ELIJAH E. CUMMINGS. MARYLAND ONE HUNDRED SIXTEENTH CONGRESS JIM JORDAN, 0qu CHAIRMAN RANKINGMINOHITY MEMBER Congress at the (?atten ?tatts Jenner at Represent-stints COMMITTEE ON OVERSIGHT AND REFORM 2157 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515?6143 Mmomrv [202}225?5051 MINORITY [203225?5074 http:I?toversighthousegov September 25, 2019 Mr. Richard Hill Chief Executive Of?cer Fontem Ventures 1100 South Tryon Street, Suite 350 Charlotte, NC 28203 Dear Mr. Hill: Today, e?cigarette market leader JUUL Labs announced its decision to cease all of its print, broadcast, and digital advertisements of e-cigarettes in the United States, effective immediately.1 In the interest of safeguarding the health and well-being of one of our nation?s most precious resources?our youth?I am writing today to respectfully, but strongly, request your company to do the same. The US. Surgeon General, the Secretary of the Department of Health and Human Services (HHS), the Director of the Centers for Disease Control and Prevention (CDC), and the former Commissioner of the Food and Drug Administration (FDA) have all declared that e? cigarette use among teenagers is an epidemic.2 From 2017 to 2018, youth e-cigarette and vaping use increased by 78% among high school students.3 The most recent figures from National Youth Tobacco Survey (NYTS) 1 JUUL Chief Executive O?icer Steps Down Amid Public Outrage Over Vaping, The Hill (Sept. 25, 2019) (online at 2 Food and Drug Administration, Statement from Food and DrugAdministration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Department of Health and Human Services, Surgeon General Releases Advisory on E-cigarette Epidemic Among Youth (Dec. 18, 2018) (online at 12/ 1 8/surgeon- Centers for Disease Control and Prevention, Sales of JUUL E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 20117-2028 (Feb. 11,2019) (online at The Future of E-cigarettes Depends on the Industry?s Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at 3 Food and Drug Administration, Statement from the Food and DrugAdministration 0mmissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E-cigarette Use (Sept. 12, 2018) (online at Mr. Richard Hill Page 2 show another signi?cantjump in youth use, with 27.5% of high school students reporting e- cigarette use. That is a 32% increase in the past year, and a 135% increase over two years.4 As Chair of the Subcommittee on Economic and Consumer Policy, I have led an aggressive investigation into the youth e-cigarette epidemic. The Subcommittee held two days of hearings on July 24 and July 25, during which we uncovered signi?cant evidence that marketing and advertising practices were violating the law. On September 5, 2019, the Subcommittee sent a letter notifying Acting FDA Commissioner Ned Sharpless that testimony from the Subcommittee?s hearings revealed that JUUL was violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes.5 Claims that a product helps users quit smoking are ?therapeutic claims? subject to FDA jurisdiction under the drug/device provisions of the Food, Drug, and Cosmetic Act Act). Such drugs or devices must be approved by FDA. If they are not, they are unapproved drugs or devices being marketed illegally under the Act.6 Therapeutic claims need not be express for a product to be subject to drug and device jurisdiction. FDA must look past the overt claims and determine the product?s intended use, which it may do by considering ?labeling claims, advertising matter, or oral or written Statements? by the company and its representatives. In determining intended use, FDA also must Department of Health and Human Services, Surgeon General Releases Advisory on E-ctgarette Epidemic Among Youth (Dec. 18, 2018) (online at Centers for Disease Control and Prevention, Sales of JU UL E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 2017-2018 (Feb. 1 l, 2019) (online at The Future of E-cigarettes Depends on the Industry ?s Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at 4 Food and Drug Administration, Trump Administration Combating Epidemic of Youth E?Cigarette Use with Plan to Clear Market of Unauthorized, Non?Tobacco-Flavored E-Cigarette Products (Sept. 1 I, 2019) (online at '5 Letter from Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, to Ned Sharpless, Acting Commissioner, Food and Drug Administration (Aug. 30, 2019) (online at 6 21 U.S.C. 321(g); Sottera Inc. v. Food and DrugAdministration, 627 F. 3d 891 (US. App. DC 2010); Clari?cation of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding ?Intended Uses,? 