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`August 7, 2018
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`Dr. Scott Gottlieb
`Commissioner, Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, Maryland 20993
`
`Dear Dr. Gottlieb:
`
`
`We write to bring to your attention numerous apparent violations of the Family Smoking
`Prevention and Tobacco Control Act (Tobacco Control Act) and the FDA’s deeming rule
`prohibiting the marketing, without a marketing order from FDA, of electronic cigarette products
`that were not commercially marketed as of August 8, 2016. The attached slides, taken from
`statements made by manufacturers themselves and bloggers who promote e-cigarettes, present
`evidence that these products are being marketed illegally in violation of the Tobacco Control Act
`and FDA’s deeming rule.
`
`This is a matter of great urgency. In response to the skyrocketing use of Juul e-cigarettes
`by young people, you stated in a July 17, 2018, interview with PBS News Hour that preventing
`the use of e-cigarettes by young people is one of “our [FDA’s] top concerns right now.” You
`added, “And so we need to be very aggressive in trying to take steps to crack down, prevent the
`youth use of these products,” and further correctly noted, “We also can’t be in a position where
`we’re playing Whac-A-Mole, where we are just going after one particular product and don’t
`have in place rules that address the overall category.” Most recently, in your August 2
`announcement summarizing recent regulatory developments you referenced “reports that some
`companies may be marketing new products that were introduced after FDA’s compliance period
`and have not gone through premarket review” and pledged to “take swift action wherever
`appropriate.”
`
`FDA does have a rule in place that gives it the authority and regulatory tools to prevent
`another Juul experience from happening. However, even as new products being modeled after
`Juul are being introduced into the marketplace, without constraints or controls, FDA does not
`appear to be exercising that authority.
`
`Under the Tobacco Control Act, no “new tobacco product” (i.e., any product not
`commercially marketed on February 15, 2007 and any modification of a product marketed on
`that date) can legally be marketed unless FDA has granted an order permitting the marketing of
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`JLI Ex. 2043, Page 1 of 5
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`that product (a “premarket order”). On May 10, 2016, FDA issued a final rule (“the deeming
`rule”) extending its authority to e-cigarettes, cigars, and all other finished tobacco products not
`previously subject to its jurisdiction and established an effective date of August 8, 2016. When
`FDA issued the deeming rule, it permitted manufacturers with newly deemed products already
`on the market before the effective date of the rule, August 8, 2016, to continue to market those
`products for up to three years.1 However, the deeming rule prohibited any new product from
`being introduced after August 8, 2016, unless the manufacturer had first filed a premarket review
`application with FDA and FDA had issued a premarket order for that product. To the best of our
`knowledge, FDA has never issued a premarket order for any new tobacco product introduced
`after August 8, 2016.
`
`
` Subsequently, in May 2017 and later in August 2017, FDA extended the compliance
`period for products that were on the market before August 8, 2016. However, as FDA explained
`in the August 2017 guidance, the extended compliance period “did not authorize the marketing
`of any new tobacco product that was not on the market on August 8, 2016.”2 Charts included in
`the guidance made clear that the only products affected by the extension were “new, newly
`deemed finished tobacco products that were on the market as of August 8, 2016.”
`
`Despite this clear statement, manufacturers of e-cigarette products have introduced new
`products at an alarming pace in total defiance of law, with no apparent concern for FDA
`enforcement. Moreover, such products are being introduced at an accelerating rate, including a
`host of new products introduced subsequent to the explosive growth in youth use of Juul.
`
`One vaping manufacturer, while promoting its new Stigpods product as being “finally
`introduced” in May 2018, aptly described the state of the market: “new revolutionary inventions
`seem to continually be released everday [sic] in the vaping industry.”3 On May 27, 2018, an
`Instagram account, Salt Porn, stated, “It feels like there is a new pod system released every day
`and we receive tons of them. So many in fact that there is no way we can review them all.”4
`Similarly, in February 2018, the website Vape Deals, announced, “The pod systems just keep
`coming! I’m having a hard time keeping track of all the new devices that are hitting the market.”5
`
`Many of the newly introduced e-cigarette products appear to be attempting to capitalize
`on the recent marketing success of Juul and present products that are sleek and easily concealed,
`
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`1 Manufacturers were permitted to continue marketing such products until August 8, 2018, provided they filed an
`application for a premarket order by that date and, if such an application were filed, one additional year pending
`FDA action on the application.
`2 Food and Drug Administration, Extension of Certain Tobacco Product Compliance Deadlines Related to the Final
`Deeming Rule, Docket No. FDA-2017-D-2834, Aug. 4, 2017.
`3 See Slide 3 in Appendix: Stigpods, “The highly anticipated STIG is available now!” Stigpods Blog, May 1, 2018,
`https://stigpods.com/blog/the-highly-anticipates-STIG-is-available-now/.
