> LEGISLATIVE FOCUS The Act also imposes substantial in- gredient reporting requirements and would require that within six months after the passage of the act, each tobacco product manufacturer or importer must submit the following to the Secretary of Health and Human Resources: A listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of the date of fil- ing, added by the manufacturer to the tobacco, paper, filter or other part of each tobacco product by brand and by quantity in each brand and sub-brand. DESCRIBING, IN DETAIL, EACH TOBACCO PRODUCT A listing of all constituents, including smoke constituents as applicable, identi- fied by the Secretary as being harmful or potentially harmful to health in each Congress Again Considers tobacco product, and as applicable in the smoke of each tobacco product, by FDA Regulation brand and sub-brand. At the request of the Secretary, a to- bacco product manufacturer or importer must submit data related to research and An inside look at the newest tobacco legislation being considered by research findings conducted, supported, or possessed by the manufacturer relat- Congress. > BY BRYAN M. HAYNES AND PAIGE S. FITZGERALD ed to the health, toxicological, behav- ioral, or physiologic effects of tobacco products and their constituents, ingredi- T he newest attempt by Congress lation imposes a completely new federal ents, or additives. Also required is re- to empower the Food and Drug registration requirement upon manufac- search related to marketing involving Administration with the authori- turers. Specifically, the legislation requires the use of tobacco products or marketing ty to regulate tobacco products has been that on or before December 31 of each practices as well as the effectiveness of given the seemingly innocuous title of year, every person who owns or operates such marketing practices. This would re- the “Family Smoking Prevention and To- any business that is “engaged in the man- quire disclosure of the underlying scien- bacco Control Act.” It has garnered pow- ufacture, preparation, compounding, or tific and financial information related to erful support — and equally powerful processing of a tobacco product or tobac- the company’s marketing. opposition. If passed in its current form, co products shall register with the Secre- After reviewing and compiling this the legislation, introduced concurrently tary of Health and Human Services.” data, the Secretary would publish a in both the Senate and House of Repre- Manufacturers must supply a prod- brand-specific list of harmful and poten- sentatives on February 15, 2007, would uct list of all tobacco products manufac- tially harmful constituents within 12 grant the FDA wide-reaching authority tured or processed, and the Secretary months of the enactment of the Act. Fi- to regulate current and new tobacco may require production of all advertise- nally, the Act requires manufacturers and products and would place tight restric- ments for a particular tobacco product. importers to establish and maintain tions on tobacco marketing. But what ex- In addition, every new manufacturer records to assure that their tobacco prod- actly would this new legislation require? must immediately register with the Sec- ucts are not adulterated or misbranded retary. The information submitted as and to “otherwise protect public health.” NEW REGISTRATION AND part of the registration process can be RECORD-KEEPING REQUIREMENTS ADDITIONAL REGULATION made publicly available. Further, every OF ADVERTISING In addition to the state-level certification manufacturer will be inspected by the requirements that tobacco product manu- designated agents of the Secretary at The Act authorizes additional regula- facturers must currently fulfill, this legis- least once every two years. tion of tobacco product advertising if 94 SMOKESHOP April 2007
> LEGISLATIVE FOCUS > The Act would require adoption of stronger, the Secretary determines that “such regulation would be appropriate for more specific health warnings which would the protection of public health.” This broad statement leaves many unan- cover 30% of the front and rear panels of swered questions for tobacco manufac- cigarette packages. turers as to how far the FDA might go in this area. As a first step, however, in restricting advertising and marketing of tobacco product, the Act requires that the FDA’s • A limitation on advertising in publica- cigarette advertising resulting in an addi- 1996 Rule, which restricted tobacco mar- tions with significant teen readership to tional layer of regulatory compliance. keting and sales to minors, be repub- black-and-white text only; NEW LABELING REQUIREMENTS lished within one month and take effect within one year of enactment of the Act. • A restriction on vending machines The legislation also provides the Secre- The major restrictions imposed would be: and self-service displays to adult-only tary of Health and Human Services facilities; with the authority to require prior ap- • Ban on all outdoor tobacco advertising • A requirement that retailers verify the proval of all statements contained on within a thousand feet of schools and age of those who purchase tobacco the labels of tobacco products. The Act playgrounds; products over-the-counter and would further require adoption of additional provision for federal stronger, more specific health warnings • Ban on all remaining tobacco brand enforcement and penalties against which would cover the top 30% of the sponsorships of sports and entertain- retailers who sell to minors; front and rear panels of the package ment events; and would bear the word “WARNING” The Act specifically establishes that in 17-point type. The FDA would be • Ban on giving away non-tobacco items its provisions won’t limit or diminish the empowered to revise labeling require- with the purchase of a tobacco product authority of the Federal Trade Commis- ments, which could include restrictions or in exchange for coupons or proofs sion to enforce its own laws regulating on text, format, size, and the use of of purchase; the advertising, sale, or distribution of to- color graphics. These same warning la- bacco products. The Act would, howev- bels would be required for advertising • Ban on free samples and the sale of er, eliminate the current federal law that and must comprise at least 20% of the cigarettes in packages that contain fewer prohibits states from banning or restrict- area of the advertisement. than twenty cigarettes; ing the time, place or manner of cigarette An area that has been the source of advertising under the Federal Cigarette more recent controversy in the tobacco • Requirement that all outdoor and Labeling and Advertising Act. As such, industry — flavored tobacco products point-of-sale advertising be in black- states would be allowed to address the — is also addressed by the Act. The leg- and-white text only; location, size, number, and placement of islation would prohibit cigarettes from 96 SMOKESHOP April 2007
> LEGISLATIVE FOCUS > The FDA would also be given the ability prior to FDA approval and sale of cer- tain “reduced harm” tobacco products. to reduce nicotine yields to very minimal CONCLUSION levels without Congressional intervention. With all of these new layers of regula- tion, a question arises: who will bear the costs of this legislation if passed? The containing any artificial or natural fla- vides that only Congress has the power answer should be no surprise: the new vor (other than tobacco or menthol) or to ban any tobacco product or reduce the FDA activity would be funded through any herb or spice, including strawberry, allowable nicotine level to zero. Howev- a fee on tobacco product manufacturers grape, orange, vanilla, chocolate, cherry, er, the practical effect of the provision is allocated by market share. As this legis- cinnamon, or coffee. The Act would also that the FDA could require the reduction lation works its way through Congress, ban the use on labels or advertising of of nicotine to very minimal levels with- it undoubtedly will be vigorously de- terms such as “light,” “mild,” or “low.” out further Congressional intervention. bated and if passed, the final version may be significantly different from the NEW REGULATION OF TOBACCO OTHER PROVISIONS current bill. Thus, any participant in the PRODUCT “CONTENT STANDARDS” The Act would establish an eleven- tobacco industry would be well-advised The Act further requires the FDA to member “Tobacco Products Scientific to stay abreast of the developments in establish tobacco product standards to Advisory Committee” to advise the this important legislation. protect the “public health,” such as the FDA on nicotine and “other safety, de- Bryan M. Haynes and Paige S. Fitzgerald reduction or elimination of harmful in- pendence, or health issues.” The Com- are attorneys in the Richmond office of gredients, additives, and constituents mittee is required to include a represen- Troutman Sanders LLP. They are mem- (including those in tobacco smoke). The tative from the tobacco industry and as bers of the firm’s tobacco team, which FDA would also be given the ability to well as a representative of tobacco represents tobacco product manufactur- reduce nicotine yields to any level other growers. In addition, the bill includes ers, importers, distributors and retailers. than zero, as the Act specifically pro- very specific standards that must be met 98 SMOKESHOP April 2007
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