44396 Federal Register / Vol. 61, No. 168 / Wednesday, August 28, 1996 / Rules and Regulations DEPARTMENT OF HEALTH AND tobacco as delivery devices for nicotine, 3. The Restricted Device Provision HUMAN SERVICES incorporated as part of the regulations Authorizes FDA to Establish Access and for purposes of, and to facilitate, Advertising Restrictions Food and Drug Administration congressional review under the Small 4. Application of Other Device Business Regulatory Enforcement Authorities 5. FDA Will Classify Cigarettes and 21 CFR Parts 801, 803, 804, 807, 820, Fairness Act of 1996. and 897 Smokeless Tobacco Under Section 513 of the DATES: Effective date. The regulation is Act [Docket No. 95N±0253] effective August 28, 1997, except that D. The Fact That the Act's Drug Authorities § 897.14(a) and (b) are effective February Authorize the Imposition of Similar RIN 0910±AA48 28, 1997 and § 897.34(c) is effective Restrictions Supports the Reasonableness of Regulations Restricting the Sale and February 28, 1998. the Restrictions That the Agency Has Imposed Distribution of Cigarettes and Compliance dates. Manufacturers and distributors are required to comply with E. Constitutional Issues Regarding Smokeless Tobacco to Protect Authority Children and Adolescents the requirements of 21 CFR parts 803 and 804 August 28, 1997; manufacturers 1. Separation of Powers 2. Nondelegation Doctrine AGENCY: Food and Drug Administration, are required to comply with the III. Overview of Comments, Smoking HHS. requirements of 21 CFR parts 807 and Prevalence Rates Among Minors, Scope, ACTION: Final rule. 820 February 28, 1998. Purpose, and Definitions ADDRESSES: References listed in the A. Overview of Comments SUMMARY: The Food and Drug footnotes of this document have been B. Smoking Prevalence Rates Among Administration (FDA) is issuing placed on public display at the Dockets Minors regulations governing access to and Management Branch (HFA±305), Food C. Scope promotion of nicotine-containing and Drug Administration, 12420 D. Purpose (§ 897.2) cigarettes and smokeless tobacco to E. Definitions (§ 897.3) Parklawn Dr., rm. 1±23, Rockville, MD IV. Access children and adolescents. 20857, and may be seen by interested The regulations prohibit the sale of A. General Comments persons between 9 a.m. and 4 p.m., B. General Responsibilities of nicotine-containing cigarettes and Monday through Friday. smokeless tobacco to individuals under Manufacturers, Distributors, and Retailers FOR FURTHER INFORMATION CONTACT: (§ 897.10) the age of 18; require manufacturers, C. Additional Responsibilities of distributors, and retailers to comply Nancy Yeates, Office of Policy (HF±26), Food and Drug Administration, 5600 Manufacturers (§ 897.12) with certain conditions regarding the 1. Removal of Manufacturer-Supplied or sale and distribution of these products; Fishers Lane, Rockville, MD 20857, 301±827±0867. Manufacturer-Owned Items That Do Not require retailers to verify a purchaser's Comply With the Regulations age by photographic identification; SUPPLEMENTARY INFORMATION: 2. Visual Inspections by a Manufacturer's prohibit all free samples and prohibit Preamble Outline Representative at Each Point of Sale the sale of these products through I. Introduction D. Additional Responsibilities of Retailers A. Purpose and Overview of the Rule vending machines and self-service (§ 897.14) B. Background 1. Use of Photographic Identification to displays except in facilities where C. Provisions of the Rule individuals under the age of 18 are not Verify Age II. Legal Authority 2. Minimum Age present or permitted at any time; limit A. Legal Principles Applicable to 3. Restrictions Against ``Impersonal'' the advertising and labeling to which Combination Drug/Device Products Modes of Sale children and adolescents are exposed to 1. The SMDA Recognized Combination 4. Restrictions Against the Sale of Products for the First Time a black-and-white, text-only format; Individual Cigarettes 2. The SMDA Leaves to FDA's Discretion prohibit the sale or distribution of 5. Additional Comments the Determination of Which Regulatory brand-identified promotional E. Conditions of Manufacture, Sale, and Authorities to Apply to Particular Distribution (§ 897.16) nontobacco items such as hats and tee Combination Products 1. Restrictions on Nontobacco Trade shirts; prohibit sponsorship of sporting 3. Interpreting the SMDA to Allow the Names on Tobacco Products and other events, teams, and entries in Agency to Determine Which Regulatory a brand name of a tobacco product, but Scheme Best Serves the Public Health is 2. Minimum Package Size permit such sponsorship in a corporate Consistent With 50 Years of Case Law 3. Maximum Package Size 4. Impersonal Modes of Sale name; and require manufacturers to 