THE FDA’S INVESTIGATION OF JUUL

In 2018, the FDA started investigating JUUL and its marketing practices. Below is a summary of the FDA findings on the e-cigarette maker and the demands the FDA made.

  • April 24, 2018 – The FDA demands JUUL Labs produce documents regarding JUUL’s marketing practices, market research, product design, public health impact, adverse events and complaints related to JUUL.
  • September 12, 2018 – The FDA conducts the largest coordinated enforcement activity in its history, focused on the sale of e-cigarettes to kids. The FDA issues warning letters and fines to more than 1,300 retailers for illegally selling JUUL and other vaping products to minors. FDA Commissioner Scott Gottlieb, M.D., said, “We see clear signs that youth use of electronic cigarettes has reached epidemic proportions.”The FDA’s letter read in part:On XX/XX/XXXX, an inspector representing the FDA completed an inspection of the establishment located at Address, City, State Zip Code. During this inspection, the establishment was in violation because you or your employee sold an e-liquid product to a minor and failed to check identification to verify purchaser’s age for a purchaser under the age of 27. This inspection revealed that the establishment sells, distributes, and/or advertises tobacco products, including e-liquid products, which requires that the establishment and its owners comply with federal laws and regulations governing such practices.The violations observed during the XX/XX/XXXX, inspection include the following:

    1. A minor was able to buy a JUUL e-liquid product on XX/XX/XXXX, at approximately XX:XX AM/PM in the establishment. A retailer must NOT sell covered tobacco products, such as e-liquid products, to a person younger than 18 years of age. Doing so violates 21 C.F.R. § 1140.14(b)(1) (2016).

    2. No one in the establishment checked the minor’s identification before the sale of a JUUL e-liquid product on XX/XX/XXXX, at approximately XX:XX AM/PM.

    You can see more details on the FDA website.

  • September 12, 2018 – The FDA sends a letter to JUUL demanding the company ‘take prompt action to address the rate of youth use of JUUL products.’; Demands ‘detailed plan to address and mitigate widespread use by minors.’; Demands ‘removing flavored products from the market…’The FDA tells JUUL they have 60 days to prove that they can keep their e-cigarette devices from getting into the hands of teens.
  • September 28, 2018 – The FDA conducts a surprise inspection of JUUL Labs and takes more than a thousand documents as it cracks down on the JUUL, vaping and e-cigarette addiction in youth. “The FDA will not tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults having unfettered access to these products [e-cigarettes]” FDA Press Conference October 2, 2018
  • October 25, 2018 – Howard A. Willard III, Chairman of Altria (a traditional cigarette manufacturer who makes Marlboro), writes a letter to FDA Commissioner Scott Gottlieb reassuring the Agency that the Company is ‘alarmed about the reported rise in youth e-vapor use to epidemic levels…’, and makes the following representations:
    • Altria will voluntarily remove its pod-based vaping products, MarkTen Elite and Apex by MarkTen, from the market ‘until…the youth issue is otherwise addressed.’
    • Altria will discontinue the sale of all other flavor variants [besides tobacco, menthol and mint].
    • “We believe pod-based products significantly contribute to the rise in youth use of e-vapor products.”
    • “Underage use of e-vapor products is further compounded by flavors in these products that go beyond traditional tobacco flavors.”
    • “These actions are essential to addressing the youth epidemic…”
  • December 20, 2018 – Just two months after Chairman Willard writes the letter to FDA concerned about the vaping epidemic in youth, Altria invests $12.8 billion in JUUL for a 35% share of JUUL Labs. Despite acknowledging concerns of pod-based vaping products causing an epidemic of youth nicotine addiction, and assurances to the contrary, to the FDA, Altria invests in the exact JUUL device that is causing the epidemic.Altria investment provides JUUL with ‘access to its premier innovative tobacco products retail shelf space…alongside combustible cigarettes.’ When consumers go into stores, now JUUL is prominently displayed next to the Marlboro man.Altria also provides JUUL with ‘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 approximately 230,000 retail locations.’You can see the full details of the JUUL investment on its own website.
  • February 6, 2019 – The FDA sends a letter to JUUL demanding a meeting following Altria’s acquisition of major ownership of JUUL; Notice is given to JUUL that its actions are inconsistent with previous representations made to the FDA concerning addressing the crisis of youth use of JUUL products. FDA Commissioner Scott Gottlieb sends the letter directly to JUUL CEO Kevin Burns.FDA demands meeting with Altria Group CEO, Howard Willard, to explain why the company is expanding its distribution of nicotine to youth, despite the company’s commitments to the FDA, and the public, to the contrary. (2/6/19 FDA Letter from Scott Gottlieb, M.D. to Howard A. Willard, III.)
  • September 9, 2019 – After reviewing Congressional hearing transcripts and reviewing JUUL’s marketing practices, the FDA sends a stern warning letter to JUUL.  The letter outlines several items that the FDA says JUUL did including marketing its products as modified tobacco products without approval from the FDA.   The FDA gives JUUL 15 days to respond.
    • The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:
      • JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
      • JUUL was “totally safe.”
      • A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
      • “FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”

Congress Questions JUUL

In July 2019, the U.S. Congress held hearings questioning JUUL’s owners and stake holders. Below is a summary of the testimony.

