Tobacco Documents Online

FDA LAWSUIT STATEMENT CONTACT (212) 907-5830 AUGUST 10, 1995 FOR IMMEDIATE REt.EASE Good afternoon. I'm Steve Parrish, Senior Vice President, Corporate Affairs for Philip Morris Companies Inc. With me today are Arthur J. Stevens, Senior Vice President and General Counsel, Lorillard Tobacco Company; Marc Firestone, Senior Vice President for Worldwide Regulatory Affairs and Asscciate General Counsel, Philip Morris Companies Inc.; and Arthur Levine and Peter Grossi, partners in the Washington law firm Arnold & Porter. Today, Philip Morris, Inc., the R.J. Reynolds Tobacco Company, the Brown & Williamson Tobacco Corporation, Liggett Group Iric., Lorillard Tobacco Company and Coyne-Beahm Inc., filed suit in the U..83. District Court for the Middle District of North Carolim in order to stop the Food and Drug Administration from proceeding on a course of action that clearly is illegal. The suit follows FDA Commissioner David Kessler's; release of proposed regulations goveming cigarettes. The regulations are based on President Clinton's decision to allow FDA to assert jurisdiction over cigarettes under a federal law that gives the FDA power to regulate medicines, medical devices and pharmaceutical products. The purported justification for the (Z) FDA regulations is to prevent minors from smoking. N ~ ~ ~ aa ~ 1

On this issue, all of us share a common goal. Everyone agrees that minors should not smoke and that kids should not have access to cigarettes. We support a number of steps, both voluntary and by stai:e legislation, that will make aa reai difference on this issue. But regulating cigarettes as medicines, medical devices or pharmaceutical products defies logic, it defies common sense, and -- most importantly -- it defies the law.. This lawsuit is not about youth smoking. This lawsuit is about whether, in defiance of 80 years of clear precedent, David Kessler and the FDA can regulate cigarettes. This lawsuit is about whether David Kessler can unilaterally impose a regulatory scheme that goes far, far beyond his statutory authority. This lawsuit is about whether David Kessler can ignore the authority and repeated directions of Congress, as well as numerous court decisions. David Kessler is trying to sneak through the back door because Congress has repeatedly slammed shut the front door on the issue of regulating cigarettes under the same law the FDA applies to products sold for therapeutic or medicinal purposes. David Kessler's action can only be described as a Trojan Horse, set forwarc~ under the guise of preventing youth smoking. Make no mistake; the real W ~ hidden agenda here is prohibition. ~ 0o U1 2

We believe this lawsuit is our only option in the face of an illegal action that, if successful, even Commissioner Kessler has admitted could lay the groundwork for far more radical action in the future -- action that could ultimately lead to severe restrictions or a ban on the sale of cigarettes to adults. Despite what the Clinton Administration says, Commissioner Kessler simply does not have the authority to regulate cigarettes as medicines, medical devices or pharmaceuticals. The law is clear. The intent of Congress is clear. FDA is the wrong government entity with the wrong legal mandate. Time after time, for more than 80 years, FDA and its predecessor agencies have informed Congress that cigarettes do not meet the criteria for regulation by FDA under existing federal law and Congress has agreed. In amending the Federal Food, Drug and Cosmetic Act nearly 70 times, Congress has never given FDA jurisdiction over tobacco. In fact, on 20 occasions, Congress has failed to pass legislation that would have granted FDA jurisdiction over the tobacco industry. Commissioner Kessler was right last year when he told Congress that he needed Congressional direction before regulating tobacco. Commissioner Kessler is wrong now to reverse himself simply ')ecause the direction he got was not the direction he wanted. And, despite what President Clinton says, he does not have the right to usurp the authority of Congress when it comes to this issue. 3

The law has not changed, the key facts have not changed and Commissioner Kessler's statutory mandate from Con gress has not changed. The stated goal of preventing youth smokirng is a laudable one -- but it does not justify a decision to defy 80 years of clearly stated FDA and Congressional policy. Simply put, Commissioner Kessler and the Clinton Administration cannot ignore the law and the Constitutional protections afforded Americans. The Americaxr people sent a very clear message last year. , As citizens we want less government intrusion in our daily lives. We want politicians to start using some common sense. Saying that cigarettes meet the strict _statutory definition of medicines, medical devices or pharmaceutical products just does not make sense. David Kessler and the anti-smoking cabal would have, the American public believe that cigarettes are an unregulated product. h'iothing could be further from the truth. Nine federal government agencies, including the Federal Trade Commission and the Justice Department, oversee various facets of the tobacco industry. But in each of those cases, oversight has been granted by Congress, and Congress has never delegated the authority to regulate cigarettes to the FDA. Commissioner Kessler says his regulatory goals are narrow and that he does not want Prohibition. 4

But in a letter dated February 25, 1994, Commissioner Kessler wrote the following: "A strict application of these provisions could mean, iItimately, removal from the market of tobacco products containing nicol:ine at levels that cause or satisfy addiction. Only those tobacco products from which the nicotine had been removed or, possibly, tobacco products approved by FDA for nicotine-replacement therapy would then remain on the market." Given the decision by the Clinton Administration and the FDA that it will regulate cigarettes, Commissioner Kessler must now answer the following questions: Does FDA have the authority to ban cigarettes sold to adults? Does FDA believe - as Commissioner Kessler has stated that it must in order to allow a drug or medic.al product to remain on the market -- that cigarettes are "safe" and "effective"? Does FDA have the authority to regulate the content of cigarettes? We do not believe most Americans want an unelected bureaucrat to wield the kind of power that could effectively le~ j to a ban of cigarettes for adults who choose to smoke. 5

There are ways to deal with the challenge of youth smoking without creating the threat to personal liberty and the affront to common sense that the FDA regulation would create. Some are in place now, others are in the process of being implemented. For example, under a recent federal statute, the Department of Health and Human Services is recommending a model law to th e states aimed at reducing minors' access to tobacco products, tying block grants to states to the enactment and enforcement of such laws. The Federal Trade Commission already has broad authority to oversee tobacco advertising and promotional practices, and Congress gave the Department of Justice the authority to enforce the ban on broadcast advertising of tobacco -products. Multi-milliton dollar programs have been put in place in many states to prevent youth smoking, some relying on state appropriations, and many utilizing one of several major sources of federal funding. Among other approaches are increased voluntary actions by the tobacco industry, including cooperative efforts with others, and granting further powers to the states for education and enforcement. If the goal is to prevent the sale of cigarettes to minors, we believe these common-sense approaches will work. Even Presicient Clinton said as recently as Wednesday that government alone car not resolve this issue. As m Philip Morris says regarding its own program on youth access, the best way ~ to keep kids away from cigarettes is to keep cigarettes away from kids. ~ 07 co 6

But we believe Commissioner Kessler -- with the blessing of the Clinton Administration - has a much different agenda. Commissioner Kessler's initiative is an outright defiance of Congress, which haS) retained the right to decide how and by whom cigarettes may be regulated, Congress has stated over and over and over again that it never intended to give FDA the authority that Commissioner Kessler is now asserting and that the Clinton Administration has now endorsed. This is the reason for our action today, and we will pursue every appropriate remedy to see that Commissioner Kessler's decision is overturned. In doing so, we will vigorously defend our right to continue to manufacture and sell cigarettes to adults and we will vigorously defE:nd the rights of adults in this country to purchase cigarettes. ### 7