The FDA says that its goal is to ensure that the agency has the scientific and regulatory foundation to implement the Family Smoking Prevention and Tobacco Control Act, and make certain that it is striking an appropriate balance between regulation and encouraging innovative tobacco products that may be less unsafe than cigarettes. FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. R Street Harm Reduction Policy Director Carrie Wade noted that this should be considered an important first step to reorient FDA regulation of tobacco products from a process created to protect the sales and profits of the major cigarette makers, to one created to reduce tobacco-related addiction, illness and death. E-cigarette users were identified from the most recent survey in 2014/15, and smoking quit rates were obtained from those who had reported smoking cigarettes 12 months before the survey. "No other company anywhere in the world can grow tobacco with such low nicotine content".
Matthew Myers, president of Campaign for Tobacco-Free Kids, said in a statement the new tobacco regulatory agenda proposed by Gottlieb "represents a bold and comprehensive vision with the potential to accelerate progress in reducing tobacco use and the death and disease it causes in the United States".
Gottlieb said other issues may arise, such as a black market in high-nicotine cigarettes.
"But this analysis presents a strong case that e-cigarette use also played an important role".
Analysts said they expect regulators in Europe to study similar actions on nicotine products. According to the FDA, manufacturers of combustible products (i.e. cigars and pipe and hookah tobacco) would have until August 2021 to submit applications for revised products while makers of non-combustible products like e-cigarettes would have until August 2022.
The FDA's announcement sets in motion a lengthy rule-making process that will involve public comment and input from multiple stakeholders before any measures take effect.
According to Commissioner Gottlieb, the approach to nicotine must be accompanied by a strict base of rules and standards for newly-regulated products which should be done in concert and not in isolation, if it is to be successful.