FDA Looks Ahead

Issue Date: CSP Daily News, April 15, 2011

By Linda Abu-Shalback Zid

LAS VEGAS — When it comes to tobacco regulation, Dr. Lawrence Deyton, director of the FDA’s Center for Tobacco Products (CTP), acknowledges that there might be discord on occasion. But as he told retailers and manufacturers at the NATO Show Thursday, communication is an important focus of the CTP, even during those times.

“We want to establish a relationship of good communication and trust,” he said. “We may not always agree on everything. But we can disagree on things, but we don’t need to be disagreeable. And we need to keep communicating with each other about how this is all going, so that we can all learn for each other.”

He added, “Tobacco retailers, we know you’re on the front line of protecting our youth from initiating tobacco use…. Tobacco retailers are crucial to us at FDA to help keep tobacco out of the hands of kids.”

Deyton also outlined what’s up next for his organization, including the recent discussions around menthol cigarettes.

In March, the Tobacco Products Scientific Advisory Committee (TPSAC) reported that “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Deyton said, “The Tobacco Products Scientific Committee is just that–it’s advisory…. That committee’s advisory does not set FDA policy; FDA sets FDA policy.”

He said the FDA is considering the report and an industry perspective document, which could “take some time,” but promised the first progress report will be available in June.

Also in June, the FDA will issue a final rule on the graphic health warnings, proposed in November. Those warnings will have to be put in place by manufacturers in September of next year. (Click here for previous CSP Daily News

coverage of the FDA’s warning labels.)

TPSAC also will be looking at dissolvable products, and will issue a report by March 2012.

April of next year will be a busy time for the CTP, as it will establish a list of harmful and potentially harmful constituents, publish that list and begin educating constituents about it. The center will also issue guidance or regulation on the scientific evidence to be used to assess modified risk tobacco products. Manufacturers must submit information to the FDA proving that their products are modified risk, if they want to market them that way. “If they do effectively prove it and FDA agrees, they can market it as having modified risk. But we have to establish what those standards are,” Deyton said.

When asked if it’s possible to prevent youth access to tobacco products, without “complete prohibition” of them, Deyton said he didn’t know the answer. “The law says that these are legal products in this country…. I do think that big-picture goal is achievable.”

He reiterated that retailers are important to that process. “Your understanding of tobacco use, tobacco sales, and tobacco marketing in this country is huge for us to understand, so we can together achieve those kinds of public health goals that the law intends for us.”

(Click here for previous CSP Daily News coverage of the FDA and tobacco.)

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