Tobacco Documents Online

tobacco R-.= EF . P~' 0`` R:. T' E R PASSPORT TO da4A W l~-I ~A T ~ By Colleen Zimmerman Blackard T he swarm brought a little smile to my face. Here, at the Department of Health and Human Services building, home to the Food & Drug Administration in Rockville, Maryland, outside the front entrance's plate glass doors, were ash- trays. And huddled around, lighting up, inhaling and exhaling, and stub- bing out, were 12 smokers. Some might have been visitors, surely others were employees. Although running against the clock, I was compelled to stand with them for a moment, light up, and commune with a nod and a smile and an occa- sional roll of the eyes. Then I went inside. Like many government buildings, FDA is situated in a maze of blank off- white corridors and shiny tiled floors. A sterile environment for the national government's hive of health policy. FDA Commissioner David Kessler was unavailable to mct~: .,ith TR. So Jim O'Hara, FDA associate commis- sioner for public affairs, and Mitch Zeller, special assistant for policy, answered questions instead. Here, a summary of what's on the FDA's mind. TR: Why didn't Commissioner Kessler pursue his tobacco agenda during the Bush Administration, when he was appointed? O'Hara: The genesis of the agency's thinking dates back to the Bush Administration. Shortly after he was named to his post, he considered a petition from COSH (the Coalition on Smoking OR Health)....We began seri- ously looking at the issue in 1991. TR: How many people-what per- centage of employees-are devoted to tobacco-related issues at FDA? O'Hara: We use people as needed to address specific questions. For the nico- tine addiction question, a number of people participated at one time or another. It's almost impossible to count. Zeller: But if you take all of these people and put them on a full-time employee equivalent basis, fewer than two dozen have been devoted to tobac- co issues. And that's out of 10,000 employees. O'Hara: But if vou counted all of the names, it would be a few dozen. Some worked on it for a day, some a week. TR: Is the agency neglecting its mission by pursuing tobacco regula- tory authority? One congressman has said that expanding FDA author- ity is not the answer, particularly when approving life-saving drugs can take years. O'Hara: The fact is, this agency is reviewing and approving drugs, in record time. Historically, during the 1980s, review and approval took 26 to 27 months. In 1994. the median time was 19.1 months. We have significant- ly decreased the agency's historical average. And for important therapeutic drugs under the user fee program, the review/approval process is 10.4 months. We're reviewing and approv- ing drugs faster than ever before. [In future] we will be reviewing all drugs in 12 months, and for important thera- pies, six months. To say that the FDA is not pursuing its core mission is wrong. TR FDA wants to regulate tobac- co: under what authority? Zeller: Under a combination drug and device authority. Nicotine is the drug, and cigarettes and smokeless tobacco are the nicotine delivery devices. 2Q48i61194

O'Hara: The law provides us to choose our approach. We have a lot of flexibility on how we approach sales, use and distribution of the product. TR: How can tobacco be declared legal by FDA if it can't declare it "safe" and "effective" as it is required to? O'Hara: As I said, under the restric- tive device provisions under the statute. TR: Doesn't the Federal Trade Commission have jurisdiction over tobacco advertising? Zeller: FTC's jurisdiction is not exclusive. What we want to do is reduce access and reduce appeal. We have the legal authority to do that. Adult smoking rates are going down; kids' smoking is increasing. This is a kids' issue. It's not about adults; it's about preventing children from smok- ing, preventing the next generation from being hooked. We have 40 million tobacco users who are addicted. Studies show that nicotine is more addictive than heroin and cocaine. We have a public health issue to grapple with, but the commis- sioner has said under oath-many times-that he's not out to ban ciga- rettes. TR: Why not? O'Hara: A ban wouldn't work. The agency's strategy is to keep kids from getting hooked in the first place. Zeller: We can't do it by ourselves. We have to change the environment in which tobacco is sold. This isn't a Big Brother issue. We're providing the tools to help keep kids