Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco: Guidance for Industry and FDA Staff

Description

This guidance is intended to provide information related to certain provisions of the regulations restricting the sale and distribution of cigarettes and smokeless tobacco. See 75 Federal Register 13225 (March 19, 2010). These regulations are effective June 22, 2010.1 More specifically, this guidance provides clarifying information related to FDA’s enforcement policy concerning 21 CFR sections 1140.16(a) and 1140.32(a) of the final rule.

Scope & Applicability

Regulatory Context

• 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 →

• 21CFR1140.16§ 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 →

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