ROCKVILLE, Md. — (Mealey’s) For what it says is the first time since the Family Smoking Prevention and Tobacco Control Act became law in 2009, the U.S. Food and Drug Administration on Feb. 21 ordered an end to the sale in the United States of a Chinese company’s “bidi” tobacco products that failed to pass regulatory approval.
The FDA says its ban covers Jash International’s Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone, which the FDA found to be “not substantially equivalent” (SE) to tobacco products commercially marketed as of Feb. 15, 2007, called predicate products under the act.
According to the FDA, bidis are thin cigarettes hand-rolled in leaves from a tendu tree and tied with string. To keep the products on the market, the FDA says, Jash International was required to submit an application by March 22, 2011, showing that the products were substantially equivalent to valid predicate products.
Eligible Predicate Products
Jash International did not identify eligible predicate tobacco products, the FDA says, and did not provide information necessary for the agency to determine whether the now-banned products “had the same characteristics as a predicate product, or had different characteristics but did not raise different questions of public health, the basis used by the FDA to review SE applications for tobacco products.”
“Historically, tobacco companies controlled which products came on and off the market without any oversight,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a press release. “But the Tobacco Control Act gave the FDA, a science-based regulatory agency, the authority to review applications and determine which new tobacco products may be sold and distributed under the law in order to protect public health.”
The act allows the FDA to seize existing inventory without notice, the agency says, although the agency does not intend to take enforcement action for 30 days against retailers’ existing inventories.
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