82 Fed. Reg. 2193 (Jan. 9, 2017) product will be regulated as a drug, device or combination product if: The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction smoking cessation), relapse prevention, or relief of nicotine withdrawal (emphasis added) and (?statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose?). Mr. Richard Hill Page 3 consider the company?s knowledge of how the product is being ?offered and used for a purpose for which it is neither labeled nor advertised.?7 Manufacturers of tobacco products may not claim that their products are healthier or safer than cigarettes (?modi?ed risk claims?) unless they have a marketing order from FDA. JUUL did not have a marketing order from FDA that would have allowed it to make these ?modi?ed risk claims.? Making modi?ed risk claims without a marketing order violates Section 911 of the Act, as amended by the Family Smoking Prevention and Tobacco Control Act.8 Currently, no e-cigarette or vaping company, including yours, has been approved for cessation or modi?ed risk claims.9 On September 9, 2019, four days after I sent my letter urging FDA to investigate illegal advertising, the agency issued a warning letter to JUUL declaring that it illegally marketed its product as safer than cigarettes.10 FDA directly cited testimony from our Subcommittee in its letter.ll In addition, CDC has identi?ed 530 cases of lung illness associated with the use of e- cigarette products in 38 states and one US. territory. The outbreak has resulted in at least nine deaths, and these ?gures may grow as state health departments conduct retro-analyses of state health records to ascertain the breadth of adverse health events. 12 On September 24, 2019, during testimony before the Subcommittee, Principal Deputy Director, Dr. Anne Schuchat, reported that the process of vaping itself may be risky and that not enough is known about the aerosol that vaping produces or its potential to negatively 7 82 Fed. Reg. at 2201. 3 Food and Drug Administration, Section 91] ofthe Federal Food, Drug, and Cosmetic Act-Modified Risk Tobacco Products (Jan. 7, 2018) (online at 91 (?No person may introduce or deliver for introduction into interstate commerce any modi?ed risk tobacco product unless an order issued pursuant to subsection is effective with respect to such product?) and (de?ning ?modi?ed risk tobacco product? as ?any tobacco product that is sold or distributed for use to reduce harm of the risk of tobacco?related disease associated with commercially marketed tobacco products?). 9 Does the Food and Drug Administration Even Regulate E-Cigs? Actually Kinda Not, Wired (Sept. 18, 2019) (online at '0 Food and Drug Administration, Warning Letter: JUUL LABS, Inc. (Sept. 9, 2019) (online at 590950-09092019). Committee on Oversight and Reform, Oversight Subcommittee Investigation Prompts the Food and Drug Administration to Issue Warning Letter to UL (Sept. 9, 2019) (online at ?2 Centers for Disease Control and Prevention, Outbreak ofLung Disease Associated with E?Cigarette Use, or Vaping (Sept. 19, 2019) (online at diseasehtml). Mr. Richard Hill Page 4 affect the lungs. She also expressed concern that the recent outbreak of lung injuries may cause permanent harm. ?3 Due to the e-cigarette and vaping-related lung illness outbreak, CDC has warned the American people to ?consider refraining from using e-cigarette or vaping products,? as CDC is unable to rule out any brand, ?avor, or component chemical as a cause of lung illness. Dr. Schuchat also refused to rule out the process of vaping itself as a contributing factor to the outbreak. 1?4 Other severe health effects have been linked to e-cigarette use as well. For example, as of August 7, 2019, FDA had received 127 reports of seizures and other neurological conditions caused by e?cigarette use.15 Seizures and convulsions are of nicotine toxicity.16 The American people should not serve as guinea pigs for the e-cigarette and vaping industry or be subject to their misleading marketing and advertising. I ask that you please notify me whether you will halt all television, radio, print, and digital advertising for your e- cigarette products. Thank you for your attention to this critical issue. I look forward to your response. Sincerely, Raja Krishnamoorthi Chairman Subcommittee on Economic and Consumer Policy cc: The Honorable Michael Cloud, Ranking Member ?3 Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, Testimony of Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention, Hearing on Don?t Vape: Examining the Outbreak of Lung Disease and the Centers for Disease Control and Prevention ?5 Urgent Warning Not to Use E?Cigarettes (Sept. 24, 2019) (online at ?4 Centers for Disease Control and Prevention, Outbreak of Lung Illness Associated with Using E-Cigarette Products, Investigation Notice (Sept. 1 1, 2019) (online at formation). '5 Food and Drug Administration, In Brief: The Food and Drug Administration Encourages Continued Submission of Reports Reiatea? to Seizures Following E?cigarette Use as Part of A gency ?s Ongoing Scientific Investigation ofPotentiai Safety Issue (Aug. 7, 2019) (online at ?6 Illinois Department of Public Health, E?cigarettes and Vapes (Sept. 12, 2019) (online at E. CUMMINGS. MARYLAND ONE HUNDRED SIXTEENTH CONGRESS JIM JORDAN, OI-IIO CHAIRMAN RANKING MINORITY MEMBER Quantum of the written ?tatta mouse at ?rpre?entatines COMMITTEE ON OVERSIGHT