U.S. Congress Oversight Committee Investigation/Testimony
July 24-25, 2019

The startling evidence presented during the questioning of JUUL Co-founder and Chief Product Officer, James Monsees, and Chief Administrative Officer Ashley Gould, indicates that:

– JUUL misappropriated Stanford University’s educational materials about youth prevention programs to the point of receiving a cease and desist from the school. JUUL claimed they had no prior knowledge of how Big Tobacco used similar programs despite evidence indicating that they carefully studied the topic.

– JUUL’s logo so closely resembled Marlboro’s logo design in the early days of the company that it resulted in a trademark infringement settlement with Philip Morris USA, whose parent company Altria ironically now owns a 35% stake in JUUL.

– JUUL programs targeted children as young as 8 years old by funding summer camps, paying community and church groups to distribute their material, and targeting veterans’ groups and other vulnerable populations.

– JUUL continues to block and prevent Food and Drug Administration regulations, investing more than $1 million in lawyers and lobbying efforts in the last quarter alone. Meanwhile, JUUL has failed to subject its products to the level of independent, clinical investigation needed to substantiate any claims of effective cessation, nor has the company applied to the FDA to be approved as a product to help smokers quit.

– At the same time as JUUL admits to what they called marketing and education program “mistakes and missteps” in the U.S. they are implementing similar efforts in Canada, the United Kingdom and other parts of the world.

– JUUL executives had trouble remembering many things under oath, including the fact that they had an entire department dedicated to social media influencer marketing clearly aimed at youth customers. James Monsees also seemed to contradict himself repeatedly as to whether or not JUUL is in the smoking cessation business.

Invited Experts testified include:

Dr. Jonathan Winickoff, Mass General Hospital, American Academy of Pediatrics, who stated:

  • Nicotine addiction can occur in only a few days, effecting Executive Function, Memory & Mood
  • e-Cigarette users are 3.5 times more likely to go to combustible tobacco products (regular cigarettes)
  • Doctors lack the tools to stop nicotine addiction
  • Withdrawal symptoms from JUUL can include: Headaches, Insomnia, Irritability and Depression, making it very difficult to quit JUUL

Dr. Robert Jackler, Stanford University, Sewall Professor and Chair, Department of Otolaryngology-Head & Neck Surgery, who stated:

  • 2015 JUUL Vaporize Campaign targeted teens, used celebrity influencers, introduced #JUUL, used models in their 20’s. (The majority of smokers are 30-60 years of age)
  • JUUL organized over 50 JUUL Parties, where 1000’s of JUUL devices where handed out freely

Other information that came out during the testimony:

https://truthinitiative.org/press/press-release/examining-juuls-role-youth-e-cigarette-epidemic

U.S. Senate Launches Investigation into JUUL Lab’s Marketing Tactics

4/8/2019

Senators investigate JUUL’s marketing tactics to children and its motives for partnership with tobacco giant Altria.

U.S. Senators send a letter to CEO Kevin Burns slamming the company for its partnership with Big Tobacco giant Altria, and questioning its marketing tactics to hook children on nicotine with kid-appealing flavors. The Senators posed an extensive series of questions and made requests for documents pertaining to JUUL’s secret business practices around youth marketing, and its

intentions to partner with Altria, and whether the vaping industry titan is in violation of regulations.

Major Points in the Letter Sent to JUUL:

  • “While JUUL has promised to address youth vaping through its modest voluntary efforts, by accepting $12.8 billion from Altria—a tobacco giant with such a disturbing record of deceptive marketing to hook children onto cigarettes—JUUL has lost what little remaining credibility the company had when it claimed to care about the public health.”
  • “While you and your investors may be perfectly content with hooking an entire new generation of children on your tobacco products in order to increase your profit margins, we will not rest until your dangerous products are out of the hands of our nation’s children.”
  • Approximately 2/3 of JUUL users are “new users of nicotine.”
  • “JUUL is more popular than ever with children and your company has decided to team up with Big Tobacco giant Altria—the maker of Marlboro cigarettes, the most popular cigarette among children in the United States—in a partnership that the American Heart Association has called “a match made in tobacco heaven.”
  • “The corporate marriage between two companies that have been the most prolific at marketing highly addictive nicotine products to children is alarming from a public health standpoint and demonstrates, yet again, that JUUL is more interested in padding its profit margins than protecting our nation’s children.”
  • “(O)ur public health agencies have identified JUUL as being largely responsible for fueling the e-cigarette epidemic among youth—and given the immense secrecy shrouding JUUL’s business practices—we request documents and responses to the following questions, in writing, by April 25, 2019.”

HEALTH ORGANIZATIONS GIVE WARNINGS ABOUT JUUL

National Public Health & Medical Organizations come out against JUUL

Below is a list of the numerous medical and pediatric organizations have made public statements about juuling and its effect on teenagers and youth. We’ve summarized their statements for you and also provided links to read the full press releases.

