Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry | Guideline Explorer

Description

FDA is issuing this guidance to help small businesses understand and comply with FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” which establishes new required cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (TCA) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of the new required warnings. FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act.

Scope & Applicability

Product Classes

Cigarette

product category example

Stakeholders

Manufacturer

Entity responsible for submitting NDINs

Distributor

Entity responsible for submitting NDINs

Retailer

Entity required to comply with cigarette warning requirements

Regulatory Context

Attributes

Front Panel

One of the two largest sides or surfaces of the cigarette package.

Effective date

The date the final rule and required warnings take effect

Top 50 percent

Required size of the warning on cigarette package panels.

20 percent

Required area of the warning in cigarette advertisements.

Random and equal display

Requirement for warnings on cigarette packaging

View on FDA.gov Download PDF

Related CFR Sections (4)

21CFR1141.10§ 1141.10 Required warnings.
(a) Required warnings. A required warning must include the following:Read full regulation →
21CFR1141.3§ 1141.3 Definitions.
For purposes of this part:Read full regulation →
21CFR1141.12§ 1141.12 Misbranding of cigarettes.
(a) A cigarette will be deemed to be misbranded under section 903(a)(1) of the Federal Food, Drug, and Cosmetic Act if its package does not bear one of the required warnings in accordance with section 4 of the Federal Cigarette Labeling and Advertising Act and this part. A cigarette will be deemed tRead full regulation →
21CFR1141.5§ 1141.5 Incorporation by reference.
(a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51 . All approved material is available for inspection at U.S. Food and Drug Administration, Division of Dockets Management, 5630 Fishers LaRead full regulation →

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