AgdaPkt 2020-03-09 Joint - Laserfiche WebLink

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9.A. - Page 16 of 31 showing that permitting the sale of a tobacco product would be appropriate for the protection of the public health, the Tobacco Control Act requires that the FDA deny an application for premarket review. (m) Virtually all electronic cigarettes that are sold today entered the market after 2007, but have not been reviewed by the FDA to determine if they are appropriate for the public health. In 2017, the FDA issued Guidance that purports to give electronic cigarette manufacturers until August 8, 2022 to submit their application for premarket review. The Guidance further purports to allow unapproved products to stay on the market indefinitely, until such time as the FDA complies with its statutory duty to conduct a premarket review to determine whether a new tobacco product poses a risk to public health. In 2019, the FDA issued draft guidance in which it considered moving the premarket application deadline up by one year for certain flavored e -cigarette products.14 In July of 2019, a U.S. District Court issued an order requiring manufacturers to submit a premarket review application by May 12, 2020 for deemed tobacco products, which includes e -cigarettes, that were on the market as of August 8, 2016. However, that order has been appealed and a stay requested. Thus, the deadlines for applications for premarket review, and timelines for any premarket review orders, are in flux and uncertain. (n) By the time e -cigarette manufacturers will be required to submit their premarket review applications, e -cigarettes will have been on the market for approximately fifteen years without any FDA analysis of their safety and alleged benefit. If current trends continue, six million more youth in the United States will begin using e -cigarettes between now and then. Until such time as the FDA fulfills its statutory duty to conduct premarket reviews of new tobacco products, a generation of young people will become addicted to tobacco, resulting in an entirely preventable increase in the burdens and tragedies associated with tobacco use. The County of San Mateo is not content to continue to wait before addressing, for its residents, what appears from the evidence to be a major public health crisis that is going unattended by federal or state regulation. SECTION 2. New Chapter 4.95 Added. A new Chapter 4.95 is added to the San Mateo County Ordinance Code, to be numbered and entitled and to read as follows: Chapter 4.95. Sale or Distribution of Electronic Cigarettes. 14 FDA. (2019, June). Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems — Guidance for Industry. Retrieved from https://www.fda.gov/media/127853/download 293