Tobacco Documents Online

August 24, 1995 Summary of Proposed FDA Regulations Advertising and Promotion • Bans all outdoor advertising within 1,000 feet of any playground, elementary school or secondary school (including signs on retail stores) [897.30(b)] • Limits all other advertising to black text on a white background (except for advertising in certain "adult" periodicals) [897.32(a)1 • Limits logos and brand names on race cars, driver uniforms, etc., to a black-on- white format [897.30(a)(2) & 897.32] • Requires all cigarette advertising to include the phrase "CIGARETTES--A NICOTINE DELIVERY DEVICE" [897.32(b)] Requires all cigarette advertising to carry a second warning statement, in addition to the Surgeon General's warning that is already required [897.32(c)I • Bans all cigarette advertising in any media not specifically enumerated in the proposed rule [897.30(a)] • Bans the use of tobacco brand names on non-tobacco products (e.g., t-shirts, caps, lighters) [897.34(a)]. ~ • Bans the use on tobacco products of brand names associated with non-tobacco products (except for brand names used on tobacco products on January 1, 1995) [897.16(a)] • Bans brand-name event sponsorships; allows only corporate sponsorships (if tobacco company name was extant on January 1, 1995) [897.34(c)] • Bans the distribution of free product samples, either in person or through the mails [897.16(d)] • Requires tobacco product manufacturers to undertake $150 million-a-year TV- based national public educational effort to discourage persons under 18 from smoking [897.29] GO ~ N • Gives FDA broad authority to pursue "false or misleading" cigarette advertising ~ and labeling, including "omissions," lack of "balance" and lack of "substantial W evidence" [897.36] b4

-2- Labels • Requires each package to display the word "CIGARETTES" under the brand name in letters at least half as large [897.24 & § 5C2(e)(2) of Actl • Bans all cigarette "labeling" in any media not specifically enumerated in the proposed rule [897.30(a)] Sales • Bans vending machine sales [897.16(c)] • Bans self-service displays [897.16(c)] • Bans sale and distribution by mail [897.16(c)] • Bans sales other than from unopened packages [897.14(c)] • Bans sale of packages containing fewer than 20 cigarettes [897.16(b)] Duties and Responsibilities • Every person who "furthers the marketing of cigarettes or smokeless tobacco products" is a "distributor" -- including, presumably, advertising agencies, publishers and outdoor companies [897.3(c)] • Every "distributor" is "responsible for ensuring that -:he cigarettes or smokeless tobacco products it manufactures, labels, advertises, packages, distributes [or] sells *** comply with the [proposed rules]" [897.101 • Every manufacturer must remove from retail outlets all self-service displays, advertising, labeling and other manufacturer-owned items that do not comply with the proposed rules [897.12(a)] • Every manufacturer must conduct visual inspections, in the normal course of business, to ensure that retailers are complying with the proposed rules [897.12(b)1 • Every retailer must check photo identification to ensure that no one who buys tobacco products is under 18 [897.14(a)] • Every retailer is responsible for ensuring that all sales are "direct, face-to-face"pr) transactions [897.14(b)] ~ N ~ m W W CR

Penalties and Sanctions • Failure to comply with any restriction or requirement in the FDA proposal would result in "misbranding" the cigarette brand(s) involved, which is a"prohibited act" [§§ 301(a)-(c), (k), 502(a), (q), 709 of the Acti. • Prohibited acts.(e.g., violative advertising) may be enjoined by court action [ § 302 of the Act] • Prohibited acts may be punished as misdemeanors uv ithout the requirement of mens rea (guilty intent); intentional acts and second offenses of the same offense are punishable as felonies [§ 303(a) of the Act] • Misbranded articles (cigarettes or labeling) may be seized and condemned by the Government [ § 304(a) of the Act] • Administratively determined civil penalties may be assessed by FDA for violations of the device provisions of the Act, in the amount of $15,000 per violation, and up to $1,000,000 for all violations joired in a single proceeding [§ 303(f) of the Act] (Based on FTC precedents, each individual violative package, piece of labeling, or advertisement in a given magazine is viewed as a separate violation.) • Based on the criteria for "restricted devices," an argument could be constructed that failure to comply with the FDA-imposed restrictions subjects the noncom- plying product or labeling to the notification, replacement-refund, or recall provisions applicable to devices [§ 518 of the Act] F. I