News

FDA Issues Order To Stop Sale Of 4 Tobacco Products

By

The U.S. Food and Drug administration has ordered Jash International Friday to stop the sale and distribution of four tobacco products currently on the market, because they do not meet regulatory standards, Reuters reported.

The federal agency gave the manufacturing company multiple opportunities to provide evidence to prove the cigarettes, called Sutra Bidis, were in compliance with the Tobacco Control Act, Mitch Zeller, director of the FDA's tobacco division, said in a statement.

The products are four types of thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string.

"Historically, tobacco companies controlled which products came on and off the market without any oversight," Zeller said in a statement. "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."

Under the Tobacco Control Act, regulated products were allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011, FDA officials said. The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent to valid predicate products.

The FDA determined the company's products to be misbranded and adulterated because of their failure to provide the required information.

 "Companies have an obligation to comply with the law - 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."

FDA officials said their action against Jash International 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.

© 2024 University Herald, All rights reserved. Do not reproduce without permission.
Join the Discussion
Real Time Analytics