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ACTION ON SMOKING AND HEALTH 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |
In response to numerous requests, ASH places the entire text of the FDA's rulemaking action with regard to the regulation of cigarettes on line where it will be available for downloading by any interested person.
Because of its size, the document as it appeared in the Federal Register [61 FR 44396, Wednesday, August 28, 1996] has been divided into this file/document and four additional files.
This document/file contains the official text of the rule plus the table of contents. This information may be sufficient for the casual reader.
Those who desire even more detailed information are invited to download the following additional files.
The other four additional files are as follows:
FDA1 = the first part of the decision from the beginning ,
approximate size = 230K
FDA2 = the second part of the decision, beginning at IV. Access,
approximate size = 290K
FDA3 = the third part of the decision, beginning at VI.
Advertising,
approximate size = 555K
FDA4 = the fourth part of the decision, beginning at VII,
Educational Campaign,
approximate size = 530K
PART 897--CIGARETTES AND SMOKELESS TOBACCO Subpart A--General Provisions 897.1 Scope. 897.2 Purpose. 897.3 Definitions. 897.10 General responsibilities of manufacturers, distributors, and retailers. 897.12 Additional responsibilities of manufacturers. 897.14 Additional responsibilities of retailers. 897.16 Conditions of manufacture, sale, and distribution. *44616 Subpart C--Labels 897.24 Established names for cigarettes and smokeless tobacco. 897.25 Statement of intended use and age restriction. Subpart D--Labeling and Advertising 897.30 Scope of permissible forms of labeling and advertising. 897.32 Format and content requirements for labeling and -- advertising. 897.34 Sale and distribution of nontobacco items and services, gifts, and sponsorship of events. Authority: Secs. 502, 510, 518, 519, 520, 701, 704, 903 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360h, 360i, 360j, 371, 374, 393). Subpart A--General Provisions s897.1 Scope. (a) This part sets out the restrictions under the Federal Food, Drug, and Cosmetic Act (the act) on the sale, distribution, and use of cigarettes and smokeless tobacco that contain nicotine. (b) The failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes and smokeless tobacco renders the product misbranded under the act. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of Title 21, unless otherwise noted. s897.2 Purpose. The purpose of this part is to establish restrictions on the sale, distribution, and use of cigarettes and smokeless tobacco in order to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use. s897.3 Definitions. (a) Cigarette means any product which contains nicotine, is intended to be burned under ordinary conditions of use, and consists of: (1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco; or (2) Any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in paragraph (a)(1) of this section. (b) Cigarette tobacco means any product that consists of loose tobacco that contains or delivers nicotine and is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements pertaining to cigarettes shall also apply to cigarette tobacco. (c) Distributor means any person who furthers the distribution of cigarettes or smokeless tobacco, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this part. (d) Manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette or smokeless tobacco product. (e) Nicotine means the chemical substance named 3-(1-Methyl-2- pyrrolidinyl)pyridine or C sub10 H sub14 N sub2 , including any salt or complex of nicotine. (f) Package means a pack, box, carton, or container of any kind in which cigarettes or smokeless tobacco are offered for sale, sold, or otherwise distributed to consumers. (g) Point of sale means any location at which a consumer can purchase or otherwise obtain cigarettes or smokeless tobacco for personal consumption. (h) Retailer means any person who sells cigarettes or smokeless tobacco to individuals for personal consumption, or who operates a facility where vending machines or self-service displays are permitted under this part. (i) Smokeless tobacco means any product that consists of cut, ground, powdered, or leaf tobacco that contains nicotine and that is intended to be placed in the oral cavity. Subpart B--Prohibition of Sale and Distribution to Persons Younger Than 18 Years of Age s897.10 General responsibilities of manufacturers, distributors, and retailers. Each manufacturer, distributor, and retailer is responsible for ensuring that the cigarettes or smokeless tobacco it manufactures, labels, advertises, packages, distributes, sells, or otherwise holds for sale comply with all applicable requirements under this part. s897.12 Additional responsibilities of manufacturers. In addition to the other responsibilities under this part, each manufacturer shall remove from each point of sale all self-service displays, advertising, labeling, and other items that