Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 1 of 10 PageID#
`39759
`
`Exhibit 21
`
`
`39759
`
`Exhibit 21
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 2 of 10 PageID#
`39760
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, DC
`
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN TOBACCO HEATING
`ARTICLES AND COMPONENTS THEREOF
`
`Investigation No. 337-TA-1199
`
`EXPERT REPORT OF BRAD Roou
`
`RELATING TO THE PUBLIC INTEREST
`
`BradRodu
`
`October 5, 2020
`
`US-DOCS\118070171.1
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 3 of 10 PageID#
`39761
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`process that gives it a different flavor than American dip, and somewhat lower levels of unwanted
`
`contaminants. Like dip, snus is marketed in many flavors and small pouches.
`
`169. The use of STPs results in similar blood nicotine levels as cigarettes, but with
`
`slower absorption that is unsatisfying to many smokers.255 These products also do not look like
`
`combustible cigarettes and to not reproduce the smoking ritual. In addition, esthetic concerns limit
`
`STPs’ usefulness for women in particular and for some ethnic and racial groups.256
`
`D.
`
`E-cigarettes are not adequate substitutes for IQOS®
`
`170. Another alternative nicotine delivery system to combustible cigarettes is an e-
`
`cigarette (which also includes any product producing vapor derived from a liquid containing
`
`various levels of, or no, nicotine).
`
`1.
`
`Performance of e-cigarettes shows a need for other PRRPs
`
`171. E-cigarettes have been sold in the American market since 2007.257 While e-
`
`cigarettes mimic some of the rituals of smoking, their haphazard development as consumer
`
`electronic products has produced a wide variation in quality, resulting in low satisfaction among
`
`traditional smokers and rare but serious battery malfunctions and misuse.258
`
`172. E-cigarettes may be a good choice for certain individuals. That said, many try e-
`
`cigarettes and then abandon them.259 A considerable number of people also engage in dual use of
`
`
`255 PMP_ITC01901802-39.
`
`256 PMP_ITC01901802-39.
`
`257 1199_RESP00010908.
`
`258 See 1199_RESP00016335-46.
`
`259 See PMP_ITC01875417; 1199_RESP00016335-46.
`
`
`66
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 4 of 10 PageID#
`39762
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`e-cigarettes and combustible cigarettes, which reduces the health benefits of completely switching
`
`to a PRRP.260 In fact, National Health Interview Surveys from the Centers for Disease Control
`
`and Prevention reveal that the number of current smokers using e-cigarettes has always been higher
`
`than the number of former smokers using them.261
`
`2.
`
`Youth use of e-cigarettes is high and remains under scrutiny
`
`173. There is no question that the use of e-cigarettes among high school and middle
`
`school students has increased. Accordingly, governmental officials are “taking a comprehensive
`
`aggressive approach “ to the situation.262 Complainants, too, acknowledge there is a problem. For
`
`example, in February 2020, RAI’s CEO testified in a House Committee hearing about the perils
`
`of youth adoption of e-cigarettes.
`
`174.
`
`In September 2020, the CDC reported that “19.6% of high school students (3.02
`
`million) and 4.7% of middle school students (550,000) reported current e-cigarette use.”263 Of
`
`those users, “38.9% of high school students and 20.0% of middle school students reported using
`
`e-cigarettes on 20 or more of the past 30 days; 22.5% of high school users and 9.4% of middle
`
`school users reported daily use.”264
`
`
`260 See 1199_RESP00011888; 1199_RESP00016335-46.
`
`261 CDC Data: Vaping Increased in 2018, Particularly Among Former Smokers, TOBACCO TRUTH
`(last visited Oct. 5, 2020), https://rodutobaccotruth.blogspot.com/2019/07/cdc-data-vaping-
`increased-in-2018.html.
`
`262 1199_RESP00010611; see also 1199_RESP00010620-21; 1199_RESP00011826-31;
`1199_RESP00014244-53;
`1199_RESP00014536-47;
`1199_RESP00010295-300;
`1199_RESP00010702-886; 1199_RESP00010908-11; 1199_RESP00011330-39.
`
`263 1199_RESP00015126.
`
`264 1199_RESP00015126.
`
`
`67
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 5 of 10 PageID#
`39763
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`175. While no measures ever taken by manufacturers and suppliers of adult substances
`
`have ever guaranteed zero use by teens, the highly restrictive sales program implemented by
`
`Respondents worldwide has minimized youth uptake of IQOS®.265 The FDA-approved post-
`
`marketing surveillance plan also will ensure that IQOS® is marketed and sold only to adult
`
`smokers.266 Moreover, as a product, studies have shown that IQOS® simply does not appeal to
`
`youth in the way that e-cigarettes do.267
`
`3.
