Washington (ISJ): Invoking the Family Smoking Prevention and Tobacco Control Act for the first time, the US Food and Drug Administration has banned sale and distribution of four Indian-origin tobacco products currently in the market.
The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone and Sutra Bidis Menthol Cone ? were banned as its manufacturers failed to provide necessary information on their products.
These products were found ?not substantially equivalent to tobacco products commercially marketed as of February 15, 2007, also known as predicate products,” said a news release by FDA.
“Historically, tobacco companies controlled which products came on and off the market without any oversight,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “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 USFDA action comes close on the heels of the agency banning drugs manufactured by certain Indian companies for failure to comply with good manufacturing practices.
The Tobacco Control Act requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products. If a company fails to provide the necessary information to show that their product is SE to a predicate product, the FDA has the authority to declare a product not substantially equivalent, which means that it can no longer be sold or distributed in interstate commerce.
Sutra Bidis, originated from Gujarat, are manufactured by Jash International, an Indian company with its headquarters in Illinois.
Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string.
US import of cigarettes from India was pegged at Rs. 4552 million in 2007-08, while that of bidis was Rs. 290 million.
An estimated 18 per cent people in the United States smoke, while the mortality rate from tobacco use is 4,80,000 every year.
