FDA to review new or altered tobacco products

Tobacco companies that want to introduce new products or make changes to existing brands will soon face more scrutiny from the U.S. Food and Drug Administration.

The FDA said Wednesday that it will start reviewing new tobacco products or changes to existing brands for public-health dangers on March 22.

The requirements cover cigarettes, smokeless tobacco and roll-your-own tobacco introduced commercially after Feb. 15, 2007, and changes to existing brands since that date. The rules were part of the legislation passed by Congress in 2009 that for the first time gave the FDA authority to regulate tobacco products. Tobacco products can be considered cigarettes like Winston cigarettes or Vogue Cigarettes.

"The law requires this because up till now, tobacco products have been the only mass-consumed product for which users do not know what they are consuming," Dr. Lawrence Deyton, director of the FDA's Center for Tobacco Products, said on a conference call with reporters.

"Manufacturers frequently alter ingredients, again without anyone knowing what they are consuming," Deyton said. "This law requires the FDA to carefully examine the impact those changes, or new products, may have on the public health."

The FDA issued guidance to the industry yesterday about how to submit products for review.

A spokesman for Henrico County-based Altria Group Inc. said the company was studying the guidelines and plans to submit comments to the FDA during a public comment period. The company had no comment Wednesday on the possible business impact of the requirements.

Altria is the parent company of the nation's largest cigarette manufacturer, Philip Morris USA, and the largest smokeless tobacco maker, U.S. Smokeless Tobacco Co.

"This guidance is certainly more restrictive than any tobacco company anticipated when the FDA initially began regulating tobacco and appears to be more restrictive than the underlying statute contemplates," said Ashley L. Taylor Jr., a partner with Troutman Sanders who heads the law firm's tobacco team.

"For example, on their face, the new guidelines will require that certain changes made by virtually every company to its cigarettes in response to state 'fire-safe' laws must now seek FDA approval for such changes when the companies were simply following the underlying state law requirements," he said.

Taylor said the firm is encouraging its clients to actively participate in the FDA's comment period as the regulations continue to be shaped.

"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 in a note to clients. The "discussion in our view could be characterized as largely procedural."

Under the law, companies can bring a new tobacco product to market or make changes to existing brands if they can show the product is "substantially equivalent" to one already being sold before Feb. 15, 2007. A product that does not meet that requirement could be banned or removed from the market if the FDA finds it poses new public-health concerns.

What constitutes a change in a product is fairly broad under the federal law. It includes changes in ingredients, design, composition and the heating source, FDA officials said.

The purpose of those requirements, Deyton said, is to ensure that new products are not more dangerous to consumers than existing ones. "FDA's involvement does not indicate that these products are safe," he said. "There is no tobacco product that is safe."

Deyton said he believes companies still will be able to make product innovations under the regulations.

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, told Bloomberg News. Howard said the specifics of the submissions were proprietary.

One major tobacco-control group said the requirements are an important step for public health. It also will be significant because the FDA will collect information about tobacco product ingredients and design, and how companies change them over time.

"As a result of the bright spotlight of FDA scrutiny, tobacco companies will no longer be able to secretly manipulate their products in ways that make them more addictive and appealing," the Campaign for Tobacco-Free Kids said in a statement.

Deyton said about 200 people are now working at the FDA's Center for Tobacco Products, which was created in late 2009. The center is still hiring, but it has "sufficient staff" now to handle the review process, he said.

Under the law, companies also may submit products for FDA approval as "modified risk" products that might be less risky to health. The FDA is still developing its guidelines for that approval pathway.