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Philip Morris

FDA Message Points

Date: Oct 1995 (est.)
Length: 33 pages
2046117391-2046117423
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Area
COUGHLIN,MARY/OFFICE
Document File
2046117335/2046117425/FDA - Messages & Op-Eds - Speech@ 2046117336/2046117424/FDA - Messages & Op-Eds - Speech
Type
REPT, REPORT, OTHER
Litigation
Stmn/Produced
Named Organization
1st Amendments Group
Aclu
Action Against Access
Associated Press
Congress
FDA, Food and Drug Administration
Paul Weiss
Wlf, Washington Legal Foundation
Site
N641
Named Person
Clinton
Kessler
Rudman, W.
Request
Stmn/R1-099
Attachment
2046117391/2046117423
Date Loaded
05 Jun 1998
UCSF Legacy ID
sji06e00

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FM Message Points Outline and Table of Contents I. Separate Youth Issue from FDA and President's Proposals p.3 A. Everyone Agrees That Kids Shouldn't Smoke 4 B. Legal Barriers to FDA Regulation 4 C. Smoking Is, and Should Remain, a Matter of Adult Choice - 5 D. FDA's Real Agenda: Prohibition 6 Ii. Advertising and the First Amendment 7 A. Truthful Commercial Speech Is Protected by the First Amendment 8 B. No Relation Between Advertising and Smoking Incidence 8 C. Advertising Designed to Promote Brand Loyalty and Brand Switching 9 D. Impact of Limits on Advertising, Promotion and Event Sponsorship 10 E. Slippery Slope of Restrictions on Free Speech 10 III. Absurdity: The Wrong Approach and the Right Approach 11 A. Youth Smoking Issue Should Be Addressed Now, With Effective, Enforceable Measures 12 B. FDA's Bureaucratic Approach Is Misguided. 13 C. Wrong Approach 14 D. Budget Implications 15 E. Right Approach: Action Against Access 15 IV. Economics, Taxes, Creation of Black Market 20 A. Economic Impact on the Tobacco Industry 21 B. Impact on Government Revenues 22 C. Creation of Black Market 22
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page 2 V. Election Messages page 24 A. Less Regulation in Our Daily Lives 25 B. An End to Federal Nannyism 25 C. Adult Choice 26 D. Budget Concerns 26 E. Administration and Presidential Priorities 26 VI. Slippery Slope 28 A. Tobacco-Specific Threats =. 29 B. Will Other Products Be Affected? 29 C. Loss of Freedom 30 VII. FDA Mission 31 A. Lacks Congressional Direction 32 B. Neglecting Vital Duties 33
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page 3 Executive Summary: Section I Key Messages "We all agree that kids should not smoke. Philip Morris U.S.A. supports measures to prevent youth access to cigarettes and reduce the incidence of underage smoking. The FDA is the wrong agency for the job, and the agency has no jurisdiction over tobacco products. Philip Morris U.S.A.'s opposition to FDA's plan has nothing to do with youth smoking. Key Messengers PM and co-plaintiffs Legal experts Former FDA officials State officials and legislators Anti-regulation groups "True mission" groups, such as end-users of FDA-regulated products Message Point Outline I. Separate Youth Issue from FDA and President's Proposals A. Everyone Agrees That Kids Shouldn't Smoke, and Philip Morris U.S.A. Fully Supports Efforts That Will Address the Central Issue -- Youth Access -- Now. B. Legal Barriers to FDA Regulation C. Adults Have the Right to Choose Legal Products D. FDA's Real Agenda: Prohibition
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page 4 I. Separate Youth Issue from FDA Jurisdiction and the President's Proposals A. Everyone agrees that kids shouldn't smoke, and Philip Morris U.S.A. fully supports efforts that will address the central issue -- youth access- now. 1) Smoking is an adult decision. Philip Morris U.S.A. agrees with President Clinton and FDA Commissioner Kessler that minors should not smoke and should not have access to cigarettes. 2) With respect to youth smoking, we believe the issue is access. The best way to keep kids away from cigarettes is to keep cigarettes away from kids. We support a number of steps, both voluntary and legislative, that will make a real difference on this issue, now. 3) Parents, teachers and other community leaders all have a critical role to play in attacking youth smoking. 4) Retailers, state policy makers and law enforcement agencies must then ensure that minors cannot buy tobacco products. Laws against tobacco sales to•minors, which are on the books in all 50 states, must be enforced. B. Legal Barriers to FDA Regulation 1) The industry's lawsuit against the FDA is not about underage smoking. The lawsuit is about whether the FDA is authorized to regulate cigarettes. 2) We believe the lawsuit is our only option in the face of an assertion-of jurisdiction that Commissioner Kessler has admitted could lay the groundwork for a ban
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page 5 on the sale of cigarettes to adults. Our own initiative against youth smoking received no response from the FDA. 3) We support the strengthening and enforcement of state laws designed to help prevent minors from gaining access to tobacco products. 4) The FDA is not authorized to regulate tobacco products. - 5) Congress has reserved to itself the power to regulate tobacco. In the 70 times Congress has,enacted legislation governing FDA jurisdiction, Congress never granted the FDA jurisdiction over tobacco. Previous FDA commissioners have stated that the FDA lacks jurisdiction over tobacco, a position that Congress and the courts have accepted. 6) In 1994, Commissioner Kessler asked Congress to provide him with "clear direction" on how to proceed. Congress issued no such directive, yet the Commissioner nevertheless decided to exercise extraordinary new powers through his agency. C. Smoking Is, and Should Remain, a Matter of Adult Choice 1) Tobacco is a legal product, adults are well- informed of the potential health risks associated with tobacco use, and adults should remain free to make their own choices about whether or not to smoke. 2) Adults should remain free to view advertisements for any legal products.
