US regulators for the first time have banned the sale and import of "bidi" products made by an Indian company as they did not meet regulatory standards.
The US Food and Drug Administration in a statement said the products manufactured by Pune-based Jash International Ė Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone Ė were found to be not substantially equivalent to tobacco products commercially marketed.
The ban is first one issued by the FDA under the 2009 Family Smoking Prevention and Tobacco Control Act.
This means they can no longer be sold or distributed in interstate commerce or imported into the United States, the FDA said.
"Historically, tobacco companies controlled which products came on and off the market without any oversight. 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," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
The regulator said under the Under the Tobacco Control Act, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an substantially equivalent (SE) review.
Also, the company did not provide information necessary to determine whether the new products had the same characteristics as that of its previous products, or had different characteristics but did not raise different questions of public health, the basis used by the FDA to review SE applications, it said.
"Companies have an obligation to comply with the law Ė in this case, by providing evidence to support an SE application," said Zeller.
"Because the company failed to meet the requirement of the Tobacco Control Act, the FDA's decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States," the official said.
Existing inventory may be subject to enforcement action, including seizure, without further notice. Companies that continue to sell and distribute these products