`
`The e-cigarette market is undergoing major disruption
`
`176.
`
`In addition to concerns about the performance or appeal of e-cigarettes and the
`
`questions surrounding youth uptake of such products, the e-cigarette market is undergoing major
`
`disruption. For years, e-cigarettes were technically on the U.S. market illegally.
`
`177. This issue of illegality was addressed through a deadline on September 9, 2020,
`
`whereby all e-cigarette companies had to file PMTAs with the FDA in order to remain on sale in
`
`the United States.268 Applications had to be filed for each device, each flavor, and each
`
`concentration of nicotine liquids or pods, making some vape shops responsible for hundreds of
`
`PMTAs.269 Each application is required to demonstrate that the products are “beneficial to the
`
`population as a whole including users and non-users . . . [taking] into account the increased or
`
`decreased likelihood that existing tobacco users will stop using such products, and the increased
`
`
`265 See 1199_RESP00011619; PMP_ITC05452788.
`
`266 1199_RESP00012398-403.
`
`267 See, e.g., PMP_ITC01768947-55; 1199_RESP00012388.
`
`268 1199_RESP00014297.
`
`269 See 1199_RESP00014300-01; 1199_RESP00014118-69.
`
`
`68
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 6 of 10 PageID#
`39764
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`or decreased likelihood that those who do not use tobacco products will start using them.”270 The
`
`burden on manufacturers is considerable.
`
`178. The director of the FDA’s CTP estimated that there are more than 400 million
`
`individual product items requiring PMTAs in order to stay on the U.S. market.271 The agency
`
`expected a huge number of PMTAs “several orders of magnitude greater than anything the Agency
`
`has experienced.”272 Each application can consist of thousands to hundreds of thousands of pages.
`
`179. Numerous e-cigarette suppliers, however, could not or chose not to file a PMTA.
`
`Indeed, “[m]any industry players say that the regulatory rule will force more than 10,000
`
`businesses to close and cause more than 100,000 jobs to be lost.”273
`
`180.
`
`It remains unclear how many PMTAs were filed, and, of those, how many will be
`
`initially accepted by the FDA as procedurally adequate.274 It is reasonable to expect that a
`
`considerable number of applications may have been submitted in haste in order to stay eligible for
`
`sale in the United States, resulting in their outright rejection or requiring multiple, major
`
`supplementations.275 Thus, it is unclear how many suppliers can continue to sell their e-cigarette
`
`
`270 https://rodutobaccotruth.blogspot.com/2015/11/fda-authorizes-eight-new-snus-products.html.
`
`271 1199_RESP00014309.
`
`272 1199_RESP00014297.
`
`273 1199_RESP00014462–1199_RESP00014463.
`
`274 See 1199_RESP00014297-305; 1199_RESP00014254-67; 1199_RESP00014118-69.
`
`275 See 1199_RESP00014302-05.
`
`
`69
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 7 of 10 PageID#
`39765
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`products over the next year.276 It is highly likely, however, that those numbers will dwindle
`
`considerably.277
`
`181. How and to what extent the FDA goes about removing e-cigarette products from
`
`U.S. shelves that did not comply with the September 9 PMTA deadline will cause its own
`
`uncertainty and interference in the U.S. e-cigarette market. The FDA has broad enforcement
`
`discretion that can manifest in a variety of ways.278
`
`182. Even if it turns out there is a substantial number of PMTAs that were filed and
`
`initially accepted for review by the FDA, it could take years before decisions on those applications
`
`are rendered, including for Complainants’ e-cigarettes. Historically, it regularly takes the FDA
`
`longer than contemplated under the relevant regulations to make determinations on market
`
`authorizations. For example, it took 2 years for the FDA to grant the IQOS PMT authorization,279
`
`which was which roughly 1.5 years past the prescribed regulatory period.280 It took over 3.5 years
`
`for the FDA to grant the IQOS MRTP authorization,281 which was which roughly 2.5 years past
`
`
`276 See 1199_RESP00014297-305; 1199_RESP00014222-29.
`
`277 See, e.g., 1199_RESP00014462.
`
`278 See 1199_RESP00016448-59; 1199_RESP00014254-67; 1199_RESP00014118-69.
`
`279 1199_RESP00011706; 1199_RESP00010615.
`
`280 See Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems,
`Guidance
`for
`Industry,”
`at
`10
`(last
`visited:
`October
`5,
`2020)
`https://www.fda.gov/media/97652/download.
`
`281 See 1199_RESP00012324, 1199_RESP00012330.
`
`
`70
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 8 of 10 PageID#
`39766
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`the prescribed regulatory period.282 It took 5.5 years for the FDA to grant the Swedish Match Snus
`
`MRTP authorization,283 which was which roughly 4.5 years past the prescribed regulatory
`
`period.284 The FDA has yet to provide a decision on Complainants’ Camel Snus MRTPA,285 which
`
`already is almost two years past the prescribed regulatory period.286
`
`183. Those are the types of delays stakeholders experience under normal circumstances.
