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Vol. 76 Wednesday, No. 120 June 22, 2011 Part II Department of Health and Human Services Food and Drug Administration 21 CFR Part 1141 Required Warnings for Cigarette Packages and Advertisements; Final Rule VerDate Mar<15>2010 17:11 Jun 21, 2011 Jkt 223001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\22JNR2.SGM 22JNR2 emcdonald on DSK2BSOYB1PROD with RULES 36628 Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations DEPARTMENT OF HEALTH AND C. Consumers’ Lack of Knowledge of the C. Random Display and Rotation of HUMAN SERVICES Health Risks Warnings D. Larger, Graphic Warnings Communicate VII. Legal Authority and Responses to Food and Drug Administration More Effectively Comments E. Need To Refresh Required Warnings A. FDA’s Legal Authority III. FDA’s Selection of Color Graphic Images B. First Amendment Commercial Speech 21 CFR Part 1141 A. Methodology for Selecting Images Issues [Docket No. FDA–2010–N–0568] B. FDA’s Research Study C. Takings Under the Fifth Amendment 1. Study Design VIII. Implementation Date RIN 0910–AG41 2. Use of FDA’s Study Results in Selection IX. Federalism of Images X. Environmental Impact Required Warnings for Cigarette 3. Comments on FDA’s Research Study XI. Analysis of Impacts Packages and Advertisements C. Comments to the Docket A. Introduction and Summary 1. Comments Submitting Research on B. Comments on the Preliminary AGENCY: Food and Drug Administration, FDA’s Proposed Required Warnings Regulatory Impact Analysis HHS. 2. Other Comments 1. General D. Selected Images 2. Need for the Rule ACTION: Final rule. 1. ‘‘WARNING: Cigarettes are addictive’’ 3. Benefits 2. ‘‘WARNING: Tobacco smoke can harm 4. Costs SUMMARY: The Food and Drug your children’’ 5. Distributional Effects Administration (FDA) is amending its 3. ‘‘WARNING: Cigarettes cause fatal lung 6. Impact on Small Entities regulations to add a new requirement disease’’ C. Need for the Rule for the display of health warnings on 4. ‘‘WARNING: Cigarettes cause cancer’’ D. Benefits cigarette packages and in cigarette 5. ‘‘WARNING: Cigarettes cause strokes 1. Reduced Cigarette Smoking Rates advertisements. This rule implements a and heart disease’’ 2. Quantifying Benefits That Accrue to provision of the Family Smoking 6. ‘‘WARNING: Smoking during pregnancy Dissuaded Smokers 3. Reduced Fire Costs Prevention and Tobacco Control Act can harm your baby’’ 7. ‘‘WARNING: Smoking can kill you’’ 4. Summary of Benefits (Tobacco Control Act) that requires FDA 8. ‘‘WARNING: Tobacco smoke causes fatal E. Costs to issue regulations requiring color lung disease in nonsmokers’’ 1. Number of Affected Entities graphics, depicting the negative health 9. ‘‘WARNING: Quitting smoking now 2. Costs of Changing Cigarette Labels consequences of smoking, to accompany greatly reduces serious risks to your 3. Ongoing Costs of Equal and Random the nine new textual warning statements health’’ Display required under the Tobacco Control Act. 10. Image for Advertisements With a Small 4. Market Testing Costs Associated With The Tobacco Control Act amends the Surface Area Changing Cigarette Package Labels E. Non-Selected Images 5. Advertising Restrictions: Removal of Federal Cigarette Labeling and Noncompliant Point-of-Sale Advertising Advertising Act (FCLAA) to require 1. ‘‘WARNING: Cigarettes are addictive’’ 2. ‘‘WARNING: Tobacco smoke can harm 6. Government Administration and each cigarette package and your children’’ Enforcement Costs advertisement to bear one of nine new 3. ‘‘WARNING: Cigarettes cause fatal lung 7. Summary of Costs textual warning statements. This final disease’’ F. Cost-Effectiveness Analysis rule specifies the color graphic images 4. ‘‘WARNING: Cigarettes cause cancer’’ G. Distributional Effects that must accompany each of the nine 5. ‘‘WARNING: Cigarettes cause strokes 1. Tobacco Manufacturers, Distributors, new textual warning statements. and heart disease’’ and Growers 6. ‘‘WARNING: Smoking during pregnancy 2. National and Regional Employment DATES: This rule is effective September can harm your baby’’ Patterns 22, 2012. See section VIII of this 7. ‘‘WARNING: Smoking can kill you’’ 3. Retail Sector document, Implementation Date, for 8. ‘‘WARNING: Tobacco smoke causes fatal 4. Advertising Industry additional information. The lung disease in nonsmokers’’ 5. Excise Tax Revenues incorporation by reference of a certain 9. ‘‘WARNING: Quitting smoking now 6. Government-Funded Medical Services, publication listed in the rule is greatly reduces serious risks to your Insurance Premiums, and Social Security approved by the Director of the Federal health’’ H. International Effects I. Regulatory Alternatives Register as of September 22, 2012. 10. Image for Advertisements With a Small Surface Area 1. 