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FDA Review Of Tobacco Products Grind To Halt
Tobacco companies have introduced almost no new cigarettes or smokeless tobacco products in the U.S. in more than 18 months because the federal government has prevented them from doing so, an Associated Press review has found.
Officials at the FDA say the reviews of applications for new products have taken so long because of “significant deficiencies” and because the agency is taking extra care in reviewing products that pose public health risks, reports the Star Tribune. Industry executives say cigarettes haven’t changed in any meaningful way and the delays don’t make sense. They say the changes are as simple as a brand name change, cigarette filters or, in some cases, different packaging.
Since June 2009, when the law allowing the agency to regulate tobacco went into effect, the tobacco industry has submitted nearly 3,500 product applications, according to data obtained by the AP under a Freedom of Information Act request. While none have been ruled upon, the vast majority of these products are already being sold.
A grandfather clause in the law allows products introduced between February 2007 and March 2011 that are similar to those previously on the market to be sold while under review. They can be removed from store shelves if they don’t pass muster with the agency. But 400 products submitted for review since March 2011 are being kept off the market.
The reviews, which the industry expected to take 90 days, have dragged on for years in some cases. About 90 percent of applications have lingered for more than a year.
The FDA does not have to disclose what the products are, and the companies won’t say, citing competitive reasons. Part of the problem is that the tobacco industry is still learning how to deal with being regulated.