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O 702 ORDINANCE NO. 702 AN ORDINANCE OF THE CITY COUNCIL OF THE CITY OF ARROYO GRANDE AMENDING CHAPTER 8.36 OF THE ARROYO GRANDE MUNICIPAL CODE TO PROHIBIT THE SALE AND DISTRIBUTION TO ANY PERSON IN ARROYO GRANDE ELECTRONIC CIGARETTES AND VAPING PRODUCTS THAT REQUIRE, BUT HAVE NOT RECEIVED, A FOOD AND DRUG ADMINISTRATION ORDER APPROVING THEIR MARKETING WHEREAS, based upon its concerns about use of tobacco products, the City Council of the City of Arroyo Grande has previously adopted Arroyo Grande Municipal Code Chapters 8.36 – Tobacco Products and Chapter 8.38 – Licensing of Tobacco Retailers; and WHEREAS, the federal government has enacted numerous tobacco related laws that include, but are not limited to the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”), enacted in 2009, that prohibited candy and fruit-flavored cigarettes, largely because these flavored products are marketed to youth and young adults, and younger smokers were more likely than older smokers to have tried these products. Among other things, the Tobacco Control Act authorized the U.S. Food and Drug Administration ("FDA") to set national standards governing the manufacture of tobacco products, to limit levels of harmful components in tobacco products and to require manufacturers to disclose information and research relating to the products' health effects; and WHEREAS, a central requirement of the Tobacco Control Act is premarket review of all new tobacco products. Specifically, every "New Tobacco Product" which is defined by federal law to be any tobacco product not on the market in the United States as of February 15, 2007, must be authorized by the FDA for sale in the United States before it may enter the marketplace; and WHEREAS, a New Tobacco Product may not be marketed until the FDA has found that the product is: (1) appropriate for the protection of the public health upon review of a premarket tobacco application; (2) substantially equivalent to a grandfathered product; or (3) exempt from substantial equivalence requirements; and WHEREAS, in determining whether the marketing of a tobacco product is appropriate for the protection of the public health, the FDA must consider the risks and benefits of the product to the population as a whole, including users and nonusers of the product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using tobacco products and the increased or decreased likelihood that those who do not use tobacco products will start using them. Where there is a lack of 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; and ORDINANCE NO. 702 PAGE 2 WHEREAS, it has been reported that nearly all electronic cigarettes and vaping products 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; and WHEREAS, in 2017, the FDA issued guidance that purports to give electronic cigarette manufacturers until August 8, 2022 to submit their application for premarket review. That 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 March 2019, the FDA issued draft guidance in which it considered moving the premarket application deadline up by one year for certain flavored electronic cigarette products. It is not known when, if ever, this narrow adjustment will become final or will take effect; and WHEREAS, on July 11, 2019, the United States District Court for the District of Maryland in the case American Academy of Pediatrics v. FDA issued a ruling to advance the submission deadlines for premarket review of certain tobacco products, including electronic cigarettes. As a function of that ruling, the deadline for applications for FDA premarket review of electronic cigarettes would have been shortened to May 11, 2020. However, on October 24, 2019, the Justice Department appealed the Judge’s decision to shorten the product approval deadline, thus creating greater uncertainty as to when such review will occur; and WHEREAS, even based on the 2017 FDA guidance, by the time electronic cigarette manufacturers will be required to submit their pre-market review applications, electronic cigarettes will have been on the market for nearly fifteen years without any FDA analysis of their safety and alleged benefit. Recent reports of illness and death caused by unregulated vaping devices is a public health crisis. In response, the City and County of San Francisco, the City of Richmond and the City of Livermore have passed Ordinances that prohibit the sale of any electronic cigarette or vaping device that has not received an order from the FDA approving their marketing. The State of Massachusetts has also enacted emergency legislation to ban the sale of all vaping products for four months in response to this public health emergency; and WHEREAS, the City of Arroyo Grande is also not content to wait and do nothing given the health issues associated with unregulated electronic cigarettes and vaping devices and therefore desires to adopt an ordinance that will prohibit the sale of all electronic cigarettes and vaping devices until such devices are approved by the FDA and deemed safe. NOW THEREFORE, THE CITY COUNCIL OF THE CITY OF ARROYO GRANDE DOES ORDAIN AS FOLLOWS: SECTION 1. The above recitals and findings are true and correct and are incorporated herein by this reference. SECTION 2. Section 8.36.050 is hereby added to Chapter 8.36 of Title 8 of the Arroyo Grande Municipal Code, to read in its entirety as follows: ORDINANCE NO. 702 PAGE 3 Section 8.36.050 – Sale and Distribution of Electronic Cigarettes and Vaping Products that Require, But Have Not Received, a Food and Drug Administration Order Approving Their Marketing. A. Definitions: The following words and phrases, whenever used in this chapter, shall have the meanings defined in this section unless the context clearly requires otherwise: "Distribute" or "distribution" means the transfer, by any person other than a common carrier, of an electronic cigarette or vaping project at any