By Toni Clarke
Feb 21 The U.S. Food and Drug Administration said on Friday it has ordered Jash International to stop selling four tobacco products that it said do not meet regulatory standards.
The agency gave Jash multiple opportunities to provide the FDA with the information it required to determine whether its Sutra Bidis cigarettes were in compliance with the law, said Mitch Zeller, head of the FDA's tobacco division.
Jash's failure to provide the information meant the FDA determined the company's products to be misbranded and adulterated, Zeller said in an interview.
The company's Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone are not substantially equivalent to tobacco products commercially marketed as of Feb. 15, 2007, as required by law, the FDA said.
Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped with tendu tree leaves tied with string, the FDA said.
Jash declined to comment on the action. The company is based in East Dundee, Illinois.
This is the first time the FDA has exercised the authority it acquired in 2009 to stop a company from selling tobacco products already on the market.
Zeller said the agency does not know how many of Jash's products are on the market.