Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 1 of 6 PageID# 35103
`
`
`
`
`
`
`
`
`
`
`
`Exhibit 8
`
`

`

`Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 2 of 6 PageID# 35104
`FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product a... Page 1 of 5
`
`FDA NEWS RELEASE
`
`FDA permits sale of IQOS Tobacco Heating System
`through premarket tobacco product application
`pathway
`
`Agency places stringent marketing restrictions on heated tobacco products aimed at
`preventing youth access and exposure to the new products
`
`For Immediate Release:
`
`April 30, 2019
`
`The U.S. Food and Drug Administration today announced it has authorized (/tobacco-
`products/premarket-tobacco-product-applications/premarket-tobacco-product-
`marketing-orders) the marketing of new tobacco products manufactured by Philip
`Morris Products S.A. for the IQOS "Tobacco Heating System" — an electronic device
`that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing
`aerosol. The FDA has placed stringent marketing restrictions on the products in an
`effort to prevent youth access and exposure.
`
`Following a rigorous science-based review through the premarket tobacco product
`application (PMTA) pathway, the agency determined that authorizing these products
`for the U.S. market is appropriate for the protection of the public health because,
`among several key considerations, the products produce fewer or lower levels of some
`toxins than combustible cigarettes. The products authorized for sale include the IQOS
`device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro
`Fresh Menthol Heatsticks. While today's action permits the tobacco products to be
`sold in the U.S., 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 not to. Additionally, today's action is not a decision
`on the separate modified risk tobacco product (MRTP) applications that the company
`also submitted for these products (/tobacco-products/advertising-and-
`promotion/philip-morris-products-sa-modified-risk-tobacco-product-mrtp-
`applications) to market them with claims of reduced exposure or reduced risk.
`
`https://www.fda.goy/news-eyents/press-announcements/fda-permits-sale-iqos-tobacco-heat... 6/25/2020
`1 199_RESP00010615
`
`PX-436
`
`

`

`FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product a... Page 2 of 5
`Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 3 of 6 PageID# 35105
`
`"Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is
`a critical part of our mission to protect the public, particularly youth, and to reduce
`tobacco-related disease and death. While the authorization of new tobacco products
`doesn't mean they are safe, the review process makes certain that the marketing of the
`products is appropriate for the protection of the public health, taking into account the
`risks and benefits to the population as a whole. This includes how the products may
`impact youth use of nicotine and tobacco, and the potential for the products to
`completely move adult smokers away from use of combustible cigarettes," said Mitch
`Zeller, J.D., director of the FDA's Center for Tobacco Products. "Importantly, the FDA
`is putting in place postmarket requirements aimed at, among other things, monitoring
`market dynamics such as potential youth uptake. We'll be keeping a close watch on the
`marketplace, including how the company is marketing these products, and will take
`action as necessary to ensure the continued sale of these products in the U.S. remains
`appropriate and make certain that the company complies with the agency's marketing
`restrictions to prevent youth access and exposure. As other manufacturers seek to
`market new tobacco products, the FDA remains committed to upholding the vital
`public health standards under the law and using all the tools at our disposal to ensure
`the efficient and appropriate oversight of tobacco products."
`
`Under the PMTA pathway (/tobacco-products/market-and-distribute-tobacco-
`product/premarket-tobacco-product-applications), manufacturers must demonstrate
`to the agency, among other things, that marketing of the new tobacco product would
`be appropriate for the protection of the public health. That standard requires the FDA
`to consider the risks and benefits to the population as a whole, including users and
`non-users of tobacco products. Importantly this includes youth. The agency's
`evaluation includes reviewing a tobacco product's components, ingredients, additives
`and health risks, as well as how the product is manufactured, packaged and labeled.
`The review for the IQOS products took into account the increased or decreased
`likelihood that existing tobacco product users will stop using tobacco products, and
`the increased or decreased likelihood that those who do not use tobacco products will
`start using them.
`
`In particular, through the FDA's scientific evaluation of the company's applications,
`peer-reviewed published literature and other sources, the agency found that the
`aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals
`than cigarette smoke, and many of the toxins identified are present at lower levels than
`
`https://www.fda.goy/news-eyents/press-announcements/fda-permits-sale-iqos-tobacco-heat... 6/25/2020
`1 199_RESP00010616
`
`

