`Case 1:20-cv-00393-LO-TCB Document 1007-9 Filed 02/11/22 Page 1 of 5 PagelD# 28197
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`EXHIBIT I
`EXHIBIT I
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`Case 1:20-cv-00393-LO-TCB Document 1007-9 Filed 02/11/22 Page 2 of 5 PageID# 28198
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`FDA NEWS RELEASE
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`FDA grants first-ever modified risk orders to eight smokeless tobacco
`products
`FDA concludes completely switching from cigarettes to these authorized products lowers certain health risks
`
`For Immediate Release:
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`October 22, 2019
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`The U.S. Food and Drug Administration announced today that, for the first time, it has authorized the marketing
`of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight
`Swedish Match USA, Inc. snus smokeless tobacco products sold under the "General" brand name.
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`These products had previously been authorized for U.S. sale without modified risk claims by the FDA in 2015 in
`response to filings of premarket tobacco applications (PMTAs). Today's action further authorizes the
`manufacturer to market these specific products with the claim "Using General Snus instead of cigarettes puts you
`at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." The
`FDA made this authorization after reviewing scientific evidence submitted by the company that supports this
`claim. In an effort to help prevent youth access and exposure, the agency has also placed stringent advertising
`and promotion restrictions on the products, including a requirement to restrict advertising to adults. In addition,
`the products' packaging and advertising must also bear the warning statements (/tobacco-products/labeling-
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`required for all smokeless tobacco products.
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`While today's decision permits the eight General brand snus smokeless tobacco products to be sold in the U.S.
`with a modified risk claim, it does not mean these products are safe or "FDA approved." All tobacco products are
`potentially harmful and addictive, and those who do not use tobacco products should continue to refrain from
`their use. The modified risk orders are product-specific and limited to five years.
`
`"Today's action demonstrates the viability of the pathway for companies to market specific tobacco products as
`less harmful to consumers, but only following a thorough scientific evaluation by the FDA. Our team of scientific
`experts examined these applications to ensure that the tobacco products meet the public health standards in the
`law. While we are authorizing these specific modified risk tobacco products, it's important for the public to
`understand that all tobacco products — including these — pose risk. Anyone who does not currently use tobacco
`products, especially youth, should refrain from doing so," said Acting FDA Commissioner Ned Sharpless, M.D.
`"In addition to stringent restrictions to limit youth access and exposure to advertising, this time-limited
`authorization comes with a number of postmarket requirements that will allow us to keep a close watch on the
`marketplace. Should any information lead us to determine that the marketing of these products as posing less
`risk no longer benefits the health of the population as a whole, the agency would consider withdrawing this
`authorization."
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`While all tobacco products pose risks, the MRTP pathway outlined in the 2009 Family Smoking Prevention and
`Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether a tobacco product
`may be sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with
`commercially marketed tobacco products. In its review, the FDA generally must look at whether the applicant
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`1 199_RESP00014240
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`Case 1:20-cv-00393-LO-TCB Document 1007-9 Filed 02/11/22 Page 3 of 5 PageID# 28199
`has demonstrated that the product — as actually used by consumers — will significantly reduce harm and the risk
`of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole. This
`includes taking into account both users of tobacco products and persons who do not currently use tobacco
`products. In making this assessment, the agency must consider, among other things, whether those who do not
`use tobacco products would start using the product and whether existing tobacco users who would have
`otherwise quit would switch to the modified risk product instead. Today's announcement marks the first time
`that the FDA has authorized an MRTP.
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`The FDA's review determined that the claim proposed by the company in its application is supported by
`scientific evidence, that consumers understand the claim and appropriately perceive the relative risk of these
`products compared to cigarettes, and that the modified risk products, as actually used by consumers, will
`significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the
`health of the population as a whole.
