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Contents
Preamble page 1-5
Title I: Reformation of the Tobacco Industry page 8
A. Restrictions on Marketing and Advertising page 8
B. Warnings, Labeling and Packaging page 9
C. Restrictions on Access to Tobacco Products page 11
D. Licensing of Retail Tobacco Product Sellers page 12
E. Regulation of Tobacco Product Development and Manufacturing page 13
F. Non-tobacco Ingredients page 19
G. Compliance and Corporate Culture page 21
H. Effective Dates page 23
Title II: "Look Back" Provisions/State Enforcement Incentives 24
Title III: Penalties and Enforcement; Consent Decrees; Non-Participating
Companies page 26
A. Penalties and Enforcement page 26
B. Consent Decrees page 27
C. Non-participating Companies page 28
Title IV. Nationwide Standards to Minimize Invo~untarv Exposure to
Environmental Tobacco Smoke page 30
TitIeV: ScopeandEffect page 32
A. Scope of FDA Authority page 32
B. State Authority page 32
Title VI: Programs/Funding page 34
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A. Up Front Commitment page 34
B. Base Annual Payments page 34
C. Applicability page 35
D. Tax Treatment page 35
Title VII: Public Health Funds From Tobacco Settlement As Recommended by The Attorneys General For Consideration by the President and the Congress page 36
Title VIII: Civil Liability page 39
A. General page 39
B. Provisions as to Civil Liability for Past Conduct page 39
C. Provisions as to Civil Liability for Future Conduct page 41
Title IX: Board Approval page 42
Appendices:
Appendix I: Warnings in Advertisements
Appendix II: Retail Tobacco Product Seller Penalties
Appendix Ill: Application to Indian Tribes
Appendix IV: Industry Associations
Appendix V: "Look Back"
Appendix VI: State Enforcement Incentives
Appendix VII: Restrictions on Point of Sale Advertising
Appendix VIII: Public Disclosure of Past and Future Tobacco Industry Documents and Health Research Page 8
TITLE I: Reformation Of The Tobacco Industry
Title I of the legislation would incorporate and expand upon FDA’s recent regulation of nicotine-containing tobacco products. The following rules would apply to all tobacco products sold in the U.S. (including all its territories and possessions, as well as duty-free shops within U.S. borders). The new regime would be allowed to operate as described below for five years. FDA would have authority to make revisions even within this period under extraordinary circumstances. Thereafter, the FDA would be authorized to review and revise the rules under applicable Agency procedures.
A. Restrictions on Marketing and Advertising
The advertising and marketing of tobacco products would be drastically curtailed, including in ways that exceed the FDA rule as originally promulgated and in ways that have previously been challenged on First Amendment grounds. As in the FDA rule? the new regime would:
-- Prohibit the use of non-tobacco brand names as brand names of tobacco products except for tobacco products in existence as of January 1,1995 (897.16(a))l
-- Restrict tobacco product advertising to FDA specified media (897.30(a)(1 )-(2))
-- Restrict permissible tobacco product advertising to black text on a white background except for advertising in adult-only facilities and in adult publications (897.32(a)-(b))
-- Require cigarette and smokeless tobacco product advertisements to carry the FDA-mandated statement of intended use ("Nicotine Delivery Device") (897.32(c))
-- Ban all non-tobacco merchandise, including caps, jackets or bags bearing the name, logo or selling message of a tobacco brand
(897.34(a))
-- Ban offers of non-tobacco items or gifts based on proof of purchase of tobacco products (897.34(b))
1-The citations in this and in the next section are to Part 897 of the FDA's tobacco regulations, 61 Fed. Reg. 44396 (August 28,1996).
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-- Ban sponsorships, including concerts and sporting events, in the name, logo or selling message of a tobacco brand (897.34(c))
Further, building on and going beyond the FDA rule, the new regime would:
-- Ban the use of human images and cartoon characters - thereby eliminating Joe Camel and the Marlboro Man - in all tobacco advertising and on tobacco product packages
-- Ban all outdoor tobacco product advertising, including in enclosed stadia as well as brand advertising directed outside from a retail establishment (modifies 897.30(a)(1) and extends 897.30(b))
-- Prohibit tobacco product advertising on the Internet unless designed to be inaccessible in or from the United States
-- Establish nationwide restrictions in non adult-only facilities on point of sale advertising with a view toward minimizing the impact of such advertising on minors. These provisions, which are detailed in Appendix VII, restrict point of sale advertising that was otherwise permitted in retail establishments by the FDA rule.
-- Ban direct and indirect payments for tobacco product placement in movies, television programs and video games
-- Prohibit direct and indirect payments to "glamorize" tobacco use in media appealing to minors, including recorded and live performances of music
-- Without limiting the FDA's normal rulemaking authority in this area, require that the use, in both existing and future brand styles, of words currently employed as product descriptors (e.g., "light" or "low tar") be accompanied by a mandatory disclaimer in advertisements (e.g., "Brand X not shown to be less hazardous than other cigarettes"); exemplars of all new advertising and tobacco products labeling shall be submitted to FDA concurrently with their introduction into the marketplace for FDA's ongoing review.
[Source/precedent: FDA Rule; 21 C.F.R. 101.70]
B. Warnings, Labeling and Packaging
The federally-mandated warning labels on cigarettes were last changed in 1984. Since then a number of countries, including Canada and members of the
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European Union, have imposed new warning labels. Further, the Federal Trade Commission's methodology to measure the "tar" and nicotine yields of cigarettes has been criticized as producing misleading information.
1. The legislation, through amendments to the Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act, would mandate new rotating warnings, to be introduced concurrently into the distribution chain on all tobacco product packages and cartons, and to be rotated quarterly in all advertisements. For cigarettes, the warnings would be:
-- "WARNING: Cigarettes are addictive"
-- "WARNING: Tobacco smoke can harm your children"
-- "WARNING: Cigarettes cause fatal lung disease"
-- "WARNING: Cigarettes cause cancer"
-- "WARNING: Cigarettes cause strokes and heart disease"
-- "WARNING: Smoking during pregnancy can harm your baby"
-- "WARNING: Smoking can kill you"
-- "WARNING: Tobacco smoke causes fatal lung disease in non-smokers"
-- "WARNING: Quitting smoking now greatly reduces serious risks to your health"
For smokeless tobacco products, the warnings would be:
-- "WARNING: This product can cause mouth cancer"
-- "WARNING: This product can cause gum disease and tooth loss"
-- "WARNING: This product is not a safe alternative to cigarettes"
--"WARNING: Smokeless tobacco is addictive"
For cigarettes, the warnings would occupy 25% of the front panel of the package (including packs and cartons) and would appear on the upper portion thereof. The legislation would contain a grandfather provision for existing brands with flip-top