`
`With the number of PMTAs the FDA received pursuant to the September 2020 deadline, those
`
`wait times are likely going to be longer, not shorter.287 Indeed, Mitch Zeller, Director of FDA’s
`
`Center for Tobacco Products has explained that “the likelihood of FDA reviewing all of these
`
`applications during the one-year review period is low, given that this would be an unprecedented
`
`number of applications and several orders of magnitude greater than anything the Agency has
`
`experienced.”288
`
`
`282 See “Q&A: Modified Risk Tobacco Products,” FDA (last visited: October 5, 2020),
`https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/qa-modified-risk-
`tobacco-products.
`
`283 1199_RESP00016099-100; 1199_RESP00014240-43.
`
`284 See “Q&A: Modified Risk Tobacco Products,” FDA (last visited: October 5, 2020),
`https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/qa-modified-risk-
`tobacco-products.
`
`285 1199_RESP00013959 -61.
`
`286 See “Q&A: Modified Risk Tobacco Products,” FDA (last visited: October 5, 2020),
`https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/qa-modified-risk-
`tobacco-products.
`
`287 See 1199_RESP00016456-59.
`
`288 1199_RESP00016450-51.
`
`71
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 9 of 10 PageID#
`39767
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`184. Moreover, at the end of this lengthy process, there is no certainty that any e-
`
`cigarette, including Complainants’ Vuse Solo and Vuse Vibe, will receive PMT authorization from
`
`the FDA. Dr. Figlar admits this:
`
`Q: So if the FDA doesn’t grant your PMT authorization request for the Solo, you
`have to – Reynolds has to take it off the market. Is that right?
`
`A: That would be correct.
`
`Q: And that would apply to the Vibe as well, correct?
`
`A: It would.289
`
`
`----------
`
`Q: And you don’t know if the FDA is going to authorize either of these products to
`be sold, correct?
`
`A: At this moment, we do not, no.290
`
`185. Some in the industry believe that e-cigarettes will have difficulty obtaining PMT
`
`authorization. For example, former FDA Commissioner David Kessler has said that “it ‘remains
`
`to be seen’ whether any e-cigarettes can survive the FDA review.”291 Whether one believes Dr.
`
`Kessler is correct or not, the fact remains that no one can predict how or when the FDA is will rule
`
`on the recent e-cigarette PMTAs, as Dr. Figlar acknowledged in his testimony.292 This means as
`
`well that no one can predict the near-term future capacity of the e-cigarette industry or the
`
`availability of FDA-authorized e-cigarette products.
`
`
`289 Figlar Dep. at 49-50.
`
`290 Figlar Dep. at 50.
`
`291 1199_RESP00014222 –1199_RESP00014229.
`
`292 See Figlar Dep. at 50.
`
`
`72
`
`
`
`Case 1:20-cv-00393-LMB-WEF Document 1462-21 Filed 04/05/23 Page 10 of 10 PageID#
`39768
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`
`186. These disruptions and uncertainties in the U.S. e-cigarette market are some of the
`
`reasons why it is in the public interest for traditional smokers to continue to have access to the
`
`PMT- and MRTP-authorized IQOS®.
`
`E.
`
`Existing PRRPs are cannot resolve the American smoking plight
`
`187.
`
`In sum, while all non-combustible nicotine delivery products have helped move
`
`smokers away from combustible cigarettes, the number of successes remains far too small. There
`
`are still 34 million American smokers, with 480,000 of them dying from cancer, circulatory, and
`
`pulmonary diseases each and every year.293 No existing PRRP possesses the same attributes as
`
`the effective and popular IQOS®. Thus, in order to reduce the ill effects of traditional smoking,
`
`IQOS® must remain available to U.S. consumers, as it is for smokers in dozens of other countries
`
`around the world.
`
`X.
`
`Existing IQOS® users in the United States should not be deprived of consumables
`
`188.
`
`If the ALJ and/or the Commission determines that a Section 337 violation has
`
`occurred and that the public interest does not warrant denial of an exclusion order, it is my opinion
`
`that, at a minimum and in order to mitigate some of the harm to the public health that would result
`
`from such a determination, existing IQOS® users should be allowed continued access to the
`
`disposable tobacco sticks used in that system.
`
`189.
`
`I understand that the Commission has allowed Respondents found in violation of
`
`Section 337 to nonetheless continue to provide products to consumers who were using them prior
`
`to the issuance of a remedial order to protect those customers against harmful disruption caused
`
`
`293 1199_RESP00011980-82.
`
`
`73
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