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page 6 D. FDA's Real Agenda: Prohibition 1) Commissioner Kessler is trying to use the youth smoking issue as a Trojan horse to gain jurisdiction over the tobacco industry. His real agenda is prohibition. In a February 1994 letter, he stated that FDA regulation of tobacco could result in "the removal from the market of tobacco products" as currently produced. _ 2) The FDA's proposed restrictions on advertising, promotion and sale are not intended merely to reduce underage smoking. Studies around the world have failed to establish a relationship between advertising and decisions to smoke -- by minors or adults. 3) The FDA's regulations are clearly intended to limit tobacco companies' ability to communicate with adult smokers. 4) Federal law states that manufacturers must prove that "drugs" subject to FDA jurisdiction are "safe and effective" before the FDA will grant approval for sale and distribution. Commissioner Kessler stated that his agency would never find cigarettes "safe and effective." Therefore, if the FDA were to gain jurisdiction over tobacco, the agency might try to ban the sale of tobacco to adults. 5) Prohibition has been attempted in this country before -- with disastrous social and economic results. We should not go down that road again.
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page 7 Executive Summary: Section II Key Messages "The FDA's plans threaten free speech and First Amendment guarantees. Cigarette advertising is designed to maintain brand loyalty and encourages competition and switching among brands. Advertising gives adult smokers a choice; it does not cause people to smoke." ~ Key Messengers Advertising/sponsorship executives, workers, suppliers, FAC Direct mail, outdoor and events people Consumers (e.g. racing fans, promotion recipients) PM and co-plaintiffs Legal experts, WLF, ACLU, First Amendment groups II. Advertising and the First Amendment A. Truthful Commercial Speech Is Protected by the First Amendment B. No Relation Between Advertising and Smoking Incidence C. Advertising Designed to Promote Brand Loyalty and Brand Switching D. Impact of Limits on Advertising and Event Sponsorship E. Slippery Slope of Restrictions on Free Speech
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page 8 II. Advertising and the First Amendment A. Truthful Commercial Speech Is Protected by the First Amendment 1) Truthful commercial speech enjoys the protection of the First Amendment to the U.S. Constitution. 2) A fundamental American belief is that open communication and the expression of truthful ideas help uphold our freedoms and keep our nation strong. B. No Relation Between Advertising and Smoking Incidence 1) No study has established that advertising or promotion.cause anyone -- minors or adults -- to begin smoking. 2) The overwhelming majority of Americans know the potential health risks associated with smoking. This is due, in part, to federally-mandated Surgeon General's health warnings that appear on every cigarette pack and in every cigarette.ad. 3) Advertising does not force people to take actions against their will. 4) Scientific evidence tells us that kids begin smoking in response the influence of peers, parents and older relatives. 5) Advertising enables manufacturers to convey important product information, especially regarding new brands, to consumers.
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page 9 C. Advertising and Promotion Designed to Promote Brand Loyalty and Brand Switching 1) Cigarette companies advertise and promote their brands to enhance brand loyalty and to encourage adult smokers to switch from other brands. Advertising is not intended to, and does not, create new smokers. 2) Advertising and promotion-do not motivate people to act against their will. Cigarette ads are directed at adult smokers just as car ads are directed at adult drivers. . 3) Event sponsorship helps companies communicate directly with target audiences efficiently and effectively. Cigarette manufacturers sponsor events, such as car races, where those in attendance are predominantly over 21. Sponsorship does not cause people to begin smoking. Sponsorship should be a business decision -- not a government decision. 4) No athletes or artists'endorse cigarettes, nor are they asked to do so. 5) Promotional items encourage brand loyalty by rewarding adult smokers. The items have never been shown to cause people to begin smoking. 6) Cigarette manufacturers distribute promotional clothing and hats in adult sizes only. In order to receive promotional items in the mail, consumers must sign a statement and certify that they are'smokers and at least 21 years old.
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page 10 D. Impact of Limits on Advertising, Promotion and Event Sponsorship 1) Tobacco advertising, promotion and sponsorship create thousands of jobs. Curtailing these businesses, as the FDA proposes, would put many people out of work. 2) Advertising, promotion and event sponsorship do not cause people to begin smoking. 3) Banning tobacco company sponsorship of musical, cultural and sporting events would devastate many of those events. Results might include higher ticket prices and fewer events. E. Slippery Slope of Restrictions on Free Speech 1) A fundamental American belief is that open communication and the expression of truthfu.l ideas help uphold our freedoms and keep our nation strong. 2) If the FDA succeeds in controlling aspects of advertising and promotion for tobacco products, the agency might later try to place similar restrictions on advertising for other products. 3) The fact that a product is unpopular within some segments of society does not justify the restriction of truthful advertisements for the product. Permitting such restrictions will open the door to censors, moralists and prohibitionists of every strain.

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