`4 See Slide 4 in Appendix: Salt Porn Instagram post, May 27, 2018,
`https://www.instagram.com/p/BjSkidRj5HS/?tagged=suorin.
`5 See Slide 5 in Appendix: Vape Deals, “7 Daze Zoor Closed Pod System $19.80,” February 27, 2018,
`http://vape.deals/7-daze-zoor-closed-pod-system-19-80/.
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`2
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`JLI Ex. 2043, Page 2 of 5
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`deliver high levels of nicotine and, most important, are attractive to kids. These include not only
`products introduced by independent e-cigarette manufacturers, such as Kandy Pens’ Rubi,
`MLV’s PHIX, and Mylé Vapor’s Mylé,6 but also products manufactured by major cigarette
`manufacturers, including Altria’s Markten Elite7 and ITG Brands’ myblu.8 R.J. Reynolds Vapor
`Co. recently announced the launch of its own Juul competitor, Vuse Alto.9 Yet, there is no
`evidence that any of these products have undergone review by the FDA as the law and FDA’s
`own current Rule requires.
`
`On February 28, 2018, CSP Daily News reported that “with the recent explosion of the
`Juul closed-system vaping device in the convenience store channel, major tobacco manufacturer
`Altria Group Inc. … announced it will enter the closed-tank segment with a product called
`MarkTen Elite.”10 And in March, 2018, Altria’s website announced that “MarkTen Elite will be
`available for purchase online in your location soon.”11 The website has since been updated to
`“Introduc[e] the MarkTen Elite…A new pod-based product from MarkTen e-vapor” and is
`available for purchase.12
`
`In February 2018, ITG Brands announced “the launch of myblu with its most expansive
`flavor range yet.”13 And in May, 2018, in an apparent effort to compete with Juul’s most popular
`flavor, ITG Brands announced that it was introducing mango as a “new flavor” of myblu pods.14
`
`As mentioned above, , on July 17, 2018, R.J. Reynolds Vapor Co. announced that in
`August it would launch its own Juul-like product, Vuse Alto.15
`
`
`6 See Slide 7: Kandy Pens’ Rubi, https://www.kandypens.com/rubi-ultra-portable-compact-pod-based-
`vaporizer.html; MLV’s PHIX, https://phixvapor.com/products/phix-starter-kit; Myle Vapors’ Myle,
`https://www.mylevapor.com/.
`7 See Slides 9-13 and Altria’s Markten Elite, https://www.markten.com/elite-intro.
`8 See Slides 16-18 and ITG Brands’ myblu, https://www.blu.com/en/US/e-cigs.
`9 See Slides 14-15 and Craver, Richard, “Reynolds Vapor prepares national launch of new e-cig rival to Juul,”
`Winston-Salem Journal, July 17, 2018, https://www.journalnow.com/business/reynolds-vapor-prepares-national-
`launch-of-new-e-cig-rival/article_7ba10442-d438-575e-af23-794173089a8a.html
`10 See Slide 9: Convenience Store News, “Altria Introducing Closed Vapor System,” February 28, 2018,
`http://www.cspdailynews.com/category-news/tobacco/articles/altria-introducing-closed-vapor-system#page=0.
`11 See Slide 11: Markten.com, “Two Pod Pack Trial Offer,” March 8, 2018,
`https://www.markten.com/shop/elite/trial-offers.
`12 See Slide 12, Markten.com, “Introducing Markten Elite,” https://www.markten.com/shop/elite/trial-offers July 27,
`2018.
`13 See Slide 16: Blu.com, February 21, 2018, https://www.multivu.com/players/English/8243551-my-blu-electronic-
`vaping-device/.
`14 See Slide 18: Blucigs Twitter post, May 14, 2018, https://twitter.com/blucigs/status/996208772711362565.
`15 Slides 14-15 and Craver, Richard, “Reynolds Prepares Launch of New E-cigarette Rival to Juul,”, Winston-Salem
`Journal, July 17, 2018, https://www.journalnow.com/business/reynolds-vapor-prepares-national-launch-of-new-e-
`cig-rival/article_7ba10442-d438-575e-af23-794173089a8a.html
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`JLI Ex. 2043, Page 3 of 5
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`In an April 2018 Instagram message, Mylé Vapor advertised “lush ice” as a new flavor.16
`In the same month, the company’s website advised viewers to “check out our Myle Pod flavors
`and look forward to more exciting options soon.” In January 2018, another independent vaping
`company, Space Jam, described its new product, “The Byrd,” as “a product the vaping industry
`has never seen before.”17
`
`Many other new products appear to mimic the sleek design of Juul, including PHIX
`Vapor’s PHIX, KandyPens’ Rubi, Juno Vapor’s Juno, Smoketech’s Infinix and FIT, Coilart’s
`UME, Vapor Storm’s Stalker, Bo Vaping’s Bo One, Cig20’s STIK, XFire Vapor’s XFire, Kilo
`Eliquids’ KILO 1K, and Vapeccino’s MATE1.18 Since these products appear to be imitating the
`design of Juul, a product that achieved popularity in 2017 and 2018, it is most unlikely that they
`were on the market on August 8, 2016.
