Seeking Clarity, Cigar Importer Sues FDA

By David B. Clissold & Ricardo Carvajal –

An importer and distributor of cigars has sued FDA to enjoin the agency from taking any adverse action with respect to Djarum brand cigars under Chapter IX of the FDCA until such time as the agency lawfully asserts jurisdiction over cigars (Chapter IX was added to the FDCA by the Family Smoking Prevention and Tobacco Control Act).  Chapter IX currently applies only to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.  It does not apply to cigars or any other type of tobacco product until FDA issues a regulation under FDCA section 901(b) asserting authority over those products.  According to the complaint, Djarum brand cigars meet statutory and regulatory definitions of a “cigar” for purposes of taxation (e.g., 26 U.S.C. § 5702) and have been classified as cigars by the Alcohol and Tobacco Tax and Trade Bureau (“TTB”).  As such, Djarum brand cigars cannot be subject to regulatory action under the authority of Chapter IX unless and until FDA issues a regulation under section 901(b).

The suit was prompted by recent FDA statements relating to flavored cigarettes.  FDCA section 907(a)(1) bans cigarettes that contain a “characterizing flavor” as of September 22, 2009.  FDA issued a Letter to Industry on the eve of the ban stating that the ban “applies to all tobacco products that meet the definition of ‘cigarette’ in section 900(3) of the Act even if they are not labeled as ‘cigarettes’ or are labeled as cigars or as some other product” (see our prior post here).  The wording of FDA’s letter aroused concern that the agency might interpret the ban to apply to cigars that contain a “characterizing flavor.”  In addition, FDA had been petitioned by retailers either to clarify the products of concern or exercise enforcement discretion until it had done so, but FDA denied that request (see our prior post here).  According to the complaint, because of the resulting uncertainty in the cigar industry and the potential for seizure and civil penalties, plaintiff sued FDA asking the court to determine that the agency was precluded from taking enforcement action against the Djarum products.

This case may help to clarify where FDA intends to draw the definitional line between cigarettes and cigars.  What the case is unlikely to resolve is whether, and to what extent, FDA might in the future seek to curtail the marketing of flavored cigars.