Tobacco product regulations announced by FDA

By Dr. Ananya Mandal, MDJan 6 2011

This Wednesday the Food and Drug Administration (FDA) released guidelines regarding agency approval for certain types of new products to be obtained by tobacco-product makers. FDA announced that products such as cigarettes, roll-your-own tobacco and smokeless products that were introduced or changed after Feb. 15, 2007 must be reviewed by the agency to show that they are “substantially equivalent” to products commercially available on Feb. 15, 2007.

The regulations that would hit major tobacco companies such as Altria Group Inc. (MO), the parent company of Philip Morris USA; Reynolds American Inc. (RAI); and Lorillard Inc. (LO). Those products that have also been on the market prior to 2007 are still being considered in the regulations. It is unclear as to what procedure these need to follow. If companies were to change or introduce a new cigarette or smokeless-tobacco product, however, they would have to apply to the FDA to gain approval, or a marketing order, before a new product can be introduced. About 230 new tobacco products are introduced every year, according to published reports, but the FDA said tighter regulation could reduce the number.

According to David Howard, a Reynolds American spokesman, the company has already submitted several applications to the FDA. Steve Callahan, an Altria spokesman added that his company is still looking at guidelines. Lorillard did not comment. It was early this week that Star Scientific Inc. (CIGX) had announced that it has developed a special kind of “moist snuff” tobacco product that has lower levels of carcinogens than products on the market now. The company said it plans to submit the product during the first quarter of this year.

The FDA was given the authority to regulate tobacco products as part of a 2009 law. Lawrence R. Deyton, the director of FDA’s Center for Tobacco Products said, “No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such.” The issue of electronic cigarettes however is still not resolved. A federal court recently ruled that FDA should regulate electronic cigarettes under the tobacco law and not drug-approval laws. FDA has appealed the decision.