After nearly a year without a permanent chef, Dr. Robert Califf is preparing to become commissioner of the Food and Drug Administration. Although Califf is not new to the job given that he was head of the FDA under President Barack Obama, the agency he returns to has changed dramatically since he last held the position.
One issue in particular – tobacco harm reduction – has been the basis of a scattered series of decisions by the FDA, which has yet to take clear and concise action in favor 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 adopt products that help people move away from the negative health effects of cigarette smoking.
In recent years, it appeared the FDA had accepted 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 achieved when a company can demonstrate “that the product will or should benefit the health of the population as a whole”.
This is exactly what harm-reducing nicotine products do. Snus is a packet of nicotine that eliminates the burning aspect of cigarettes and therefore helps consumers avoid carcinogens and harmful chemicals that come from cigarettes. Research has shown that these products can successfully steer smokers away from cigarettes and help them quit completely. Adopting more products like these would help provide a safer alternative for those currently addicted to smoking.
Unfortunately, the FDA recently took a step back from its last MRTP approval of two combustible cigarettes. The decision illuminates the FDA’s internal struggle to advance a clear strategy that encompasses safer alternatives that could wean smokers off cigarettes. While these products were “low in nicotine”, nicotine does not have the same inherent negative health effects that come from inhaling cigarette smoke.
Although Califf has stated its support for a nicotine reduction approach, it is essential that the FDA recognize that nicotine levels should not be the priority, but rather the transition from combustible products.
The nicotine replacement theory is a strategy for smokers to use alternative nicotine products to help reduce general withdrawal symptoms while quitting smoking. Studies show this method is almost twice as likely to help smokers quit their addiction, but the FDA has turned down thousands of harm reduction products based on flavor. But these efforts are misguided and often make it much harder for smokers to switch to a safer alternative, given that studies have shown smokers are more likely to quit 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 health outcomes by encouraging the use of alternative harm reduction products. Many lawmakers look to the FDA to help guide their decision-making process at the state and federal level, and Califf now has a great opportunity to course-correct the agency and present a strategy. clear and effective in favor of smoking cessation in the future.