from using tobacco. And with those tools, anyone who cares can use them. It's up to the rest of us to use those tools. O'Hara: The industry has said repeatedly that we are going to do things we haven't said and haven't done. TR: Why not have the FTC, or another agency that already regu- lates the tobacco industry, expand its jurisdiction? Was there any investi- gation by your agency, or another government agency, to expand juris- diction already in force? O'Hara: The investigation we undertook was within our jurisdiction. But no, I'm not aware of any other investigation [to expand jurisdiction] by any govemment agency. TR: In Dr. Kessler's letter to Scott Ballin, chairman of the Coalition on Smoking OR Health, he says a strict application of agency provisions could mean, ultimately, removal from the market of tobacco products containing nicotine at levels that cause or satisfy addiction. O'Hara: But in the follow- ing paragraph he says he would not pursue a ban. [Editor's Note: What Dr. Kessler actually says in the follow- ing paragraph(s), in his letter to Ballin of Feb. 25, 1994, is: "Given the wide- spread use of ciga- rettes and the preva- AuNo2try. lence of nicotine addiction, such a regulatory action could have dramat- ic effects on our society. One must consider the possible effects of the loss of this source of nicotine on the health of some people who are addicted to nicotine and the possible need for a weaning period. It is also important to consider the potential for a black market in nicotine-con- taining cigarettes. "We recognize that the regulation of cigarettes raises societal issues of great complexity and magnitude. It is vital in this context that Congress provide clear direction to the agency. We intend therefore to work with Congress to resolve, once and for all, the regula- tory status of cigarettes under the Food, Drug and Cosmetic .'u.t."] TR: How does the FDA define addiction? O'Hara: An advisory committee has looked at this. Every major medical group has looked at this question, and each has said cigarettes are addictive. Is there a level below which nicotine in cigarettes is not addictive? We don't have a clue what that level is. There are researchers looking at it, though, inde- pendently. TR: When the FDA asserted it had jurisdiction over tobacco, it surely expected a lawsuit, which of course delays action. Isn't it in youths' best interest to allow Congress to legis- late or work for a voluntary agree- ment with the tobacco industry, which could take effect quickly, rather than assert jurisdiction and tie up your proposal in court for per- haps years? O'Hara: It's the industry that's going to tie this up in court. If the industry is serious about wanting to keep kids off cigarettes, it's time the industry's actions matched its words. The industry can try to improve the proposal. TR: Doesn't Dr. Kessler's initiative need congressional approval? Zeller: Congress' approval is not required. Congress can act now, but it does not require an act of Congress for FDA authority. 10. October 1995 '1T! 25 The industry has not presented any argument to the contrary. Zeller. The industry says cigarettes are not addictive because they do not intoxicate. Intoxication is just one pos- sible criteria. And under no one's defi- nition is it essential. TR: Is it possible the FDA, if it reg- ulated tobacco, would phase down nicotine levels to what it deemed nonaddictive levels? Zeller. It's a theoretical proposition. dOfVG2..E6S CA(tl ACT" Now, F3ur tr 0065 Nar 2EQUi2.E AIV ACf" OF COf\IG2.ESv Fd2. t-r At

4oU cAIV'T 56 Ma26 5Erz,oUs r~Am T2201205imG A 2U LE. TR: Some tobacco compa- nies have already launched their own efforts to reduce teen smoking, like Philip Morris' Action Against Access. Do the industry's efforts go far enough in your opinion? O'Hara: The President has said voluntary efforts will not work. If voluntary efforts mean they're serious, TR: What actions has the agency taken so far? O'Hara: Documents are on display in the Federal Register, and they're available on the Internet. We're accepting com- ments until November 9th. TR: Will FDA extend the com- ment period? O'Hara: The current comment period is November 9. At times, the agency has extended the comment period. But I don't know of any decision made on this. Big Star Warehouse Wilson, North Carolina The heart of U. S flue-cured tobacco country! November 14-15-16,1996 ~A.M.