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`In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative
`to cigarette smoking, exclusive use of these specific smokeless tobacco products poses lower risk of mouth
`cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. Evidence submitted in the
`application also demonstrated that consumers can understand the claim and the relative risk of the products,
`and that seeing the claim influenced their intentions to buy the products among smokers 25 years of age or older
`— a group who stands to benefit the most from the modified risk tobacco products. Consumers also generally
`understood that the risk reduction is not achieved from partial switching (i.e., dual use of the products with
`continued use of cigarettes), thereby increasing the likelihood that smokers will switch completely. In addition to
`these lower risks relative to cigarette smoking, the FDA previously determined that the levels of two potent
`carcinogens in smokeless tobacco products called NNN and NNK (/tobacco-products/rules-regulations-and-
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`are lower in these General snus products than the vast majority of smokeless tobacco products on the U.S.
`market. In addition, the evidence showed when used exclusively instead of other smokeless tobacco products, the
`General snus products offer the potential for reductions in oral cancer risk.
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`The available evidence does not demonstrate significant youth initiation of these products, and evidence
`submitted by the company also found low levels of intentions to buy the product among non-users of tobacco
`(including young adults) and, importantly, found that the inclusion of the modified risk claim did not affect these
`intentions. In addition, to further limit the likelihood of youth initiation, the FDA is placing stringent restrictions
`on how the products are advertised and promoted — particularly via websites and through social media platforms
`— by including restrictions that prevent advertising from being targeted to youth.
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`With the authorization of these products, the company is required to conduct postmarket studies to determine
`the impact of modified risk tobacco product orders on consumer perception, behavior, and health. Relatedly, the
`FDA will evaluate new available data regarding the products through postmarket records and reports required in
`the modified risk orders. The company is required to report regularly to the FDA with information regarding the
`products on the market, including, but not limited to, ongoing and completed consumer research studies,
`advertising, marketing plans, sales data, information on current and new users, manufacturing changes and
`adverse experiences.
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`To continuously market these same products with the same modified risk information beyond the five-year limit
`would require the company to submit a request for renewal and receive renewal authorization from the FDA
`before the current orders expire. The FDA may withdraw the initial and any potential subsequent modified risk
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`Case 1:20-cv-00393-LO-TCB Document 1007-9 Filed 02/11/22 Page 4 of 5 PageID# 28200
`orders if the agency determines that, among other things, the continued marketing of the product no longer
`benefits the health of the population as a whole.
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`Prior to today's MRTP authorization, the eight General brand snus smokeless tobacco products were authorized
`to be marketed (http://wayback.archive-
`it.org/7993/2131813125m1455/https:/www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472026.htm)
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) without modified risk claims through
`the PMTA pathway in November 21315.The FDA's review of those applications found, among other things, that
`levels of harmful and potentially harmful constituents in these products are lower than most other smokeless
`tobacco products. The FDA previously denied (http://wayback.archive-
`it.org/7993/213181312513721329/https:/www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533219.htm)
`(http://www.fda.gov/about-fda/website-policies/website-disclaimer) an MRTP request from the company
`for these same products to remove a currently required warning stating that the products can cause gum disease
`and tooth loss. At that time, the FDA also issued a response to the applicant's requests to remove a currently
`required warning stating that the products can cause mouth cancer and to revise a currently required warning
`stating that the products are not a safe alternative to cigarettes. This response offered the company an option to
`amend its MRTP applications.
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`The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by
`assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological
`products for human use, and medical devices. The agency also is responsible for the safety and security of our
`nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for
`regulating tobacco products.
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`# # #
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`Inquiries
`Media:
`
`6M Jeremy Kahn (mailtoleremy.kahn@fda.hhs.goy
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`t. 301-796-8671
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`Consumer:
`
`888-INFO-FDA
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`6M Stephanie Caccomo (mailto:stephanie.caccomo@fda.hhs.goy)
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`t. 301-348-1956
`
`Related Information
`• Modified Risk Tobacco Products (/tobacco-products/advertising-and-promotion/modified-risk-tobacco-
`products)
`
`• Modified Risk Orders (/tobacco-products/advertising-and-promotion/modified-risk-orders)
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`1 199_RESP00014242
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`Case 1:20-cv-00393-LO-TCB Document 1007-9 Filed 02/11/22 Page 5 of 5 PageID# 28201
`• Swedish Match USA, Inc. MRTP Applications (/tobacco-products/advertising-and-promotion/swedish-
`match-usa-inc-mrtp-applications)
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`0 More Press Announcements (/news-events/newsroom/press-announcements)
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`1199_RESP00014243
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