In an effort to better protect American children and to reduce to tobacco-related disease, the Food and Drug Administration (FDA) plans to place tighter regulations on tobacco and nicotine.
“Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users,” stated FDA Commissioner Scott Gottlieb, MD. “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources. FDA stands ready to do its share.”
The FDA has regulated the tobacco industry since 2009, following the approval of the Family Smoking Prevention and Tobacco Control Act. However, it will now make nicotine, which causes tobacco addiction, the center of regulation.
According to Gottlieb, the FDA’s Center for Tobacco Products will soon develop a comprehensive plan to increase regulations on nicotine and will review more literature on cigarette addiction. The commissioner also strives to develop an Advance Notice of Proposed Rulemaking, which would identify issues related to nicotine in combustibles cigarettes under the FDA’s regulatory authority, as well as aim to make cigarettes minimally or non-addictive.
“We have the potential to improve the lives of tens of millions of currently addicted cigarette smokers, and future generations of kids,” said Gottlieb. “But if we’re going to meaningfully improve the public health, we need to be willing to take a hard look at our entire approach to tobacco, to make sure we have the right regulatory gates in place to evaluate products, and to focus more squarely on the nicotine.”
In addition to nicotine regulation, the FDA supports the development of tobacco products that may be less harmful than cigarettes. It plans to delay a regulation requiring that cigars and e-cigarettes receive FDA approval before being sold in stores. Nonetheless, it still seeks to develop regulations that will make tobacco products less toxic, appealing and addictive.
Though the FDA plans to be stricter on electronic nicotine delivery systems battery issues and on liquid nicotine, for example, it will give manufacturers more time to prepare higher quality, more complete applications, along with FDA guidance.
“Looking at ways to reduce nicotine levels in cigarettes so that they are minimally or non-addictive, while not altering the nicotine content of noncombustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation,” continued Gottlieb. “As I see it, taking the next step and addressing nicotine is not just within our authority; it’s an enormous public health opportunity and falls squarely within FDA’s mission.”