the manufacturer owns that do not comply with the requirements under this part. s897.14 Additional responsibilities of retailers. In addition to the other requirements under this part, each retailer is responsible for ensuring that all sales of cigarettes or smokeless tobacco to any person comply with the following requirements: (a) No retailer may sell cigarettes or smokeless tobacco to any person younger than 18 years of age; (b)(1) Except as otherwise provided in s897.16(c)(2)(i) and in paragraph (b)(2) of this section, each retailer shall verify by means of photographic identification containing the bearer's date of birth that no person purchasing the product is younger than 18 years of age; (2) No such verification is required for any person over the age of 26; (c) Except as otherwise provided in s897.16(c)(2)(ii), a retailer may sell cigarettes or smokeless tobacco only in a direct, face-to-face exchange without the assistance of any electronic or mechanical device (such as a vending machine); (d) No retailer may break or otherwise open any cigarette or smokeless tobacco package to sell or distribute individual cigarettes or a number of unpackaged cigarettes that is smaller than the quantity in the minimum cigarette package size defined in s897.16(b), or any quantity of cigarette tobacco or smokeless tobacco that is smaller than the smallest package distributed by the manufacturer for individual consumer use; and (e) Each retailer shall ensure that all self-service displays, advertising, labeling, and other items, that are located in the retailer's establishment and that do not comply with the requirements of this part, are removed or are brought into compliance with the requirements under this part. s897.16 Conditions of manufacture, sale, and distribution. (a) Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that were sold in the United States on January 1, 1995. (b) Minimum cigarette package size. Except as otherwise provided under this section, no manufacturer, distributor, or retailer may sell or cause to be sold, or distribute or cause to be distributed, any cigarette package that contains fewer than 20 cigarettes. *44617 (c) Vending machines, self-service displays, mail-order sales, and other "impersonal" modes of sale. (1) Except as otherwise provided under this section, a retailer may sell cigarettes and smokeless tobacco only in a direct, face-to-face exchange between the retailer and the consumer. Examples of methods of sale that are not permitted include vending machines and self-service displays. (2) Exceptions. The following methods of sale are permitted: (i) Mail-order sales, excluding mail-order redemption of coupons and distribution of free samples through the mail; and (ii) Vending machines (including vending machines that sell packaged, single cigarettes) and self-service displays that are located in facilities where the retailer ensures that no person younger than 18 years of age is present, or permitted to enter, at any time. (d) Free samples. No manufacturer, distributor, or retailer may distribute or cause to be distributed any free samples of cigarettes or smokeless tobacco. (e) Restrictions on labels, labeling, and advertising. No manufacturer, distributor, or retailer may sell or distribute, or cause to be sold or distributed, cigarettes or smokeless tobacco with labels, labeling, or advertising not in compliance with subpartsC and D of this part, and other applicable requirements. Subpart C--Labels s897.24 Established names for cigarettes and smokeless tobacco. Each cigarette or smokeless tobacco package shall bear, as provided in section 502 of the act, the following established name: "Cigarettes", "Cigarette Tobacco", "Loose Leaf Chewing Tobacco", "Plug Chewing Tobacco", "Twist Chewing Tobacco", "Moist Snuff", or "Dry Snuff", whichever name is appropriate. s897.25 Statement of intended use and age restriction. Each cigarette or smokeless tobacco package, that is offered for sale, sold, or otherwise distributed shall bear the following statement: "Nicotine-Delivery Device for Persons 18 or Older". Subpart D--Labeling and Advertising s897.30 Scope of permissible forms of labeling and advertising. - (a)(1) A manufacturer, distributor, or retailer may, in accordance with this subpart D, disseminate or cause to be disseminated advertising or labeling which bears a cigarette or smokeless tobacco brand name (alone or in conjunction with any other word) or any other indicia of tobacco product identification, in newspapers; in magazines; in periodicals or other publications (whether periodic or limited distribution); on billboards, posters, and placards; in nonpoint-of-sale promotional material (including direct mail); in point-of-sale promotional material; and in audio or video formats delivered at a point-of-sale. (2) A manufacturer, distributor, or retailer intending to disseminate, or to cause to be disseminated, advertising or labeling for cigarettes or smokeless tobacco in a medium that is not listed in paragraph (a)(1) of this section, shall notify the agency 30 days prior to the use of such