This week, the Wall Street Journal reported that GlaxoSmithKline PLC has asked the FDA to remove dissolvable smokeless tobacco products from the market until companies that manufacture the products demonstrate to the FDA that the marketing of such products is appropriate for the protection of the public health, the National Association of Tobacco Outlets (NATO) noted.
GlaxoSmithKline markets Nicorette gum, Commit lozenges and other over-the-counter smoking cessation aids.
The FDA tobacco regulatory law allows a manufacturer to apply for an approval to market and sell a “modified risk tobacco product.” Under the law, a “modified risk tobacco product” is defined as “any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products,” NATO noted.
Currently, Reynolds American is test-marketing Camel Orbs, which are oval shaped lozenges, and Star Scientific has been selling dissolvable products under the brand names Ariva and Stonewall.
In response to the request filed with the FDA by GlaxoSmithKline, Reynolds American Spokesman David Howard told the Wall Street Journal, “Our Camel dissolvable tobacco products provide an option for adult tobacco consumers who have made an informed choice to use tobacco.”
Paul Perito, the chairman and chief operating officer of Star Scientific, told the Wall Street Journal that GlaxoSmithKline’s request is “another anticompetitive tactic.”
In a statement to NATO, Perito added, “When Ariva, the first dissolvable tobacco product, entered the market almost 10 years ago, GlaxoSmithKline filed a citizen’s petition with the FDA seeking to have it withdrawn from the market on the grounds that it was a “food” or a “drug.”
In August, 2003 the FDA denied that petition, stating that Ariva was a tobacco product and not subject to food or drug regulation.
NATO reported that Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), stated last month that citizens petitions by “competitor” companies are not appropriate to attempt to initiate FDA enforcement activity.”
Star Scientific has filed an application with the FDA to classify its dissolvable lozenges as a modified risk tobacco product. The FDA’s Center for Tobacco Products has not yet finalized a guidance document with the procedures for reviewing and approving a modified risk tobacco product application.