How Will FDA Handle Tobacco Harm Reduction?

  • December 19, 2011

By Marla Scarola

Tobacco harm reduction has been a controversial topic for decades. Many on the side of tobacco control argue that any tobacco product is harmful and that all public health efforts should be focused on eliminating the use of tobacco entirely. On the other side of the argument are those that believe trading cigarettes for a less harmful form of tobacco reduces the overall risk of disease or death and that any reduction, even if it comes with continued tobacco use, is beneficial.

Before the approval of various nicotine replacement therapies, products considered as potentially reduced risk included traditional tobacco products such as smokeless tobacco and Swedish snus. Now there are not only a variety of nicotine replacement therapies (e.g. gum, patch, inhaler) on the market, there are also novel nicotine delivery devices available to consumers. So far, nicotine replacement therapies have all been regulated as drugs and have been labeled as smoking cessation aids intended for short-term use only. While it is theoretically possible for these products to obtain labeling as reduced risk products, the exact regulatory pathway for achieving this goal is unclear.

To complicate matters, a recent court ruling determined that novel nicotine delivery devices, specifically electronic cigarettes, are tobacco products rather than drugs. This ruling means that FDA’s Center for Tobacco Products (CTP) now has jurisdiction over these products and potentially all nicotine replacement therapies. CTP has initiated the discussion of what it will take to become a modified risk tobacco product and held a workshop in late August to discuss the regulatory and clinical issues surrounding this designation. However, this path is yet to be taken by anyone and, therefore, there are many unknowns regarding how CTP will handle this type of application.

The world of tobacco harm reduction is changing. There are more products becoming available that may be able to provide current smokers with a less harmful form of tobacco. The FDA should develop a clear path to approval for these products that would allow for long term use and labeling as a reduced harm product. The first sponsor to gain approval of a reduced risk product either via CDER or CTP has the opportunity to have a part in laying the groundwork and setting the bar for future applications.

Marla Scarola is a Senior Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us.