`

`FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product a... Page 3 of 5
`Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 4 of 6 PageID# 35106
`
`in cigarette smoke. For example, the carbon monoxide exposure from IQOS aerosol is
`comparable to environmental exposure, and levels of acrolein and formaldehyde are
`89% to 95% and 66% to 91% lower than from combustible cigarettes, respectively.
`
`Additionally, IQOS delivers nicotine in levels close to combustible cigarettes
`suggesting a likelihood that IQOS users may be able to completely transition away
`from combustible cigarettes and use IQOS exclusively. Available data, while limited,
`also indicate that few non-tobacco users would be likely to choose to start using IQOS,
`including youth.
`
`While these non-combusted cigarettes may be referred to as "heat-not-burn" or
`"heated" tobacco products, they meet the definition of a cigarette in the Federal Food,
`Drug and Cosmetic Act. Therefore, these products must adhere to existing restrictions
`for cigarettes under FDA regulations, as well as other federal laws that, among other
`things, prohibit television and radio advertising. In addition, to further limit youth
`access to the products and exposure to their advertising and promotion, the FDA is
`placing stringent restrictions on how the products are marketed — particularly via
`websites and through social media platforms — by including requirements that
`advertising be targeted to adults. The company must also give notification to the FDA
`of, among other things, its labeling, advertising, marketing plans, including
`information about specific adult target audiences, and how it plans to restrict youth
`access and limit youth exposure to the products' labeling, advertising, marketing and
`promotion. The agency has issued a document
`(https://www.fda.gov/media/124174/download) providing its rationale for these
`postmarket requirements, which highlight important considerations for reviewing the
`company's applications as well any potential future PMTAs for other products.
`
`The FDA also is requiring all package labels and advertisements for these products to
`include a warning about the addictiveness of nicotine, in addition to other warnings
`required for cigarettes, to prevent consumer misperceptions about the relative
`addiction risk of using IQOS compared to combusted cigarettes.
`
`With the authorization of these products, the FDA will evaluate new available data
`regarding the products through postmarketing records and reports required in the
`marketing order. 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
`
`https://www.fda.goy/news-eyents/press-announcements/fda-permits-sale-iqos-tobacco-heat... 6/25/2020
`1 199_RESP00010617
`
`

`

`FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product a... Page 4 of 5
`Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 5 of 6 PageID# 35107
`
`experiences. The FDA may withdraw a marketing order if it, among other reasons,
`determines that the continued marketing of a product is no longer appropriate for the
`protection of the public health, such as if there is an uptake of the product by youth.
`
`The FDA is continuing its substantive scientific review of the company's MRTP
`applications. The company would need to receive an MRTP order from the FDA before
`they could market a tobacco product with any implicit or explicit claims that, among
`other things, a product reduces exposure to certain chemicals or that use of the
`product is less harmful than another tobacco product or would reduce the risk of
`disease. If a company markets a tobacco product as an MRTP without authorization,
`the company would be in violation of the law and may face FDA advisory or
`enforcement actions.
`
`###
`
`Inquiries
`
`Media:
`
`M Michael Felberbaum (mailto:michael.felberbaum@fda.hhs.gov)
`
`k. 240-402-9548
`
`Consumer:
`
`888-INFO-FDA
`
`Related Information
`
`• Premarket Tobacco Product Marketing Orders (/tobacco-products/premarket-
`tobacco-product-applications/premarket-tobacco-product-marketing-orders)
`
`• Premarket Tobacco Product Applications (/tobacco-products/market-and-
`distribute-tobacco-product/premarket-tobacco-product-applications)
`
`• Modified Risk Tobacco Products (Modified Risk Tobacco Products)
`
`• Market and Distribute a Tobacco Product (/tobacco-products/products-
`guidance-regulations/market-and-distribute-tobacco-product)
`
`https://www.fda.goy/news-eyents/press-announcements/fda-permits-sale-iqos-tobacco-heat... 6/25/2020
`1 199_RESP00010618
`
`

`

`FDA permits sale of IQOS Tobacco Heating System through premarket tobacco product a... Page 5 of 5
`Case 1:20-cv-00393-LMB-TCB Document 1406-8 Filed 08/12/22 Page 6 of 6 PageID# 35108
`
`• Modified Risk Tobacco Products (/tobacco-products/advertising-and-
`promotion/modified-risk-tobacco-products)
`
`0 More Press Announcements (hews-events/newsroom/press-announcements)
`
`https://www.fda.goy/news-eyents/press-announcements/fda-permits-sale-iqos-tobacco-heat... 6/25/2020
`1 199_RESP00010619
`
`