1 Compliance Training for Retailers Required Warnings for Cigarette Advertising & Packaging July 26, 2011 Ele Ibarra-Pratt, R.N., MPH Group Leader, Promotion, Advertising and Labeling Group Office of Compliance and Enforcement FDA Center for Tobacco Products

2 Agenda Required Warnings for Cigarette Packaging & Advertising Final Rule 21 CFR 1141 Background Scope of the Final Rule Retailer Responsibilities for Required Warnings –Cigarette Advertising –Cigarette Packaging Cigarette Required Warnings –Electronic files incorporated by reference Summary

3 Background – Tobacco Control Act On June 22, 2009, the President signed into law the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). Tobacco Control Act granted FDA new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act amended Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA).

4 Background—Tobacco Control Act (cont.) FCLAA requires nine new larger and more noticeable textual warning statements to appear on cigarette packages and in cigarette advertisements. [FCLAA section 4(a) and (b)] It also directed FDA to issue regulations requiring color graphic images depicting the negative health consequences of smoking to accompany the nine new textual warning statements.

5 Background (cont.) Graphic health warnings are required under the Tobacco Control Act 443,000 preventable deaths each year Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers Existing warnings have not changed in approximately 25 years and these often go unnoticed Last few years, smoking rates plateau at ~20% At least 30 other countries have required graphic warnings Larger, graphic warnings communicate health risks more effectively

6 Background—Final Rule November 12, 2010 – FDA releases a proposed rule and 36 color graphics for public comment –36 proposed graphic images developed by FDA in consultation with health and media experts June 22, 2011 – FDA’s final rule (21 CFR 1141), “Required Warnings for Cigarette Packages and Advertisements,” publishes in the Federal Register –FDA selected nine new graphic health warnings –FDA conducted study based on 36 graphic images (~ 18,000 participants) –Researched scientific literature –Public comments (1,700) received on proposed rule

7 Final Rule — Requirements The rule applies to: –Cigarette packaging, and –Cigarette advertising. The rule requires the use of: –textual warning statements –corresponding color graphics, and –smoking cessation resource reference QUIT-NOW.

8 Cigarette Definition The rule defines a cigarette as: (1)any roll of tobacco wrapped in paper or in any substance not containing tobacco; and (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 (1) of this definition.

9 Textual Warning Statements- Cigarettes Packaging and Advertising WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Cigarettes cause fatal lung disease. WARNING: Cigarettes cause cancer. WARNING: Cigarettes cause strokes and heart disease. WARNING: Smoking during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your health.

10 Required Warnings Cessation Resource Color Graphic Image Textual Warning Statement

11 Graphic Warning for Small Advertisements The exclamation point graphic is for ads with an area less than 12 square inches. The graphic must be used with one of the textual warning statements.

12 Effective Dates The final rule will take effect 15 months after issuance of the rule (September 22, 2012). After September 22, 2012, no person may manufacture for sale or distribution within the United States any cigarette package that does not comply with the rule. Additionally, no manufacturer, importer, distributor, or retailer may advertise cigarettes within the United States if the advertisement does not comply with the rule. For cigarette packages manufactured prior to September 22, 2012, manufacturers may continue to distribute the packages for an additional 30 days after the rule goes into effect.

13 Enforcement Cigarette packages and advertisements that do not include a required warning violate the Food, Drug, And Cosmetic Act (FD&C Act) and the Federal Cigarette Labeling and Advertising Act (FCLAA).

14 Warning Label Requirements for Cigarette Advertising

15 Examples of Advertising

16 Cigarette Advertising Requirements If a retailer advertises or causes to be advertised any cigarettes within the U.S., its advertising must bear one the required warnings and comply with requirements under the new rule and other applicable requirements under the Tobacco Control Act. This applies regardless of form, which could include materials such as magazine ads, newspaper ads, pamphlets, leaflets, brochures, coupons, catalogues, retail or point-of-sale displays, posters, billboards, direct mailers, and Internet advertising (e.g., Web pages, banner ads).

17 Cigarette Advertising Requirements The rule requires advertisements to: –Display required warnings, which must be accurately reproduced from FDA’s electronic files –Display the text of the required warnings in English with 2 (two) exceptions –Display required warnings to occupy at least 20% of the top area of the advertisement –Permanently print or affix the required warning so that it is irremovable

18 Cigarette Advertising Requirements – Retailer Responsibilities (cont.) Quarterly Rotation – FCLAA section 4(c) –The nine required warnings must be rotated quarterly in alternating sequence in advertisements for each brand of cigarettes, in accordance with an FDA-approved warning plan.

19 Exemption for Retailers – Cigarette Advertising Requirements A retailer will not be in violation of the rule for advertising that it displays, in a location open to the public, so long as the advertisement: –contains a health warning, –the ad is not created by or on behalf of the retailer (and the retailer is not otherwise responsible for including the required warning), and –the health warning is not altered by the retailer in a way that is material to the requirements of FCLAA section 4 or the rule (e.g., obscuring the warning, reducing the warning’s size, severing the warning in any way).

20 Cigarette Advertising Requirements – Retailer Responsibilities (cont.) Other Regulatory Requirements –Regulated entities are also responsible for ensuring compliance with other requirements applicable to packages under the Tobacco Control Act and regulations (e.g., sections 903, 911 of the FD&C Act, 21 CFR Part 1140).

