JUUL Labs: FDA Investigation Timeline

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Date FDA intervention and JUUL Labs response
24 April 2018 Based on the growing concern regarding the popularity of JUUL products amongst youth, the FDA sent an official request to JUUL Labs to disclose information (deadline 19 June 2019) about its “marketing practices and research on marketing effects of product design, public health impact, and adverse experiences related to JUUL products”.[1]
25 April 2018 JUUL Labs issued a press release stating that the company “will work with Tom Miller, the Iowa Attorney General, and a group of public officials and tobacco control individuals he will assemble to continue to strengthen existing initiatives and new efforts to keep JUUL out of the hands of young people”. The statement also said that Miller and the group would work with JUUL Labs “to develop a transparent and effective framework for independent research focused on the scientific and societal implications of vapor products”.[2] Correspondence between Miller’s office and JUUL Labs, released under freedom om Information requests by VICE Media (which at the time was collaborating with Philip Morris International on the Change.Inc website[3]), have since revealed Miller’s key role in supporting JUUL Labs in navigating the controversies it found itself in. This included advising JUUL on how to deal with criticism the company received from the FDA.[4]
12 September 2018 FDA issued a “call to action” to JUUL Labs and four other e-cigarette manufacturers, requesting them to come back in 60 days “with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA”s exercise of enforcement discretion for products currently on the market”.[5][6] The FDA Commissioner described e-cigarette use amongst teenagers “…nothing short of an epidemic proportion of growth. I use the word epidemic with great care. E-cigs have become an almost ubiquitous -and dangerous- trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable. I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these products”.[5]
24-28 September 2018 FDA conducted a surprise inspection of JUUL Labs offices and impounded documents related to the company’s sales & marketing practices.[7] In response, JUUL Labs released a statement that said that the company remains “committed to preventing underage use” and that since April it had released over 50,000 pages of documents and that it has held a “constructive and transparent dialogue” with the FDA about JUUL’s business from “our marketing practices to our industry-leading online age-verification protocols to our youth prevention efforts”.[8]
16 October 2018 FDA had “constructive” meeting with JUUL Labs.[9][10]
13 November 2018 JUUL Labs announced its action plan to combat underaged use of its products which included the following steps: a) Stop the sale of flavoured Juul pods in 90,000+ retail stores (but continue to sell the flavoured pods on its age-verified secure website, b) Strengthen retail compliance by increasing JUUL’s ‘secret shopper’ program from 500 to 2000 visits per month and cut of retailers with multiple violations, c) Continue enforcement against online marketplaces which sell JUUL products unauthorised, and d) Shut down JUUL’s social media accounts and monitor and remove inappropriate material from third party accounts.[11]
6 February 2019 FDA sent Kevin Burns a letter to request a joint meeting with Altria, in which JUUL “should be prepared to explain how this acquisition by Altria affects the commitments you made to the FDA about addressing the crisis of youth use of JUUL products”.[10][12] Gottlieb added: “ I am aware of deeply concerning data showing that youth use of JUUL represents a significant proportion of the overall use of e-cigarettes by children”.
March 2019 FDA has a meeting with Juul and Altria, which was described by the FDA Commissioner as “difficult”.[13]
5 April 2019 In an interview, announcing his retirement from the FDA, Gottlieb said “I hope they [JUUL Labs] recognize the problem that’s been created [underaged e-cigarette use] largely by their product”.[14]
13 June 2019 FDA proposed a 10-month deadline for e-cigarette manufacturers, including JUUL Labs, to submit applications to be allowed to continue to sell their e-cigarette products on the US market.[15] The announcement came after the U.S. District Court for Maryland ruled that the FDA had exceeded its authority in July 2017 when the FDA had announced that e-cigarette companies had until 2022 to apply for market approval for e-cigarettes already on the US market.[16]
9 September 2019 FDA sent JUUL Labs a formal warning letter, accusing the company of marketing “explicitly and/or implicitly” its e-cigarette as reduced risk without having been granted approval to do so.[17] Although the letter referenced evidence of JUUL Labs making reduced risk claims to school students, it stopped short of including an official warning for targeting children. Instead, the company was ordered to show the FDA, within 15 working days, how it intends to correct the violations, in respect of misleading labelling, advertising and promotion.

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Notes

  1. M.R. Holman, Letter from Holman to Rouag dated 24 April 2018, FDA website, accessed April 2019
  2. JUUL Labs, JUUL Labs Announces Comprehensive Strategy to Combat Underage Us, 25 April 2018, accessed April 2019
  3. D. Voshart, VICE and Philip Moris: Partners in Crime, notvice.com, 22 March 2019, accessed August 2019
  4. A. Conti, Exclusive: Emails Show This Anti-Tobacco Crusader’s Close Relationship with JUUL, VICE.com, 9 August 2019, accessed August 2019
  5. 5.0 5.1 Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to address epidemic of youth e-cigarette use, FDA website, 12 September 2018, accessed April 2019
  6. S. Gottlieb, Letter from Scott Gottlieb to Kevin Burns dates 12 September 2018, FDA website, accessed April 2019
  7. J. Hoffman, F.D.A. Seizes Documents From Juul Headquarters, The New York Times, 2 October 2018, accessed January 2018
  8. JUUL Labs, JUUL Labs Issues Statement on FDA Inspection, PR Newswire, 2 October 2018, accessed April 2019
  9. Food and Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D., on meetings with industry related to the agency’s ongoing policy commitment to firmly address rising epidemic rates in youth e-cigarette use, FDA website, 31 October 2018, accessed April 2019
  10. 10.0 10.1 S. Gottlieb, Letter from Scott Gottlieb to Kevin Burns dated 6 February 2019, FDA website, accessed April 2019
  11. JUUL Labs, JUUL Labs Action Plan, 13 November 2018, accessed April 2019
  12. S. Gottlieb, Letter to Howard A. Willard III, Chairman and Chief Executive Officer Altria Group Inc, dated 6 February 2019, FDA website, accessed March 2019
  13. K. Rooney, A. LaVito, Altria shares fall after FDA’s Gottlieb describe ‘difficult’ meeting on Juul, CNBC News, 19 March 2019, accessed April 2019
  14. J. Belluz, Scott Gottlieb’s last word as FDA chief: Juul drove a youth addiction crisis, Vox Media, 5 April 2019, accessed April 2019
  15. U. Sampath Kumar, UPDATE 1-FDA proposes shorter deadline for e-cigarette applications, Reuters, 13 June 2019, accessed July 2019
  16. U.S federal judge orders FDA to implement 10-month deadline for e-cig applications, Reuters, 12 July 2019, accessed August 2019
  17. Center for Tobacco Products, Warning Letter, FDA website, 9 September 2019, accessed September 2019