Road map to substantial pitfalls

In the wake of its issuing its first six judgments on proposed new but ‘substantially equivalent’ tobacco products, the US Food and Drug Administration has issued a ‘brief summary’ on why such applications might fail.

Under the Tobacco Control Act of 2009, new cigarettes cannot be introduced on the US market without an order from the FDA, and there are two routes to obtaining such an order. One route, for completely new tobacco products, requires a highly detailed review, while a second route provides for products that are ‘substantially equivalent’ to those already on the market.

The FDA, which is said to have thousands of substantially equivalent applications to deal with, issued six judgments earlier this week, two positive and four negative.

The FDA said that it might find a new tobacco product to be not substantially equivalent (NSE) because there was inadequate information submitted, or because it found that the new product had different characteristics from the product it was supposed to be equivalent to and information demonstrated that the new product raised different questions of public health.

‘Four new tobacco products were found to be not substantially equivalent to specific predicate products due to factors such as inadequate evidence that the proposed predicate products were valid predicates and lack of complete information on the characteristics of the new products and the predicate products,’ it said. ‘After considering all the evidence, the agency determined that there were differences in characteristics between the new products and the predicate products, and there was not an adequate showing that the new products do not raise different questions of public health requiring a premarket tobacco product application.’

The types of deficiencies FDA found in one or more of these applications are summarized below.

‘Predicate: Insufficient information for FDA to determine whether or not the tobacco product that was referenced as a predicate was predicate-eligible. Specifically, adequate evidence was not provided to demonstrate that the predicate product was commercially marketed in the United States as of February 15, 2007.

‘Design Features: Inadequate information on design features such as ventilation and filter efficiency. This information is needed to understand if any changes in these characteristics are present and, if they are, whether the new product raises different questions of public health.

‘Tobacco Type: Inadequate information on the type of tobacco used in the cigarette. This is a significant deficiency because the type of tobacco can alter the levels of harmful and potentially harmful constituents. This information is needed to understand if any changes in these characteristics are present and, if they are, whether the new product raises different questions of public health.

‘Added Chemicals: Where information was provided about the levels of specific ingredients showing they were present at higher levels than in the predicate product, there was not adequate evidence that the changes did not result in the new product not raising different questions of public health. Moreover, some of these ingredients have been shown scientifically to cause both toxicological and dependence concerns. For example, some of these ingredients are listed in the Hazardous Substances Data Bank and have known toxicities.

‘Harmful and Potentially Harmful Constituents: Inadequate information regarding “Harmful and Potentially Harmful Constituents” (HPHCs) in new and/or predicate tobacco products and tobacco smoke. Lacking this information, FDA was not able to determine whether the new product raised different questions of public health.’