Bidi products of company banned by FDA

The products do not meet regulatory standards and hence can no more be sold, distributed or imported in the US

US regulators today banned the sale and import of a company's "bidi" products as they did not meet regulatory standards.

The US Food and Drug Administration in a statement said the products manufactured by Jash International - Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone - were found to be not substantially equivalent to tobacco products commercially marketed.

This means they can no longer be sold or distributed in interstate commerce or imported into the United States.

The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.

"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.

"Companies have an obligation to comply with the law - in this case, by providing evidence to support an SE application," Zeller said.

"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 FDA official said.

FDA said existing inventory may be subject to enforcement action, including seizure, without further notice.

Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by the FDA, it said.