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Tobacco Product Changes Must Be Reviewed by U.S. FDA

Tobacco companies led by Altria Group Inc. must get U.S. approval for product changes, helping regulators keep more addictive items off the market.

Products introduced after Feb. 15, 2007, must also be reviewed, the Food and Drug Administration said today in a statement. New or modified items that aren’t “substantially equivalent” to those already for sale on that date and raise health questions may be banned or withdrawn, the agency said.

The reviews are required under a 2009 law that empowered the FDA to restrict tobacco marketing, and forced makers to pay the agency fees to fund reviews. Altria Group’s Philip Morris USA, the biggest U.S. cigarette maker, broke with competitors to back the law as a way to standardize manufacturing and spur development of less-harmful products.

“Manufacturers frequently alter ingredients without anyone knowing what they’re consuming,” Lawrence Deyton, director of the FDA’s Center for Tobacco Products, said on a conference call with reporters. “No longer will changes to products consumed by millions of Americans be made without anyone knowing.”

More than 20 percent of adults in the U.S., or 46 million people, smoke cigarettes, according to the Centers for Disease Control and Prevention in Atlanta. Smoking is the biggest cause of preventable death in the U.S., killing about 443,000 people a year, according to the CDC.

Shielding Children

“Tobacco companies will no longer be able to secretly manipulate their products in ways that make them more addictive and appealing,” said Matthew Myers, president of the nonprofit Campaign for Tobacco-Free Kids in Washington, in an e-mail today.

“The FDA is simply beginning the process to establish the framework it will use in its approval of new products,” Christopher Growe, an analyst at Stifel Nicolaus & Co. in St. Louis, said today in a note to clients. “Today’s discussion in our view could be characterized as largely procedural.”

Companies must submit documents to the FDA by March 22 for tobacco products introduced or modified since Feb. 15, 2007, to show they are substantially equivalent to existing products. Manufacturers also must seek marketing approval for any new products they plan to offer after March 22.

Equivalent Products

“For a new product to be a substantial equivalent, it must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing single predicate product,” said David Ashley, director of the Office of Science at the FDA’s Center for Tobacco Products, on the conference call. “If it has different characteristics, they must not raise different questions of public health.”

The agency issued guidance to the industry today on how to comply with the law’s substantial-equivalence requirements, which cover cigarettes, “roll-your-own” tobacco and smokeless products. The rules don’t apply to electronic cigarettes, which are battery-powered and produce a nicotine vapor instead of tobacco smoke, agency officials said.

FDA approval of new or modified tobacco items “does not indicate that these products are safe,” Deyton said. “There are no tobacco products that are safe.”

Assessing Guidance

Today’s FDA actions “were expected as they relate to requirements outlined in the legislation that gave the FDA authority to regulate tobacco,” Steve Callahan, a spokesman for Richmond, Virginia-based Altria, said today in an e-mail. “We are assessing the guidance and proposed rule and will provide our comments through the public comment process.”

Reynolds American Inc., the second-biggest U.S. tobacco company, is reviewing the FDA guidance and has submitted “several applications to date on substantial equivalence” to the agency, David Howard, a spokesman for the North Carolina-based company, said today in an interview.

“What those are is proprietary information,” Howard said. “The bottom line is we look forward to working together with the FDA on the applications we have submitted, as well as the development of the guidance and a proposed rulemaking on exemptions to the substantial equivalence process.”

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