fem pryuuces o wends TARA AA, t OBACCO eae a PA y SUC aer LCM Graphic health warnings reach the US With the latest suggestion by the Food and Drug Administration (FDA), graphic health warnings on cigarette packs will come to the United States, too. On 12 November 2010, the FDA issued a pro- posed rule entitled “Required warnings for cigarette packages and advertisements”. Sa oe ae a 68 and advertisements for many years, the proposed rule states there was “con siderable evidence” that current warn Ings were largely ignored and viewed as “invisible” to current cigarette users ‘The FDA reportedly found evidence to Suggest that certain warnings, if they ‘were large and included graphic im ages, may have a greater impact. The new warnings are designed to clearly and effectively convey the negative health consequences of smoking on ci garette packages and in cigasette adver In essence » FDA tointroduce larger, more graphic health warnings to US cigarette market > Effectiveness of warnings doubtful as far as smoking cessation is concerned > Action plan to enforce restrictions re- lated to prometion and advertising of tobacco products issued tisements to help discourage non- smokers, including minors, from smok- ing and to encourage cussent smokers 10 stop smoking [As required by the Tobacco Control Act, the warnings would cover at least 50 ppet cent of the front and sear panels of cigarette packs and 20 per cent of the area of advertisements. Cigarette packs that do not carry the new warnings will, bbe deemed misbranded and subject to further regulatory action, By law, the FDA may adjust the type size, text and format t0 ensure the ‘graphics are clear, conspicuous, legible, and appear in the specified area. The FDA apparently adjusted the images to provide a mix of a range of images coupled with varying “frightening™ or visually-disturbing imagery. The FDA, therefore, can still modity the proposed mages based on the comments that it receives on the proposed rule. Other countries have already imple- ‘mented more graphic warnings on ciga- rette packs or advertising. For example, in 2001 Canada introduced more graphic TOBACCO JOURNAL INTERNATIONAL | 6/2010TNs Smoking can kill health warnings on the upper $0 per ‘cent of two primary panels of cigarette packs, including photographs or other images. A 2001 Canadian survey re portedly found that 44 per cent of adult smokers found the new graphic warm. ings increased their motivation to quit. Another Canadian survey found that 37 10 48 per cent of young adults (20 10 24) ‘were thinking about quitting based on ‘the new graphic warnings. Other studies suggested that graphic wamings might reduce cigarette consumption and help cigarette quitters fom smoking again However, more recent findings are not that positive about the effects of graphic health warnings. The FDA tested the 36 ‘proposed graphic warnings in national study of almost 19,000 smokers aged 13 to over 25 in October 2010; the suevey showed that more graphic warning le- bels on cigarette packs may stir the emo- tions of smokers, but might not spur them to quit. Most of the 36 graphics being considered by the FDA “did not elicit strong responses in terms of inten: tions related to cessation”: One excep- tion was an image of a male corpse with a stapled chest that appeared to boost adult smokers’ intentions to quit (see picture). Among the cartoon images, 2 Cigarette being injected into an arm proved to be most effective in terms of discouraging youth smoking, By mid 2009, 28 other countries had im plemented similar, more graphic warn- ings on cigarette packages and related advertising Uruguay now has the lar {gest warnings in the world; they cover 80 per cent of the front and back of packages. Honduras will be implement ing similar 80 per cent warnings in Av gust 2011 ‘The Tobacco Control! Act requires the FDA toissue final regulations by 22 June 2011. FDA proposes that any final rule implementing the required warnings would take effect 15 months after the final rule publishes. One cannot help but wondes whether covers for cigi- rette packs or other ways to repackage cigarettes will soon become vogue 10 make packages more stylish than frightening, New tobacco control strategy (On 10 November 2010, the US Depart ment of Health and Human Services (HHS) “unveiled” its "new" tobacco str tegy that included the new warnings and graphics proposed by the FDA for cigs rette packages and advertising, The LIHS's plan appears to be geared at ener ising federal, state, and local authorities to mobilise to gather public health in- formation about the sks of tobacco use, communicate this information to physicians and users or potential users, and strengthen all programmes to help individuals quit smoking, Specifically, within the HHS, the "National Institutes of Health (NIED and ‘the Centers for Disease Control and Pre- vention (CDG) are scheduled to expand the scientific base of information about Dehaviours known about tobacco use CIGARETTES ARE ADDICTIVE. products & trends mam and control and the constituents in to- bacco and tobacco smoke through in- creased surveillance. Key communt cation documents include the Surgeon General's reports on tobacco and the National Cancer Institute's part of NIH), tobacco control monograph series. The FDA isalso involved in regulating const: ‘uents in tobacco products and tobacco smoke, inchiding additional regulatory controls on tobacco product adverts ‘ng and labelling, as well as reviewing new and modifiedsisk tobacco prod: ucts, The Substance Abuse and Mental Health Services Administration enforces, and enacts laws to prohibit the sale of tobacco products to people younger than 18 years old, The National Tobacco Control Pro: ‘gramme, through CDC, helps to provide free tobacco product cessation counsel! ‘ng, and will leverage state investments to implement evidence-based tobacco control interventions. The Centers for Medicare and Medicaid (CMS) include coverage for smoking cessation pro- ducts and counselling, These HHS com- ponents will continue to work with in- ternational public health authorities 10 increase surveillance and information ‘exchange regarding tobacco products, ‘use and