logo
















logo

logo
October,
2009

FDA’s Early Approach to Tobacco Regulation Leaves Plenty for Industry to Worry About

Perhaps it’s an omen of a bumpy road ahead as far as the eye can see, but the tobacco industry’s introduction to the new era of FDA oversight kicked off to a dubious start, but I doubt it came as a shock to most. Despite the civilities, the overall mood was clear: the government is here keep a close watch on this industry all in the name of protecting public health - but don’t expect logic to prevail.

The first hint of trouble was the agency’s inability to provide clear answers to simple questions regarding which classes of product do or do not fall under the ban on cigarettes with “characterizing flavors.” The agency’s clear determination to set aside established distinctions between cigars and cigarettes created no small amount of chaos. Unfortunately those “clear distinctions” aren’t all that clear, it turns out: just refer to the U.S. Department of the Treasury’s Tobacco Tax and Trade Bureau (TTB) for their glossary definition of a cigarette:

(1) Any roll of tobacco wrapped in paper or in any substance not containing tobacco, and

(2) 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 paragraph (1) of this definition.

So the TTB itself blurs the lines based on how a product may be perceived by consumers - not just the FDA. None-the-less, companies like Kretek International, which had in hand an advance ruling issued from the TTB stating that one of its new products, Djarum filtered clove cigars, met the legal test as a cigar product, still couldn’t get an definitive assurance from the FDA that a different government agency wouldn’t red flag the same product as a cigarette and hold the company in violation of the law. The industry has every right to expect a stable framework in which to operate, and different agencies interpreting the same guidelines/definitions in different manners is unacceptable.

Unlike the TTB, which uses its definitions to determine which tax class a product is assigned to, the stakes are much higher with the FDA, which is now applying these same definitions to determine whether a product is legal to sell or is banned. That is crucial, because the agency doesn’t legally have oversight over cigars - yet - but the dust-up over the definition of a cigarette left little doubt that the FDA intends to evaluate the effectiveness of this initial ban on flavored cigarettes and how it may fall short in meeting the agency’s goal of eliminating “gateway products” that Congress feels may appeal to children leading to regular full-time adult smokers.

Dr. Lawrence Deyton, the director of the FDA’s newly-established Center for Tobacco Products, said on a media conference call that “The act provides us with authority today to ban cigarettes with certain characterizing flavors. Other flavored tobacco products are issues which we will be studying and certainly be discussing with the Scientific Advisory Committee, which is being set up.” It will certainly have plenty of help from the anti-tobacco industry, which will lobby heavily to close all the “obvious” loopholes.

Menthol cigarettes, flavored cigar wraps, and flavored pipe tobaccos (providing they are bona-fide pipe tobaccos intended for use in pipes by pipe smokers) remain legal, but there’s obvious interest and pressure in considering further control, and it shouldn’t surprise anyone if the FDA moves to activate its authority over cigars sooner than later. The writing is on the wall.

- E. Edward Hoyt III