FDA tells company to stop sale of tobacco products
RICHMOND, Va. (AP) — For the first time, federal regulators on Friday ordered four tobacco products pulled from U.S. shelves that the company says it hasn't sold in years.
The Food and Drug Administration told Jash International Inc. to stop selling Sutra-branded cigarettes called bidis (BEE-dees) under a 2009 law that gave the FDA authority to regulate tobacco.
Mitch Zeller, the director of the FDA's Center for Tobacco Products said the company, after multiple opportunities, failed to give the agency adequate information to allow the products to remain on the market.
Zeller called the action an important step in the history of tobacco regulation because it is the first time the federal government has halted the sale of a tobacco product.
"Historically, tobacco companies controlled which products came on and off the market without any oversight," Zeller said.
Despite the symbolic milestone, a company representative said it hasn't sold the products being targeted by the FDA since around 2010 when flavored tobacco products were banned.
Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string. They are popular in India and are often flavored.
"They haven't been selling the bidis in years ... because we abandoned all those applications," said Barry Boren, a lawyer that handled communications between the FDA and Jash International, which does sell cigarettes.
"They couldn't comply. So basically that whole industry disappeared."
The FDA said despite the claim that the products were no longer being sold, until today the company was legally able to sell them if they wanted to, but now they can't. And the company had not withdrawn or abandoned the applications for the products, the agency said.
In addition to regulating a number of aspects of tobacco marketing and manufacturing, the 2009 law requires the FDA to review cigarette or smokeless tobacco products.
An Associated Press review in December 2012 found that the agency hadn't ruled on thousands of those applications for more than a year despite the 90-day review process the industry expected.
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 about 500 products submitted for review since March 2011 are being kept off the market.
According to data obtained by the AP under a Freedom of Information Act request, about 90 percent of the applications submitted to the FDA have been with the agency for more than a year.
The FDA had said the review process was taking so long because the applications from manufacturers lacked the information the agency deemed necessary to complete its analysis.
Michael Felberbaum can be reached at http://www.twitter.com/MLFelberbaum.