On October 17, 2013, concurring with the end to the government shutdown, FDA responded to a Citizen Petition filed by Lorillard Tobacco Company, Inc. (“Lorillard”). The Petition requested that FDA exercise enforcement discretion to allow the marketing of new tobacco products introduced after March 22, 2011 that are the subject of reports intended to demonstrate substantial equivalence and compliance with the Federal Food, Drug & Cosmetic Act (“FD&C Act”) Section 906(j)(1)(A)(i) (“SE Report”). Lorillard specifically asked that FDA exercise enforcement for two of its tobacco products that were the source of SE Reports and for similarly-situated tobacco products where the SE Report had been submitted at least 90 days prior to introduction in the market. As a preliminary matter, FDA said that requesting enforcement discretion in a citizen petition is not “within the scope of the FDA’s citizen petition procedures,” yet FDA elected to address the concerns underlying the request for a policy of enforcement discretion. FDA also indicated that it had issued orders for both Lorillard products, SE0003730 and SE0003731.
Lorillard had submitted SE Reports for its two new products, non-menthol versions of its 2007 Newport Lights Menthol, in October 2011. FDA indicated it its Technical Project Lead Memoranda for the products that both products had amendments and responses to deficiencies, with the most recent response dated February 8, 2013, and FDA’s response dated June 25, 2013. The new products differed from the grandfathered predicate products by: 1) absence of menthol, 20 presence of fire standard compliant cigarette paper, and 3) changes to design features to maintain consistency of smoke delivery. FDA’s reviews included chemistry, engineering, toxicology, social science, addiction, and an environmental assessment. FDA found the two new products to be substantially equivalent because: 1) the exclusion of menthol would not adversely impact initiation, dependence, or cessation of use, 2) the depth of inhalation would be equivalent and not raise different questions of public health, and 3) constituents in smoke delivered from the comparison products maintains an equivalent risk to the user and does not raise different questions of public health.
FDA agreed with Lorillard’s assertion that the FD&C Act did not mandate a timeframe for FDA’s response to an SE Report. FDA said that it has been “working diligently” to provide feedback to parties to address filing deficiencies, which have been significant and omnipresent, as well as “working expeditiously” to review SE Reports. FDA further intends to “establish performance measures” to include specific timeframes for SE Report review phases. In addition, FDA has conducted and webinars to provide information concerning observed deficiencies to the tobacco product industry to help to improve future submissions and reduce the number of review cycles. FDA described the SE Report review process as “can be complex” with “a wide range in the quality and completeness,” which further requires a review of the product to determine if it complies with the FD&C Act.
Interestingly, FDA’s response to Lorillard’s two referenced SE Reports via the Technical Project Lead Memoranda were just a day short of one year after the Petition was filed. Time will tell whether FDA provides more definitive timeframes for reviewing such SE Reports and how industry addresses the perceived review cycles in terms of filing their SE Reports before intended marketing of the new tobacco products.