FDA seeks tobacco industry input, but some firms frustrated with process

CRE Note:  In the article below the author states:  “Ashley also assured industry representatives that the agency’s decision-making on tobacco regulation would be based on solid scientific evidence.”  Dr. Ashley personally addressed the CRE Data Quality petition; based upon Dr. Ashley’s actions to date CRE  concludes that his actions are going to be science-based.


Richmond Times Dispatch


Some tobacco industry representatives expressed frustration Monday with how the U.S. Food and Drug Administration has handled its regulatory authority over tobacco products so far.

Officials with the FDA assured more than 200 people at an industry trade group meeting in Williamsburg that the agency wants to treat tobacco manufacturers and merchants fairly.

“We are going to communicate as clearly and openly with you as we can,” said David Ashley, director of the office of science at the FDA’s Center for Tobacco Products. “We want to be as transparent as we can.”

Ashley was one of five department directors at the Center for Tobacco Products who spoke at the annual conference of the Tobacco Merchants Association. The three-day meeting, which ends today, is focusing on federal regulation of the industry.

Congress passed legislation in June 2009 that gave the FDA authority to regulate tobacco products for the first time. Henrico County-based Altria Group Inc., the nation’s largest tobacco company, supported the legislation, but many other firms did not.

Adapting to regulation has been a tough and expensive process for small tobacco companies, said Ron Tully, vice president of National Tobacco Co., a Chicago-based firm.

“It has been an enormously burdensome exercise,” Tully told conference attendees.

Small companies that have limited resources compared with industry giants have put extensive resources into compliance, such as reporting ingredients to the FDA and adjusting to new product-labeling requirements, he said.

“None of those are lightweight things for a small business to deal with,” Tully said.

The FDA already has put into effect some regulations, such as a ban on the terms “lights” and “low-tar” to describe cigarette brands, and a ban on most added flavorings in cigarettes.

Issues that remain include what kinds of larger, graphic warning labels the FDA will require on cigarette packages starting next year, whether menthol will be restricted or banned in cigarettes, and how the agency will approach “modified risk” products that might be less hazardous.

FDA officials at the conference said they want more input from all stakeholders, including the industry. The FDA wants to visit tobacco farms and manufacturing plants to gather more information from industry stakeholders, officials said.

Ashley also assured industry representatives that the agency’s decision-making on tobacco regulation would be based on solid scientific evidence.

Some conference attendees were critical of the methods the agency has used to reach scientific conclusions.

Michael Ogden, senior director of regulatory oversight for Winston-Salem, N.C.-based R.J. Reynolds Tobacco Co., said the company is committed to complying with FDA regulation.

Yet Ogden said there were “significant deficiencies” in how an FDA scientific advisory panel handled a recent study on menthol cigarettes.

“There were real and apparent conflicts of interest” on the committee, Ogden said. “There were numerous instances of open hostility from the advisory committee to representatives of the industry.”

R.J. Reynolds and cigarette maker Lorillard Inc. filed a federal lawsuit in February claiming several members of the committee had conflicts of interest because they had testified against tobacco companies in smokers’ lawsuits or worked for pharmaceutical firms that make smoking-cessation products.

In March, the advisory panel said removing menthol cigarettes from the U.S. market would benefit public health, but it stopped short of formally recommending a ban to the FDA.

The FDA officials at the conference were asked what they think the tobacco industry will look like in 10 years, including how many manufacturers there might be, how many tobacco products will be sold in the U.S., and how many smokers there might be.

“That is an interesting question,” Ashley said, drawing nervous chuckles from the crowd.

“I’ve told you what our vision is,” Ashley said. “Our vision is to have the morbidity and mortality due to tobacco use no longer a problem in the United States.”

“That is where we see things going,” he said. “I have been told by a number of industry representatives that is where you guys are headed also, so I am hoping we will all be headed there together.”


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