The Food and Drug Administration (FDA) has announced a comprehensive, multi-year plan for tobacco and nicotine regulation designed to reduce tobacco-related disease and death. The approach will focus on reducing levels of nicotine to make tobacco products less addictive. The FDA also hopes to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes.
“Addressing the addiction crises that are claiming young lives and hurting American families is our most pressing mandate at FDA,” said FDA commissioner Scott Gottlieb, MD. “In particular, examining the presence of nicotine in combustible cigarettes has to be part of a much broader strategy. I’ve pledged a deep commitment to taking aggressive steps to address the epidemic of addiction to opioids. I view our opportunity to confront addiction to nicotine with the same obligation.”
The FDA also will provide targeted relief on some timelines described in the May 2016 Final Rule that extended its authority to additional tobacco products. Additionally, the FDA will seek input on critical public health issues such as the role of flavors in tobacco products, which has been a growing concern since the introduction of electronic cigarettes and the youth-oriented marketing that has been associated with them.
“When I last served, FDA lacked the authority to regulate tobacco products as traditionally marketed. Since that time, our statute has been amended to include an entire chapter of new authorities,” said Gottlieb. “There’s also been enormous change in the marketplace since I was last at FDA. In just the last few years, we’ve seen the advent and adoption of new product categories that may be able to deliver nicotine without having to burn tobacco.”
With a previous deadline of August 8, 2017, applications for newly regulated tobacco products such as cigars, pipe tobacco, and hookah tobacco now must be submitted to the FDA by August 8, 2021. Applications for non-combustible products such as electronic cigarettes must be submitted by August 8, 2022. Manufacturers can continue to market products while the FDA reviews product applications.
The FDA hopes that these companies will use the time to develop both traditional cigarettes and alternative tobacco products with lower nicotine content, in effect making them less addictive or potentially not addictive at all. The agency notes that it’s not nicotine that’s directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year, but the other chemicals inside these products.
“The bigger problem is the delivery mechanism—how the nicotine gets delivered,” said Gottlieb. “Attach it to smoke particles created by burning cigarettes, and the mechanism is deadly. But attach the very same nicotine to a medicinal product without the other chemicals found in tobacco products, and these therapeutic products have been found to be safe and effective by FDA in helping smokers to quit.”
Considering the impact that tobacco products have on oral health—ranging from stained teeth and tongue to a dulled sense of taste and smell, slow healing after oral surgeries, gum disease, and oral cancer—the ADA has formally opposed delays in implementing FDA regulations. It also remains skeptical about the FDA’s new strategy of focusing on nicotine levels and the usage of alternative nicotine delivery products.
“We’re not convinced that swapping one cancer-causing product for another is in the public’s best interest,” said ADA president Gary L. Roberts, DDS. “You can’t say that ‘innovative’ tobacco products are ‘less dangerous’ than cigarettes without knowing their immediate and long-term effects on oral health. The FDA has mostly focused on lung cancer, but oral cancer can be just as deadly.”