After nearly a year without a permanent leader, Dr. Robert Califf is gearing up to serve as commissioner of the Food and Drug Administration. Though Califf is not new to the position given his time as head of the FDA under President Barack Obama, the agency he is returning to has drastically changed since he last held the position.
One issue in particular — tobacco harm reduction — has been the foundation of a series of scattered decisions by the FDA, which has yet to take clear and concise action in support of many products that would effectively reduce the number of smokers. If the FDA and Califf, as commissioner, hope to advance harm reduction efforts, they must embrace products that help transition people away from the negative health effects caused by smoking cigarettes.
In recent years, it seemed the FDA had come to terms with this strategy after approving Snus, a smokeless tobacco product, and IQOS, which heats tobacco instead of burning it, as modified risk tobacco products (MRTP). This designation is only earned when a company can demonstrate “that the product will or is expected to benefit the health of the population as a whole.”
Harm-reducing nicotine products do just this. Snus is a nicotine pouch that eliminates the combustion aspect from cigarettes and therefore helps consumers avoid harmful carcinogens and chemicals that come from smoking cigarettes. Research has shown that these products can successfully transition smokers away from cigarettes, and can help them quit entirely. Embracing more products like these would help offer a safer alternative for those currently addicted to smoking.
Unfortunately the FDA recently took a step backward after its most recent MRTP approval of two combustible cigarettes. This decision illuminates the FDA’s internal struggle to advance a clear strategy that embraces safer alternatives that could wean smokers off cigarettes. While these products were “low-nicotine,” nicotine does not carry the same inherent negative health effects that come from the inhalation of cigarette smoke.
While Califf has stated his support for a nicotine reduction approach, it is critical that the FDA recognizes that nicotine levels should not be the priority, transitioning away from combustible products should.
Nicotine replacement theory is a strategy for smokers to use alternative nicotine products to help reduce overall withdrawal symptoms while quitting smoking. Studies show this method is almost twice as likely to help smokers quit their addiction, yet the FDA has denied thousands of harm reduction products on the basis of flavor. But these efforts are misguided and often make it much harder for smokers to make the jump to a safer alternative considering studies have shown smokers are more likely to quit smoking for other “sweet” flavored products.
Now that the FDA has a permanent head, I hope Califf can work to advance a concise strategy for smoking cessation that prioritizes healthcare outcomes by encouraging the use of alternative harm reduction products. Many lawmakers look to the FDA to help guide their decision-making process on the state and federal level, and Califf now has a prime opportunity to correct the course of the agency and present a clear and effective strategy in favor of smoking cessation going forward.
