Today, 02 21 2014, the FDA announced that they had first exercised their authority given to them under the Tobacco Control Act to stop the sale of four different Sutra Bidis tobacco products because they, like other companies such as 23andme, did not communicate with the FDA.
The product was not shown to be equivalent to the predicate tobacco product that they were supposed to be similar to. Without assurance of the similarity of these Sutra Bidis tobacco products to those that are already approved, the FDA classified them as "Not Substantially Equivalent" and has stopped their sale, import, and resale.
Ensuring compliance with the law is critical to FDA’s mission to protect public health. As part of that mission, FDA is committed to making sure that all tobacco products that are sold and distributed to the public meet the requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
In support of this commitment, it has been recently announced that four tobacco products currently on the market – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – do not meet the criteria in the law to remain on the market.
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.
A released draft guidance document that explains the enforcement policy the agency intends to follow with respect to tobacco products that entered the market during the grace period and later received NSE orders is available for public comment, details and thoughts on the topic.
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