FDA Puts Tobacco Marketers on Notice for Product Violations

Agency Calls for Elimination of Artificial Flavorings

December 14, 2016 11:01 am News Staff

In keeping with longstanding advocacy efforts by the AAFP and other stakeholders, the FDA continues to call out tobacco product manufacturers and distributors for violating the Food, Drug and Cosmetic Act (FD&C Act) as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).

Most recently, the agency sent letters warning a number of companies that market what they term "cigars," "little cigars" and "filtered cigars" that these products are, in fact, cigarettes and are therefore subject to the FD&C Act's restrictions on cigarettes.

Furthermore, say the letters sent Dec. 9 by the Center for Tobacco Products' Office of Compliance and Enforcement, because these products are purported to contain "a natural or artificial characterizing flavor," they are considered adulterated and, thus, fail to comply with the act's prohibition against any "constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice … that is a characterizing flavor of the tobacco product or tobacco smoke."

Finally, in a particularly adroit twist of irony, the FDA's communication continues by noting, "If, however, these cigarette products do not contain a characterizing flavor, they are misbranded under … the FD&C Act" because their labeling and/or advertising would then be considered false or misleading.

Four companies are on the agency's latest list of tobacco transgressors. They are:

In each letter, the FDA demands that the company immediately correct the violations referenced "and take any necessary actions to bring your tobacco products into compliance with the FD&C Act." Failure to respond with a description of corrective actions taken -- or a refutation (with supporting evidence) of the agency's claims -- could result in further punitive actions, including monetary penalties, no-tobacco-sale orders, criminal prosecution, seizure and/or injunction.

Along these same lines, the Academy joined with other stakeholder groups last year to urge the FDA's Center for Tobacco Products to take enforcement action against the Santa Fe Natural Tobacco Co. and two other manufacturers for making misleading claims about their cigarettes.

Just three days later, the FDA issued a warning letter to the companies in which, for the first time, it used its authority under the TCA to pursue regulatory action regarding their use of "additive-free" and "natural" claims on tobacco product labels. At issue, said the agency at the time, was a concern that consumers would interpret use of these terms to mean the products posed fewer health risks than other cigarettes, in the absence of evidence to support any such claim.

Related AAFP News Coverage
FPs, Patients Score Big Win as FDA Finalizes Tobacco Rule
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Additional Resource
Campaign for Tobacco-Free Kids(www.tobaccofreekids.org)