To reduce the number of children and adolescents who use tobacco products and to prevent health consequences associated with tobacco use, the Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations restrict the way tobacco product manufacturers, retailers, and distributors can advertise and promote tobacco products.
- When Do I Need To Comply?
- Sponsoring an Event
- Use of Brand Name, Logo, Symbol, Motto, etc.
- Free Sample Restrictions
- Format and Display Requirements for Required Warning Statements on Advertisements
For newly-regulated tobacco products, FDA has provided a compliance period for certain labeling and advertising requirements:
- Stop distributing products with modified risk claims, i.e., "light," "low," or "mild," or similar descriptors by September 8, 2017, unless you have a Modified Risk Tobacco Product order in place.
- Summary of deeming related provisions
- Chart on compliance and effective dates
Manufacturers, retailers, and distributors are restricted from sponsoring in a cigarette or smokeless brand name any athletic, musical, or other social or cultural event, or any entry or team in any event, per 21 CFR Part 1140.
Manufacturers and distributors are prohibited from selling or distributing any item or service (other than cigarettes or smokeless tobacco or roll-your-own paper) that bears the brand name, logo, symbol, motto, etc. that are identifiable with those used for any brand of cigarettes or smokeless tobacco, per 21 CFR Part 1140
The prohibition on the distribution of free samples applies to all "tobacco products," (except for smokeless tobacco products 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—including their components and parts, but not accessories, per 21 CFR sect; 1140.16(d).
What is considered a "free sample"?
If the prospective buyer lights and draws, puffs on, otherwise consumes the tobacco product, or leaves the retail establishment with a free tobacco product (in whole or part), this would constitute a "free sample" in violation of 21 CFR § 1140.16(d).
What is not considered a "free sample"?
Allowing prospective adult buyers to smell or handle one of the newly-deemed products is not considered distribution of a "free sample" as long as the product is not actually consumed, in whole or in part, in the retail facility for free and the prospective buyer does not leave the facility with a free tobacco product. In most circumstances, retail facilities, including vape shops, can allow customers to touch, hold, and smell their products without violating the free sample ban.
Advertisements include print advertisements and other advertisements with a visual component (including, for example, advertisements on signs, shelf-talkers, Web pages, and email). The required warning statement on advertisements 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 printed material on the advertisement;
- Be capitalized and punctuated;
- 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.