cessation methods. Within states and communities, HS's plan includes working to crease smokefree laws in every state ‘with greater enforcement, as well a5 ga thering information about tobacco con- tol programmes and cessation efforts across all populations and through tar * theQuam prouuce o wenus ‘ected interventions for highsisk popu: lations, such prison inmates of the homeless. Part of the HHS's goal is to change social norms about tobacco prochiets, to make them less attractive by the way these products are depicted Jn films, television and other public media. The HHIS's plan includes having all federal agencies involved in this pro- ‘cess to have a more unified message in print and electronic media ‘The HHS plansto “lead by example’, by using resources that encourage moze smokefree polices, inchuding confer ences to be held in jurisdictions with smoke-free laws and inereasing health care coverage for smoking. cessation products and counselling, It plans to provide clinical intervention guidelines for smokers und additional training for physicians to help them deliver smok {ng cessation advice to their patients, Teplansto mount an effort use its - sources to suppor the FDA's new regu: latory authorities and expand surveil Jance to increase the understanding of tobacco use Hsks and benefits for quit- ting or not smoking ata, Par of the edu cation and intervention includes incor porating cigarette use and monitoring its we in its Healthy People 2020 objec- tives, The HHS, through Healthy People, provides scencebased, ten-year national objectives for promoting heaith and preventing disease. Final, it plans to develop more syncrgies with federal agencies, suchas the Office of Personnel “Management, non governmental organi sations, state, and local leaders, and the international community Time willtell whether this strategic plan amounts to something more than mere repackaging ofits general public health goals, with some weight given to the To- bacco Control Act and the FDA's new regulatory authorities over tobacco products Restrictions on advertising In October, the FDA issued an action plan to enforce restrictions relating to promotion and advertising for tobacco products, as required by the Tobacco Control Act. The FDA's principal pro- 70 Brian J. Malkin is partner at New York City-based law firm Frommer Lawrence & Haug, which specialises In all aspects of in- tellectual_ proper- ty, the FDA and ntirust law. Prior to jaining the com- pany. Malkin worked 2 a regulatory ‘counsel atthe FDA, in both the Center for Drug Evaluation and Research and ‘the office ofthe commissioner. ‘motion and advertising restrictions are contained in the final rales that became effective on 22 june 2010, published in the Federal Register as Regulations re- Stricting the sale and distribution of ck. garettes and smokeless tobacco to pro- tect children and adolescents. The FDA solicited public comments fom a docket for this final rule, as well as an- other docket, Web-based public meet ing to discuss issues related to the de- velopment of an enforcement action plan; request for data, information, and views, ‘The FDA's plan outlines two provisions where the FDA has voluntarily decided to exercise “enforcement discretion” ‘not to enforce a this time, The frst con: ccems a restriction to prevent the use of trade names or brand names of nonto- bacco products that are the sime asa ce garctte or smokeless tobacco product. Here, the FDA decided to take no action as ongas the trade name or brand name Of the cigarctte or smokeless product ‘was registered, orthe product marketed in the US before 22 June 2009 and the first marketing of the tobacco product ‘occurred before the marketing or regis: ‘ation in the US of the nontobacco product with the same name.'The FDA's enforcement discretion further requires that the tobacco and nontobaceo prog uctare not owned by the same manufac ‘turer, distributor or related or afiated entities, ‘The FDA's second enforcement discre- tion concerns the requirement to only use black text on a white background, ‘The FDA was permanently enjoined from enforcing this requirement it posed by the Tobacco Control Act in a United States District Court for the Western District of Kentucky, Com- monwealth Brands, Inc. v. US, (WD. Ky. 4 Jan 2010). On 8 March 2010, the DA filed an appeal to this order, which is pending, ‘The FDA’s enforcement plan intends to ltiise a variety of mechanisms that in- cludes leveraging state resources. The administration describes ts approach as surveillance, inspections, enforcement actions, and education, with an empha- sis to prevent the promotion and adver tising of cigarettes and smokeless to- bacco to youths, especially youths in mi nority communities. The FDA plans to ‘work with contracted states for retail business inspections and will inspect ‘manufacturers and distributors, as well as targeted inspections of retailers. Its principal enforcement tools include ‘warming letters, civil money penalties, no-tobaccosale orders, seizures, injunc tions and/or criminal prosecution, Edu- cation plans include components to ‘educate the tobacco industry regarding the FDA’s new laws and regulations and toencourage voluntary compliance. For example, the FDA conducted several live retailer training sessions in five ve- rues across the US in 2010. The FDA plans to conduct routine monk toring of tobacco product marketing, in addition to its review of reguiatory sub- missions. Monitoring includes pro- ‘motion and advertising found in news- papers, magazines, periodicals, ple ‘ards, non-pointofsale promotional ma terial (eg., direct mail), as well as point. ofsale advertising, including audio or video formats. The FDA will also mont ‘or intemet advertising and complaints thas plans to monitor the effectiveness of ts outlined enforcement plan, includ- ing reviewing existing surveys, such as, youth smoking rates and exposure to to bacco advertising, tobacco marketing expenditures, and ongoing. collabor ations with other federal and state agen- cies, public health agencies, profes: sional groups, advocacy groups, com- ‘munity leaders, and other stakeholders. 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