LAKEVILLE, Minn. -- The U.S. Food and Drug Administration (FDA) is requiring new warning statements to be included on packaging and advertisements for cigarette tobacco, roll-your-own (RYO) tobacco, pipe tobacco, electronic cigarettes, vapor products, hookah tobacco and cigars.
In a guidance document issued by the FDA on May 10 titled “Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,” the agency summarized the new health-warning statement requirements and compliance dates. This article highlights some of those compliance requirements.
New addictiveness warning statement: The FDA refers to all the previously mentioned product types (cigarettes, RYO, pipe tobacco, etc.) collectively as “covered tobacco products.” The new addictiveness warning statement reads: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Note that cigars have six new health-warning statements, one of which is this new addictiveness health warning.
The FDA requirements and compliance dates for the new nicotine addictiveness warning statement regarding covered tobacco products are as follows:
- Advertisements for the covered tobacco products must bear the new addictiveness warning as of Aug. 10, 2018. This requirement applies to manufacturers, importers, distributors and retailers that create their own advertisements for covered tobacco products.
- Manufacturers must include the new addictiveness warning on packages for manufactured covered tobacco products beginning Aug. 10, 2018.
- Manufacturers can distribute covered tobacco products in packages without the new addictiveness warning statement up to Sept. 11, 2018. After that date, manufacturers can no longer distribute covered tobacco products in packaging that does not contain the new addictiveness warning statement.
Retail safe-harbor exception: Retailers cannot offer for sale, sell or distribute covered tobacco products in packages without the addictiveness warning statement beginning Aug. 10, 2018, unless a covered tobacco product falls within a “safe harbor.” A “safe harbor” is a provision in a statute or a regulation that specifies that certain actions will not violate the statute or regulation. To fall within the FDA safe-harbor exception, a retailer can offer to sell or sell a covered tobacco product on and after Aug. 10, 2018, and not be in violation of FDA regulations if the following three conditions are met:
- The package for the covered tobacco product “contains a health warning.”
- The covered tobacco product is supplied to the retailer by a manufacturer, importer or distributor who has a required state, local or federal Alcohol Tobacco Tax and Trade Bureau (TTB) issued license or permit.
- The health warning is not altered by the retailer.
As noted above, the new warning statement requirements also apply to advertisements created by a manufacturer, packager, importer, distributor or a retailer for covered tobacco products and cigars. For print advertisements and other advertisements with a visual component, a required warning statement must comply with the following requirements:
- Appear in the upper portion of the advertisement within the trim around the edge.
- Occupy at least 20% of the area of the advertisement.
- Appear in at least 12-point font size that ensures that the required warning statement occupies the greatest possible proportion of the warning area set aside for the text required.
- Be in Helvetica bold or Arial bold type (or other similar sans serif fonts) 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 exactly as statements provided by the FDA.
- Be centered in the warning area in which the text is required to appear and positioned such that the text of the required warning statement and the other textual information in the advertisement have the same orientation.
- 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 or more than 4 millimeters.
The kinds of advertisements created by a retailer for either covered tobacco products or cigars that must have a new health-warning statement include promotional materials (point-of-sale or non-point-of-sale), posters, placards, newspapers, magazines, catalogues, leaflets, brochures, direct mail, display racks, websites, internet webpages, TV and email correspondence, as well as advertisements communicated via cellphone, social-media applications or other programs that allow for the sharing of audio, video or photography files.