Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry

Description

This guidance is intended to assist manufacturers, distributors, retailers, and others who sell cigarettes and/or smokeless tobacco in understanding the final Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents and to explain what you should do in order to comply with the regulations. The document explains, among other things:

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

5

Cigarettes

Tobacco product subject to 21 CFR Part 1140

Smokeless Tobacco

Tobacco product subject to 21 CFR Part 1140

Combination Product

Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.

Cigarette

product category example

Roll-your-own tobacco

Class of tobacco product subject to user fees

Stakeholders

4

Manufacturer

Entity responsible for submitting NDINs

Retailer

Entity required to comply with cigarette warning requirements

Distributor

Entity responsible for submitting NDINs

Common carrier

Excluded from the definition of distributor.

Regulatory Context

Regulatory Activities

4

Family Smoking Prevention and Tobacco Control Act

Legislation that provides FDA with the authority to regulate tobacco products.

compliance check inspections

FDA actions to determine if items comply with regulations.

No-tobacco-sale orders

Enforcement action taken by FDA for non-compliance.

Civil money penalties

Financial enforcement action for violations.

Document Types

1

cover letter

The cover letter should identify the affected investigations and the relevant sections of the application or submission.

Attributes

1

Minimum package size

Requirement for maintaining a minimum package size for cigarettes.; Requirement that cigarette packages contain at least 20 cigarettes.; free samples limited to one package containing no more than 0.53 ounces

Technical Details

Substances

1

Roll-your-own tobacco

Included in the definition of a cigarette.

Identified Hazards

Hazards

1

Addictive nature of tobacco products

Legislative finding regarding the public health risk of tobacco.

Standards & References

External Standards

5

FD&C Act

Federal Food, Drug, and Cosmetic Act; See section 514(c) of the FD&C Act; see section 513(i)(1)(A) of the FD&C Act; per section 201(h) of the FD&C Act; Combination Product Provisions – Per 503(g) of the FD&C Act; Referenced for definitions and patent certifications.; Section 502(a) regarding labeling symbols; Combination Product Provisions – Per 503(g) of the FD&C Act.

PACT Act

Prevent All Cigarette Trafficking Act governing mail delivery of tobacco.

Tobacco Control Act

Family Smoking Prevention and Tobacco Control Act

Federal Cigarette Labeling and Advertising Act

Requires each cigarette package and advertisement to bear one of the new required warnings.

Comprehensive Smokeless Tobacco Health Education Act

Requires warnings on smokeless tobacco packages.

Related CFR Sections (10)

21CFR1140.34§ 1140.34 Sale and distribution of nontobacco items and services, gifts, and sponsorship of events.
(a) No manufacturer and no distributor of imported cigarettes or smokeless tobacco may market, license, distribute, sell, or cause to be marketed, licensed, distributed, or sold any item (other than cigarettes or smokeless tobacco or roll-your-own paper) or service, which bears the brand name (aloneRead full regulation →
21CFR1140.32§ 1140.32 Format and content requirements for labeling and advertising.
(a) Except as provided in paragraph (b) of this section, each manufacturer, distributor, and retailer advertising or causing to be advertised, disseminating or causing to be disseminated, any labeling or advertising for cigarettes or smokeless tobacco shall use only black text on a white background.Read full regulation →
21CFR1140.30§ 1140.30 Scope of permissible forms of labeling and advertising.
(a)Read full regulation →
21CFR1140.16§ 1140.16 Conditions of manufacture, sale, and distribution.
(a) Restriction on product names. A manufacturer shall not use a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, except for a tobacco product whose trade or brand name was on both a tobacco product and a nontobacco product that werRead full regulation →
21CFR1140.14§ 1140.14 Additional responsibilities of retailers.
(a) In addition to the other requirements under this part, each cigarette and smokeless tobacco retailer is responsible for ensuring that all sales of cigarettes or smokeless tobacco to any person comply with the following requirements:Read full regulation →
21CFR1140.3§ 1140.3 Definitions.
For the purposes of this part:Read full regulation →
21CFR1140.10§ 1140.10 General responsibilities of manufacturers, distributors, and retailers.
Each manufacturer, distributor, importer, and retailer is responsible for ensuring that the cigarettes, smokeless tobacco, or covered tobacco products it manufactures, labels, advertises, packages, distributes, imports, sells, or otherwise holds for sale comply with all applicable requirements underRead full regulation →
21CFR1140.1§ 1140.1 Scope.
(a) This part sets out the restrictions under the Federal Food, Drug, and Cosmetic Act on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products. Section 1140.16(d) sets out restrictions on the distribution of free samples for cigarettes, smokeless tobacco, anRead full regulation →
21CFR1140.2§ 1140.2 Purpose.
The purpose of this part is to establish restrictions on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products in order to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with toRead full regulation →
21CFR1140.12§ 1140.12 Additional responsibilities of manufacturers.
In addition to the other responsibilities under this part, each manufacturer shall remove from each point of sale all self-service displays, advertising, labeling, and other items that the manufacturer owns that do not comply with the requirements under this part.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

Misbranded under section 903(a)(6)

441

Adulterated under section 902(6)(A)

441

Marketing new tobacco products without required marketing authorization

203

Misbranded tobacco product

50

Adulterated tobacco product

47

Misbranded

38

Adulterated

37

Misbranded device

35

Adulterated drug

35

Marketing a new tobacco product without a marketing authorization order

33