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41314 Fedesal Register, / Vol. e0, No. 155 / Friday, August 11, 1995 / Proposed Rules DEPARTMENT OF HEALTH AND HUMAN SERVIM Food and Drug Adtninbtration 21 CFR Parts 801, 8a'i, 804, and 897 (Doetat Na OSN-o28.11 Reg"ladoca bttlon of ~ ~ fyts~s and Dbbi C Smokeiess Tobsooo Products To Protsat C1Wdren and Ado/.sc.nts At3ENCr: Food and Drug Administration, HHS. ACTION: Proposed rtile, summARY: The Food and Drug Administration (FDA) is proposing new regulations goveeaing the sale and distribution of nicotine-containing cigarettes and smokeless tabacco products to children and adolescents in order to address the seriouspub1ic health problems caused by the use of and addiction to these products. The proposed rule would reduce children's and adolescents' easy access to cigarettes and smokeless tobacco as well as significantly decrease the amount of positive imagery that makes these products so appealing to them. The proposed rule would not restrict the use of tobacco products by adults. Spec~fically, the proposed rule would establish 18 years of age as the Federal minimum age of purchase and would prohibit cigarette vending machines, free samples, mail-order sales, and self- service displays. It would also require that retailers comply with certain conditions regarding sales of tobacco, especially verification that the purchaser is at least 18 ysars of age before a tobacco sale is mads. Finally. the proposed rule would limit advertising and labeling to which children and adolescents are exposed to a text-only format; ban the sale or distribution of branded non-tobacco items such as hats and tee shirts; restrict sponsorship of events to the corporate name only; and require manufacxuiers- to establish and maintain a national public education campaign aimed at children and adolescents to counter the pervasive imagery and reduce the appeal created by decades of pro- tobacco messages and thus to help reduce young people's use of tobacco products. The objective of the proposed rule is to meet the goal of the report "Healthy People 2000" by reducing roughly by half children's and adolescents' use of tobacco products. If this objective is not met within seven years of the date of publication of the final rule, the agency will take additional measures to help achieve the reduction in the use of tobacco products by young people. FDA is requesting comment regarding the type of additional measures that would be most effective. DATES: Written comments and recommendations by November 5.1995. ADDRE3sE8: Submit written comments and recommendatioa. to the Doclrets Management Branch (HFA-305). Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.. Rockville, MD 20857. FOR FURTHER INFORMATtON QONTACT: Philip Chao, Office of Policy (HI-23), Food and Drug Administration, 5800 Fishers Iane, Rockville, MD, 20857, 301-827-3380. SUPPLEMENTARRr INFORMATtON: L Introduction Approximately 50 million Americans currently smoke cigarettes and another 6 million use smokeless tobacco products., 1'hese tobacco products are responsible for more than 400.000 deaths each year due to cancer, respiratory illnesses, heart disease, and other health problems.= Cagarettes kill more Americans each year than acquired immune deficiency syndrome (AIDS), alcohol, car accidents, murders, suicides, illegal drugs, and fires combined.3 On average, smokers who die from a disease caused by smoking lose 12 to 15 years of life because of tobacco use.