AND REFORM 2157 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515?6143 I [202] 225?5051 MINORITY September 25, 2019 Mr. Eddy Pirard President and Chief Executive Of?cer Japan Tobacco International, USA, Inc. Glenpointe Centre West 500 Frank W. Burr Boulevard, #24 Teaneck, NJ 07666 Dear Mr. Pirard: Today, e-cigarette market leader UUL Labs announced its decision to cease all of its print, broadcast, and digital advertisements of e-cigarettes in the United States, effective immediately.1 In the interest of safeguarding the health and well-being of one of our nation?s most precious resources?our youthwv?I am writing today to respectfully, but strongly, request your company to do the same. The US. Surgeon General, the Secretary of the Department of Health and Human Services (HHS), the Director of the Centers for Disease Control and Prevention (CDC), and the former Commissioner of the Food and Drug Administration (FDA) have all declared that e- cigarette use among teenagers is an epidemic.2 1 JUUL Chief Executive O?icer Steps Down Amid Public Outrage Over Vaping, The Hill (Sept. 25, 2019) (online at 2 Food and Drug Administration, Statement from Food and DrugAdministration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2013) (online at Department of Health and Human Services, Surgeon General Releases Advisory on E-cigarette Epidemic Among Youth (Dec. 18, 2018) (online at Centers for Disease Control and Prevention, Sales of JUUL E?cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 2017-2018 (Feb. 1 1, 2019) (online at The Future of E?cigarettes Depends on the Industry ?5 Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at Mr. Eddy Pirard Page 2 From 2017 to 2018, youth e-cigarette and vaping use increased by 78% among high school students.3 The most recent ?gures from National Youth Tobacco Survey (NYTS) show another signi?cant jump in youth use, with 27.5% of high school students reporting e? cigarette use. That is a 32% increase in the past year, and a 135% increase over two years.4 As Chair of the Subcommittee on Economic and Consumer Policy, I have led an aggressive investigation into the youth evcigarette epidemic. The Subcommittee held two days of hearings on July 24 and July 25, during which we uncovered signi?cant evidence that marketing and advertising practices were violating the law. On September 5, 2019, the Subcommittee sent a letter notifying Acting FDA Commissioner Ned Sharpless that testimony from the Subcommittee?s hearings revealed that UUL was violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes.5 Claims that a product helps users quit smoking are ?therapeutic claims? subject to FDA jurisdiction under the drug/device provisions of the Food, Drug, and Cosmetic Act Act). Such drugs or devices must be approved by FDA. If they are not, they are unapproved drugs or devices being marketed illegally under the Act.6 3 Food and Drug Administration, Statement from the Food and Drug Administration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Department of Health and Human Services, Surgeon General Releases Advisory on E-cigarette Epidemic Among Youth (Dec. 18, 2018) (online at Centers for Disease Control and Prevention, Sales of UUL E?cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 2017-2018 (Feb. 11, 2019) (online at The Future of E-cigareites Depends on the Industry?s Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at 4 Food and Drug Administration, Trump Administration Combating Epidemic of Youth E?Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products (Sept. 1 1, 2019) (online at 5 Letter from Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, to Ned Sharpless, Acting Commissioner, Food and Drug Administration (Aug. 30, 2019) (online at 6 21 U.S.C. 321(g); Sottera Inc. v. Food and Drug Administration, 627 F. 3d 891 (US. App. DC 2010); Clari?cation of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding ?Intended Uses,? 82 Fed. Reg. 2193 (Jan. 9, 2017) product will be regulated as a drug, device or combination product if: The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction smoking cessation), relapse prevention, or relief of nicotine withdrawal (emphasis added) and (?statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose?). Therapeutic claims need not be express for a product to be subject to drug and device jurisdiction. FDA must look past the overt claims and determine the product?s intended use, which it may do by considering ?labeling claims, advertising matter, or oral or written statements? by the company and its representatives. In determining intended use, FDA also must consider the company?s knowledge of how the product is being ?offered and used for a purpose for which it is neither labeled'nor advertised?l Manufacturers of tobacco products may not claim that their products are healthier or safer than cigarettes (?modi?ed risk claims?) unless they have a marketing order from FDA. UUL did not have a marketing order from FDA