Monday, October 7, 2013

Chapel Hill to get two of FDA's new tobacco regulatory centers

Winston-Salem Journal
by Richard Craver

The Food and Drug Administration plans to spend up to $273 million over five years to operate 14 tobacco centers of regulatory science, two of which will be based at UNC Chapel Hill.

The agencies called the initiative a “first-of-its-kind” program. The centers will have scientists with expertise in epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications and marketing.

The goal is conducting research on seven main topics: diversity of current and new tobacco products, such as smokeless and electronic cigarettes; reducing addiction; reducing toxicity and carcinogenicity; adverse health consequences; communication; marketing of tobacco products; and economics and policies.
The FDA began regulating tobacco products and marketing in June 2009, but it cannot ban nicotine or tobacco. The Wall Street Journal has reported that the FDA could unveil its electronic-cigarette recommendations in October.

The tobacco industry, advocacy groups and consumers have been waiting several years for the FDA to decide how it will regulate e-cigs for product safety, minimum legal age for use, flavors, marketing and retail availability.

Determining regulations for e-cigs has been a priority of Mitch Zeller, who became director of the FDA's Center for Tobacco Products in March.

Elaine Keller
President of CASAA
The centers will “bring science-based regulation to the manufacturing, marketing and distribution of tobacco products,” Dr. Margaret Hamburg, the FDA’s commissioner, said in a statement.

Elaine Keller, president of Consumer Advocates for Smoke-free Alternatives Association, said she is concerned that the FDA "may have built-in recommendations in place, and the awarding of research grants is just one more ploy to make the regulatory process look legitimate."

For example, Keller said the Centers for Disease Control and Prevention "is already feeding false information into the propaganda machine" when its director, Tom Frieden, recently said that "many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventionanl cigarettes.

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