In March, I became the director of the FDA’s Center for Tobacco Products (CTP), after spending more than three decades working on FDA-related issues, including a seven-year stint at FDA from 1993-2000. From 1997-2000 I was the first director of the agency’s office of tobacco programs. Since I returned FDA, CTP has made significant progress on many fronts. I look forward to discussing my strategic goals and priorities for the future blog post, but today I want to share some information about priority-review decisions regarding tobacco products.
Today, for the first time since received FDA authority to regulate tobacco products identified, the agency authorized the marketing of two new tobacco products through substantial equivalence (SE) pathway, while denying the marketing of the four other new products.
These actions are unprecedented and mark the beginning of other upcoming decisions related to the marketing of new tobacco products. Substantial equivalence is one way manufacturers can use to market new tobacco product. To do this, the manufacturer must prove that their product has the same characteristics as the actual formerly marketed tobacco products, which we call the predicate product, or if the new product has different characteristics that it does not raise different questions of public health.
SE representations require careful study. FDA is responsible for protecting public health, and to do that, we are working to ensure that any new tobacco product brought to market by the way does not introduce more harm to public health than the actual product predicate specified by the manufacturer.
Today’s SE orders allow the marketing of two new Lorillard Tobacco Company Tobacco Newport Non-Menthol gold box 100s and Newport Non-Menthol gold box. The agency has found these two products are substantially equivalent to the predicate products based on materials of the company and other readily available science and information to demonstrate that each product will not pose more harm to public health than the predicate.
It is important to emphasize that the decision does not in itself mean that the Agency considers the product to be safe, and its not-FDA approved. SE decision only means that the new product does not cause various public health issues, compared to the predicate product.
The FDA has also released the first non-equivalent, or NSE, orders denying marketing of four new tobacco products after discovering that the products have different characteristics from their products predicate and that the applicant does not fully show that the new products did not raise different questions of public health.
FDA had been working diligently to address all the pending SE submissions. We know it took some time, but expect that the process will move more quickly in the future all the participants get more experience. FDA proposed to feedback from the industry about the requirements for substantial equivalence, and will continue to provide such feedback. We also created a new Web page that tracks SE decision on the date and provides general information on how the FDA to market new tobacco products. Our goal is to work through the remaining SE submissions in a consistent, transparent and predictable manner.