US regulator issues first orders to stop sale of tobacco products

Source:Xinhua Published: 2014-2-22 9:34:24

 The US Food and Drug Administration on Friday issued orders to stop the sale of four tobacco products called Bidis in the American market.

The FDA said the products, Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone, failed to meet the requirements of a 2009 law known as the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

The action marks the first time the agency has used its mandate to stop the sale of tobacco products. The FDA said that it is not an action it takes lightly.

"These products entered the market during a grace period set up in the Tobacco Control Act," Ann Simonea, director of the Office of Compliance and Enforcement at the FDA's Center for Tobacco Products, wrote in a blog. "However, after a thorough review of the submitted applications, FDA determined that Jash International, the manufacturer of the four new products, did not provide sufficient evidence to demonstrate that they are 'substantially equivalent' to eligible products that were previously marketed ( otherwise known as predicate products)."

"Specifically, the company did not identify eligible predicate tobacco products and was unresponsive to multiple requests for information that was necessary for FDA to determine whether the new products raised different questions of public health."

Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string.

The FDA said that existing inventory may be subject to enforcement action, including seizure, without further notice, and that companies that continue to sell and distribute these products in the United States may be subject to enforcement actions.



Posted in: Americas

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