• In a separate document 3 FDA is addressing the issue of its jurisdiction over nicotine-containing cigarettes and smokeless tobacco products. The results of an extensive investigation and comprehensive legal analysis support a finding at this time that the nicotine in these products is a drug and that these products are nicotine-delivery devices within the meaning of the Federal Food. Drug, and Cosmetic Act (the act). FDA proposes to regulate cigarettes and smokeless tobacco products by employing its restricted device authority, which affords the most appropriate and flexible mechanism for regulating the sale, distribution, and use of these products. The primary objective of the proposed rule is to reduce the death and disease caused by tobacco products. Rather than banning tobacco products for the millions of Americans who are currently addicted to them, this regulation focuses on preventing future generations from developing an addiction to nicotine- containing tobacco products. In addition, the scientific evidence strongly suggests that nicotine addiction begins when most tobacco uaers are teenageis or younger and, thus, is a pediatric disease. Therefore, reducing the number of young people who regularly start to use tobacco products will help to prevent future generations of individuals from becoming addicted to nicotine. The goal of the proposed rule is to help the country achieve one of the objectives of "Healthy People 2000: • which is to reduce the number of children and adolescents who use tobacco products by roughly one half by the year 2000. The agency has modi$ed the goal to include a different measurement tool and established 7 years after publication of the final rule as the goal's endpoint. "Healthy People 2000" discussed national health promotion and disease prevention objectives in this country. It was facilitated by the Institute of Medicine of the National Academy of Sciences, with the help of the U.S. Public Health Service, and included almost 300 national membership organizations and all State health departments.6 To determine the most appropriate regulatory measures, the agency reviewed the current patterns of use of tobacco products. According to the 1994 Surgeon General's Report, "Preventing Tobacco Use Among Young People: A Report of the Surgeon General" (the 1994 Surgeon General's Report), more than 3 million American adolescents currently smoke cigarettes and an additional 1 million adolescent males use smokeless tobacco.7 Every day, another 3,000 young people become regular smokers.9 U.S. data suggest that anyone who does not begin smoking in childhood or adolescence is unlikely to ever begin.9 Eighty-two percent of adults who ever smoked had their first cigarette before age 18, and more than half of them had already become regular smokers by that age.1O Moreover, the younger one begins to smoke. the more likely one is to become a heavy smoker. I I Many young tobacco users become addicted to nicotine, a chemical substance in tobacco. Although they ' believe that they will not become addicted to nicotine or become long- term users of tobacco products, they often find themselves unable to quit smoking.12 In fact. among smokers aged 12-17 years. 70 percent already regret their decision to smoke and 66 percent state that they want to quit.13 Those who are able to quit experience relapse rates OD and withdrawal symptoms similar to tG those reported in adults.14 tV Long-term addiction to nicotine can 6.1 result in serious chronic diseases and 00 premature death. An adolescent whose W cigarette use continues into adulthood ~ increases his or her risk of dying from

