FDA moves ahead on tobacco regulation

SILVER SPRING, Md. — The Food and Drug Administration has taken significant steps toward setting up the nation’s new anti-smoking agency, less than 90 days after the federal government was given the authority to regulate tobacco products.

The FDA has named Dr. Lawrence Deyton of Washington, D.C., to lead the Center for Tobacco Products, which will decide on rules for the manufacture, marketing and sales of tobacco products. And it has established a scientific advisory committee and is seeking nominees to provide input for the FDA’s tobacco regulators.

In addition, the agency is asking for public comment on how it should proceed with policies aimed at reducing tobacco use — the chief goal of the Family Smoking Prevention and Tobacco Control Act, signed into law by President Barack Obama on June 22.

“We are definitely making progress on implementing the act,” said FDA spokeswoman Kathleen Quinn.

Rep. Henry Waxman, D-Calif., one of the chief sponsors of the legislation, said he was pleased with the FDA’s first moves.

“In the short time since its creation, the FDA Center for Tobacco Products has moved rapidly to fulfill its crucial mission,” Waxman said in a statement. “I have great confidence that it will make major progress in combating tobacco use and improving the public health of all Americans.”

Deyton, who starts Monday, was most recently chief public health and environmental hazards officer at the Veterans Health Administration. He is declining requests for interviews until after he assumes his new post, Quinn said.

Under the law, the FDA is empowered to force the tobacco companies to reveal by January the ingredients in cigarettes, to put larger and more graphic health warnings on cigarette packs by October 2012 and end any marketing activities deemed to be targeting children.

The agency is barred from outlawing tobacco.

Public health groups instrumental in pushing for federal tobacco regulation agree the FDA is moving quickly.

“We think they’ve hit the ground running and all bodes well for moving ahead,” said Paul Billings, vice president for national policy and advocacy at the American Lung Association in Washington. “It demonstrates that the FDA is taking its responsibilities very seriously and acting quickly and decisively to organize and implement the law.”

Gregg Haifley, associate director of federal relations for the American Cancer Society Cancer Action Network in Washington, said the FDA’s leaders, Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein, have good track records on tobacco issues.

“I’d have to say we are … very pleased,” Haifley said.

Some changes either already have taken place automatically or will soon.

For example, unsubstantiated claims of “reduced-risk” tobacco products were banned immediately when the law was signed. And flavored tobacco products, except those with menthol, are outlawed as of next month. But a portion of the law is already facing a legal challenge.

Last week two major tobacco companies and some smaller ones filed suit in U.S. District Court in Bowling Green, challenging provisions that govern marketing restrictions.

The plaintiffs, which include R.J. Reynolds Tobacco Co. and Lorillard Inc., claim marketing provisions in the law restrict their right to free speech.

Those provisions “severely restrict the few remaining channels we have to communicate with adult tobacco consumers,” Martin L. Holton III, senior vice president and general counsel for Reynolds, said in a statement.

The suit does not challenge the FDA’s right to regulate tobacco.

Quinn declined to discuss the potential impact of the suit, saying the agency doesn’t comment on pending litigation.

The FDA already has detailed about 20 employees to work full-time on setting up the tobacco center, according to Quinn. An additional 20 people from various offices are contributing time to assist in the start-up, she said.

The center has begun advertising for some upper-level management positions and eventually will hire several hundred people.

The FDA has set aside $5 million from this year’s budget for the tobacco center, and additional funds will begin flowing after Oct. 1, when special fees from tobacco manufacturers and importers are first collected.

According to a Congressional Budget Office estimate, the tobacco center will collect about $235 million in fees in 2010, a figure that will grow to an annual cap of $712 million in 2019.

The FDA’s request for public comments was published in The Federal Register on July 1, just nine days after Obama signed the law.

The agency pointed out that tobacco-related diseases kill about 430,000 Americans annually. Tobacco-related medical expenditures and lost productivity cost the nation $193 billion annually, the FDA said.

“Curbing the significant adverse consequences of tobacco use is one of the most important public health goals of our time,” the FDA said in seeking public comment. “We are requesting comments that will inform strategies to protect the public health as we implement this new authority.”

Reporter James R. Carroll can be reached at (202) 906-8141.

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