that would have allowed it to make these ?modi?ed risk claims.? Making modi?ed risk claims without a marketing order violates Section 911 of the Act, as amended by the Family Smoking Prevention and Tobacco Control Act.8 Currently, no e-cigarette or vaping company, including yours, has been approved for cessation or modi?ed risk claims.9 On September 9, 2019, four days after I sent my letter urging FDA to investigate illegal advertising, the agency issued a warning letter to UUL declaring that it illegally marketed its product as safer than cigarettes.10 FDA directly cited testimony from our Subcommittee in its letter.11 In addition, CDC has identi?ed 530 cases of lung illness associated with the use of e- cigarette products in 38 states and one US. territory. The outbreak has resulted in at least nine deaths, and these ?gures may grow as state health departments conduct retro-analyses of state health records to ascertain the breadth of adverse health events.12 7 82 Fed. Reg. at 2201. 3 Food and Drug Administration, Section 91? 1 of the Federal Food, Drug, and Cosmetic Act-Modi?ed Risk Tobacco Products (Jan. 7, 2018) (online at 91 (?No person may introduce or deliver for introduction into interstate commerce any modi?ed risk tobacco product unless an order issued pursuant to subsection is effective with respect to such product") and (de?ning ?modi?ed risk tobacco product? as ?any tobacco product that is sold or distributed for use to reduce harm of the risk of tobacco-related disease associated with commercially marketed tobacco products?). 9 Does the Food and Drug Administration Even Regulate E?Cigs? Actually Kinda Not, Wired (Sept. 18, 2019) (online at ?0 Food and Drug Administration, Warning Letter." JUUL LABS, inc. (Sept. 9, 2019) (online at 590950-09092019). Committee on Oversight and Reform, Oversight Subcommittee Investigation Prompts the Food and Drug Administration to issue Warning Letter to JUUL (Sept. 9, 2019) (online at '2 Centers for Disease Control and Prevention, Outbreak of Lung Disease Associated with E-Cigarette Use, or Vaping (Sept. 19, 2019) (online at diseasehtml). Mr. Eddy Pirard Page4 On September 24, 2019, during testimony before the Subcommittee, CDC's Principal Deputy Director, Dr. Anne Schuchat, reported that the process of vaping itself may be risky and that not enough is known about the aerosol that vaping produces or its potential to negatively affect the lungs. She also expressed concern that the recent outbreak of lung injuries may cause permanent harm. 13 Due to the e-cigarette and vaping-related lung illness outbreak, CDC has warned the American people to "consider refraining from using e-cigarette or vaping products," as CDC is unable to rule out any brand, flavor, or component chemical as a cause of lung illness. Dr. Schuchat also refused to rule out the process of vaping itself as a contributing factor to the outbreak. 14 Other severe health effects have been linked to e-cigarette use as well. For example, as of August7, 2019, FDA had received 127 reports of seizures and other neurological conditions caused by e-cigarette use. 15 Seizures and convulsions are symptoms of nicotine toxicity. 16 The American people should not serve as guinea pigs for the e-cigarette and vaping industry or be subject to their misleading marketing and advertising. I ask that you please notify me whether you will halt all television, radio, print, and digital advertising for your e­ cigarette products. Thank you for your attention to this critical issue. I look forward to your response. Sincerely, Raja Krishnamoorthi Chairman Subcommittee on Economic and Consumer Policy Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, Testimony of Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention, Hearing on Don't Vape: Examining the Outbreak of Lung Disease and the Centers for Disease Control and Prevention's Urgent Warning Not to Use £-Cigarettes (Sept. 24, 2019) (online at https://oversight.house.gov/legislation/hearings/don-t-vape­ examining-the-outbreak-of-lung-disease-and-cdc-s-urgent-warning-not). 13 Centers for Disease Control and Prevention, Outbreak of Lung Illness Associated with Using £-Cigarette Products, Investigation Notice (Sept. 11, 2019) (online at www.cdc.gov/tobacco/basic_information/e­ cigarettes/severe-lung-disease.html#latest-outbreak-information). 14 Food and Drug Administration, In Brief The Food and Drug Administration Encourages Continued Submission of Reports Related to Seizures Following £-cigarette Use as Part of Agency's Ongoing Scientific Investigation of Potential Safety Issue (Aug. 7, 2019) (online at www.fda.gov/news-events/fda-brief/fda-brief-fda­ encourages-continued-submission-reports-re lated-seizures-following-e-cigarette-use). 15 Illinois Department of Public Health, £-cigarettes and Vapes (Sept. 12, 2019) (online at http://dph.illinois.gov/topics-services/prevention-wellness/tobacco/e-cigarettes-and-vapes). 