medium. The notice shall describe the medium and discuss the extent to which the advertising or labeling may be seen by persons younger than 18 years of age. The manufacturer, distributor, or retailer shall send this notice to the Division of Drug Marketing, Advertising, and Communications, 5600 Fishers Lane (HFD-40), rm. 17B-20, Rockville, MD 20857. (b) No outdoor advertising for cigarettes or smokeless tobacco, including billboards, posters, or placards, may be placed within 1,000 feet of the perimeter of any public playground or playground area in a public park (e.g., a public park with equipment such as swings and seesaws, baseball diamonds, or basketball courts), elementary school, or secondary school. (c) This subpart D does not apply to cigarette or smokeless tobacco package labels. s897.32 Format and content requirements for labeling and advertising. (a) Except as provided in paragraph (b) of this section, each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating or causing to be disseminated, any labeling or advertising for cigarettes or smokeless tobacco shall use only black text on a white background. This section does not apply to advertising: (1) In any facility where vending machines and self- service displays are permitted under this part, provided that the advertising is not visible from outside the facility and that it is affixed to a wall or fixture in the facility; or (2) Appearing in any publication (whether periodic or limited distribution) that the manufacturer, distributor, or retailer demonstrates is an adult publication. For the purposes of this section, an adult publication is a newspaper, magazine, periodical, or other publication: (i) Whose readers younger than 18 years of age constitute 15 percent or less of the total readership as measured by competent and reliable survey evidence; and (ii) That is read by fewer than 2 million persons younger than 18 years of age as measured by competent and reliable survey evidence. (b) Labeling and advertising in an audio or video format shall be limited as follows: (1) Audio format shall be limited to words only with no music or sound effects. (2) Video formats shall be limited to static black text only on a white background. Any audio with the video shall be limited to words only with no music or sound effects. (c) Each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating or causing to be disseminated, advertising permitted under this subpart D, shall include, as provided in section 502 of the act, the product's established name and a statement of its intended use as follows: "Cigarettes--A Nicotine-Delivery Device for Persons 18 or Older", "Cigarette Tobacco--A Nicotine-Delivery Device for Persons 18 or Older", or "Loose Leaf Chewing Tobacco", "Plug Chewing Tobacco", "Twist Chewing Tobacco", "Moist Snuff" or "Dry Snuff", whichever is appropriate for the product, followed by the words "A Nicotine- Delivery Device for Persons 18 or Older". s897.34 Sale and dstribution of nontobacco items and services, - gifts, and sponsorship of events. (a) No manufacturer and no distributor of imported cigarettes or smokeless tobacco may market, license, distribute, sell, or cause to be marketed, licensed, distributed, or sold any item (other than cigarettes or smokeless tobacco) or service, which bears the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. (b) No manufacturer, distributor, or retailer may offer or cause to be offered any gift or item (other then cigarettes or smokeless tobacco) to any person *44618 purchasing cigarettes or smokeless tobacco in consideration of the purchase thereof, or to any person in consideration of furnishing evidence, such as credits, proofs-of-purchase, or coupons, of such a purchase. (c) No manufacturer, distributor, or retailer may sponsor or cause to be sponsored any athletic, musical, artistic, or other social or cultural event, or any entry or team in any event, in the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. Nothing in this paragraph prevents a manufacturer, distributor, or retailer from sponsoring or causing to be sponsored any athletic, musical, artistic, or other social or cultural event, or team or entry, in the name of the corporation which manufactures the tobacco product, provided that both the corporate name and the corporation were registered and in use in the United States prior to January 1, 1995, and that the corporate name does not include any brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with, those used for any brand of cigarettes or smokeless tobacco. Dated: August 22, 1996.
