FDA Releases Guidelines For Reviews Of New Tobacco Products

The Food and Drug Administration unveiled guidelines Wednesday about how tobacco-product makers can gain agency approval for new products.

The agency said 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.

It's not immediately clear how the regulations would affect major tobacco companies such as Altria Group Inc. (MO), the parent company of Philip Morris USA; Reynolds American Inc. (RAI); and Lorillard Inc. (LO), which have been marketing cigarettes for decades, as well as smokeless or chewing tobacco brands that have also been on the market prior to 2007.

However, if those companies were to change or introduce a new cigarette or smokeless-tobacco product they would have to apply to the FDA to gain approval, or a marketing order, before a new product can be introduced.

FDA said products that are equivalent to those that are on the market on Feb. 15, 2007, may be cleared to go to market, but products that aren't similar could be prohibited from going on the market or removed from the market.

The FDA was given the authority to regulate tobacco products as part of a 2009 law.

The agency isn't allowed to ban tobacco products but will require that new products aren't more dangerous than existing ones.

"No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such," said Lawrence R. Deyton, the director of FDA's Center for Tobacco Products.

The FDA is engaged in a separate battle with the makers of electronic-cigarettes, which use a device to turn nicotine liquid into a vapor mist. The agency is trying to regulate those products as drugs and wants to require pre-market approval similar to other nicotine-replacement products.

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.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

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