FDA Enlists Parents and Other Consumers in Battle Against Flavored Cigarettes, And Denies Retailers’ Citizen Petition

By David B. Clissold & Ricardo Carvajal –

As we discussed in a prior post, the FDC Act’s  ban on "characterizing flavors" in cigarettes took effect on September 22, 2009.  FDA marked the occasion by issuing a press release that highlights the effects of those cigarettes on youth, and by publishing an advisory to parents on “the serious risks associated with flavored tobacco products.”  According to that advisory, such products “[a]ppeal to kids,. . .[d]isguise the bad taste of tobacco,. . . [a]re just as addictive as regular tobacco products,. . . [and] [h]ave the same harmful health effects as regular tobacco products.”  Parents and other consumers are encouraged to submit an electronic report of the availability of a flavored cigarette that identifies the product and the date and location of purchase.  Consumers are also given the option of mailing packages, advertisements, or labels to the Center for Tobacco Products.  A Federal Register notice announcing the ban is scheduled to publish on September 25.

Perhaps not coincidentally, FDA has denied a citizen petition submitted by retailers that asked FDA to exercise enforcement discretion with respect to cigarettes that are not "expressly labeled" as containing fruit, candy, herb, or spice flavoring as a "characterizing flavor" of the product or its smoke, and to issue a regulation that defines a standard for flavored cigarettes.  In its denial letter, FDA noted that decisions regarding the exercise of enforcement discretion fall outside the scope of the citizen petition process.  Furthermore, FDA refused to issue the requested regulation on the ground that FDC Act section 907(a)(1) "provides sufficient clarity as to the definition of 'characterizing flavor.'"