FDA to the Tobacco Industry: We’re Serious About Flavored Cigarettes, in All Their Guises

By Ricardo Carvajal –

FDA has issued a letter to the tobacco industry offering a reminder that, under the standard for cigarettes in FDCA section 907(a)(1)(A), a cigarette or any of its component parts may not contain “an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.”  That prohibition on "characterizing flavors" takes effect on September 22, 2009, and any cigarette that violates the prohibition is adulterated and subject to seizure.  FDA has not explained what makes a flavor a "characterizing flavor."  However, those responsible for the violation may be subject to injunction, civil penalties, and criminal prosecution.  The letter states that FDA “intends to use the full range of enforcement tools within the Agency’s authority to ensure compliance with the new requirement.”

The standard for cigarettes applies to any tobacco product that meets the following definition:

(3) CIGARETTE.—The term “cigarette”—
(A) means a product that—
(i) is a tobacco product; and
(ii) meets the definition of the term “cigarette” in section 3(1) of the Federal Cigarette Labeling and Advertising Act [("FCLAA")]; and

(B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

Section 3(1) of the FCLAA defines a cigarette as “(A) any roll of tobacco wrapped in paper or in any substance not containing tobacco, and (B) any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette described in subparagraph (A).”

The letter states that FDA will consider products that meet these criteria to be cigarettes, “even if they are not labeled as ‘cigarettes’ or are labeled as cigars or as some other product.”  This would seem to indicate that some manufacturers that have been reported to be revamping their flavored cigarette offerings to try to work around the prohibition may be in FDA's crosshairs.