`
`Moreover, Juul itself has just announced a new line of lower-nicotine products that
`evidently will first be marketed in 2018.19
`
`In addition to the Juul-style products that look like a USB stick, new concealable e-
`cigarettes have recently been introduced in additional shapes. An electronic cigarette known as
`“Suorin” was marketed online as being “new” in September 2017 and the online advertisement
`for it invited viewers to submit a “pre-order,” an indication that even on that date the product
`may not have been commercially marketed.20 The earliest online review we could find for the
`product was dated January 201721 and the first Instagram posts for the product were dated April
`25, 2017.22
`
` Other new products in various sleek, concealable shapes include KandyPens’ Feather,
`SMOK’s ROLO Badge, Kado’s Stealth Pod Vape, and Daze Manufacturing’s ZOOR.23 Based
`
`
`16 See Slides 19-21: Mylé Vapor Instagram post, April 3, 2018, https://www.instagram.com/p/BhIFhSDh4_I/?taken-
`by=mylevapor; Mylé Vapor, April 16, 2018, https://mylevapor.com/.
`17 See Slide 22: Space Jam, January 29, 2018, https://globenewswire.com/news-
`release/2018/01/29/1313815/0/en/Space-Jam-Tells-Consumers-to-Give-Smoking-THE-BYRD-With-Its-New-
`Closed-Tank-Vaping-Device.html.
`18 See Slides 24-38: http://phixvapor.com/; https://www.kandypens.com; http://junovapor.com/shop-juno-
`kits/twelve-juno-menthol-kit; https://ejuiceplug.com/products/smoktech-infinix-kit;
`https://www.smoktech.com/kit/fit; https://www.strictlyecig.com/coilart-ume.html;
`https://www.dhgate.com/store/product/original-vapor-storm-stalker-kit-ecig-starter/415693502.html;
`https://bovaping.co/; https://cig2o.com/stik; , https://xfirevapor.com/; https://www.kiloeliquids.com/product/kilo-1k-
`device/; http://www.vapeccino.com/.
`19 The Verge, “Juul plans to release lower-nicotine vape juice starting in August,” July 12, 2018,
`https://www.theverge.com/2018/7/12/17565066/juul-labs-reduces-nicotine-dose-virginia-tobacco-mint-flavors.
`20 See Slide 40: Suorinair, September 25, 2017, https://www.instagram.com/p/BZe8s5llcOC/?taken-by=suorinair.
`21 See Slide 42: Tony Huang vapejoy, “Suorin air coming,” YouTube, January 3, 2017,
`https://www.youtube.com/watch?v=9y2Z5ADXPzY.
`22 See Slide 41: Suorinair, April 25, 2017, https://www.instagram.com/p/BTUp_B-FW1K/?taken-by=suorinair.
`23 See Slides 43-6: Vapor Nation, https://www.vapornation.com/blog/kandypens-feather-review-ecig-
`vaporizer.html; SMOK Twitter post, https://twitter.com/SMOKTECHLOGY/status/955741967790456832;
`AVAndy reviewing Kado’s Stealth Pod Vape, https://www.youtube.com/watch?v=PV4Sr3tCxyM.
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`JLI Ex. 2043, Page 4 of 5
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`on the date of the initial appearance of social media posts and YouTube product reviews, it
`appears unlikely that these products were introduced by August 8, 2016. Joyetech announced it is
`launching the e-cigarette TEROS on May 18, 2018.24 This announcement joins a long list of
`products launched after August 8, 2016, listed on Joyetech’s website with specific launch dates.25
`
`It is apparent that a wave of new e-cigarette products continues to be introduced, despite
`the fact that no such products can legally be introduced after August 8, 2016, without a
`marketing order from FDA. As we have in the past, we urge FDA to take quick and aggressive
`action to enforce the law before one or more of these products becomes the next Juul
`phenomenon among our nation’s youth. We hope that you will use the information provided in
`this letter to prevent the marketing of products that have evaded the mandatory review process
`without the necessity of our taking legal action.
`
`Sincerely yours,
`
`American Academy of Pediatrics
`
`American Cancer Society Cancer Action Network
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`American Heart Association
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`American Lung Association
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`Campaign for Tobacco-Free Kids
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`Truth Initiative
`
`
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`cc: Mr. Mitch Zeller, Director, Center for Tobacco Products
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`24 See Slide 47: Joyetech, May 18, 2018, : http://www.joyetech.com/news/joyetech-teros-launching/.
`25 See Slide 49: Joyetech, July 17, 2018, http://www.joyetech.com/news/joyetech-teros-launching/.
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`JLI Ex. 2043, Page 5 of 5
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