FDA Announces First Decisions on New Tobacco Products

By Mitch Zeller, J.D.

Mitch Zeller, J.D., Director of FDA's Center for Tobacco Products

In March, I became 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 director of the agency’s first Office of Tobacco Programs. Since I’ve rejoined FDA, CTP has made great progress on multiple fronts. I look forward to discussing my strategic goals and priorities in a future blog post, but today I want to share some information about one immediate priority—decisions regarding tobacco product reviews.

Today, for the first time since FDA received the authority to regulate certain tobacco products, the agency has authorized the marketing of two new tobacco products through the substantial equivalence (SE) pathway, while denying the marketing of four other new products.

These actions are unprecedented and mark the start of other forthcoming decisions related to the marketing of new tobacco products. Substantial equivalence is one pathway manufacturers can use to market a new tobacco product. To do so, a manufacturer must establish that their product has the same characteristics as a valid previously marketed tobacco product, what we call a predicate product, or, if the new product has different characteristics, that it does not raise different questions of public health.

SE submissions require rigorous review. FDA has a responsibility to protect public health, and to do so, we work to ensure that any new tobacco product brought to market through the SE pathway will not present more harm to public health than a valid predicate product identified by the manufacturer.

Today’s SE orders allow the marketing of two new Lorillard Tobacco Company tobacco products: Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. The agency has found these two products to be substantially equivalent to predicate products, based on the company’s submissions and other readily available science and information that demonstrate that each product will not present more harm to the public health than the predicate.

It is important to emphasize that an SE decision does not mean that the agency considers a product to be safe, nor is it FDA-approved. The SE decision only means that a new product does not raise different questions of public health as compared to the predicate product.

FDA is also issuing the first not substantially equivalent, or NSE, orders denying marketing of four new tobacco products after finding that the products have different characteristics from their predicate products and that the applicant did not adequately show that the new products did not raise different questions of public health.

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. FDA has offered feedback to the industry on the requirements for substantial equivalence and will continue to offer such feedback. We have also created a new webpage that tracks SE decisions to date and provides general information on FDA’s pathways to market new tobacco products. Our goal is to work through the remaining SE submissions in a consistent, transparent and predictable manner.

Mitch Zeller, J.D., is the Director of FDA’s Center for Tobacco Products.

FDA Voice Interviews Lawrence R. Deyton, M.S.P.H., M.D.

FDA Voice: What is your current position at FDA and, briefly, what is the mission of the Center for Tobacco Products?

Dr. Deyton: I joined FDA in the fall of 2009 as Director of FDA’s Center for Tobacco Products. CTP has a clear-cut mission: to help make tobacco-related death and disease part of America’s past, not America’s future, and, by doing so, ensure a healthier life for every person and every family.  That means putting programs and regulations in place that will help people, especially children, to not start using tobacco products, help current users to quit, and educate Americans about the risks of tobacco use. 

Lawrence R. Deyton, M.S.P.H., M.D. FDA Voice: Can you tell us in basic terms about the Family Smoking Prevention and Tobacco Control Act?

Dr. Deyton: Sure. When the Tobacco Control Act was enacted in 2009, FDA was given a series of important new responsibilities and authorities to protect the public from the dangers of tobacco use. And we’re implementing and enforcing the law’s provisions as they take effect.

For example, we’re helping to reduce access and the attractiveness of tobacco to kids by restricting advertising, marketing and retail practices related to cigarettes and smokeless tobacco products. We’ll be educating Americans about the contents of tobacco products and smoke and, as we do, we’ll be helping families understand the health effects of tobacco use.

The law is also requiring tobacco manufacturers to register with us and submit information about their products and product ingredients, including additives. As incredible as it sounds, consumers of cigarettes, a mass-consumed product, currently don’t know the chemicals they’re inhaling that cause or have the potential to cause harm to them.  And, FDA now has the authority to set standards that can make tobacco products less addictive and harmful.

I should add that FDA has clear authority to enforce all these provisions. Take the case of retailers. Most retailers are happy to take on their new responsibilities under the Tobacco Control Act to make sure kids don’t buy cigarettes or smokeless tobacco products. But some are not.  And FDA has not been shy about using our authority to enforce penalties against them.

FDA Voice: Can you tell us how CTP is unique and how it differs from other Centers at FDA?

At CTP we’re regulating a product which, if you look at what is available today, is fundamentally unsafe. So, we employ a different regulatory standard than other centers: a public health/population health standard that focuses on reducing the health threat tobacco use poses to all of us, not just the individual consumer. That’s a different strategy than other FDA Centers use, but CTP is regulating a very different product.

FDA Voice:  If you could tell the American public one thing that they might not know about what CTP does to directly benefit them, what would it be?

Dr. Deyton: I think Americans ought to know that, even though we’re a new part of FDA, CTP is really grounded in values that have guided FDA since its inception: the belief that government has a responsibility to take action when people’s lives are needlessly put in danger.

You know, I’ve yet to meet anyone anywhere in this country who wants kids to start to use tobacco. Current smokers tell us, “Help keep this stuff out of kids’ hands.” They want them to grow up healthy. And I should add that those smokers also tell us how badly they’d like to quit. That’s why this law doesn’t only help to prevent initiation; it also promotes cessation and includes provisions for reducing the addictiveness and toxicity of future tobacco products. If we achieve these goals, we will accomplish our mission of making the harm caused by tobacco use part of America’s past, not America’s future.

Lawrence R. Deyton, M.S.P.H., M.D., is the Director of FDA’s Center for Tobacco Products