- FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act). Section 911(b)(1) of the FD&C Act defines a “modified risk tobacco product” as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” “Modified risk” status may be established where a product’s label, labeling, or advertising suggest that the product lacks harmful substances, presents a lower risk of disease, or is somehow less harmful than other commercially marketed tobacco products. The marketing of “modified risk” products is not per se unlawful. Rather, companies seeking to market tobacco products with claims of modified risk must obtain FDA authorization for such claims through the Section 911 Modified Risk Tobacco Product Application process.
- On August 27, 2015, FDA issued Warning Letters to three companies marketing tobacco products with claims that they are “natural” and/or “additive free.” Specifically, the Agency warned: (1) ITG Brands LLC, maker of “Additive Free” Winston cigarettes; (2) Santa Fe Natural Tobacco Company, Inc., maker of “Natural” and “Additive Free” Natural American Spirit cigarettes; and (3) Sherman’s 1400 Broadway N.Y.C. Ltd., maker of “Natural” Nat Sherman cigarettes. In two of the Warning Letters, FDA acknowledged the existence of a consent order between certain companies and the Federal Trade Commission (FTC) regarding the use of “additive free” claims in conjunction with certain required disclosures (e.g., “No additives in our tobacco does NOT mean safer”). Although the consent order predates the Tobacco Control Act, FDA has taken the position that it now has jurisdiction over the promotion of tobacco products, including authority over “modified risk” claims.
- FDA’s action marks the first time that the Agency has used its authority under the Tobacco Control Act to curtail the use of “additive free” or “natural” claims on tobacco product labeling. These Warning Letters are a shot across the bow of the tobacco industry, suggesting that general claims (or even historically permitted claims) that imply “modified risk” status may incur regulatory scrutiny and enforcement action.
Keller and Heckman LLP has an active tobacco & e-vapor regulatory practice and will be hosting a pre-conference seminar on these topics in conjunction with our upcoming Food Packaging Law Seminar. For more information and to RSVP to these events, click here.
For more information about our tobacco & e-vapor regulatory practice in general, click here.