Lorillard Tobacco Company First to Cross the Substantial Equivalence Finish Line

By Dave B. Clissold –FDA Law Blog

Earlier this week, FDA’s Center for Tobacco Products (“CTP”) released its first determinations regarding the marketing of new tobacco products through the substantial equivalence (SE) pathway.  CTP authorized the marketing of two new tobacco products and denied the marketing of four others.  Under the Family Smoking Prevention and Tobacco Control Act of 2009, one way manufacturers can legally sell a new tobacco product is to establish that their product is substantially equivalent to a predicate product that has been marketed at least since February 15, 2007 (for more on the SE pathway, see our previous posts here and here).  Before marketing the new product, the manufacturer must submit a SE Report under Section 905(j) of the Federal Food, Drug, and Cosmetic Act.  If the new and predicate products have different characteristics, the SE Report must demonstrate that the new product will not raise new questions of public health compared with the predicate product.  After reviewing the SE Reports for two Lorillard Tobacco Company cigarette products, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box, CTP issued each a SE Marketing Order.

According to the Technical Project Lead Memorandum released for each product (Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box), the original SE Reports were both submitted in October 2011 and amended several times in response to questions from CTP.  As outlined in the memoranda, the CTP Office of Compliance and Enforcement agreed with the predicate product identified in the SE Reports (Newport Lights Menthol 80 Hard Box and Newport Lights Menthol 100s Hard Box).  CTP compared the characteristics of the new products with the predicates and noted three differences:  absence of menthol; presence of fire standard compliant (“FSC”) cigarette paper (as opposed to conventional cigarette paper); and, changes to design features to maintain consistency of smoke delivery.  Scientific reviews were then conducted by the CTP Office of Science for the following disciplines:  Chemistry, Engineering, Toxicology, Social Science, and Addiction.  These reviews all concluded that the new product did not raise different questions of public health.

CTP also released a document summarizing the reasons it had determined that four new products were not SE.  CTP determined that in all four cases there were differences in characteristics between the new products and the predicate products, but the SE Reports did not show that the new products would not raise different questions of public health.  Accordingly, CTP determined that they would require a premarket tobacco product application.  Neither the applicants nor the four products were identified, but CTP stated that they were deficient in one or more of the following areas:  failure to establish the predicate tobacco product was marketed as of February 15, 2007; inadequate description of design features; inadequate information presented regarding the type of tobacco used; inadequate information submitted about new chemicals or higher levels of chemicals used in the new product; or, inadequate information presented regarding harmful and potentially harmful constituents of the new tobacco product.

More than 3,000 SE Reports have been submitted to FDA since the law was enacted, and reducing the backlog has been a high priority for CTP.  In announcing the authorizations, CTP Director Mitch Zeller, J.D., stated:  “FDA has been working diligently to review all pending SE submissions.  We know it’s taken time, but expect the process will move more quickly in the future as everyone involved gains more experience.”  The decisions announced yesterday will be scrutinized by tobacco companies and public health organizations alike for any insights they may provide regarding how CTP will address all of the pending SE Reports.

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