The FDA has halted sales of four cigarette brands known as Sutra Bidis, marking the first use of its authority to take tobacco products off the market.
The
move will end import, sale, and distribution of Jash International's
thin, hand-rolled cigarette products Sutra Bidis Red, Sutra Bidis
Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone.
"Historically,
tobacco companies controlled which products came on and off the market
without any oversight," Mitch Zeller, JD, director of the FDA's Center
for Tobacco Products, said in a statement issued Friday. "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 manufacturer failed to provide the information
necessary to show its products were "substantially equivalent" to other
accepted tobacco products in terms of characteristics and public health
issues, according to the FDA.
The agency said it would give
retailers 30 days to liquidate their inventory of previously purchased
Sutra Bidis but that it would enforce the order against further sales or
distribution.
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