems out of the hands of young people. In response, JUUL Labs has intensified its efforts to combat these illegal products by focusing on:
- Eliminating Counterfeit Goods
- Eliminating Plug Compatible Infringing Products
- Studying the Problem to Create Additional Measures
Eliminating Counterfeit Goods
JUUL Labs recently hired Adrian Punderson (previously at PwC and Apple) along with an industry-leading team with decades of experience to help implement the company’s plan to eliminate counterfeit goods.
Our first step is to try and shut down manufacturers before they can even distribute counterfeit products. We partner with law enforcement agencies around the world to identify producers and then take administrative and criminal action to dismantle their manufacturing facilities and seize their illegal, and potentially harmful, products.
Seizing Product Before it Enters the Marketplace
Customs and Border Protection agencies are critical partners in stopping counterfeit products from entering marketplaces. We work closely with customs agencies at ports around the world — including in China, where approximately 90% of counterfeit products originate — to seize counterfeit products by:
- Conducting training sessions with customs agencies to identify counterfeit JUUL products
- Working closely with investigators to identify smugglers attempting to bring counterfeit products into markets
- Exposing smuggling routes used by counterfeiters and distributors so they can be shut down
Through these initiatives, we have already conducted multiple seizures of counterfeit products.
Removing Products in the Marketplace
We are taking significant actions to remove counterfeit products that make it to the marketplace through online and retail outlets.
We scour physical stores, online retailers, and social media accounts to identify outlets that are either selling or promoting counterfeit products.
Once we find that someone is distributing or selling counterfeit product, we have a robust toolbox of measures that we utilize: sending cease and desist letters, conducting investigations, pursuing litigation, and referring cases to law enforcement. So far, we have deployed each one of these measures.
Eliminating Plug-Compatible Infringing Products
JUUL Labs’ industry-leading intellectual property legal group, led by Wayne Sobon, focuses on eliminating infringing plug-compatible and other illegal knock-off products by pursuing infringers that misuse JUUL Labs’ intellectual property without our permission, or falsely imply association with JUUL Labs to sell unregulated, and potentially harmful, products that often target youth.
First, the IP legal team, working with JUUL Labs’ Brand Protection team, monitors online and retail stores for infringing plug-compatible and other illegal copy-cat products, and then aggressively goes after illegal manufacturers and distributors. We use all means to get bad player to stop these illegal actions, including everything from cease and desist letters to litigation.
JUUL Labs’ IP team has already filed trademark lawsuits in multiple federal district courts and patent infringement actions at the U.S. International Trade Commission (ITC) and federal district courts, against a number of counterfeiters, infringing knock-offs, and purveyors of illegal plug-compatible cartridges. Scores of defendants have already settled with us; and we are seeking swift resolution in a number of the other actions, helping ensure that illegal products leave the marketplace forever.
We are also actively pursuing civil actions across several federal courts against those involved in distribution and sales of such infringing and potentially dangerous products.
For infringers and knock-offs, we are also communicating with government agencies about supporting their investigations and ensuring compliance.
Studying the Problem
Counterfeiters and infringing plug-compatible manufacturers and distributors constantly change their infringement methods. We are aggressively studying their actions and patterns, so we can always be one step ahead.
We have built a global team to investigate what these bad actors do and how they adapt to our enforcement efforts. We are also working on a peer reviewed research study that may illuminate the role that counterfeit and infringing products have on youth usage.
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 taking swift and decisive action against counterfeit and infringing products is one of our key priorities.
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.
Last year, we announced our action plan, laying out our multi-pronged strategy for curbing underage use of our products in the U.S. We have taken many steps to implement this plan, such as currently restricting non-tobacco/non-menthol-based flavored JUUL products to our secure website, JUUL.com, where adults must be 21 or over to purchase.
As of January 2019, we have implemented all of the online age verification enhancements we outlined in our plan to ensure no one under the age of 21 can buy any JUUL products on our website, regardless of flavor, while preventing bulk purchases to all customers.
To make a purchase on our website, a customer must first create an account. When a new user creates an account going forward, or an existing user returns to our website for the first time since rolling out this feature last November, we ask that they input their cell phone number for verification. We then send a code to their phone that must be confirmed with us to move forward and make an account on JUUL.com. Two-factor authentication will further improve identity verification and create additional barriers to prevent someone from using another person’s information.
