Source: The Wall St. Journal
Author: David Kesmodel
WILLIAMSBURG, Va.—The top tobacco regulator at the Food and Drug Administration signaled to industry executives Monday that he would take a firm approach to overseeing the industry, but pledged to keep an open mind about new products and ideas to reduce tobacco-related illnesses.
Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a speech at an annual tobacco-industry conference here that his job “is to address this enormous toll of confusion, suffering and death caused by the current state of tobacco use in this country.”
In one of his first speeches to a large group of tobacco executives, Mr. Deyton told members of the Tobacco Merchants Association that he would place strong emphasis on reducing the number of minors who become tobacco users. He said 4,000 kids begin smoking each day, on average, and 1,000 become regular users.
He reiterated his concern that new, dissolvable forms of smokeless tobacco produced by companies such as Reynolds American Inc. are candy-like in their appearance. Reynolds is complying with a review of such products by the FDA and has said its dissolvable products, which are being test-marketed in three cities, are made and marketed for adults.
Mr. Deyton, a longtime public-health expert, began his job in September, a few months after the agency was given broad powers to regulate the industry under a landmark law signed by President Obama.
The agency is still in the early stages of solidifying the framework under which it will oversee such industry categories as menthol cigarettes and smokeless tobacco. Mr. Deyton said the tobacco center now has about 90 employees.
Mr. Deyton said he’s a fan of competition in industries and that he would be open-minded about new products that might reduce illness and death associated with tobacco use. He did not specify smokeless tobacco, but some tobacco companies have argued that the agency should permit them to market the products as being less dangerous than cigarettes.
The tobacco law, however, creates a high bar for a company to be able to market a product as posing less harm to consumers than conventional tobacco products.
“There’s no monopoly on great ideas, so we at FDA will keep an ear open for great ideas as we move ahead,” Mr. Deyton said.
He said, however, that the industry “has a long history of resistance to government action” and warned that the agency would not hesitate to issue civil penalties and take other actions to enforce regulations.
Mr. Deyton said the FDA had just begun a fact-finding effort to decide whether to add cigars to the list of tobacco products that it will closely regulate.
“We are examining the public health impact of other products” besides cigarettes and smokeless tobacco, he said, “but on no particular deadline.”
One of the first priorities of the agency’s tobacco center is evaluate the public-health effects of menthol in cigarettes and to decide what actions, if any, to take about the products, including a possible ban. Most flavorings already were barred from being used in tobacco as part of the law, but not menthol.
Mr. Deyton didn’t specifically address menthol in his speech. Several industry analysts speaking at the conference Monday, however, said they didn’t think the FDA would ultimately prohibit menthol cigarettes, a category led by Lorillard Inc.’s Newport brand.
Banning menthol cigarettes, which account for about a third of the U.S. cigarette market, could result in the rise of a large, illegal sector in which the government garners no tax revenue from sales, said Nik Modi, an analyst with UBS.
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