41372 Irederal Register / Vol. 60, No. 155 1 Fdday, August 11, 1995 / Proposed Rules 30. "Appendix V: Regulatory Impact Petition for Regulation of Unfair and 21 CFR Part 897 Analysis Guidance:" in "Regulatory Progratn Deceptive Alcoholic Beverage Advertising of the United States Government: Office of and Marketing Practices: ' Appendix A, pp. Cigarettes, Smokeless tobacco, Management and Budget, pp. 663-666. April 3-4. March 1985. Labeling, Advertising. Sale and 1.1990-March 31. 1991. 50. Scheter, F.M. "Industrfal Market Distribution, Reporting and 31. ld., p. 663. Strtu'tttre and Economic Pertermanc.e: " 2nd recordkeeping requirements. 32. "1994 State of the Industry Report." in Edition. Rand McNally College Publishing Therefore under the Federal Food Automotic Merclandiser, August 1994, p. Co.. Chicago, p. 380.1980. , , Drug and Cosmetic Act and under As. " ' 51. Beclcer, G.S. and tCM. Mtuphy, "A , authority dele ated to the Commissioner 33. Censtte of thrlndusay Isane: in Simple Theory of Advertising as a Good or g of Food and Dru it is osed that s ro veading Tlme,e, August 1994. Bad." QuarterlyJournal oJEconomics vol g , p p 34 "Tar andCacbon Monoxide Niaotine „ . 21 CFR parts 801 803 and 804 be . , . of the St>nke of 933 Varietiea of Domestic 106, p. 941, November 1993. 52. "The Economic impact of the Tobacco , , amended and that a new part 897 be Csgarettes," Federal Trade Catnmission, Industry on the United States in 1990 " Priai added as follows: 1994. , waterhouse. October 1992 p. ES-3 Notm The ut 897 as art number fot 35. French, M.T.. at aL, ".Complianm Costs " . . 53. Vending Timss "Census of the p p ro osed at e0 FR 32417 will be chan ed b Final Report. of Food Labeling Regulations. , Industry Issue:' 1994 42 p p g y the a enc in a future issue of the Federal RTI Pro;sct Number 233U-3972-02 DFR. January 1991. , p. . 54. Automatic Merchandiser, "State of the g y Register• 36. Department of National. Health and Industry Report," p. A8, Augtut.1994. • Welfate, "Tob.cco Products Control 55. Wolfson. A. "Canada's Ad Ban Puts PART 801-LABELING Re ulatiana amendment " Canada GosetDe Cigarettes Out of Sight," The Courierti/ourna 1, g . . , Na 16 pp. 3277-3294 Pbrt il: vol. 127 pp. A1,-A4, August 1.1994. 1. The.authority citation for 21 CFR . , . Attsust ii.1993. 56. Teinowitz, L. "Pitst Smoke, Then Fir.". part 801 continues to read as follows: 37. Kaismm.n, M:. Dep.etmamt of National Advertising Age, p. 30. Spting 1995. Authority: Seat. 201. 301, 501. 502. 507, Health and Welfats, Canadiaas Government. 57. Sndicott. RG, "Top Advertisers 519. 520, 701, 704 of the Federal Food. Drug, person.l eammuniutioo. February t.1995. Rebound. Spending to $36 Billion.' attd Cosmetic Act (21 U.S.C. 321, 331, 351. 38. iCropp. R.. "A Position Paper on Advertising Age, voL 64, No. 41, p.1. 352, 357. 3601. 360j. 371. 374). Reducing Tobacco Sales to Minors by September 29. 1993. Prohibitin the S.le of Tobacco Products by 58. 56 FR 11681. (March 20 1991). 2. Section 801.61 is amended by g Means of Self-Service Merchandising and , 59. Expert Panel Report. "When Packages adding a new paragraph (d) to read as Requiring only Vendor Assisted Tobacco Can't Speak: Possible impacts of plain and follows: Sales " North Bay Health Resources Center generic packaging of tobacco products: " . , Petaluma,.Caiifomia, p. S. November 3.1994. Prepared at the request of Health Canada. p. § 801.61 Statement of Identity. . . . . . 39. Cumings. K. M., T. Pechacek. and D. 140. March 1995. Shopland.'"rhe Legal Sale of Cigarettes to 60. "An Advertising Supplement" (d) This provision does not apply to U.S. Mitars: Estirn tes by State." American Advertising Age, p. 2, September 26.1994. cigarettes or to smokeless tobacco /oumal of Public Healtlt, vol. 84. No. 2. 