If we are unable to confirm that the account holder is 21 or over through publicly available records, or if they don’t wish to enter the last four digits of their social security number, they’re asked to upload the front and back of a photo I.D. that is then checked by our system and an age verification expert. A user will also be asked upload a photo of themselves to match against the photo on their I.D. This extra layer of protection, which utilizes automated facial-recognition technology, as well as a review by a human expert, will guard against a user using someone else’s I.D.
Extra Background Checks and Better Checks Against Fake I.D.s
On top of the upgrades we have made to our age verification system that users interact with, we’ve also made improvements that work in the background to ensure that a user is 21 or over, such as using an account-holder’s phone number as an extra public-records check. We’ve also put extra protections in place that provide a more stringent verification process to protect against fake I.D.s., both with our advanced fake I.D. detection algorithm and our human verification experts.
JUUL Labs has always made our online age verification process a top priority. We have an industry-leading online age verification system, and we will continue to observe and improve our system, through security and innovation, to ensure that no underage user obtains our product.
JUUL Labs’ mission is simple – to improve the lives of the world’s one billion adult smokers by providing the first true alternative to combustible cigarettes.
Smoking combustible cigarettes is the number one cause of preventable death. In the U.S., half of cigarette smokers will die from a tobacco-related illness, according to the Centers for Disease Control and Prevention.
So, our success ultimately depends on our ability to get our product in the hands of the adult smokers and out of the hands of youth. When adult smokers try it, it works. And, the impact is life-changing.
The new JUUL Labs adult education campaign features testimonials as a continuation of our efforts to educate adult smokers about switching to the JUUL system. These stories highlight former smokers who made the switch from combustible cigarettes.
These stories, which have already appeared in print, online and on radio, will now be featured on television and include adult smokers describing the impact switching from cigarettes has had on their lives. We want adult smokers to hear directly from former adult smokers that JUUL Labs provides a true alternative to combustible cigarettes and is showing unprecedented success, with studies showing 40 to 56 percent of adult smokers fully switching within 90 days of use.
Each story strictly adheres to our marketing code, which ensures that we carefully target adult smokers and forego paid promotion on social media platforms.
JUUL’s mission is simple – to improve the lives of the world’s one billion adult smokers by providing the first true alternative to combustible cigarettes.
It’s a simple but powerful north star that guides us through the challenges that surround our category and our company. We are driven by the huge opportunity in front of us – finding a solution to the number one source of preventable death in the world – cigarette smoking. Through all of these challenges, we will listen to our critics. We are not perfect. We are constantly learning and getting better at what we do.
We have made huge progress and are showing unprecedented signs of success in our mission:
- Switching data shows that almost 50% of smokers who purchase JUUL switch from combustible cigarettes within 90 days.
- Cigarette decline rates in the US are at record levels with the last 2 months demonstrating decline rates at almost 3x the previous 3-year average. The single most important driver of this decline is JUUL’s growth.
As we have said before, our intent was never to have youth use JUUL products. But intent is not enough, the numbers are what matter, and the numbers tell us underage use of e-cigarette products is a problem. As a result, we recently began implementing a number of actions to prevent underage vaping, including stopping the sales of flavored products to retail stores, enhancing age-verification for our online sales, eliminating social media accounts, and developing further technology solutions.
Today, we have been joined by an unlikely – and seemingly counterintuitive – investor in our journey. Altria today announced a minority investment of $12.8 billion into JUUL for a 35% ownership in the company along with services to accelerate our mission. We understand the controversy and skepticism that comes with an affiliation and partnership with the largest tobacco company in the US. We were skeptical as well. But over the course of the last several months we were convinced by actions, not words, that in fact this partnership could help accelerate our success switching adult smokers. We understand the doubt. We doubted as well. We made it very clear that any investment would need to meet demanding and specific criteria to ensure that they are committed to our mission:
- An investor would have to adopt and support our mission. Today Altria did that with its largest investment and stated, “We are taking significant action to prepare for a future where adult smokers overwhelmingly choose non-combustible products over cigarettes by investing $12.8 billion in JUUL, a world leader in switching adult smokers. We have long said that providing adult smokers with superior, satisfying products with the potential to reduce harm is the best way to achieve tobacco harm reduction. Through JUUL, we are making the biggest investment in our history to achieve that goal. We strongly believe that working with JUUL to accelerate its mission will have long-term benefits for adult smokers and our shareholders.”
