04-23-1997 Council Agenda - Laserfiche WebLink

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(• • FDA tobacco regulation pre - emption update Kent Sulem The February 12 Cities Bulletin provided a summary of the new FDA tobacco along with a warning to cities about the possible pre- emption of certain local tobacco - related ordi- nances and the need of cities to seek a waiver of pre- emption from the FDA. While final details are still being discussed, the League has obtained additional information as to who will need to seek a waiver and how the waiver process will work. First, only those provisions of a local tobacco ordinance that provide for a different regulation on a matter expressly covered by the FDA regula- tions will be considered pre - empted without a waiver. Provisions not regulated by the FDA or that impose the same restrictions as the FDA regulations are not pre - empted. In other words, a city ordinance prohibit- ing anyone under the age of 18 from selling tobacco products would not be pre- empted by the FDA regulations since those regulations do not address the age of clerks. Similarly, a local ordinance prohibiting the sale of individual cigarettes would not be pre- empted as such a restriction would be identical to the provision in the FDA regulations. On the other hand, a complete ban on vending machines would be pre - empted without a waiver since the FDA regulations will allow vending machines in certain busi- nesses, provided that no one under the age of 18 is allowed in the establishment. Differences in penalty provisions are exempt from the scope of possible preemption. Also, contrary to original reports, a local ordinance will not be pre - empted simply because it fails to address an area the FDA has decided to regulate. Vendors, however, will still need to comply with the FDA regula- tions. Law enforcement agents will be expected to enforce the FDA regula- tions in the same manner as any other state or federal law. If a local ordinance does not regulate an area covered by the FDA regulations, advertising for example, the city may elect to adopt the FDA language and enforce the requirements through their local ordinances. Cities may also elect to amend their ordi- nances to require compliance with the FDA regulations as condition of licensure and provide for the denial, suspension or revocation of a license upon violation of the FDA regulations. Finally, cities may elect to simply keep their local ordinances separate from the enforcement of the FDA regula- tions provided no pre - emption exists. Any city that has a tobacco ordinance, should review the provi- sions of that ordinance against the summary of the FDA regulations in the February 12 Cities Bulletin to see if any differences exist that might subject the ordinance to pre - emption. The Cities Bulletin will include any additional information for making this determination as it becomes available. In the meantime cities should consult their city attorneys. As always, the League is happy to answer questions. It is unlikely, however, that there will be time to review each city's indi- vidual ordinance. The FDA will provide formal letter rulings on pre- emption questions, but there is likely to be a significant delay in response given the anticipated backlog brought on by review requests coming in from across the nation as the FDA regula- tions take effect. The Tobacco Control Resource Center at Northeastern University School of Law in Boston has estab- lished the "FDA Exemption Clearing- house" as a resource for local units of government to obtain information about the FDA regulations, how to determine if an ordinance is pre- empted by the regulations and, if it is, how to seek a waiver. Bob Kline of the Clearinghouse contacted the League and has offered to extend his organization's resources to Minnesota cities. The Clearinghouse can be reached by calling toll free (888) FDA - EXEMPT or (888) 332 -3936. Informa- tion can also be obtained through the Clearinghouse's website at www.tobacco.neu.edu. Mr. Kline has already given the League a model application that could be used for requesting a pre - emption waiver from the FDA. League staff will be meeting with the Minnesota Attorney General's office on March 10 to discuss a coordinated waiver application to the FDA, which is the FDA's stated preference. It appears, however, that even in a coordinated application, each individual city in need of a wavier will have to supply certain information. Because a May 6 deadline has been imposed for receiving priority review of waiver applications, cities that believe they may need a waiver are encouraged to begin collecting the following information: • A copy of all minutes in which any discussion leading to the adoption of the tobacco ordinance is recorded. • Any interpretation of the local ordinance that may have been issued. • A listing of all provisions of the ordinance that may trigger pre- emption. • An explanation of why the city adopted the provision(s) subject to pre - emption. • A summary of how the provision(s) is either more restrictive than the FDA regulation, or the compelling local conditions that require that the provision and not the conflicting FDA regulations be enforced. • The name of the primary person responsible for administration of the ordinance. The standard of review the FDA will use in granting a waiver will be to see if the local ordinance provision is in fact more restrictive than the FDA regulation or, if it is not, whether there is a compelling need for the local regulation instead of the FDA regula- tion. Waivers are expected to be granted fairly liberally. Please contact Kent Sulem, LMC codification attorney, at (612) 281- 1245 if you have any questions about this issue. It Page 129 March 5, 1997 Page 7