21 “Health Warning” A “health warning” for purposes of these exemptions is a warning of smoking’s risks.

22 Would the retailer be held responsible for advertising that lacks a warning? –Yes. The retailer would not meet the exemption criteria because there is no health warning on the advertisement. –If retailer-made, the retailer must ensure that the ad has the required warning and complies with all other advertising requirements under the Tobacco Control Act.

23 Warning Label Requirements for Cigarette Packaging

24 Examples of Cigarette Packs

25 Cigarette Packaging Requirements – Retailer Responsibilities Any person who manufactures, packages, sells, offers for sale, distributes, or imports cigarettes for sale or distribution in the United States must ensure the cigarette package bears, in accordance with FCLAA and Part 1141, one of the required warnings on the front and the rear panels.

26 Cigarette Packaging Requirements – Retailer Responsibilities (cont.)  The required warnings must: be accurately reproduced from FDA’s electronic files display the text of the required warning in English only display at the top 50% of Front and Rear Panels for cigarette packages display on the left 50% of Front and Rear Panels for cigarette cartons display the text of the warning in the same orientation as other information on the panel of the package/carton be placed directly on the package and be clearly visible under any cellophane or other clear wrapping be irremovable or permanently affixed

27 Cigarette Packaging Requirements – Retailer Responsibilities (cont.) Display & Distribution – FCLAA section 4(c) The nine required warnings must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of the product, and be randomly distributed throughout the United States, in accordance with a FDA-approved warning plan.

28 Exemption for Retailers– Cigarette Packaging Requirements A retailer will not be in violation of the rule for packaging so long as the cigarette package: –contains a health warning, –is supplied to the retailer by a license- or permit- holding tobacco product manufacturer, distributor, or importer, and –is not altered by the retailer in a way that is material to the requirements of FCLAA section 4 or the rule (e.g., obscuring the warning, reducing the warning’s size, severing the warning in any way).

29 Cigarette Packaging Requirements – Retailer Responsibilities (cont.) Other Regulatory Requirements Retailers are also responsible for ensuring compliance with other applicable packaging requirements under the Tobacco Control Act and regulations (e.g., sections 903, 911, 920 of the FD&C Act, 21 CFR Part 1140)

30 Would the retailer be held responsible for packaging that lacks a warning? Yes. The retailer does not meet the exemption criteria because there is no health warning, even it the packaged cigarette was supplied to the retailer by a licensed manufacturer. Also, if the cigarettes were packaged by the retailer, the retailer would be held responsible for complying with all of the requirements for packaging under the new rule, and subject to enforcement penalties.

31 “Cigarette Required Warnings” Electronic Files

32 Cigarette Required Warnings” Electronic Files” If a retailer is creating their own cigarette advertisements or packaging, it must obtain the required warnings contained in the “Cigarette Required Warnings” Edition 1.0 (June 2011). “Cigarette Required Warnings” includes electronic graphic vector files of required warnings in different formats/aspect ratios for both packaging and advertising instructions for using the files

33 “Cigarette Required Warnings” The required warnings must be accurately reproduced and must be printed with the greatest clarity possible taking into account the printing method used. Use of the required warnings for any purpose, other than for the purpose of displaying them on cigarette packages (including cartons) and in cigarette advertising as required by 21 C.F.R. § 1141, is not permitted without the express written permission of FDA or as permitted under the Copyright Act.

34 “Cigarette Required Warnings” Cigarette Required Warning may be accessed from FDA through various sources: –by Web – request –written request Center for Tobacco Products, Food and Drug Administration, Office of Health Communication and Education, ATTN: Cigarette Warning File Requests, 9200 Corporate Blvd., Rockville, MD –contact CTP via toll free number CTP-1373

35 Summary of Responsibilities for Cigarette Advertising If the retailer is advertising or causing the advertisement of cigarettes, the ads must: –bear one of the required warnings, which must be accurately reproduced from FDA’s electronic files –display the text of the required warning in English with 2 exceptions –display required warnings that occupy at least 20% of the top area of the advertisement –display required warnings that are irremovable or permanently affixed –quarterly rotate the required warnings, in accordance with an FDA approved plan –comply with other applicable requirements under the Tobacco Control Act.

36 Summary of Responsibilities for Cigarette Packaging If any person manufactures, packages, sells, offers for sale, distributes, or imports for sale or distribution in the United States cigarettes, the packaging must bear one of the required warnings that must: –be accurately reproduced from the electronic files –display the text of the required warning in English only –display at the top 50% of Front and Rear Panels for cigarette packages –display on left 50% of Front and Rear Panels for cigarette cartons –display the text of the warning be in the same orientation as other information on the panel of the package/carton –appear directly on the package and be clearly visible under any cellophane or other wrapping. –be irremovable or permanently affixed –be equally display required warnings on packaging and randomly distributed in the U.S., in accordance with an FDA-approved plan –Comply with other requirements under the Tobacco Control Act.

37 Summary of Retailer Exemptions For advertisements not created by or on behalf of the retailer, retailers will not be held in violation of the rule if it publicly posts an advertisement that is not in compliance as long as they meet the exemption criteria for retailers. For packages that are supplied to the retailer, retailers are exempt from these requirements as long as they meet the exemption criteria for retailers.

38 Questions?