61. Kropp. R.. "A Position Paper on products as defined in part 897 of this February 1994. p. 301. (Derived by Reducing Tobacco Sales to Minors by chapter. substracting s.les to 18-yearoids from the Prohibiting the Sale of Tobacco Products by reported 516 million packs consumed). Means of Self-Serviat Merchandising and PART 803-MEDICAL DEVICE 40. 58 FR 45156.;5159-t5160 (August 26. Requiring Only Vendor-Assisted Tobacco REPORTING 1993). Sales." North Bay Health Resources Center. 41. "The Economic Impact of the Tobacco Petaluma. California, p. 2. November 3,1994. 3. The authority citation for 21 CFR Industry on the United States in 1990." Price . 62. "The Economic Impact of the Tobacco part 803 continues to read as follows: Waterhouse. p. It-10. October 1992 Industry on the United States in 1990 " Priar 42. 1194 SGR, p. 85. . Waterhouse OctoDer 1992 Authority: Secs. 502, 530. S39, 701, 704 of 43. U.S. p.t~w t of Commerce. D ,, . 63. Gray Ii.P.. and L Walter '7he the Federal Food, Drug, and CoansBc Act (21 "Statistiatl A~tratx of the United States . Economic Contribution of the Tobacco U.S.C. 352, 360, 360i, 371, 374). 1993." 113 edition.1993, p. I3T, Department Industry." in "Smoking and Society: Towarcl 4. Section 803.1 is amended by of Health and Human Services. Office of a More Balanced Assessment", R.D. Tollisoa. adding a new paragraph (d) to read.as Inspector General. "Spit Tobacco and Youth" editor. Lexington Books, p. 248, 1986. follows: Additional Analysis. June 1993. 64. The Tobacco Institute,"The Tax 44. "The Economic Impact of the Tobacco Burden on Tobacco," voL 28. 1993, p. 4. § 803.1 Scope. Industry on the United States ia 1990." Price 65. U.S. Department of Commerce. . . . . .' Waterhouse. P.11-i0. Octobsc 1992. "Staeistical Abstract of the United States (d) This part does not apply to 45. Kropp, R. "A Position Paper on 1994„' 114th-edition. no. 464!1994, p. 298. cigarettes or to smokeless tobacco Reducing Tobacco Sales to Minors by 66. ,"1994 State of the Industry Report." in roducts as defined in * 897 of this Prohibiting the Sale of Tobacco Products by Automatic Merchandiser August 1994 p p Means of Welfare Merchandising and , . . A2. chapter. Requiring only Vendor•Assisted Tobacco Sales." North Bay Health Resources Center. List of 5ubjects PART 804-MEDICAL DEVICE Pentaluma November 3 California S p DISTRIBUTOR RF_sORTiNG . . . . . 21 CFR'Port 801 1994. 46 artment of Commerce U S De 1 5. The authority citation for 21 CFR . . . . p "Statistiatl Abstract of the United States Labeliag, Medical devices, Reporting part 804 continues to read as follows: 787 1994 1994 " 114th edition 1284 ao and recordkeeping requirements~ 70 h . . . p. . , . 47. National Association of Chain Drug 21 CFR Part 803 1. (b Aut ority: Secs. 502. 510, 519. 520, 704 of the Federal Food. Drug, and CosmetioW Stores. "Prescription Drug Marketplace Act (21 U.S.C. 352. 360. 3601. 360/. 371. 374.N Simulation Mode: User's Guide." Appendix Imports Medical devices Reporting B 1992 . , 6. Section 804.1 is amended by . . 48 "The Economic Impact of the Tobacco and recordkeeping requirements. adding a new paragraph (c) to read as an . on the United States in 1990 " Price Industr 21 CFR Part 804 follows: W , y Waterhouse p. IH10. Octobaz 1992. CJ , 4A Recaaamend.tioen of the Staff of the Imports, Medical devices, Reporting 6804.1 SCOpe. W Fedaed Ttade Cammiseiao:"Omaibua and recordkeeping requirsmaata. . . . . .

