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P I rn 0 M <br /> %..aq C I li . 4 I ON <br /> • <br /> ONLy <br /> • 5. What is the impact of the FDA regulations on local ordinances? <br /> The FDA has made it clear that they want to encourage local units of government to continue to <br /> adopt and enforce local regulations that have the effect of furthering the prevention of youth <br /> access to cigarettes and tobacco. However, under the provisions of the Federal Act authorizing <br /> the regulations, any provision of a local regulation that regulates in a different manner any matter <br /> covered by the FDA regulation is preempted. Provisions that are identical or substantially <br /> similar to the language contained in the FDA regulations are not preempted, nor are provisions <br /> governing issues not directly addressed in the FDA regulations. <br /> Examples of preempted ordinance provisions include complete bans on vending machines and <br /> self-service restrictions that are not a complete ban on such transactions. On the other hand, <br /> general licensing requirements are not preempted as the FDA regulations are silent on the issue <br /> of licensure. Further, an ordinance provision prohibiting the sale of cigarettes to anyone under <br /> the age of 18 would not be preempted as such a provision mirrors the FDA requirement. Penalty <br /> provisions are also specifically exempt from preemption. <br /> A waiver process has been established to allow local regulations that are more restrictive than the <br /> FDA regulations, or for which the local unit of government can demonstrate a compelling need <br /> based on the unique circumstances of that particular entity. The League is working with <br /> 4110 representatives of the Minnesota Attorney General's office and the Minnesota Department of <br /> Health to develop a coordinated waiver application process for cities with ordinances containing <br /> preempted language. A preemption review guide and model waiver application form will be <br /> made available to cities by late March or early April. May 6, 1997 has been set as the deadline <br /> for priority review of waiver applications and it is hoped that a coordinated application on behalf <br /> of at least a majority of cities in need of a waiver can be submitted by that date. <br /> 6. Isn't there a pending lawsuit over the FDA tobacco regulations? <br /> Coyne Beahm, Inc. et al. V. United States Food& Drug Administration and David Kessler was <br /> filed in Greensboro, North Carolina seeking an injunction against the regulations as well as a <br /> finding the FDA lacks authority to regulate tobacco, and that the regulations as adopted are <br /> unconstitutional. A hearing was held on February 10 seeking a preliminary injunction blocking <br /> enforcement of the requirements but no immediate order was granted. At least a preliminary <br /> ruling is expected in April. Even if the regulations were to be enjoined or held unconstitutional <br /> in North Carolina, which is in the fourth federal judicial district, the FDA may elect to continue <br /> enforcement in other districts such as Minnesota, which is in the 8th federal judicial district, until <br /> such time as a Supreme Court ruling is issued or further successful challenges are made in other <br /> judicial districts. <br /> III <br /> -over- <br />