-5 P.M. that's welcome. But what we need are comprehen- sive, enforceable measures. TR: FDA argued it didn't have jurisdiction over tobacco when anti- tobacco group ASH petitioned it in 1980. O'Hara: The court decision said that if circumstances change, the agency could revisit the issue. TR: The President has stated that if teen smoking is not reduce by 50 percent from a 1993 statisti, additional regulations may b introduced. What, in your opir ion, would additional regulatio entail? O'Hara: This is an area open L comment, as to what would be appr( priate. TR: Some observers say FDA h< no intention of regulating tobacco- that actually it is attempting to forc the issue in Congress. O'Hara: We've proposed a rul~ Colleen. You can't be more seriou than proposing a rule. The President has said that ' Congress wants to act as compreher. sively as his approach, he's willing t take a look at that. TR: Do you believe your curren proposal will affect adults? O'Hara: No. There is nothing in ou proposal that affects access to adults tf what will continue to be a legal prod uct. Tn MID-ATLi%iT1C FARM SHOW You'll see the latest in tobacco-growing technology, along with equipment and supplies for a wide range of other crops. a th co For more information contact: ~ ~ ~. jim Swindeii, Mary Taylor or Marge Cazares ~ Specialized Agricultural Publications 3000 Highwoods Blvd., Suite 300, Raleigh, NC 27604, USA 919/872-5040 9s Tn f1,r,tn}~g~r 1Qo1;

tobacco _ " PASSPORT TO . , R ;%:E'~~`P '0 = R ;"T ::f :R INDUSTRY RESPONDS: uct AwiT TR Staff Report F ive U.S. tobacco companies filed suit against the U.S. Food and Drug Administration and David Kessler, the Commis- sioner of Food and Drugs, on 10 August-Brown & Williamson Tobacco Corp., Liggett Group Inc., Lorillard Tobacco Co., Philip Morris Inc. and R.J. Reynolds Tobacco Co.- along with advertising agency Coyne- Beahm Inc. The complaint seeks judicial decla- ration that the FDA has no authority to regulate cigarettes as drugs, and asks that the court enjoin FDA to withdraw its rulemaking proceeding to establish such authority. The suit was filed in federal court in the Middle District of North Carolina. In a 32-page complaint, the plain- tiffs allege that FDA's action is con- trary to Congress' intent to withhold from FDA jurisdiction over cigarettes, is irreconcilable with the existing Federal Cigarette Labeling and Advertising Act, and is beyond FDA's authority in the Federal Food, Drug and Cosmetic Act. For 80 years Congress, the courts and FDA have repeatedly affirmed that FDA lacks authority to regulate cigarettes, or nicotine in cigarettes, as drugs. The plaintiffs allege that FDA's ini- tiative has had and will have a signifi- cant negative impact on them. While the FDA initiative has no immediate legal effect, FDA's assertion of jurisdic- tion is its final determination. Accordingly, the plaintiffs are seeking judicial review. On Aug. 10, the plaintiffs gathered to make a statement on their FDA lawsuit. Speaking on behalf of the group was Steve Parrish, senior vice president, corporate affairs, for Philip Morris Cos. Following, his remarks: "Today, [the plaintiffs] ... filed suit in the U.S. District Court for the Middle District of North Carolina in order to stop the Food and Drug Administration from proceeding on a course of action that clearly is illegal. "The suit follows FDA Commis- sioner David Kessler's release of pro- posed regulations governing ciga- rettes. The regulations are based on President Clinton's decision to allow FDA to assert jurisdiction over ciga- rettes under a federal law that gives the FDA power to regulate medicines, medical devices and pharmaceutical products. The purported justification for the FDA regulations is to prevent minors from smoking. "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 ciga- rettes. We support a number of steps, both voluntary and by state legisla- tion, that will make a real difference on this issue. "But regulating cigarettes as medi- cines, medical devices or pharmaceu- tical products defies logic, it defies common sense, and-most impor- tant-it defies the law. "This lawsuit is not about youth 2R TR QnfnBer 1995

