FDA Clarifies Tobacco Ban

Flavored products including cigarettes, RYO and loose tobaccos and rolling papers are no longer legal in U.S. stores; administration said it would look at “little cigars” and similar products on a “case-by-case basis.”

The smoking lamp on the majority of flavored tobacco products sold in convenience stores has been extinguished, but the ruling has ignited a firestorm among retailers.

In a media briefing on Sept. 22, the Food and Drug Administration (FDA) issued additional information on its far-reaching ban of flavored cigarettes. The salient points of the ruling, which went immediately into effect, include:

• Cigarettes containing an artificial or natural flavor (excluding tobacco or menthol) that is a characterizing flavor are banned.  The banned characterizing flavors include an herb or spice, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee.

• Loose tobacco and roll-your-own (RYO) tobacco intended to be used in cigarettes can continue to be sold provided that the tobacco does not contain a characterizing flavor that is banned under the new FDA law.

• Cigarette rolling papers and cigarette filters for use in RYO cigarettes that contain a characterizing flavor are banned. Only those cigarette rolling papers and cigarette filters that do not contain a characterizing flavor are legal to sell.

• The advisory published by the FDA continues to take an ambiguous position regarding whether flavored little cigars are banned. The FDA essentially repeats the sentence that it included in its letter issued on Sept. 14 and states in the advisory that “the ban applies to all tobacco products with certain characterizing flavors” that meet its definition of a cigarette under the new Food, Drug and Cosmetic Act (FDCA) “even if they are not labeled as cigarettes or are labeled as cigars or as some other product.”

At presstime, when questioned flatly on whether the flavored tobacco ban includes flavored little cigars, Dr. Lawrence Deyton of the FDA refused to give a definitive “yes” or “no” answer. Instead, FDA lawyers said the administration would look at “little cigars” and similar products on a “case-by-case basis.”

• Pipe tobacco, that according to the FDA is bona fide pipe tobacco, is not banned.

Under the new law, the agency has broad authority to regulate the marketing and manufacture of tobacco products, but cannot ban regular cigarettes, cigars or chewing tobacco. By January, manufacturers must submit information to the agency about ingredients and additives, and by July, the industry will be barred from using terms like “light,” “low” and “mild” on products. The ban is the first major step taken by the FDA since the agency was given jurisdiction over the tobacco industry in June.

Swift Response
Retailers fear the FDA’s involvement in tobacco sales will have lasting ramifications.

“While the FDA’s initial foray into tobacco’s already much troubled and diminishing business might be labeled as somewhat mild given that most cigarette manufacturers do very little with flavored cigarettes, I do feel this is just the tip of the iceberg,” said Jim Callahan, a retailer with more than 25 years of experience and president of Convenience Store Solutions, a Georgia-based consulting firm. “Overall, I think the industry should have done more in its fight against the FDA governing the tobacco industry, which may be a short-term gain for some, but will have severe long term implications for the entire industry.”

Suppliers quickly responded to the FDA. Kretek International Inc., which imports Djarum-branded tobacco products, filed a request for declaratory judgment against the FDA in Washington, D.C.

Earlier, R.J. Reynolds, seller of Camel cigarettes, and some other tobacco makers filed a lawsuit against the FDA saying their free-speech rights have been violated by the administration’s authority to regulate tobacco. Reynolds said it seeks to protect its right to communicate with adult consumers.

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