FDA takes fresh step towards curbing U.S. nicotine addiction

[March 16, 2018] By Yasmeen Abutaleb

WASHINGTON (Reuters) - The U.S. Food and Drug Administration took a fresh step on Thursday towards setting a maximum nicotine level for tobacco products in a bid to lower tobacco-related deaths across the country, saying it would collect public comment and scientific research over the next three months.

The move was part of a comprehensive plan the agency announced last summer to regulate tobacco and nicotine, FDA Commissioner Scott Gottlieb said on a call with reporters. That plan marked a major shift designed to give adult smokers a wider range of alternatives, including potentially less harmful e-cigarettes.

The agency is seeking to determine a level of nicotine in cigarettes and other tobacco products that would be minimally addictive or nonaddictive, according to a draft proposal.

It hopes setting such a standard would also help prevent teenagers who experiment with tobacco from becoming addicted.

The FDA estimates that setting such a standard would help 5 million smokers quit within a year and prevent more than 33 million teens and young adults from becoming regular smokers by the year 2100.

"There is no other single action our country can take that would prevent more young people from smoking or save more lives," said Matthew L. Myers, president of Campaign for Tobacco-Free Kids.

Major tobacco players such as Altria Group and British American Tobacco are grappling with sales declines in the U.S. market and hoping to recoup revenue through novel tobacco and nicotine products such as e-cigarettes.

Altria Group has partnered with Philip Morris International to sell a novel device called iQOS, which heats but does not burn tobacco. The FDA is currently reviewing the iQOS application.

The FDA is seeking additional research and data for public review, Gottlieb said, as it tries to develop a nicotine product standard. Gottlieb said the FDA was also seeking public opinion on whether a product standard should be implemented all at once or gradually.

The comment period will be open through mid-June, said Mitch Zeller, director of FDA's Center for Tobacco Products.

The FDA will continue to take enforcement actions against companies that inappropriately target children, including through the promotion of e-cigarettes, Gottlieb said.

James Figlar, executive vice president of research and development for R.J. Reynolds Tobacco Company, part of British American Tobacco, said the company would work with the agency to create a path for alternative, less harmful tobacco products to reach the market.

The FDA will seek public input and scientific research on the role that flavors such as menthol play in tobacco addiction, and for the regulation of premium cigars, Gottlieb said.

"We'll also advance key parts of our tobacco plan very soon," he said.

(Reporting by Yasmeen Abutaleb in Washington and Sharnya G in Bengaluru; Editing by Savio D'Souza and Bernadette Baum)

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