A Fed.rd Regster / VoL 80, Na 15s'`fFriday, August 'i i, 1995 / Proposed Rules 41373 (c) This part does not apply to distributors of cigarettes or smokeless tobacco products as defined in part 897 of this chapter. 7. New part 897 is added to read as follows: PAAT 897-CIGARETTES AND SMOKELESS TOBACCO PRODUC78 8ubpart A-4.nea/ Prod.iooa SeL 897.1 Scope. 897.2 PurpoN. 897.3 Definitiona Subpart B-Sale and Dbtrfbutloe to Parsotta under ta Yaars or Age 897.10 General rsspmsibilities of manufacturers, dittributoes, and retailers. a97.i2 Additional nnponsibilities of mannfar3suu+a - 897.14 Additloe•ir.apoosibiliwsef . retailers. 897.16 Conditioas of maaubetur., s.4 and distribution. Subpart C--lab.ls and Educationat fsrograrns 897.24 Established names for cigarettes and smokeless tobacco products. 897.29 Educational programs concerning - cigarettes and smokeless tobacco products. Subpart D-.abeling 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 non-tobacco items and services. contests and games of. chance end sponsorship of events. 897.38 False or misleading labeling and advertising. Subpart E-#tbpllartaotte Raqulnntents 897.40 Records and reports. 897.42 Freemption of State and local requirements and requests for advisory opinions. 897.44 Adciitional regulatory mcasures. Authority: Sacs. 502. 510. 520. 701. 704 of the Federal Food. Drug and Cosmetic Act (21 U.S.G 352, 360. 3601, 371, 374). Subpart A-General Provisions § 897.1 Scopa. (a) This part is intended to establish the conditions under which cigarettes and smokeless tobacco products that contain or deliver nicotine, because of their potential for harmful effect, shall be sold, distributed, or used under the restricted device provisions of the Federal Food. Drug, and Cosmetic Act. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter 1 of Title 21. unless otherwise noted. § SY'r.2 Ntrpo;. --^ • The purpose of this part is to establi sh conditions for the sale, distribution, a:zd use of cigarettes and smokeless tobaa o products in order to: (a) Reduce the number of people under 18 years of age who become addicted to nicotine, thus avoiding tb s life-threatening consequences associa•:ed with tobaoco useet and (b) Provide important information regarding the use of these products to users and potential users. §W7.9 Defintttotta. (a) Cigarttte means any product (including components, accessories. <r parts) which contains or delivers ' nicotine, is intended to be burned under ordinary conditions of use, and consi;xs ofi (i) Any roll of tobacco wrapped in paper or in any substance not containing tobacco: (2) Any roll of tobacco wrapped in any substance containing tobacco which, becsuse 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, consumeis as a cigarette described in paragraph (a)(1) of this section; or (3) Any roll of tobacco wrapped in leaf tobacco or any substance contain ing tobacco (other than atiy roll of tobacc3 described by paragraphs (a)(1) or (a)(::) of this section) and as to which 1,000 units weigh not more than 3 pounds. (b) Cigarett tobacco means any loos e tobacco that contains or delivers nicotine and is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements pertat'n}ng to cigarettes shall also apply to cigafette tobacco: (c) Distributor means any person w ho furthers the marketing of cigarettes or smokeless tobacco products, whether domestic or imported. at any point from the original place of manufacture to t he person who makes final delivery or st)e to the ultimate user, but who does not repackage or otherwise change the container. wrapper. or labeling of the cigarettes or smokeless tobacco products, or the package of the cigarettes or smokeless tobacco products. (d) Manufacturer means any person, including any repacker and/or relabeler. who manufacttues, fabricates, assembles, processes, or labels a finished cigarette or smokeless tobac:o product. The term does not include any person who only distributes finished cigarettes or smokeless tobacco products. .. (e) Nicotine means the chemical substance named 3-(1-Methyl-2- p)'r+'ohdinyl) pyridine or C,oHiJd=. ~~nding any salt or complex of (f) Package means a pack, box, carton, or container of any kind in which cigarettes or smokeless tobacco produds are offered for sale, sold, or otherwise distributed to consumers. (g) Point of sale means any location at which a consumer can purchess or otherwise obtain cigarettes or smokeless tobacco products for personal consumption. (h) Aetailer means any person who sells or distributes cigarettes or smokeless tobacco products to individuals for personal consumption. (i) Smokeless tobacco means any cut, ground, powdered, or leaf tobacco that contains or delivers nicotine