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Compliance Training for Small Tobacco Manufacturers

Required Warnings for Cigarette Packaging & Advertising

Final Rule 21 CFR 1141

July 26, 2011

Ann Simoneau, JDDirector

Office of Compliance and EnforcementCenter for Tobacco Products

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AgendaRequired Warnings

for Cigarette Packaging & AdvertisingFinal Rule 21 CFR 1141

• Background• Scope of the Final Rule • Manufacturer Responsibilities for Required

Warnings– Cigarette Packaging– Cigarette Advertising

• Electronic files incorporated by reference– Cigarette Required Warnings, Edition 1.0

• Summary

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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).

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Background - FCLAA• 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.

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Background - Public Health Impact• 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

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Background - Rulemaking Process

• Proposed Rule

• Public Comment

• Final Rule

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Background - Final Rule

• Proposed Rule: November 12, 2010– Included 36 proposed graphic images developed by

FDA in consultation with health and media experts• Comment

– FDA conducted study based on 36 graphic images (~ 18,000 participants)

– Researched scientific literature– Public comments (1,700) received on proposed rule

• Final Rule 21 CFR 1141: June 22, 2011– Entitled “Required Warnings for Cigarette Packages

and Advertisements”– FDA selected nine new graphic health warnings

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Requirements

• The final rule applies to: – Cigarette packaging, and– Cigarette advertising.

• The final rule requires the use of: – textual warning statements– corresponding color graphics, and– smoking cessation resource reference

1-800-QUIT-NOW.

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Required Warnings

Cessation Resource

Color Graphic Image

Textual Warning Statement

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Regulated Entities - Packages

The final rule applies to any person who manufactures, distributes, packages, sells, or offers to sell, cigarettes within the U.S. and any person who imports cigarettes for sale or distribution within the U.S.– Manufacturer: any person, including any repacker or

relabeler, who manufactures, fabricates, assembles, processes, or labels a finished cigarette product.

– Distributor: any person who furthers the distribution of cigarettes at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption, but excludes common carriers.

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Regulated Entities - Packages

The final rule applies to any person who manufactures, distributes, packages, sells, or offers to sell, cigarettes within the U.S. and any person who imports cigarettes for sale or distribution within the U.S.

– Importer: any person who imports any cigarette that is intended for sale or distribution to consumers in the United States.

– Retailer: any person who sells cigarettes to individuals for personal consumption.

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Cigarette Definition

The final rule defines 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.

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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.

– 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.

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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).

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Cigarette Required Warnings

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Warning Label Requirements for Cigarette Packages

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Cigarette Package Requirements

• The required warnings must:• be accurately reproduced from FDA’s electronic files• display the text of the required warning in English• 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 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

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Additional Packaging Requirements

• 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.

• Other 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, 920 of the FD&C Act, 21 CFR Part 1140)

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Packaging Examples

Cartons

Packs

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Warning Label Requirements for Cigarette Advertising

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Cigarette Advertising Requirements

• If a manufacturer, importer, distributor, or 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).

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Cigarette Advertising Requirements

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• 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

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Additional Advertising Requirements

• Quarterly Rotation – FCLAA section 4(c)– The nine required warnings must be rotated quarterly

in cigarette advertisements for each brand of cigarettes, in accordance with an FDA-approved warning plan.

• Other Requirements– Regulated entities are also responsible for ensuring

compliance with other applicable advertising requirements under the Tobacco Control Act and relevant regulations (e.g., sections 903, 911 of the FD&C Act, 21 CFR Part 1140)

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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.

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Advertising Examples

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“Cigarette Required Warnings” Electronic Files

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“Cigarette Required Warnings”Electronic Files

• FDA has made available electronic files and instructions for the required warnings. The files are entitled “Cigarette Required Warnings” Edition 1.0, June 2011.

• The files may be accessed

– by Web: http://www.fda.gov/cigarettewarningfiles

– by e-mail request: Cigarettewarningfiles@fda.hhs.gov

– by 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 20850

– by phone request: 1-877-CTP-1373

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“Cigarette Required Warnings” Electronic Files

• “Cigarette Required Warnings” Edition 1.0, June 2011 includes:

• electronic files of the required warnings for both packaging and advertising

• instructions for using the files

• The electronic files come in different formats and aspect ratio, and are designed to fit packages of various sizes and shapes and various dimensions for advertisements.

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“Cigarette Required Warnings” Electronic Files

• 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.

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• 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.

Retailer Exemptions

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Questions?