61 FR 44396-01 1996 WL 482785 (F.R.) (Cite as: 61 FR 44396) RULES and REGULATIONS DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 801, 803, 804, 807, 820, and 897 [Docket No. 95N-0253] RIN 0910-AA48 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents Book 1 of 2 Books Wednesday, August 28, 1996 *44396 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is issuing regulations governing access to and promotion of nicotine- containing cigarettes and smokeless tobacco to children and adolescents. The regulations prohibit the sale of nicotine-containing cigarettes and smokeless tobacco to individuals under the age of 18; require manufacturers, distributors, and retailers to comply with certain conditions regarding the sale and distribution of these products; require retailers to verify a purchaser's age by photographic identification; prohibit all free samples and prohibit the sale of these products through vending machines and self-service displays except in facilities where individuals under the age of 18 are not present or permitted at any time; limit the advertising and labeling to which children and adolescents are exposed to a black- and-white, text-only format; prohibit the sale or distribution of brand-identified promotional nontobacco items such as hats and tee shirts; prohibit sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permit such sponsorship in a corporate name; and require manufacturers to provide intended use information on all cigarette and smokeless tobacco product labels and in cigarette advertising. These regulations will address the serious public health problems caused by cigarettes and smokeless tobacco products. They will reduce children's and adolescents' easy access to cigarettes and smokeless tobacco and will significantly decrease the amount of positive imagery that makes these products so appealing to that age group. The regulations are predicated on the agency's assertion of jurisdiction under the Federal Food, Drug, and Cosmetic Act over cigarettes and smokeless tobacco as delivery devices for nicotine, incorporated as part of the regulations for purposes of, and to facilitate, congressional review under the Small Business Regulatory Enforcement Fairness Act of 1996. DATES: Effective date. The regulation is effective August 28, 1997, except that s897.14(a) and (b) are effective February 28, 1997 and s897.34(c) is effective February 28, 1998. Compliance dates. Manufacturers and distributors are required to comply with the requirements of 21 CFR parts 803 and 804 August 28, 1997; manufacturers are required to comply with the requirements of 21 CFR parts 807 and 820 February 28, 1998. ADDRESSES: References listed in the footnotes of this document have been placed on public display at the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FOR FURTHER INFORMATION CONTACT: Nancy Yeates, Office of Policy (HF-26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827- 0867. SUPPLEMENTARY INFORMATION: Preamble Outline I. Introduction A. Purpose and Overview of the Rule B. Background C. Provisions of the Rule II. Legal Authority A. Legal Principles Applicable to Combination Drug/Device Products 1. The SMDA Recognized Combination Products for the First Time 2. The SMDA Leaves to FDA's Discretion the Determination of Which Regulatory Authorities to Apply to Particular Combination Products 3. Interpreting the SMDA to Allow the Agency to Determine Which Regulatory Scheme Best Serves the Public Health is Consistent With 50 Years of Case Law 4. The Implementing Regulations and the Delegations of Authority Reflect FDA's Interpretation That Section 503(g) of the Act Authorizes the Agency to Determine the Appropriate Regulatory Authorities 5. The Intercenter Agreements and Administrative Precedent Recognize That FDA May Determine Which Regulatory Authority to Apply to a Particular Product B. Cigarettes and Smokeless Tobacco Have Both a Drug and a Device Component and Are Therefore Combination Products C. FDA's Choice of Legal Authorities 1. FDA Will Regulate Cigarettes and Smokeless Tobacco Under the Act's Device Authorities 2. Cigarettes and Smokeless Tobacco Will be Subject to the Full Range of Device Authorities 3. The Restricted Device Provision Authorizes FDA to Establish Access and Advertising Restrictions 4. Application of Other Device Authorities 5. FDA Will Classify Cigarettes and Smokeless Tobacco Under Section 513 of the Act D. The Fact That the Act's Drug Authorities Authorize the Imposition of Similar Restrictions Supports the Reasonableness of the Restrictions That the Agency Has Imposed E. Constitutional Issues Regarding Authority 1. Separation of Powers 2. Nondelegation Doctrine III. Overview of Comments, Smoking Prevalence Rates Among Minors, Scope, Purpose, and Definitions A. Overview of Comments B. Smoking Prevalence Rates Among Minors C. Scope D. Purpose (s897.2) E. Definitions (s897.3) IV. Access A. General Comments B. General Responsibilities of Manufacturers, Distributors, and Retailers (s897.10) C. Additional Responsibilities of Manufacturers (s897.12) 1. Removal of Manufacturer-Supplied or Manufacturer-Owned Items That Do Not Comply With the Regulations 2. Visual Inspections by a Manufacturer's Representative at Each Point of Sale D. Additional Responsibilities of Retailers (s897.14)- 1. Use of Photographic Identification to Verify Age 2. Minimum Age 3. Restrictions Against "Impersonal" Modes of Sale 4. Restrictions Against the Sale of Individual Cigarettes 5. Additional Comments E. Conditions of Manufacture, Sale, and Distribution (s897.16) 1. Restrictions on Nontobacco Trade Names on Tobacco Products 2. Minimum Package Size 3. Maximum Package Size 4. Impersonal Modes of Sale V. Label A. Established Name (s897.24) B. Package Design C. Ingredient Labeling D. Labeling for Intended Use E. Adequate Directions for Use and Warnings Against Use (Section 502(f) of the act) F. Package Inserts VI. Advertising A. Subpart D--Restrictions on Advertising and Labeling of Tobacco Products B. The Need for Advertising Restrictions 1. Advertising and Young People 2. Advertising and Adults C. The Regulations Under the First Amendment 1. Introduction *44397 2. The Central Hudson Test 3. Is Cigarette and Smokeless Tobacco Advertising Misleading, or Does It Relate to Unlawful Activity? 