Attn: Robert M. Califf, M.D. Commissioner of Food and Drugs - Food and Drug Administration
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
RE: JUUL/Altria Litigation and the FDA Marketing Distribution Order of June 23, 2022
Frantz Law Group, APLC represents 780 school districts across 38 states which consist of approximately 50,000 schools and at least 2 million students. Each of these school districts face the same problem: students vaping on campus in epidemic proportion. The youth vaping epidemic significantly interferes with the nationwide administration of education at school districts as well as the districts’ ability to teach students to their fullest potential. The lawsuit against JUUL and Altria 1 seeks, among other remedies, injunctive relief and an abatement remedy to combat the JUUL epidemic. 2 The FDA’s decision of June 23, 2022, to ban JUUL products provided a significant, albeit short lived, reprieve to superintendents, educators, as well as parents of addicted minors, as they all believed they could finally gain control of the havoc created by the JUUL epidemic. School districts have incurred an enormous financial burden (in the billions) for increased staffing and resources to educate and deter students from vaping as well as educating students with respect to the health risks associated with it. As a result of the JUUL/Altria vaping debacle, school districts must incur additional costs for educational resources and staff. For example, some of the costs incurred include: • Installing vape detectors and video surveillance to detect and abate JUUL use on campus. ● Disruption of traditional educational curriculum at school (almost daily). ● Interference with student attendance. (Vaping has led to a rise in student absences due to sickness, absenteeism, and/or suspension which reduces the amount of funding school districts receive. 3 ) ● Diversion of school funding away from traditional teaching curriculum in order to provide added instruction about the abatement of JUUL use. ● Medical care with respect to increased student health resources for observation and medical treatment of students who suffer JUUL vaping side effects while at school. In the current litigation against JUUL/Altria directors, 4 Frantz Law Group alleges that JUUL/Altria directly targeted young students with their mass marketing scheme; this marketing scheme may constitute evidence of a violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”). As alleged in the JUUL/Altria et al. multi-District Litigation complaint, JUUL/Altria directors may be responsible for violating RICO because they jointly conspired to fail to warn the public of all of the potential widespread physical harm caused by JUUL products. In 2019, the FDA issued a warning letter 5 to JUUL/Altria for marketing risky unauthorized modified tobacco products and for labeling them as “totally safe” and that “JUUL was ‘much safer than other cigarettes.’” Tragically, JUUL/Altria have allegedly caused those who were not previously addicted to nicotine to now become addicted. JUUL smoking devices have affected the well-being of more than 2 million U.S. teens who claim to use e-cigarettes 6 and claim to have become addicted to JUUL products due to the unreasonably high concentration of nicotine and other unknown allegedly hazardous chemicals in each vaping pod. 7 It has been reported that youth e-cigarette use rose 1,800% from 2011 to 2019. 8 It is striking that many students, within a very short time period of smoking JUUL, began to suffer significant cognitive impairment, early onset lung disease, and extreme addiction to nicotine. The nicotine addiction of youth has caused, and will continue to cause, potentially significant long-term health consequences in minors as set forth below. JUUL/Altria products allegedly cause an increased risk of negative long-term health conditions as follows 9 : ● Risk of severe pulmonary disease (such as lung disease) and in some instances requiring lung transplants ● Risk of cardiovascular disease and heart attacks ● Risk of strokes ● Risk of severe nicotine addiction ● Risk of nicotine poisoning ● Risk of seizures ● Risk of increased neurological damage and significant cognitive impairment adversely affecting learning and concentration ● Risk of reproductive damage, including infertility Consequentially, Frantz Law Group strongly urges the FDA to uphold and make final its preliminary determination to permanently ban JUUL/Altria products. That decision will assist in eliminating the immeasurable and unconscionable damage to the health of America’s youth who have been exposed to JUUL/Altria products. The JUUL/Altria vaping products are allegedly a “clear and present danger” to the health of the nation’s students and youth, and the JUUL/Altria vaping product causes a significant financial burden to each and every school within all school districts in the United States. We understand that there may be extreme political pressures directed at the FDA by JUUL/Altria et. al., and by their lobbyists to maintain the status quo, i.e., allowing JUUL and similar products to be manufactured, marketed, and distributed throughout the nation. However, school districts across the nation are struggling daily to protect their student populations from the dangers and consequences of JUUL nicotine addiction and the potentially deadly side effects. If you have questions or would like additional information with respect to the JUUL/Altria litigation, please feel free to contact the undersigned.
Sincerely,
Frantz Law Group, APLC James P. Frantz, Esq. William B. Shinoff, Esq.
1 JUUL and Altria are referred to as JUUL/Altria since Altria owns a 35% stake in JUUL. Moreover, in 2019, JUUL named former Phillip Morris CEO, KC Crosthwaite, as JUUL’s new CEO. Altria was formally known as Philip Morris Companies, which is the American parent company of Philip Morris USA, a cigarette manufacturer. 2 From the time that JUUL was introduced in 2015, the school districts have been incurring tremendous financial losses. The purpose of this letter is to attempt to mitigate the financial harm incurred by the school districts as well as the harm they will continue to incur if JUUL/Altria products are not banned in the United States. 3 C HRONICALLY A BSENT S TUDENTS C OST C OUNTY S CHOOLS M ILLIONS https://www.kpbs.org/news/education/2011/06/27/chronically-absent-students-cost-county-schools-mi 4 The violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”) in the complaint is alleged solely against the directors whereas the remaining causes of action are against JUUL, Altria, and the other named defendants. Attached hereto for reference is a copy of the complaint that is filed on behalf of one of the 780 School Districts Frantz Law Group represents. 5 FDA WARNS JUUL L ABS FOR MARKETING UNAUTHORIZED MODIFIED RISK TOBACCO PRODUCTS , INCLUDING IN OUTREACH TO YOUTH https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth 6 N OTES FROM THE F IELD : E-C IGARETTE U SE A MONG M IDDLE AND H IGH S CHOOL S TUDENTS — N ATIONAL Y OUTH T OBACCO S URVEY , U NITED S TATES , 2021 https://www.cdc.gov/mmwr/volumes/70/wr/mm7039a4.htm?s_cid=mm7039a4_w 7 It has been reported that each pod used in JUUL vaping device is the equivalent of one pack of cigarettes worth of nicotine. 8 V APING STATISTICS 2022 https://www.singlecare.com/blog/news/vaping-statistics/ 9 JUUL AND E-C IGARETTE S IDE E FFECTS https://www.drugwatch.com/e-cigarettes/side-effects/; F ERTILITY AND V APING : T HE I MPACT E-C IGARETTES H AVE ON M EN AND W OMEN https://www.onefertilitykitchenerwaterloo.com/fertility-vaping-men- women/#:~:text=Women%20who%20vape%20are%20likely,as%20those%20found%20in%20cigarettes; S ERIOUS & P OTENTIALLY L ONG -T ERM E FFECTS OF V APING https://www.drugwatch.com/e-cigarettes/side-effects/#:~:text=While%20the%20long%2Dterm%20side,of%20heart%20attacks%20and%20strokes; 4 M AJOR H EALTH R ISKS L INKED TO E-C IGARETTE U SE : https://www.webmd.com/connect-to-care/vaping/vaping-ecigarette-health-risks-lung-he
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