FDA Clarifies Flavored Cigarette Ban

The FDA hosted a media briefing this morning and has posted documents on the FDA Web site issuing additional information regarding the ban on flavored cigarettes, authorized by the Family Smoking Prevention and Tobacco Control Act that was signed into law in June.

According to the new documents, cigarettes containing an artificial or natural flavor (excluding tobacco or menthol) that is a characterizing flavor are banned as of today, Sept. 22.

View the FDA’s Flavored Cigarettes’ Guidance for Industry and FDA Staff whitepaper.

The banned flavors include herb, spice, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry and coffee.

Loose tobacco and roll-your-own tobacco intended to be used in cigarettes can continue to be sold as long as the tobacco does not contain a characterizing flavor, such as those mentioned above, that is banned under the new FDA law.

“Flavored cigarettes attract and allure kids into lifetime addiction,” said U.S. Department of Health and Human Services Assistant Secretary for Health Howard K. Kohl, M.D., M.P.H. “FDA’s ban on these cigarettes will break that cycle for more than 3,600 young people who start smoking daily.”

The FDA is still examining options of regulating menthol cigarettes and other flavored  tobacco products other than cigarettes.

Cigarette rolling papers and cigarette filters for use in roll-your-own cigarettes that contain a characterizing flavor are also banned. Only cigarette rolling papers and cigarette filters that do not contain a characterizing flavor are legal to sell. Pipe tobacco, that according to the FDA is bona fide pipe tobacco, is not banned.

As far as flavored little cigars, the FDA stated-similar to what it said in previously-that “the ban applies to all tobacco products with certain characterizing flavors that meet the definition of a ‘cigarette’ in section 900(3) of the FDCA [Food, Drug and Cosmetic Act] even if they are not labeled as “cigarettes” or are labeled as cigars or as some other product.” 

During the conference call, a reporter from the New York Times asked if the flavored cigarette ban includes a ban on flavored little cigars, the National Association of Tobacco Outlets (NATO) reported. Dr. Lawrence Deyton of the FDA said the issue of a ban on other flavored tobacco products will be studied by the FDA in the near future.

The FDA is taking several steps to enforce the ban on flavored cigarettes. A letter recently sent to the tobacco industry provided information about the law and explained that any company who continues to make, ship or sell such products may be subject to FDA enforcement actions.

In the advisory, the FDA clarified that it will “issue Warning Letters to firms to notify them that they or their products are in violation of the law and to give them the opportunity to come into compliance,” before confiscating banned tobacco products, handing out fines or bringing criminal prosecutions.





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