s7noking. This lawsuit is about whether, in defiance of 80 vears 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 for- ward under the guise of preventing youth smoking. Make no mistake; the real hidden agenda here is prohibi- tion. "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 restric- tions 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 phar- maceuticals. 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 agen- cies have informed Congress that cig- arettes do not meet the criteria for reg- ulation 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 juris- diction 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 because the direction he got was not the direc- tion he wanted. And, despite what President Clinton says, he does not have the right to usurp the authority of Congress when it comR•, to this issue. "The law has not changed, the key facts have not changed and Commissioner Kessler's statutory mandate from Congress has not changed. The stated goal cau2-4_5E OF Acrlam r~4rAr iS CLE(A2LY iLLEGAL. of pre venting youth smoking 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 can- not ignore the law and the constitu- tional protections afforded Amer- icans. "The American 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-smok- ing cabal would have the American public believe that cigarettes are an unregulated product. Nothing 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. But in a letter dated Feb. 25, 19Q-k, Commissioner Kessler «•r<,re the tol- lowing: 'A strict application of these provisions could mean, ultimately, removal from the market of tobacco products contain- ing nico- tine at PLAil`!?iF'F'r'- FILED 5uizr...iN a2vE2 ro 5roT" t-r A F'2UM VQOCEEDiNG ON A levels that cause or satisfv addic- tion. Onlv those tobacco products from which the nicotine had been removed or, possibly, tobacco products approved by FDA for nico- tine-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 follow- ing questions: • Does FDA have the authoritv to ban cigarettes sold to adults? • Does FDA believe-as Com- missioner Kessler has stated that it must in order to allow a drug or med- ical product to remain on the mar- ket-that cigarettes are "safe" and "effective"? • Does FDA have the authority to regulate the content of cigarettes? "We do not believe most Ameri- cans want an unelected bureaucrat to wield the kind of power that could effectively lead to a ban of cigarettes for adults who choose to smoke. "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 I I I

the FDA regulation would create. Some are in place now, others are in the process of being implemented. "For example, under a recent feder- al statute, the Department of Health and Human Services is recommend- ing a model law to the 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 alreadv has broad authority to oversee tobacco advertising and promotional practices, and Congress gave the Departmer: of justice the authority to enforce the ban on broadcas` ea~rtisinb of tobacco products. "Multimillion dollar pro- grams have been put in place in many states to pre- vent youth smoking, some relying on state appropria- tions, and mant ~ one of several maior sources of feder- al 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 President Clinton said as recent- ly as Wednesday that Qovernment alone cannot resolvt ti.rs issue. As 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. "But we believe Commissioner Kessler-with the blessing of the Clinton Administration-has a much different agenda. Commissioner Kessler's initiative is an outright defi- ance 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 pur- sue every appropriate remedy to see that Commissioner Kessler's decision is overturned. "In doing so, we will vigorously defend our right to continue to manu- facture and sell cigarettes to adults, and we will vigorously defend the rights of adults in this country to pur- chase cigarettes." 'R't WITHOUT OUR IDEAS, YOUR PRODUCTS WOULD BE OUT OF SHAPE When the garniture tape successfully combines production speed with perfect rod quality, when the suction tape transports tobacco with precision and minimum waste, in short: when your machine efficiency is high and your production costs are low... you will find one of our ideas at work. Ideas that have proven themselves: each and every ciga- rette and filter making machine is originally equipped with Esband®. There is no better re- commendation. Count on the world's leading spe- cialist for endless garniture and suction tapes, drum tyres and high-performance drive belts. Call us: Germany 7324- it* 150. Or send us a fax: Germany 7324-1515. Our ideas will optimize your production process as well. Schlatterer Esband® Puttinp Ilut in Motlon C, Fr R Pt pr