16 The Honorable Michael Cloud, Ranking Member ELIJAH E. CUMMINGS. MARYLAND ONE HUNDRED SIXTEENTH CONGRESS .JIM JORDAN, omo CHAIRMAN RANKING MINORITY MEMBER at the ?lim?trh ?tatts 31mm of Representatives COMMITTEE ON OVERSIGHT AND REFORM 2157 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515?6143 MAJUHITY (202)225?5051 (202) 225?50174 September 25, 2019 Mr. Ricardo Oberlander President and Chief Executive Of?cer Reynolds American Inc. 401 North Main Street Winston Salem, NC 27101 Dear Mr. Oberlander: Today, e-cigarette market leader JUUL Labs announced its decision to cease all of its print, broadcast, and digital advertisements of e-cigarettes in the United States, effective immediately.1 In the interest of safeguarding the health and well-being of one of our nation?s most precious resources?our youth?I am writing today to respectfully, but strongly, request your company to do the same. The US. Surgeon General, the Secretary of the Department of Health and Human Services (HHS), the Director of the Centers for Disease Control and Prevention (CDC), and the former Commissioner of the Food and Drug Administration (FDA) have all declared that e- cigarette use among teenagers is an epidemic.2 From 2017 to 2018, youth e-cigarette and vaping use increased by 78% among high school students.3 The most recent ?gures from National Youth Tobacco Survey (N YTS) JUUL Chief Executive O?icer Steps Down Amid Public Outrage Over Vaping, The Hill (Sept. 25, 2019) (online at 2 Food and Drug Administration, Statement ?om Food and Drug Administration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Department of Health and Human Services, Surgeon General Releases Advisory on E?cigarette Epidemic Among Youth (Dec. 18, 2018) (online at Centers for Disease Control and Prevention, Sales of JUUL E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 20 8) (online at Centers for Disease Control and Prevention, Progress Erased. Youth Tobacco Use Increased During 2017-2018 (Feb. 1 1,2019) (online at cdc. gov/media/releases/2019/p02l l-youth- -tobacco- -use- increased. html); The Future of cigarettes Depends on the Industry? Willingness to Protect Teens, Washington Post (Mar. 20,2019) (online at washingtonpost. cigarettes- depends- willingness?protect- 3 Food and Drug Administration, Statement from the Food and Drug Administration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Mr. Ricardo Oberlander Page 2 show another signi?cant jump in youth use, with 27.5% of high school students reporting e- cigarette use. That is a 32% increase in the past year, and a 135% increase over two years.4 As Chair of the Subcommittee on Economic and Consumer Policy, I have led an aggressive investigation into the youth e-cigarette epidemic. The Subcommittee held two days of hearings on July 24 and July 25, during which we uncovered signi?cant evidence that marketing and advertising practices were violating the law. On September 5, 2019, the Subcommittee sent a letter notifying Acting FDA Commissioner Ned Sharpless that testimony from the Subcommittee?s hearings revealed that JUUL was violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes.5 Claims that a product helps users quit smoking are ?therapeutic claims? subject to FDA jurisdiction under the drug/device provisions of the Food, Drug, and Cosmetic Act Act). Such drugs or devices must be approved by FDA. If they are not, they are unapproved drugs or devices being marketed illegally under the Act.6 Therapeutic claims need not be express for a product to be subject to drug and device jurisdiction. FDA must look past the overt claims and determine the product?s intended use, which it may do by considering ?labeling claims, advertising matter, or oral or written Department of Health and Human Services, Surgeon General Releases Advisory on E?cigarette Epidemic Among Youth (Dec. 18, 2018) (online at 12/ 1 8/Surgeon- Centers for Disease Control and Prevention, Sales E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 2017-2018 (Feb. 1 l, 2019) (online at The Future of E?cigarettes Depends on the Industry ?s Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at 4 Food and Drug Administration, Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products (Sept. 1 1, 2019) (online at 5 Letter from Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, to Ned Sharpless, Acting Commissioner, Food and Drug Administration (Aug. 30, 2019) (online at 6 21 U.S.C. 321(g); Sottera Inc. v. Food and DrugAdministration, 627 F. 3d 891 (US. App. DC 2010); Clari?cation of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding ?Intended Uses,? 