point from the place of manufacture or thereafter to the person who sells the electronic cigarette or vaping product to an individual for personal consumption, including but not limited to such transfers by licensed tobacco retailers, excluding online transactions. “Electronic cigarette” and “vaping product” shall mean: 1) any product intended for human consumption by inhalation regardless of nicotine content, whether for one- time use or reusable, that relies on vaporization or aerosolization, including but not limited to electronic cigarettes, electronic cigars, electronic cigarillos, electronic pipes, electronic vaping product delivery pens, hookah pens, and any other similar devices that rely on vaporization or aerosolization; and 2) any component, part, or accessory of a product or device defined in 1 above, including flavored vape juices and liquids used in such devices, even if sold separately. “Electronic cigarette” and “vaping product” does not include any product that has been approved by the federal Food and Drug Administration either as a tobacco use cessation product or for other medical purposes and which is being marketed and sold or prescribed solely for the approved purpose. “New Tobacco Product” shall have the meaning set forth in 21 U.S.C. § 387j(a)(1), as may be amended from time to time. "Sell,” "Sale, " and "to Sell" mean any transaction where, for any consideration, ownership of an electronic cigarette or vaping product is transferred from one person to another, including but not limited to any transfer of title or possession for consideration, exchange, or barter, in any manner or by any means, including but not limited to such transactions by licensed tobacco retailers, excluding online transactions. In addition, “Person” and "Tobacco retailer" shall have the meanings defined in Arroyo Grande Municipal Code Section 8.38.020. B. Sale of electronic cigarettes and vaping products prohibited. 1. No person shall sell or distribute an electronic cigarette or vaping product in retail establishments, excluding online, including all non-flavored and flavored vaping products, including mint and menthol, to a person in the City of Arroyo Grande where the electronic cigarette or vaping product is: a. is a New Tobacco Product; ORDINANCE NO. 702 PAGE 4 b. requires premarket review under 21 U.S.C. § 387j, as may be amended from time to time; and c. does not have a premarket review order under 21 U.S.C. § 387j(c)(1)(A)(i), as may be amended from time to time. C. Violations. Persons violating any provisions of this section shall be deemed guilty of a misdemeanor and, upon conviction thereof, shall be punished by a fine not to exceed one thousand ($1,000) dollars or by imprisonment in the county jail for a period not to exceed six months or by both such fine and imprisonment. Any violations of these provisions shall constitute a separate offense for each and every day during which such violation is committed or continued. In addition to any other penalty authorized by law, violations by licensed tobacco retailers shall also be subject to suspension or revocation of their license in accordance with the provisions of AGMC Section 8.38.110.” SECTION 3. This ordinance is exempt from CEQA pursuant to CEQA Guidelines Section15061 (b)(3) which is the general rule that CEQA applies only to projects that have the potential for causing a significant effect on the environment and CEQA does not apply where it can be seen with certainty that there is no possibility that the activity may have a significant effect on the environment. SECTION 4. A summary of this Ordinance shall be published in a newspaper published and circulated in the City of Arroyo Grande at least five (5) days prior to the City Council meeting at which the proposed Ordinance is to be adopted. A certified copy of the full text of the proposed Ordinance shall be posted in the office of the City Clerk. Within fifteen (15) days after adoption of the Ordinance, the summary with the names of those City Council members voting for and against the Ordinance shall be published again, and the City Clerk shall post a certified copy of the full text of such adopted Ordinance. SECTION 5. This Ordinance shall take effect and be in full force and effect three months after its passage. SECTION 6. If any section, subsection, sentence, clause, or phrase of this Ordinance is for any reason held to be invalid or unconstitutional by a decision of any court of competent jurisdiction, such decision shall not affect the validity of the remaining portions of this Ordinance. The City Council hereby declares that it would have passed this Ordinance and each and every section, subsection, sentence, clause, or phrase not declared invalid or unconstitutional without regard to whether any portion of the ordinance would be subsequently declared invalid or unconstitutional. On motion by Mayor Ray Russom, seconded by Council Member George, and by the following roll call vote to wit: AYES: Mayor Ray Russom and Council Members George, Paulding, Storton, Barneich NOES: None ABSENT: None th the foregoing Ordinance was adopted this 26 day of November, 2019. ORDINANCE NO. 7o2- PAGE 5 i) r CAREN RAY - U., SOM, MAYOR ATTEST: 4 th4 A _ KELLY E RE, CITY CLERK APPROVED AS TO CONTENT: .1-h• { *ter JAMES AN, CITY MANAGER APPROVED AS TO FORM: TIMOTHY J. CARMEL, CITY ATTORNEY OFFICIAL CERTIFICATION I, KELLY WETMORE, City Clerk of the City of Arroyo Grande, County of San Luis Obispo, State of California, do hereby certify under penalty of perjury, that the attached Ordinance No. 702 which was introduced at a regular meeting of the City Council on November 12, 2019; was passed and adopted at a regular meeting of the City Council on the 26th day of November 2019; and was duly published in accordance with State law (G.C. 40806). WITNESS my hand and the Seal of the City of Arroyo Grande affixed this 27th day of November 2019. rl - KELLY ET RE, CITY CLERK