- An investor would have to back up its commitment with tangible actions and real value outside of its financial investment. Altria has agreed to provide us services that will accelerate our ability to get JUUL in the hands of adult smokers:
- Altria will provide JUUL access to its premier innovative tobacco products retail shelf space, allowing JUUL’s tobacco and menthol-based products to appear alongside combustible cigarettes. JUUL’s flavored products will continue to only be available at JUUL.com.
- Altria will enable JUUL to reach adult smokers with direct communications through cigarette pack inserts and mailings to adult smokers via Altria companies’ databases.
- Altria will apply its logistics and distribution experience to help JUUL expand its reach and efficiency, and JUUL will have the option to be supported by Altria’s sales organization, which covers more than 230,000 retail locations.
- An investor would have to allow JUUL to remain in control. As part of this investment JUUL remains fully independent and retains full operating control. Altria has stated it will be subject to a standstill agreement that will not allow them to acquire additional shares above its current 35% level.
- An investor would have to provide funds that would benefit our employees and our investors. As part of this investment investors and employees will receive immediate and long-term benefits.
As a result, we are excited about the opportunity presented by Altria, its investment and service agreements. We are fully committed to our mission and our values. We know we need to earn trust and prove that this partnership may provide the opportunity to improve upon our early successes and better equip us to tackle the opportunities and challenges that lie ahead. When you take a step back, our success ultimately depends on our ability to get our product in the hands of adult smokers and out of the hands of youth. When adult smokers try it, it works. And, the impact is life-changing. This investment and service agreements helps us do just that.
From Victoria Davis, JUUL Labs Senior Director of Communications.
“JUUL Labs shares a common goal with the Surgeon General and other federal health regulators – preventing youth from initiating on nicotine. We are committed to preventing youth access of JUUL products. 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. As we said before, our intent was never to have youth use JUUL products. We have taken dramatic action to contribute to solve this problem, which is why we implemented the JUUL Labs Action Plan to address underage use of JUUL products.
“We stopped the distribution of certain flavored JUULpods to retail stores as of November 17, 2018, strengthened the age verification of our industry leading site, eliminated our Facebook and Instagram accounts, and are developing new technology to further limit youth access and use. We are committed to working with the Surgeon General, FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in this effort.”
JUUL Labs, Inc. (“JLI”) announced today that the United States International Trade Commission (“ITC”) has voted to institute an investigation of alleged patent infringement by 21 named Respondents, including Eonsmoke, LLC, Ziip Lab Co., Limited, and XFire, Inc. The ITC’s decision to institute this investigation of the Respondents and their activities is based on JLI’s amended complaint filed October 26, 2018.
JLI’s amended complaint asserts that Respondents violate U.S. trade laws by selling for importation and importing infringing Electronic Nicotine Delivery Systems (ENDS) (or more commonly referred to as “nicotine vaporizers”) and associated components. JLI asserts 68 claims from five U.S Patents – U.S. Patent Nos. 10,070,669; 10,076,139; 10,045,568; 10,058,130; and 10,104,915 – and requests the ITC issue a limited exclusion order prohibiting any of the Respondents from continuing to import their infringing nicotine vaporizers and components into the US. The ITC may issue the requested exclusionary orders against a given Respondent if the Commission determines that a Respondent has violated even one of the multiple patent claims asserted in JLI’s amended complaint.
“We are pleased with the ITC’s decision to institute the investigation into the alleged infringements,” said Gerald Masoudi, Chief Legal Officer at JUUL Labs based in Washington, D.C. “We will continue to defend our intellectual property to protect our business providing an alternative to adult smokers who want to switch from combustible cigarettes.”
The assigned ITC administrative law judge will soon set a target date for completing the investigation, but generally such investigations conclude 12-14 months from institution.
About JUUL Labs, Inc.
JUUL Labs is a technology company dedicated to eliminating cigarettes by offering existing adult smokers a true alternative to combustible cigarettes. The company’s research shows that more than one million smokers have already switched to JUUL, and we are working to enable millions more to switch in the coming years through technological innovations.
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