82 Fed. Reg. 2193 (Jan. 9, 2017) product will be regulated as a drug, device or combination product if: The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction smoking cessation), relapse prevention, or relief of nicotine withdrawal (emphasis added) and (?statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose?). Mr. Ricardo Oberlander Page 3 statements? by the company and its representatives. In determining intended use, FDA also must consider the company?s knowledge of how the product is being ?offered and used for a purpose for which it is neither labeled nor advertised?? Manufacturers of tobacco products may not claim that their products are healthier or safer than cigarettes (?modi?ed risk claims?) unless they have a marketing order from FDA. UUL did not have a marketing order from FDA that would have allowed it to make these ?modi?ed risk claims.? Making modi?ed risk claims without a marketing order violates Section 911 of the Act, as amended by the Family Smoking Prevention and Tobacco Control Act.8 Currently, no e-cigarette or vaping company, including yours, has been approved for cessation or modi?ed risk claims.9 On September 9, 2019, four days after I sent my letter urging FDA to investigate illegal advertising, the agency issued a warning letter to JUUL declaring that it illegally marketed its product as safer than cigarettes. '0 FDA directly cited testimony from our Subcommittee in its letter.11 In addition, CDC has identi?ed 530 cases of lung illness associated with the use of e- cigarette products in 38 states and one US. territory. The outbreak has resulted in at least nine deaths, and these ?gures may grow as state health departments conduct retro-analyses of state health records to ascertain the breadth of adverse health events. 12 On September 24, 2019, during testimony before the Subcommittee, Principal Deputy Director, Dr. Anne Schuchat, reported that the process of vaping itself may be risky and that not enough is known about the aerosol that vaping produces or its potential to negatively 7 82 Fed. Reg. at 2201. 8 Food and Drug Administration, Section 9] of the Federal ood, Drug, and Cosmetic Act-Modi?ed Risk Tobacco Products (Jan. 7, 2018) (online at (?No person may introduce or deliver for introduction into interstate commerce any modi?ed risk tobacco product unless an order issued pursuant to subsection is effective with respect to such product?) and (de?ning ?modi?ed risk tobacco product? as ?any tobacco product that is sold or distributed for use to reduce harm of the risk of tobacco-related disease associated with commercially marketed tobacco products?). 9 Does the Food and Drug Administration Evert Regulate E-Cigs? Actually inda Not, Wired (Sept. 18, 2019) (online at '0 Food and Drug Administration, Warning Letter: JUUL LABS, Inc. (Sept. 9, 2019) (online at 5 9095 0-09092019). Committee on Oversight and Reform, Oversight Subcommittee Investigation Prompts the Food and Drug Administration to Issue Warning Letter to JUUL (Sept. 9, 2019) (online at '2 Centers for Disease Control and Prevention, Outbreak othmg Disease Associated with E-Cigarette Use, or Vaping (Sept. 19, 2019) (online at diseasehtml). Mr. Ricardo Oberlander Page 4 affect the lungs. She also expressed concern that the recent outbreak of lung injuries may cause permanent harm. ?3 Due to the e-cigarette and vaping?related lung illness outbreak, CDC has warned the American people to ?consider refraining from using e-cigarette or vaping products,? as CDC is unable to rule out any brand, flavor, or component chemical as a cause of lung illness. Dr. Schuchat also refused to rule out the process of vaping itself as a contributing factor to the outbreak.?4 Other severe health effects have been linked to e?cigarette use as well. For example, as of August 7, 2019, FDA had received 127 reports of seizures and other neurological conditions caused by e-cigarette use.l5 Seizures and convulsions are of nicotine toxicity. 16 The American people should not serve as guinea pigs for the e-cigarette and vaping industry or be subject to their misleading marketing and advertising. I ask that you please notify me whether you will halt all television, radio, print, and digital advertising for your e- cigarette products. Thank you for your attention to this critical issue. I look forward to your response. Sincerely, Raja Krishnamoorthi Chairman Subcommittee on Economic and Consumer Policy cc: The Honorable Michael Cloud, Ranking Member 1-3 Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, Testimony of Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention, Hearing on Don?t Vape: Examining the Outbreak of Lung Disease and the Centers for Disease Control and Prevention ?s Urgent Warning Not to Use E-Cigarettes (Sept. 24, 2019) (online at ?4 Centers for Disease Control and Prevention, Outbreak of Lung Illness Associated with Using E?Ctgarette Products, Investigation Notice (Sept. 11, 2019) (online at 15 Food and Drug Administration, In Brief' The Food and Drug Administration Encourages Continued Submission of Reports Related to Seizures Following E-cigarette Use as Part of Agency ?s Ongoing Investigation of Potential Safety Issue (Aug. 7, 2019) (online at 16 Illinois Department ofPublic Health, E-cigarettes and Vapes (Sept. 12, 2019) (online at FI LIAH E. CUMMINGS, MARYLAND ONE HUNDRED SIXTEENTH CONGRESS JIM JORDAN, OHIO CHAIRMAN RANKING MINORITY MEMBER (tongues at the @Hm?teh ?tates 1501152 of Representatives COMMITTEE ON OVERSIGHT AND REFORM 2157 RAYBURN HOUSE OFFICE BUILDING WASHINGTON, DC 20515?6143 MAJORITY MINCHIIY {202]225?50td .housegov September 25, 2019 Mr. Ryan Nivakoff Chief Executive Of?cer NJ OY, LLC 15211 North Kierland Boulevard, Suite 200 Scottsdale, AZ 85254 Dear Mr. Nivakoff: Today, e-cigarette market leader JUUL Labs announced its decision to cease all of its print, broadcast, and digital advertisements of e-cigarettes in the United States, effective immediately.1 In the interest of safeguarding the health and well-being of one of our nation?s most precious resources?our youth?I am writing today to respectfully, but strongly, request your company to do the same. The US. Surgeon General, the Secretary of the Department of Health and Human Services (HHS), the Director of the Centers for Disease Control and Prevention (CDC), and the former Commissioner of the Food and Drug Administration (FDA) have all declared that e? cigarette use among teenagers is an epidemic.2 From 2017 to 2018, youth e-cigarette and vaping use increased by 78% among high school students.3 The most recent ?gures from National Youth Tobacco Survey (NYTS) 1 JUUL Chief Executive Of?cer Steps Down Amid Public Outrage Over Vaping, The Hill (Sept. 25, 2019) (online at 2 Food and Drug Administration, Statement from Food and Drug Administration Commissioner Scott Gottiieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Department of Health and Human Services, Surgeon General Releases Advisory on E?cigarette Epidemic Among Youth (Dec. 18, 2018) (online at Centers for Disease Control and Prevention, Sales E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 20] 7-2018 (Feb. 1 l, 2019) (online at The Future of E?cigarettes Depends on the Industry ?s Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at 3 Food and Drug Administration, Statement from the Food and Drug Administration Commissioner Scott Gottlieb, MD, on New Steps to Address Epidemic of Youth E?cigarette Use (Sept. 12, 2018) (online at Mr. Ryan Nivakoff Page 2 show another signi?cant jump in youth use, with 27.5% of high school students reporting e- cigarette use. That is a 32% increase in the past year, and a 135% increase over two years.4 As Chair of the Subcommittee on Economic and Consumer Policy, I have led an aggressive investigation into the youth e-cigarette epidemic. The Subcommittee held two days, of hearings on July 24 and July 25, during which we uncovered signi?cant evidence that marketing and advertising practices were violating the law. On September 5, 2019, the Subcommittee sent a letter notifying Acting FDA Commissioner Ned Sharpless that testimony from the Subcommittee?s hearings revealed that JUUL was violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes.5 Claims that a product helps users quit smoking are ?therapeutic claims? subject to FDA jurisdiction under the drug/device provisions of the Food, Drug, and Cosmetic Act Act). Such drugs or devices must be approved by FDA. If they are not, they are unapproved drugs or devices being marketed illegally under the Act.6 Therapeutic claims need not be express for a product to be subject to drug and device jurisdiction. FDA must look past the overt claims and determine the product?s intended use, which it may do by considering ?labeling claims, advertising matter, or oral or written statements? by the company and its representatives. In determining intended use, FDA also must Department of Health and Human Services, Surgeon General Releases Advisory on E?cigarette Epidemic Among Youth (Dec. 18, 2018) (online at 12/ 8/surgeon- Centers for Disease Control and Prevention, Sales of JUUL E-cigarettes Skyrocket, Posing Danger to Youth (Oct. 2, 2018) (online at Centers for Disease Control and Prevention, Progress Erased: Youth Tobacco Use Increased During 2017-2018 (Feb. 1 1, 2019) (online at The Future of E-cigarettes Depends on the Industry ?5 Willingness to Protect Teens, Washington Post (Mar. 20, 2019) (online at washingtonpostcom/opinions/Z0 1 9/ 03/ 4 Food and Drug Administration, Trump Administration Combating Epidemic of Youth E?Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products (Sept. 1 1, 2019) (online at 5 Letter from Chairman Raja Krishnamoorthi, Subcommittee on Economic and Consumer Policy, Committee on Oversight and Reform, to Ned Sharpless, Acting Commissioner, Food and Drug Administration (Aug. 30, 2019) (online at 6 21 U.S.C. 321(g); Sottera Inc. v. Food and DrugAdminis-tration, 627 F. 3d 891 (US. App. DC 2010); Clari?cation of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices or Combination Products; Amendments to Regulations Regarding ?Intended Uses,? 