Tobacco Chief to Start Ruling on Product Backlog at FDA
The top U.S. tobacco regulator said he’s ready to reduce a backlog of 4,000 applications from companies asking to determine which of their products can stay on the market and what new ones may be introduced.
The Food and Drug Administration is “very close” to ruling whether tobacco companies can sell new products they say have the same characteristics as existing ones, Mitch Zeller, appointed in March as head of the agency’s Center for Tobacco Products, said in an interview. There are 500 requests to approve products not currently sold and 3,500 for products already in stores, he said.
The changing regulatory standards for cigarettes have created a backlog of requests from Altria Group Inc. (MO) and other companies, which Congress put under FDA oversight in 2009. That authority provided an exception to rigorous new-product reviews by letting companies ask the agency to determine that proposed products are “substantially equivalent” to those on the market, requiring less scrutiny.
The industry “has the greatest degree of concern” over products they can’t currently sell, Zeller said. The agency plans to rule first on some of those requests before issuing decisions on the 3,500 products already being sold, he said.
Zeller declined to provide specifics on the timing of rulings.
The FDA can allow products to be sold even if the agency determines they have different characteristics than existing ones, Zeller said yesterday. In those cases, the agency must consider whether the variances raise new questions about public health. If the FDA decides that the issues aren’t different, it can rule the products as substantially equivalent, he said.
Companies such as Richmond, Virginia-based Altria and Winston-Salem, North Carolina-based Reynolds American Inc. (RAI) are regulated by the 2009 Family Smoking and Tobacco Control Act.
Altria declined to comment on Zeller’s remarks, said Bill Phelps, a company spokesman, as did Reynolds, spokesman Bryan Hatchell said. Robert Bannon, a spokesman for Lorillard Inc. (LO), didn’t reply to an e-mail and telephone message seeking comment.
New tobacco products marketed after Feb. 15, 2007, must be cleared for sale by the FDA. A tobacco product marketed before March 22, 2011, can continue to be sold if the FDA issues an order that it is substantially equivalent to an older product or one that has been declared substantially equivalent.
Advertisements to prevent smoking among 12- to 17-year-olds are planned by the agency by the end of this year with more in 2014, Zeller said. The FDA will spend $300 million on the campaign that will target multiple media platforms, he said. The research is taking place now to determine the best design and placement for the ads.
There will be parallel ad campaigns targeting rural, minority and lesbian, gay, and transgender youth. “These are some of the most vulnerable and at-risk youth out there,” Zeller said.
The ads will complement the campaign by the Atlanta-based Centers for Disease Control and Prevention that targets adults, Zeller said.
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