24-Month Compliance Period FOR FURTHER INFORMATION CONTACT: IV. Comments Regarding Textual Warning 2. 6-Month Compliance Period Gerie Voss or Kristin Davis, Center for Statements 3. Alternative Graphic Images Tobacco Products, Food and Drug A. Changes to Textual Warning Statements 4. Summary of Regulatory Alternatives Administration, 9200 Corporate Blvd., B. Attribution to the Surgeon General J. Impact on Small Entities Rockville, MD 20850–3229, 877–287– C. Foreign Language Translations 1. Description and Number of Affected 1373, [email protected] or V. Description of the Final Rule Small Entities 2. Description of the Potential Impacts of [email protected]. A. Overview of the Final Rule B. Description of Final Regulations and the Final Rule on Small Entities SUPPLEMENTARY INFORMATION: Responses to Comments 3. Alternatives to Minimize the Burden on Small Entities Table of Contents 1. Section 1141.1—Scope 2. Section 1141.3—Definitions XII. Paperwork Reduction Act of 1995 I. Introduction 3. Section 1141.10—Required Warnings XIII. References A. Purpose and Overview 4. Section 1141.12—Incorporation by I. Introduction B. Background Reference of Required Warnings II. Need for the Rule and Responses to 5. Section 1141.14—Misbranding of A. Purpose and Overview Comments Cigarettes The Tobacco Control Act was enacted A. Cigarette Use in the United States and 6. Section 1141.16—Disclosures Regarding the Resulting Health Consequences Cessation on June 22, 2009, amending the Federal 1. Smoking Prevalence and Initiation in the VI. Comments Regarding Implementation Food, Drug, and Cosmetic Act (FD&C United States Issues Act) and FCLAA, and providing FDA 2. Health Consequences of Smoking A. Technical Issues Regarding Compliance with the authority to regulate tobacco B. Inadequacy of Existing Warnings B. Textual Statement Color Formats products (Pub. L. 111–31; 123 Stat. VerDate Mar<15>2010 17:11 Jun 21, 2011 Jkt 223001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\22JNR2.SGM 22JNR2 emcdonald on DSK2BSOYB1PROD with RULES Federal Register / Vol. 76, No. 120 / Wednesday, June 22, 2011 / Rules and Regulations 36629 1776). Section 201 of the Tobacco evidence in the scientific literature that II. Need for the Rule and Responses to Control Act modifies section 4 of larger, graphic health warnings promote Comments FCLAA (15 U.S.C. 1333) to require that greater understanding of the health risks A. Cigarette Use in the United States the following nine new health warning of smoking and would help to reduce and the Resulting Health Consequences statements appear on cigarette packages consumption (see 75 FR 69524 at 69531 and in cigarette advertisements: through 69533). In proposing this 1. Smoking Prevalence and Initiation in • WARNING: Cigarettes are addictive regulation and preparing this final rule, the United States • WARNING: Tobacco smoke can we found substantial evidence In explaining the need for the harm your children indicating that larger cigarette health proposed rule, we provided information • WARNING: Cigarettes cause fatal warnings including a graphic lung disease in the NPRM on smoking prevalence component, like those being required in and initiation rates among adults and • WARNING: Cigarettes cause cancer this rule, would offer significant health children in the United States. As stated • WARNING: Cigarettes cause strokes benefits over the existing warnings. in the NPRM (75 FR 69524 at 69526), and heart disease Consistent with Executive Order 13563, • approximately 46.6 million U.S. adults WARNING: Smoking during this regulation is ‘‘based on the best (or 20.6 percent of the adult population) pregnancy can harm your baby available evidence’’ and has allowed • are cigarette smokers (Ref. 4). Moreover, WARNING: Smoking can kill you ‘‘for public participation and an open • almost half (46.3 percent) of youth in WARNING: Tobacco smoke causes exchange of ideas.’’ fatal lung disease in nonsmokers grades 9 through 12 in the United States • WARNING: Quitting smoking now B. Background have tried cigarette smoking, and 19.5 greatly reduces serious risks to your On November 12, 2010, as directed by percent of youth in grades 9 through 12 health. section 201 of the Tobacco Control Act are current cigarette smokers (Ref. 5 at Section 201 of the Tobacco Control and in the interest of public health, we p. 10). Smoking rates among U.S. adults Act also states that ‘‘the Secretary [of issued a proposed rule seeking to have shown virtually no change during Health and Human Services] shall issue modify the warnings that appear on the 5-year period from 2005 to 2009 regulations that require color graphics cigarette packages and in cigarette (Ref. 4), and smoking rates among U.S. depicting the negative health advertisements to include color graphic youth