82 Fed. Reg. 2193 (Jan. 9, 2017) product will be regulated as a drug, device or combination product if: The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in the cure or treatment of nicotine addiction smoking cessation), relapse prevention, or relief ofnicotine withdrawal (emphasis added) and (?statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose?). Mr. Ryan Nivakoff Page 3 consider the company?s knowledge of how the product is being ?offered and used for a purpose for which it is neither labeled nor advertised.?7 Manufacturers of tobacco products may not claim that their products are healthier or safer than cigarettes (?modi?ed risk claims?) unless they have a marketing order from FDA. UUL did not have a marketing order from FDA that would have allowed it to make these ?modi?ed risk claims.? Making modi?ed risk claims without a marketing order violates Section 911 of the Act, as amended by the Family Smoking Prevention and Tobacco Control Act.8 Currently, no e?cigarette or vaping company, including yours, has been approved for cessation or modi?ed risk claims.9 On September 9, 2019, four days after I sent my letter urging FDA to investigate illegal advertising, the agency issued a warning letter to UUL declaring that it illegally marketed its product as safer than cigarettes.10 FDA directly cited testimony from our Subcommittee in its letter.11 In addition, CDC has identi?ed 530 cases of lung illness associated with the use of e- cigarette products in 38 states and one US. territory. The outbreak has resulted in at least nine deaths, and these ?gures may grow as state health departments conduct retro-analyses of state health records to ascertain the breadth of adverse health events. 12 On September 24, 2019, during testimony before the Subcommittee, Principal Deputy Director, Dr. Anne Schuchat, reported that the process of vaping itself may be risky and that not enough is known about the aerosol that vaping produces or its potential to negatively 7 32 Fed. Reg. at 2201. 3 Food and Drug Administration, Section 9] I of the Federal Food, Drug, and Cosmetic Act-Modi?ed Risk Tobacco Products (Jan. 7, 2018) (online at (?No person may introduce or deliver for introduction into interstate commerce any modi?ed risk tobacco product unless an order issued pursuant to subsection is effective with respect to such product?) and (de?ning ?modi?ed risk tobacco product? as ?any tobacco product that is sold or distributed for use to reduce harm of the risk of tobacco-related disease associated with commercially marketed tobacco products"). 9 Does the Food and Drug Administration Even Regulate E-Cigs? Actually Kinda Not, Wired (Sept. 18, 2019) (online at ?0 Food and Drug Administration, Warning Letter: JUUL LABS, Inc. (Sept. 9, 2019) (online at 590950-09092019). Committee on Oversight and Reform, Oversight Subcommittee Investigation Prompts the Food and Drug Administration to Issue Warning Letter to JUUL (Sept. 9, 2019) (online at '2 Centers for Disease Control and Prevention, Outbreak of Lung Disease Associated with E?Cigarette Use. or Vaping (Sept. 19, 2019) (online at diseasehtml). Mr. Ryan Nivakoff Page 4 affect the lungs. She also expressed concern that the recent outbreak of lung injuries may cause permanent harm. ?3 Due to the e-cigarette and vaping-related lung illness outbreak, CDC has warned the American people to ?consider refraining from using e?cigarette or vaping products,? as CDC is unable to rule out any brand, ?avor, or component chemical as a cause of lung illness. Dr. Schuchat also refused to rule out the process of vaping itself as a contributing factor to the outbreak}4 Other severe health effects have been linked to e-cigarette use as well. For example, as of August 7, 2019, FDA had received 127 reports of seizures and other neurological conditions caused by e-cigarette use.15 Seizures and convulsions are of nicotine toxicity. '6 The American people should not serve as guinea pigs for the e-cigarette and vaping industry or be subject to their misleading marketing and advertising. I ask that you please notify me whether you will halt all television, radio, print, and digital advertising for your e- cigarette products. Thank you for your attention to this critical issue. I look forward to your response. Sincerely, Raja Krishnamoorthi Chairman Subcommittee on Economic and Consumer Policy cc: The Honorable Michael Cloud, Ranking Member '3 Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy, Testimony of Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention, Hearing on Don?t Vape: Examining the Outbreak of Lung Disease and the Centers for Disease Control and Prevention ?s Urgent Warning Not to Use E?Cigarettes (Sept. 24, 2019) (online at '4 Centers for Disease Control and Prevention, Outbreak of Lung Illness Associated with Using E?Cigarette Products, Investigation Notice (Sept. 1 l, 2019) (online at '5 Food and Drug Administration, In Brief The Food and DrugAdministration Encourages Continued Submission of Reports Related to Seizures Following E-cigarette Use as Part of A gency ?s Ongoing Scientific investigation of Potential Safety Issue (Aug. 7, 2019) (online at '6 Illinois Department of Public Health, E?cigarettes and Vapes (Sept. 12, 2019) (online at