and that is intended to be placed in the oral cavity. Subpart B-Sale and Distribution to Persons Under 18 Years of Age § 897.10 O;ensral responeiblMtles of manufacturers, distributors, and retail.rs. Each manufacturer, distributor, and retailer is responsible for ensuring that the cigarettes or smokeless tobacco products it manufactures, labels, advertises, packages, distributes, sells, or otherwise holds for sale comply with all applicable requirements under this part. § 897.12 Additional responsibilities of manufacturers. In addition to the other responsibilities under this part, each manufacturer shall: (a) Remove, from each point of sale, all self-service displays, advertising, labeling, and other manufacturer- supplied or manufacturer-owned items that do not comply with the requirements under this part; (b) Through its representatives, when they visit any point of sale in their normal course of business, visually inspect and ensure that the products are labeled, advertised, and distributed in accordance with this part. § 897.14 Additionai responsibilities of retaifers. In addition to the other requirements under this part, each retailer is responsible for ensuring that all sales of cigarettes or smokeless tobaccc, roducts to any person (other than a distributor or retailer) comply with the following requirements: (a) The retailer or an employee of the retailer shall verify by means of photographic identification containing the bearer's date of birth that no person purchasing or intending to purchase the product is vounger than 18 years of age: 89278340

C 41374 Federal Register / Vol. 60. No. 155 / Friday, August 11, 1995 / Proposed Rules (b) The cigarette or smokeless tobacco product shall be provided to the person purchasing the product by the retailer or by an employee of the retailer, without the assistance of any electronic or machanical device (such as a vending machine or remove-operated machine); and (c) The retailer or an employee of the retailer shall not break or otherwise open any cigarette package or smokeless tobacco product to sell or distribute individual cigarettes or number of cigarettes or any quantity of cigarette tobacco or of a smokeless tobacco product that is smaller than the quantity in the unopened product. g897.ts condltlone o/ nairwfacWter aale, and distrlbutaon. (a) Restriction on product names. A manufacturer may 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 tobacco products on which a trade or brand na._lne of a nontobacco product was in use on January 1. 1995. (b) Minimum cigarette package size. No manufacturer, distributor, or retailer shall sell or cause to be sold. distribute or cause to be distributed, any cigarette package that contains fewer than 20 cigarettes. (c) Vending machines, self-service displays, mail-order sales, and other "impersonal" modes of sale. Cigarettes and smokeless tobacco products may be sold only in a direct, face-to-face exchange between the retailer and the consumer. Examples of methods of sale that are not permitted include, but are not limited, vending machines, self- service displays, mail-order sales, and mail-order redemption of coupons. (d) Free samples. Manufacturers. distributors, and retailers may not distribute or cause to be distributed any free samples of cigarettes or smokeless tobacco products. Subpart C-Labels and Educational Programs . § 897.24 Estabtashed names for cigarettes and smokeless tobacco products. Each cigarette or smokeless tobacco product package, carton, box, or container of any kind that is offered for sale, sold, or otherwise distributed shall bear the following established name: ..Cigarettes•', "Cigarette Tobacco". "Loose Leaf Chewing Tobacco". "Plug Chewing tobacco". "Twist Chewing Tobacco", "Moist Snuff", or "Dry " :,ff , whichever name is appropriate. § 897.29 Eduoatlonat programs concerning clganttaa and enwkelesa tobacco products. (a) Each manufacturer shall establish and maintain an effectiIve national public educational progeam to discourage persons under 18 years of age from using cigarettes and smokeless tobacco products. The major portion of this rogram must appear on television. (br. Each manufacturer shall allocate an amount for the educational program that is proportionate to its share of the total advertising and promotional expenditures for the most recent year repotted by all manufacturers to the Federal Trade Commission pursuant to the Federal Cigarette Labeling and Advertising Act or the Comprehensive Smokeless Tobacco Health Education Act. The Total amount to be spent shall be $150,000,000 per year. Subpart D-Labeling and Advertising § 1197.30 Scope of permissible forms of labeling and advertising. (a) This subpart