4. Is the Asserted Government Interest Substantial? D. Evidence Supporting FDA's Advertising Restrictions 1. Introduction 2. Do the Regulations Directly Advance the Governmental Interest Asserted? 3. Is There Harm? Does Advertising Affect the Decision by Young People to Use Tobacco Products? 4. Why Young People Use Tobacco and the Role of Advertising in That Process 5. Has The Agency Met Its Burden? 6. The Efficacy of the Restrictions; Empirical Evidence Concerning Advertising Restrictions E. Provisions of the Final Rule 1. Are FDA's Regulations Narrowly Drawn? 2. Section 897.30(a)--Permissible Forms of Labeling and Advertising 3. Section 897.30(b)--Billboards 4. Section 897.32(a)--Text-Only Format 5. Section 897.32(a)--Definition of "Adult Publication" 6. Advertising--s897.32 Requirements for Disclosure of Important Information 7. Section 897.34(a) and (b)--Promotions, Nontobacco Items, and Contests and Games of Chance 8. Section 897.34(c)-- Sponsorship of Events 9. Proposed s897.36--False or Misleading Statements F. Additional First Amendment Issues VII. Education Campaign VIII. Additional Regulatory Requirements IX. Implementation Dates X. Relationship Between the Rule and Other Federal and State Laws A. The Federal Cigarette Labeling and Advertising Act B. The Comprehensive Smokeless Tobacco Health Education Act C. Conflict with Congressional Purpose Behind Current Regulatory Scheme for Tobacco Products 1. The Cigarette Act and the Smokeless Act 2. The PHS Act D. Occupation of the Field E. Preemption of State and Local Requirements Under Section 521(a) of the Act F. Preemption of State Product Liability Claims Under Section 521(a) of the Act XI. Miscellaneous Constitutional Issues A. Takings Under the Fifth Amendment 1. The Interests at Issue 2. The Takings Analysis 3. The Character of the Governmental Action 4. The Economic Impact of the Governmental Action 5. Interference with Reasonable Investment-backed Expectations 6. Summary B. Substantive Due Process, Equal Protection, and Restrictions on Use of Trade Names C. Procedural Due Process Under the Fifth Amendment XII. Procedural Issues A. Introduction B. Adequacy of the Record 1. The Administrative Record 2. The Agency's Use of Confidential Documents 3. The Claim that FDA Relied on "Unknown" Undisclosed Data 4. The Claim that FDA Failed to Include in the Record New Drug Application (NDA) Data on Which it Relied 5. The Agency's Reliance in the Final Rulemaking on New Materials C. Adequacy of the Notice 1. The Agency Provided Adequate Notice of the Key Legal and Factual Issues 2. The Agency Provided a "Reasoned Explanation" for its Current Position D. Adequacy of the Comment Period E. Conclusion XIII. Executive Orders A. Executive Order 12606: The Family B. Executive Order 12612: Federalism C. Executive Order 12630: Governmental Actions and Interference with Constitutionally Protected Property Rights XIV. Environmental Impact XV. Analysis of Impacts A. Introduction and Summary B. Statement of Need for Action C. Regulatory Benefits 1. Prevalence-Based Studies 2. FDA's Methodology 3. Reduced Incidence of New Young Smokers 4. Reduced Number of Adult Smokers 5. Lives Saved 6. Life-Years Saved 7. Monetized Benefits of Reduced Tobacco Use 8. Reduced Medical Costs 9. Reduced Morbidity Costs 10. Benefits of Reduced Mortality Rates 11. Reduced Fire Costs 12. Smokeless Tobacco 13. Summary of Benefits D. Regulatory Costs 1. Number of Affected Retail Establishments 2. Removing Self-Service and Other Prohibited Retail Displays 3. Label Changes 4. Educational Program 5. Restricted Advertising and Promotional Activities 6. Training 7. Access Restrictions 8. I.D. Checks 9. Vending Machines 10. Readership Surveys 11. Records and Reports 12. Government Enforcement 13. Comparison of Benefits to Cost E. Distributional Effects 1. Tobacco Manufacturers and Distributors 2. Tobacco Growers 3. Vending Machine Operators 4. Advertising Sector 5. Retail Sector 6. Other Private Sectors 7. Excise Tax Revenues F. Small Business Impacts G. Other Alternatives H. Unfunded Mandates Reform Act of 1995 XVI. Paperwork Reduction Act of 1995 A. Comments on the Paperwork Reduction Act Statement B. Information Collection Provisions in the Final Rule XVII. Congressional Review Codified Language
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ACTION ON SMOKING AND HEALTH 2013 H Street, NW / Washington, DC 20006 / (202) 659-4310 |