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CORRESPONDENCE - #39
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CORRESPONDENCE - #39
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FDA Actions on Electronic Cigarettes and Other Nicotine Products: The FDA has taken significant <br /> actions that have resulted in the removal of a substantial number of flavored electronic nicotine delivery <br /> system (ENDS) products from the market. These strong measures should be allowed to work to further <br /> reduce youth access to and use of electronic nicotine vapor products. <br /> Specifically, in February 2020, the FDA adopted a ban on the sale of all flavored cartridge-based and pod- <br /> based electronic cigarettes, except for tobacco and menthol flavored products. This action removed <br /> hundreds of ENDS products from the market. In addition, the FDA required that manufacturers of all <br /> electronic cigarette products file what is known as a pre-market tobacco product application(PMTA)with <br /> the agency by September 9, 2020, to keep their products on the market. <br /> The FDA was required to process those PMTAs within one year. That year elapsed in September 2021, and <br /> the Food and Drug Administration has thus far completed about 99% of the reviews of the Pre-Market <br /> Tobacco Applications it received by its September 2020 deadline.Most of the applications are for electronic <br /> smoking devices and products used with them. The FDA has thus far rejected over 6 million electronic <br /> smoking devices and has granted exactly one application for an e-cigarette,Vuse Solo,and for two tobacco- <br /> flavored cartridges used with that device. <br /> The FDA has also granted marketing applications for four flavored modern nicotine products,Verve Discs <br /> and Verve Chews in Blue Mint and Green Mint flavors. These are the first non-tobacco flavored products <br /> that have been granted marketing authority by the FDA. The significance of the Vuse and Verve decisions <br /> should not be lost on the Council. For the FDA to grant those applications, it was required to and did find, <br /> after exhaustive scientific studies, that the marketing of those products was "appropriate for the protection <br /> of the public health." By granting these applications, for the first time the FDA has stated that electronic <br /> smoking devices and modern oral nicotine products, including non-tobacco flavored versions of the latter, <br /> could protect public health. As the FDA is still working on the remaining 1% of applications (covering <br /> about 55,000 products) filed by the September 2020 deadline, it would be premature for the City to issue a <br /> blanket ban on all flavored tobacco products as the FDA may well grant marketing approval of other <br /> products,some of which may be flavored,that are"appropriate for the protection of the public health." The <br /> city's ban on those products would work against the public health benefits of those products. <br /> Voters Want to Decide Whether Flavor Bans Make Sense: California Senate Bill 793, which would <br /> have banned most flavored tobacco products statewide, has been referred to the voters who will vote in <br /> November 2022 whether to allow the statewide flavor ban bill to go into effect. Voters want their say on <br /> flavor bans.We respectfully suggest that deferring action until the voters have spoken is in the best interests <br /> of Santa Ana and its retailers. <br /> Store Closures and Layoffs May Follow the Proposed Ban: Our convenience store members recently <br /> experienced losses of up to 45%in gasoline sales and 20%or more in grocery,snack,beverage,and tobacco <br /> product sales during the recent market disruptions, significant numbers because convenience stores usually <br /> rely on tobacco product sales for approximately 36% of in-store sales. Tobacco specialty stores that rely <br /> on tobacco product sales for up to 90%of total sales will be devastated by the loss of hundreds of products. <br /> Additionally, retailers have recently found it difficult to attract and retain employees and combined with <br /> the effects of inflation,payroll costs continue to rise. <br /> If Santa Ana retailers must remove hundreds of products from their shelves, it will be very difficult to <br /> compete with retailers in neighboring localities or with illicit sellers who do not care to whom they sell their <br /> products. Employee layoffs and even store closures are real possibilities. <br /> National Association of Tobacco Outlets,Inc.,17595 Kenwood Trail,Minneapolis,MN 55044 952-683-9270 <br /> www.natocentral.org <br />
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