does not apply to cigarette or smokeless tobacco product package labels. A manufacturer, distributor, or retailer may distribute or cause to be distributed: (1) Advertising which bears the cigarette or smokeless tobacco product brand name (alone or in conjunction with any other word) or any other indicia of tobacco product identification only in newspapers; in magazines: in periodicals or other publications (whether periodic or limited distribution); on billboards. posters, an placards in a4icordance with paragraph (b) of this section: and in nonpoint of sale promotional material (including direct mail): and (2) Labeling which bears the cigarette or smokeless tobacco product brand name (alone or in conjunction with any other word) or any other indicia of tobacco product identification only in point of sale promotional material: audio and/or video formats delivered at a point of sale; and on entries and teams in sponsored events. (b) No outdoor advertising, including but not limited to billboards, rosters, or placards, may be placed wiGt n 1,000 feet of any playground. elementary school or secondary school. 5897.32 Format and content requirements for labeling and advertising. % (a) Each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating or causinglo be disseminated, labeling and advertising permitted under § 897.30 shall use only black text on a white background. This section sball not apply to advertising appearing in adult nawspapers, magazines„periodicals, or other publications (whether periodic or liinited distribution). For the purposes of this section, an adult newspaper, magazine, periodical, or publication, as m easured by competent and reliable sttrvey evidence, is any newspaper, cr.agazine, perfodical, or gublication: (1) Whose readers aged 18 years or o;der constitute 85 percent or more of the total readership, and (2) That is read by fewer than 2 million persons under age 18. (b) Each manufacturer, distributor, aad retailer advertising or causing to be advertised, disseminating or causing to be disseminated, advertising, but not labeling, permitted under § 897.30(a). shall include, as provided in section 502 c f the Federal Food, Drug, and Cosmetic Act, the product's established name and a statement of its intended use as f3llows: "Cigarettes-A Nicotine- Delivery Device", "Cigarette Tobacco- ,~ Nicotine-Delivery Device", or "Loose l.eaf Chewing Tobacco", "Plug Chewing "bbacco", "Twist Chewing Tobacco". "Moist Snuff" or "Dry Snuff", whichever is appropriate for the product, followed by the words "A IJicotine-Delivery Device". (c) Each manufacturer, distributor. +utd retailer of cigarettes shall include, n all advertising, but not labeling, :)ermitted under § 897.30(a), a brief ;tatement, such as the one specified :)elow, printed in black text on a white :iackground: About one out of three kids who become smokers will die from their smoking. (d) The statement required under paragraph (c) of this section shall be readable, clear, conspicuous, prominent, and contiguous to the Surgeon General's warning. § 897.34 Sale and distribution of non- tobacco items and services, contests and games of chance and sponsorship of events. (a) No manufacturer, distributor, or retailer shall market, license, distribute. sell, or cause to be marketed, licensed. distributed. or sold any item or service (other than cigarettes or smokeless tobacco products), which bears the brand name (alone or in conjunction with any other word), logo, symbol, motto, selling message, recognizable GID color or pattern of colors, or any other CD indicia of product identification similar?3 or identifiable to those used for -1 cigarettes or smokeless tobacco on products. W (b) No manufacturer, distributor, or 4)b retailer shall offer or cause to be offered b4 any gift or item, or the right to participate in any contest, lottery, or

Federal RasWer / Vol, 60, No. 15S t F"rlday. August 11: 19g5 ! Proposed Rules 41375-41451 game of chance to any person should be plainly marked aa "Labela", (f) SeCtion 521(a) of the Federal Food. purchasing cigarettes or smokeless or' labeling and Advertising". Drug, and Cosmetic Act does not tobacco products in consideration of.the whichever is appropriate. preempt a State or local requirement for purchase thereof, or to nny person in (c) Manufacturers, distributors, and which an application for exemption consideration of furnishing evidence, retailers shall, upon the presentation by from preemption has been submitted such as tsedits, proofs-of-purchase, or an FDA representative of official under § 808.20 of this chapter because coupons, of such a purchase. credentials, make all records and other the State or local requirement is equal (c) No manufacturer, distributor, or information collected under this part to or substantially equivalent to a retailer shall sponsor or cause to be and all records and other infotntation requirement under the Federal Food, sponsored any athletic, musical, artistic related to the events and persons Drug, and Cosmetic Act, is not a cr other social or cultural event, in the identified in such records available to requirement within the meaning of brand name, logo, motto, selling the FDA representative for purposes of section 521(a) of the Federal Food, Drug, message, recognizable color or pattern of inspection, review, copying, or any and Cosmetic Act, or is more stringent colors, or any other indicia of product other use related to the enforcement of than and does not conflict with the identification similar or identical to the Federal Food. Drug, and Cosmetic requirements under this part. or those used for cigarettes or smokeless Act and this part. tobacco products. A manufacturer, (ii) lssuance of an advisory opinion is distributor, or retailer may sponsor or 4887.42 Proemptlon of Sta» and loeal in the public interest. cause to be sponsored any athletic. ~~"ena ~~~ ~ a~~ musical, artistic or other social or °pinkins. 4 89T•44 Addltlonal regulatory measuros. cultural event in the name of the (a) General. In addition to the Seven years after the publication date corporation which manufactures the requirements imposed under this part, of any final rule based on the proposed tobscco product, provided that both the manufacturers, distributors, and rule published in the Federal Register teglstsrad corporate name and the retailers shall comply with any more on (date of publication of the final rule). corporation were in existence prior to stringent State or local requirements if the percentage of people under the age January 1,1995. relating to the sale, distribution, of 18 years who smoke cigarettes has not labeling, advertising, or use of cigarettes decreased by 50 percent since 1994 (as 48i7.3s False o. rNslsdln9 taDNIn9 2na and smokeless tobacco products, determined by an objective, advewsing. • provided that those State or local scientifically valid, and generally Labeling or advertising of any requirements do not conflict with the accepted program), and/orif the cigarette or smokeless tobacco product requirements under this part. These percentage of males under the age of 18 is false or misleading if the labeling or more stringent State or local years who use smokeless tobacco advertising contains any express or requirements are not preempted under implied false, deceptive, or misleading section 521(a) of the Federal Food. Drug, products has not decreased by 50 statement, omits important information, and Cosmetic Act (21 U.S.C. 360k(a)). percent sc enrifically valid, iandd oy an lacks fair balance, or lacks substantial (b) Requests for advisory opinions. (1) generally accepted program), and the evidence to support any claims made for Any State or political subdivision of a the product. State may request an advisory opinion percentage of females under the age of from the Food and Drug Administration 18 years who use smokeless tobacco Subpart E-fMistelfaneous with respect to the preemptive effect of products has increased since 1994 (as Requirements determined by an objective. this part on any particular State or local scientifically valid, and generally 1897.40 ReP A Fin aW report& requirement. The request for an accepted program), then the agency (a) Each manufacturer shall, on an advisory opinion should comply with shall take additional measures to help _annual basis, submit: the requirements at § 10.85 of this achieve the reduction in the use of (i) Copies of all labels, except that a chapter. The agency may, in its tobacco products by children and manufacturer ma submit a discretion 8nd after consulting the State adolescents described above. representative sample of such labels if or political subdivision, treat a request the labels will be similar for multiple for an advisory opinion as an Dated: August 9,1995. packages or products; and application for exemption from David A. Kessler, (2) Copies of all labeling and a preemption under § 808.20 of this Commissioner of Food and Druga. representative sampling of advertising. chapter. ponna E. Shalala. (b) The manufactiuer shall send this (2) The Commissioner, on his or her inforr•.tation to the Document and own initiative, may issue an advisory Secnetary of Health and Human Services. Records Section. 12420 Parklawn Dr.. opinion relating to a State or local (FR Doc. 95-20051 Filed 8-10-95; 8:45 am1. ,ockville, NID 20852. The information requirement if he or she finds that: eIwi+a cooE .1eo-o+-v