4. The Implementing Regulations and the V. Label provide intended use information on all Delegations of Authority Reflect FDA's Interpretation That Section 503(g) of the Act A. Established Name (§ 897.24) cigarette and smokeless tobacco product B. Package Design labels and in cigarette advertising. Authorizes the Agency to Determine the Appropriate Regulatory Authorities C. Ingredient Labeling These regulations will address the 5. The Intercenter Agreements and D. Labeling for Intended Use serious public health problems caused Administrative Precedent Recognize That E. Adequate Directions for Use and by cigarettes and smokeless tobacco FDA May Determine Which Regulatory Warnings Against Use (Section 502(f) of the products. They will reduce children's Authority to Apply to a Particular Product act) and adolescents' easy access to B. Cigarettes and Smokeless Tobacco Have F. Package Inserts cigarettes and smokeless tobacco and Both a Drug and a Device Component and VI. Advertising will significantly decrease the amount Are Therefore Combination Products A. Subpart DÐRestrictions on Advertising of positive imagery that makes these C. FDA's Choice of Legal Authorities and Labeling of Tobacco Products products so appealing to that age group. 1. FDA Will Regulate Cigarettes and B. The Need for Advertising Restrictions Smokeless Tobacco Under the Act's Device 1. Advertising and Young People The regulations are predicated on the Authorities 2. Advertising and Adults agency's assertion of jurisdiction under 2. Cigarettes and Smokeless Tobacco C. The Regulations Under the First the Federal Food, Drug, and Cosmetic Will be Subject to the Full Range of Device Amendment Act over cigarettes and smokeless Authorities 1. Introduction Federal Register / Vol. 61, No. 168 / Wednesday, August 28, 1996 / Rules and Regulations 44397 2. The Central Hudson Test C. Procedural Due Process Under the Fifth 7. Excise Tax Revenues 3. Is Cigarette and Smokeless Tobacco Amendment F. Small Business Impacts Advertising Misleading, or Does It Relate to XII. Procedural Issues G. Other Alternatives Unlawful Activity? A. Introduction H. Unfunded Mandates Reform Act of 1995 4. Is the Asserted Government Interest B. Adequacy of the Record XVI. Paperwork Reduction Act of 1995 Substantial? 1. The Administrative Record A. Comments on the Paperwork Reduction D. Evidence Supporting FDA's Advertising 2. The Agency's Use of Confidential Act Statement Restrictions Documents B. Information Collection Provisions in the 1. Introduction 3. The Claim that FDA Relied on Final Rule 2. Do the Regulations Directly Advance ``Unknown'' Undisclosed Data XVII. Congressional Review the Governmental Interest Asserted? 4. The Claim that FDA Failed to Include Codified Language 3. Is There Harm? Does Advertising in the Record New Drug Application (NDA) Affect the Decision by Young People to Use Data on Which it Relied I. Introduction Tobacco Products? 5. The Agency's Reliance in the Final 4. Why Young People Use Tobacco and Rulemaking on New Materials A. Purpose and Overview of the Rule the Role of Advertising in That Process C. Adequacy of the Notice 5. Has The Agency Met Its Burden? 1. The Agency Provided Adequate Notice This rule establishes regulations 6. The Efficacy of the Restrictions; of the Key Legal and Factual Issues restricting the sale and distribution of Empirical Evidence Concerning Advertising 2. The Agency Provided a ``Reasoned cigarettes and smokeless tobacco to Restrictions Explanation'' for its Current Position E. Provisions of the Final Rule children and adolescents, implementing D. Adequacy of the Comment Period FDA's determination that it has 1. Are FDA's Regulations Narrowly E. Conclusion jurisdiction over these products under Drawn? XIII. Executive Orders 2. Section 897.30(a)ÐPermissible Forms A. Executive Order 12606: The Family the Federal Food, Drug, and Cosmetic of Labeling and Advertising B. Executive Order 12612: Federalism Act (the act). As described in ``Nicotine 3. Section 897.30(b)ÐBillboards C. Executive Order 12630: Governmental in Cigarettes and Smokeless Tobacco Is 4. Section 897.32(a)ÐText-Only Format Actions and Interference with a Drug and These Products Are Nicotine 5. Section 897.32(a)ÐDefinition of Constitutionally Protected Property Rights Delivery Devices Under the Federal ``Adult Publication'' XIV. Environmental Impact Food, Drug, and Cosmetic Act: 6. AdvertisingЧ 897.32 Requirements XV. Analysis of Impacts Jurisdictional Determination'' (the 1996 for Disclosure of Important Information A. Introduction and Summary Jurisdictional Determination), annexed 7. Section 897.34(a) and (b)Ð B. Statement of Need for Action Promotions, Nontobacco Items, and Contests hereto, FDA has determined that C. Regulatory Benefits cigarettes and smokeless