U.S. Surgeon General

2016

Study Released: E-cigarette Use Among Youth and Young Adults: A Report of the Surgeon General

Major Findings:

  • E-cigarette use among youth and young adults has become a public health concern.
  • E-cigarettes are now the most commonly used tobacco product among youth, surpassing conventional cigarettes in 2014. E-cigarette use is strongly associated with the use of other tobacco products among youth and young adults, including combustible tobacco products.
  • The use of products containing nicotine poses dangers to youth, pregnant women, and fetuses. The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe
  • E-cigarette aerosol is not harmless. It can contain harmful and potentially harmful constituents, including nicotine. Nicotine exposure during adolescence can cause addiction and can harm the developing adolescent brain.
  • E-cigarettes are marketed by promoting flavors and using a wide variety of media channels and approaches that have been used in the past for marketing conventional tobacco products to youth and young adults. (“E-cigarette use among youth and young adults : a report of the Surgeon General”, U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2016.

December 18, 2018

U.S. Surgeon General Releases Advisory on E-cigarette Epidemic Among Youth

All JUUL e-cigarettes have a high level of nicotine. A typical JUUL cartridge, or “pod,” contains about as much nicotine as a pack of 20 regular cigarettes. These products also use nicotine salts, which allow particularly high levels of nicotine to be inhaled more easily and with less irritation than the free-base nicotine that has traditionally been used in tobacco products, including e-cigarettes. This is of particular concern for young people, because it could make it easier for them to initiate the use of nicotine through these products and also could make it easier to progress to regular e-cigarette use and nicotine dependence. However, despite these risks, approximately two-thirds of JUUL users aged 15-24 do not know that JUUL always contains nicotine.

You can ready the full advisory on the Surgeon General’s website.

U.S. Centers for Disease Control

9/6/2019  The CDC tells everyone to stop vaping. If you have been vaping and experience any health problems, the CDC tells consumers to seek medical attention.   You can read the full warning on the CDC website.

10/2/2018

CDC Press Release

  • “The popularity of JUUL among kids threatens our progress in reducing youth e-cigarette use,” said Robert Redfield, M.D., director of CDC. “We are alarmed that these new high nicotine content e-cigarettes, marketed and sold in kid-friendly flavors, are so appealing to our nation’s young people.”
  • “There are no redeeming benefits of e-cigarettes for young people,” said Corinne Graffunder, DrPH, director of CDC’s Office on Smoking and Health. “The use of certain USB-shaped e-cigarettes is especially dangerous among youth because these products contain extremely high levels of nicotine, which can harm the developing adolescent brain.”
  • The U.S. Surgeon General has concluded that e-cigarette use among youth and young adults is a public health concern, and that e-cigarette aerosol is not harmless.

American Academy of Pediatrics (AAP)

4/17/18

American Academy of Pediatrics Posts Warning to Parents Regarding the Dangers of JUUL

  • JUUL is highly addictive, the concentration of nicotine is more than twice the amount found in other e-cigarettes. Youth are already more likely to become addicted to nicotine than adults, and the US Surgeon General warns that use of nicotine by youth in any form is unsafe.
  • JUULing raises the risk of becoming a regular cigarette smoker
  • The AAP is particularly concerned about the threats to child and adolescent health posed by JUUL, including heightened risk of nicotine-dependence and other health concerns related to vaping.

5/15/2018

American Academy of Pediatrics Releases Statement Urging FDA to Protect Youths from JUULing and Other Tobacco Products

National Academy of Science

1/23/2018

New Report: One of the Most Comprehensive Studies on Health Effects of E-Cigarettes; Finds That Using E-Cigarettes May Lead Youth to Start Smoking

“There is substantial evidence that e-cigarette use by youth and young adults increases their risk of ever using conventional cigarettes.”

6 Medical & Public Health Organizations Letter to FDA

4/18/2018

The American Academy of Pediatrics, The American Heart Association, The American Lung Association, The Cancer Action Network, The Truth Initiative & Campaign for Tobacco Free Kids

Important Information from the Letter:

  • “[The Organizations] urge you [FDA] to take immediate action to protect the nation’s young people, and the public health, from the dramatic rise in teen usage of JUUL…”
  • “Educators and students report an alarming level of JUUL use in middle and high schools, making this an urgent public health issue.”
  • “JUUL comes in sweet flavors that appeal to youth, including mango, fruit medley, creme brulee, cool mint and cool cucumber,…evidence is clear that flavors play a key role in youth use of tobacco products.”
  • 81.5% of young users cited flavors as the reason for their use of the product.
  • “JUUL appears to deliver nicotine more quickly, more effectively and at higher doses than other e-cigarettes, increasing users’ risk of addiction.”
  • “63% of users aged 15-24 did not know that the product [JUUL] always contains nicotine.”
  • “The alarming increase in youth use of JUUL makes this an urgent public health problem that requires strong and immediate action by the Food and Drug Administration to protect kids.