Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 1 of 5 PageID# 37043
`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 1 of 5 PagelD# 37043
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`EXHIBIT 72
`EXHIBIT 72
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`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 2 of 5 PageID# 37044
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`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 3 of 5 PageID# 37045
`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 3 of 5 PagelD# 37045
`popular ENDSproductsthat accountfor a large part of the market. The continued
`marketingof these products hasthe potential to have a substantial public health impact—
`either positively or negatively—as they hold an overall large market share and are used by
`a lot of people.
`
`“As a cardiologist, I’ve personally seen the devastating health effects of tobacco
`use, so I’m highly motivated for the FDA to help reduce death anddisability caused
`by these products,” said FDA Commissioner Robert M.Califf, M.D. “We know that
`there is a demand among adult smokersto use e-cigarette products to try to switch
`from more harmful combustedcigarettes, but millions of youth are using these
`products andgetting addicted to nicotine. The balance of these issues was
`considered by the agency’s careerscientists when evaluating the potential
`marketing of e-cigarette products. They have madegreat progress and I know they
`will use the best available evidence with the most robust methodsto ensurethat
`
`products that continue to be marketed are appropriate for the protection of the
`public health.”
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`products/market-and-distribute-tobacco-and-distribute-tobacco-product/premarket-tobacco-product-applications),
`
`manufacturers or importers must demonstrate to the agency, amongotherthings, that
`marketingof a new tobacco product would be appropriate for the protection of the public health.
`That statutory standard requires the FDA to considertherisks and benefits to the population as
`a whole, including users and non-usersof tobacco products. The FDA mustalso consider the
`likely impactof the products on people’s behavior—specifically, the likelihood that existing users
`will stop using such products andthe likelihood that those who do not use tobacco products will
`start using such products. This is especially important for youth. Before a productis authorized
`under the PMTApathway,the agency reviews a tobacco product’s components, ingredients,
`additives, constituents andhealth risks, as well as how the product is manufactured, packaged
`andlabeled.
`
`“Ensuring new tobacco products undergo premarket evaluation by the FDAis a
`critical part of our work to reduce tobacco-related disease and death,” said Mitch
`Zeller, J.D., director of the FDA’s Center for Tobacco Products. “For the
`authorized products, the manufacturer demonstratedthat possible benefits to
`adult smokers outweighthe risk of youth possibly initiating. We are making
`progressin our review of flavored ENDS, and wewill continue to deny marketing
`of products wherethe applicant hasn’t provided enough evidence to show that the
`potential benefit to adult smokers outweighs the considerable risk to youth. We
`are committed to continuing to take the appropriate actions to protect our nation’s
`youth from the dangersof all tobacco products, including e-cigarettes, which
`aA
`remain the most commonly usedtobacco product by youth in the United StatesI%p ()
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 4 of 5 PageID# 37046
`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 4 of 5 PagelD# 37046
`Logic Authorizations
`
`The FDA's review of the applications for the products authorized today determined that the
`marketingof the tobacco-flavored products and associated componentsis appropriate for the
`protection of the public health. The FDA authorized these tobacco-flavored ENDSproducts
`because, amongseveral key considerations, the data submitted by the company and the
`available evidence show that marketing these products mayhelp addicted adult smokers
`transition away from combustedcigarettes and reducetheir risk of exposure to harmful and
`potentially harmful toxins compared to combusted cigarettes. At the same time, the data showed
`there waslowrisk for non-users, including youth, to use the products. Therisk wasalso low for
`non-users, including youth, to progress to regular use of the products.
`
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`As evidenced through datacollected via the National Youth Tobacco Survey(/news-
`events/press-announcements/youth-e-cigarette-use-remains-serious-public-health-concern-
`amid-covid-19-pandemic), compared to users of non-tobacco-flavored ENDS products, young
`peoplearelesslikely to start using tobacco-flavored ENDS products. The data also suggest that
`mostyouth and young adults who use ENDSbegin with flavors such as fruit, candy or mint, and
`not tobacco flavors. These data reinforce the FDA’s decision today, consistent with past
`decisions, to authorize the marketing of the tobacco-flavored ENDSproducts in part because
`they are not significantly appealing to youth and authorizing these products may be beneficial
`for individual adult combusted cigarette users who completely switch to ENDSorsignificantly
`reduce their cigarette consumption.
`
`Specifically, available data showedthat current tobacco users who used these tobacco-flavored
`products were morelikely to significantly decrease their use of combusted cigarettes and that
`those who don’t smokeare unlikely to start using these products. Most study subjects decreased
`the numberof combustedcigarettes they smoked each day by greater than 80%, from an
`average of 13-16 cigarettes per day at screening to 1-2 by day 59. The data also showedthat the
`products produce feweror lowerlevels of sometoxins, like carbon monoxide, than combustible
`cigarettes and the products’ abuseliability, or their ability to encourage continued tobaccouse,
`addiction or dependence, was lower than combustedcigarettes.
`
`Additionally, today’s authorization imposesstrict marketingrestrictions on the companyto
`greatly reduce the potential for youth exposure to tobacco advertising for these products. The
`FDAwill closely monitor how these ENDSproducts are marketed andwill act as necessary if the
`companyfails to comply with any applicable statutory or regulatory requirements,or if there is a
`notable increase in the number of non-smokers—including youth—using these products.
`
`The FDA maysuspendor withdraw a marketing order issued under the PMTApathwayfor a
`variety of reasons, including if the agency determinesthe continued marketing of a product is no
`
`longer “appropriate for the protection ofthe public health,” such as ifthere is a notable incred&Top
`
`

`

`Case 1:20-cv-00393-LMB-WEF Document 1425-16 Filed 09/09/22 Page 5 of 5 PageID# 37047
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