The FDA has issued not substantially equivalent (NSE) orders to Star Scientific, Inc. to stop the sale and distribution of seven dissolvable tobacco products – Ariva Cinnamon, Ariva Wintergreen, Ariva Mint, Ariva Java, Ariva Citrus, Stonewall Natural, and Stonewall Java. These NSE orders were based on a complete scientific review that found that the seven products had different characteristics compared to the predicate products identified by the manufacturer and that the company failed to show that the new products did not raise different questions of public health.
These products entered the market during a provisional period established by the Tobacco Control Act. As part of that provisional period, the company had to submit a substantial equivalence (SE) Report to the FDA by March 22, 2011 in order for the products to remain on the market.
Although Star Scientific has previously announced that it discontinued the manufacturing of these products, they did not withdraw their pending SE Reports for these products. The FDA’s action prohibits these products from being unilaterally reintroduced to the marketplace by the company. This NSE order means these products cannot be sold or distributed in interstate commerce in the future without the company submitting new applications to the FDA and receiving the proper marketing authorization.
To determine whether a product is SE, a new tobacco product is compared to a predicate tobacco product, which is a product that was commercially marketed in the United States as of February 15, 2007, or a product previously found to be substantially equivalent.
A new tobacco product is SE to a predicate if the FDA determines that it: 1) has the same characteristics as the predicate tobacco product, or 2) has different characteristics but does not raise different questions of public health.
Compared to the predicate products selected by Star Scientific, the FDA’s scientific review found that these new products had several differences. For example, most of the new products had increases in total nicotine content, additions of acetaldehyde, and/or substantial increases in other harmful and potentially harmful constituents (HPHCs). An increase in nicotine content has the potential to make these products to be more addictive than their predicates. Though the decisions for each product are based on multiple factors, changes to characteristics such as these may raise different questions of public health, and these factors combined with the lack of adequate evidence submitted by the manufacturer ultimately led the FDA to issue NSE orders for these seven products.
Going forward, the manufacturer has the option to seek marketing authorization by submitting another application to FDA, for example, a premarket tobacco application (PMTA). The FDA encourages all manufacturers to review the requirements of the three pathways to market for tobacco products and choose the appropriate pathway for their product applications.
The FDA would also like to note that for new tobacco products not yet on the market (because they did not submit an SE report during the provisional period), there is no longer a queue to enter the SE review process, and submitted applications will immediately enter review. Additionally, the agency is now actively reviewing, and will continue to issue, decisions on provisional reports for tobacco products. The FDA will also continue to prioritize review of SE reports for marketed products based on their potential to raise different questions of public health.
By continuing to review provisional applications such as these, and by issuing NSE orders to stop the marketing of products that raise different questions of public health, the FDA is actively working to reduce the disease and death associated with tobacco. Previously, tobacco manufacturers determined what products came on and off the shelves without oversight – today’s actions underscore the importance of the Tobacco Control Act in granting the FDA the responsibility to guard the public health related to tobacco products. The FDA takes this responsibility seriously and will continue to take action as appropriate on all tobacco product reviews, including for currently marketed products.