On this page:
- Relevant Dates
- Sponsoring an Event
- Use of Brand Name, Logo, Symbol, Motto, etc in Items and Services
- Free Sample Restrictions
- Format and Display Requirements for Required Warning Statements on Advertisements
For tobacco products regulated by the deeming final rule, FDA has provided a compliance period for certain labeling and advertising requirements:
- FDA has provided a compliance date of August 10, 2018, for the required health warning statements on packages and advertisements for "covered" tobacco products and roll-your-own / cigarette tobacco products.1, 2
For deemed products, FDA has also provided a compliance period for certain modified risk tobacco product requirements.
- November 8, 2017: Stop manufacturing tobacco products, the label, labeling, or advertising of which uses the descriptors "light," "mild," "low" or similar descriptors unless you have a Modified Risk Tobacco Product order in effect. (Stop distributing these modified risk tobacco products in interstate commerce by December 8, 2017.)
For all other deemed, modified risk tobacco products, stop introduction or delivery for introduction into interstate commerce as of the effective date of the deeming rule (August 8, 2016), unless you have a Modified Risk Tobacco Product order in effect.
- Effective and Compliance Dates Applicable to Retailers, Manufacturers, Importers, and Distributors of Deemed Tobacco Products
- Summary of deeming related provisions
Manufacturers, retailers, and distributors are prohibited from sponsoring or causing to be sponsored any athletic, musical, artistic or other social or cultural event, or any entry or team in any event, in the brand name, logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with those used for any brand of cigarettes or smokeless tobacco, per 21 CFR§ 1140.34(c).
Manufacturers and distributors of imported cigarettes and smokeless tobacco, are prohibited from marketing, licensing, distributing, selling, or causing to be marketed, licensed, distributed, or sold any item (other than cigarettes or smokeless tobacco or roll-your-own paper) or service that bears the brand name, logo, symbol, motto, selling message, recognizable color or pattern of colors, or any other indicia of product identification identical or similar to, or identifiable with those used for any brand of cigarettes or smokeless tobacco, per 21 CFR§ 1140.34(a).
The prohibition on the distribution of free samples applies to all "tobacco products," (except for smokeless tobacco products distributed in a "qualified adult-only facility" and in limited quantities as specified in the law, per section 102 of the Tobacco Control Act) including newly-deemed tobacco products, per 21 CFR § 1140.16(d).
For cigarette tobacco, roll-your-own tobacco, and covered1 tobacco products, it is unlawful for any such tobacco product manufacturer, packager, importer, distributor, or retailer of the tobacco product to advertise or cause to be advertised within the United States any tobacco product unless each advertisement bears the required warning statement. The required warning statement(s) on print advertisements or other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Web pages, and email) for cigarette tobacco, roll-your-own tobacco, and covered tobacco products must:
- Appear on the upper portion of the advertisement within the trim area;
- Occupy at least 20 percent of the area of the advertisement (warning area);
- Be printed in at least 12-point font size and ensure that the required warning statement occupies the greatest possible proportion of the warning area set aside for the required warning statement;
- Be printed in conspicuous and legible Helvetica bold or Arial bold type or other similar sans serif fonts and in black text on a white background or white text on a black background in a manner that contrasts by typography, layout, or color, with all other material on the advertisement;
- Be capitalized and punctuated, as described in the regulations (21 CFR §§ 1143.3(a)(1), 1143.3(c), and 1143.5(a)(1));
- Be centered in the warning area in which the text is required to be printed and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation; and
- Be surrounded by a rectangular border that is the same color as the text of the required warning statement and that is not less than 3 millimeters (mm) or more than 4 mm.
The warning statement requirement for advertisements outlined in 21 CFR §§ 1143.3(b) and 1143.5(b) apply to a retailer only if that retailer is responsible for or directs the health warning required under the paragraph. However, this does not relieve a retailer of liability if the retailer displays, in a location open to the public, an advertisement that:
- Does not contain a health warning; or
- Contains a health warning that has been altered by the retailer in a way that is material to the requirements of sections 1143.3(b) and 1143.5(b) (21 CFR §§ 1143.3(b)(3) and 1143.5(b)(3)).
- Smokeless Tobacco Labeling and Warning Statement Requirements
- Cigarette Labeling and Warning Statement Requirements
- Labeling of Tobacco Products
- Summary of Federal Rules for Tobacco Retailers
1. For cigars and pipe tobacco, please see Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
2. FDA does not intend to enforce these warning statement requirements for products that were manufactured before the compliance date (August 10, 2018) of the new required warning statement for covered tobacco products, cigarette tobacco, and RYO tobacco. See Guidance for Industry, Small Entity Compliance Guide, FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements (Revised).