On February 21, 2014, the FDA issued it’s first orders to stop the sale & distribution of tobacco products that are currently on the market, as they were found not substantially equivalent (NSE). FDA’s press release on the subject can be found here.
The products in question are Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone, which are manufactured by Jash International. During a telebriefing that FDA held on the subject, Mitch Zeller stated that the reason for the denials was because the company failed to identify eligible predicate tobacco products and did not provide information regarding product characteristics after repeated attempts by the FDA to obtain such information. Owing to the company’s lack of response, these four products will now be included on the FDA’s list of Misbranded and Adulterated Products.
During the question and answer session, the FDA stated (1) the NSE orders were not based on scientific analysis of the products, but rather based on lack of information, (2) that they are giving priority to those provisional applications where there is potential for the products to raise new questions of public health, and (3) that the “regular” applications (new product applications) are still given priority over provisional applications, but that they are reviewing the provisional applications and their average review times are getting shorter and shorter.
For questions and/or comments, please contact Nancyellen Keane, Troutman Sanders Tobacco practice attorney, at 804.697.1272 or by email.