Firms told to divulge all changes to tobacco

Posted: 1/7/2011

Federal regulators on Wednesday outlined rules for the tobacco industry that for the first time require disclosure of any changes to their products, and that detail how to seek permission to market new products under the sweeping tobacco control law signed by President Obama in June 2009.

"Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," Dr. Lawrence R. Deyton, director of the Center for Tobacco Products of the Food and Drug Administration, said in a conference call with reporters.

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, a Washington advocacy group, praised the F.D.A. for its progress regulating tobacco. "As a result of the bright spotlight of F.D.A. scrutiny, tobacco companies will no longer be able to secretly manipulate their products in ways that make them more addictive and appealing," he said in a statement.

Any tobacco product changed after Feb. 15, 2007, when the legislation was introduced in Congress, must be reviewed by the agency. The disclosures by the companies are expected by March 22. Companies may apply for a fast track review of new products that are "substantially equivalent" to earlier products.

One of the practical effects, Mr. Myers said, is that tobacco products changed after March 22 cannot be sold unless the F.D.A. permits it. The agency has the power to order some products to be removed from the market that were introduced in the period from Feb. 15, 2007, to March 22.

Steven Callahan, a spokesman for Altria, the maker of Marlboro cigarettes and the largest tobacco company, said the proposed rules were expected and under review by Altria.

David Howard, a spokesman for R.J. Reynolds Tobacco, maker of Camel products and the second-largest tobacco firm, said the company's products are all identical or substantially similar to earlier products, and it had applied for the designation. "We'll see what happens," he added.

Lorillard, the third-largest tobacco company, declined comment.

Lorillard is facing a F.D.A. review of menthol flavored products, which account for 90 percent of its sales. The F.D.A. Tobacco Products Scientific Advisory Committee plans to hear evidence about menthol at a hearing Monday and Tuesday, and is expected to issue recommendations by March.

Also Wednesday, Gregory N. Connolly of the Harvard School of Public Health, a critic of the tobacco industry, said he had resigned from the scientific advisory panel. "The responsibilities of the advisory committee were very narrow, and they also place burdens on members in terms of you can't report on your own science, you can't communicate with your fellow members unless it's in public, and implicit restraint from speaking with the media," he said in an interview. "I think my effectiveness can be much greater not being on the board."

He also said the panel was in effect acting as tobacco industry scientists and had been too cautious in attacking menthol and nicotine.

Dr. Connolly said he planned to testify on Monday about a new study showing the promotion of menthol cigarettes to women in Japan had increased the rate of female smoking even as Japanese men smoked less.

The American law banned candy-, fruit- and spice-flavored cigarettes but left the issue of menthol to the F.D.A. Congress questioned whether menthol contributed to smoking initiation or deterred quitting.

David J. Adelman, tobacco industry analyst for Morgan Stanley, said in a note to investors Wednesday that the chances of an F.D.A. ban of menthol were reduced by the resignations of Dr. Connolly and Dr. Joshua M. Sharfstein, the F.D.A. deputy commissioner.

Dr. Connolly was the "dominant antitobacco voice in the menthol hearings thus far," Mr. Adelman wrote.

Dr. Sharfstein, who is leaving to become Maryland's secretary of health, was a former Congressional staff member involved in developing the legislation.

Original here.