U.S.- creating the FDA's Center for Tobacco Products..

July 21, 2009 - Now that the U.S. Food & Drug Administration (FDA) has been given that job, the FDA must set up a new center devoted to regulating a multibillion-dollar industry that employs tens of thousands of people -- many of them in the Richmond region. The industry reaches from farm fields to retail stores, has more than 40 million U.S. customers and has long enjoyed a high degree of autonomy.

"It's a daunting task," said Mitch Zeller, a former associate commissioner of the FDA and a longtime tobacco-control advocate. "There is no infrastructure at FDA yet" geared specifically for tobacco regulation, Zeller said. "It can be built, and it needs to be done quickly. That will happen simultaneously with FDA beginning to meet the deadlines that are in the legislation," such as a Sept. 29 ban on candy-flavored cigarettes.

The legislation, passed by Congress and signed by President Barack Obama on June 22, calls for the creation within 90 days of a Center for Tobacco Products in the FDA.

The FDA has announced that it is seeking public input on the implementation of its new authority overseeing tobacco products in the United States.

Observers say the new tobacco center likely will be structured in a similar fashion to other FDA offices, such as its Center for Food Safety and Applied Nutrition, which is responsible for making sure the nation's food supply is safe, and its Center for Drug Evaluation and Research, which regulates over-the-counter and prescription drugs. But the tobacco center will have a unique role for the FDA -- regulating a product that, when used as intended, causes disease and death for more than 400,000 of its consumers in the U.S. each year. In that light, the FDA's approach to tobacco will likely be "a hybrid" of the way it regulates foods, drugs and devices, Zeller said. Tobacco doesn't fit clearly into one of those categories, but it has characteristics of all of them.

"Tobacco is in a category by itself, given its inherent toxicity," Zeller said. "Having said that, I think the regulatory tools that [the FDA] will use in this unique category are pretty much the tools that we have seen the agency use for as long as there has been an FDA." Those tools include pre-market evaluation of products, scrutiny of marketing claims, and ingredient disclosures, he said.

Yet some issues are still left open to interpretation in the FDA legislation. For example, it requires the FDA to set product standards for tobacco that must be "appropriate for the protection of public health," rather than the "safe and effective" standard used for pharmaceuticals.

"That's pretty broad," said Scott Ballin, a tobacco and health policy consultant who lobbied for FDA regulation of the industry. "There are going to be a lot of questions as to what the agency decides to do with that. Are they going to be reasonable standards? Are they going to be economically feasible standards?" There is a whole spectrum of new, complex issues that need to be addressed carefully and openly and in a way that will achieve public-health goals," Ballin said.

The FDA's decisions on tobacco regulations should be based on scientific evidence, Ballin and other tobacco-control advocates said. That view was echoed by the nation's largest tobacco company, Henrico County-based Altria Group Inc., parent company of Philip Morris USA. "The FDA has a history of making decisions using a thoughtful, science-based process that includes input from the public, other stakeholders and the regulated community," said Bill Phelps, a spokesman for Altria Group Inc. "We believe whoever leads the [FDA] tobacco center should follow the same model, and we are hopeful that would be the case."

Much of the decision-making on implementing the regulations will be made by the director of the Center for Tobacco Products, who has not yet been hired. The FDA closed its application process for the director position on July 9. The agency would not comment on how many people have applied, but a director is expected to be named within 45 days. The director will have to build a staff, likely to eventually include hundreds of people with various scientific, regulatory and legal backgrounds.

The job description posted by the FDA for the director's job called for applicants with "substantial scientific expertise" in areas such as toxicology and epidemiology, and experience in public health and "administrative procedure and regulation, including deep familiarity with congressional operations and policymaking in the executive branch."

Whoever fills that role, said Matt Myers, president of the Campaign For Tobacco-Free Kids, "will need to be someone with exceptional leadership and management skills, and an ability to create a vision, build a staff, set priorities and meet deadlines under intense scrutiny on a highly controversial topic."

The FDA also must appoint a 12-member scientific advisory board on tobacco products to provide recommendations and advise the agency on product regulations. That board will be heavily weighted toward public health, with seven members from medical, health-care or scientific fields. Two members will represent the interests of tobacco manufacturers, and one member the interests of tobacco farmers, but they will be nonvoting members, serving in what the legislation calls a "consulting" role.

Before it sets product standards, the agency likely will seek out information from the tobacco industry itself, Zeller said. The legislation requires tobacco companies to disclose product ingredients to the FDA, but the agency can also go further than that by requiring companies to submit their research on toxic compounds and the health impacts of products.

Zeller: "Right now much of the scientific knowledge about the delivery of toxic compounds in smoke is in the hands of the tobacco companies," he said. "One of the tools in the legislation that I think is very important is the power that FDA is given to demand health-related information from the companies." Zeller headed the FDA's office of tobacco programs from 1993 to 2000, after the agency had asserted authority to regulate tobacco products. Tobacco companies disputed that in court, and in 2000 the U.S. Supreme Court ruled that only Congress could grant the agency regulatory power over tobacco.

In the 1990s, Zeller said, the FDA had primarily focused on ways to prevent youth smoking, but the agency's ability to continue that work was always in doubt because of the lawsuit. "Congress has spoken now," he said. "The day is here when those tools have been given to the agency." The FDA's Center for Tobacco Products primary focus should be to prevent youth from using tobacco products.

Reference: Next regulatory step: the Center for Tobacco Products by JOHN REID BLACKWELL Richmond Times-Dispatch Staff Writer, 7/21/2009.

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