FDA Announcements on Tobacco Products and What They Mean for Public Health

April 12, 2018|11:07 a.m.| ASTHO Staff

FDA’s Steps Toward Broad Regulation of Tobacco Products

In March, FDA Commissioner Scott Gottlieb announced three separate advanced notices of proposed rulemaking (ANPRMs) reducing nicotine levels in combustible cigarettes, regulating flavor in tobacco products, and adopting a different regulatory policy concerning premium cigars. These announcements, which ask the public to provide scientific research, data, and other information on the population health impacts of each potential tobacco policy by June, signal that the FDA’s Center for Tobacco Products may, in the future, move to implement new tobacco product regulations under the authority given to it by 2009’s Family Smoking Prevention and Tobacco Control Act.

This trio of rulemaking notices from FDA is the first in a series of steps in the plan that Gottlieb announced in July 2017 to fundamentally change how FDA regulates products containing nicotine. In that announcement, Gottlieb and Mitch Zeller, director of FDA’s Center for Tobacco Products, described their intentions to reduce the use and initiation of combustible cigarettes and reevaluate how FDA regulates e-cigarettes and other nicotine-containing products that may represent a lesser health risk to adult consumers. The language in these recent rulemaking notices sheds additional light on how FDA may eventually alter the landscape on what tobacco products can be produced and sold in the United States. However, while these notices and comment periods are the first steps in a comprehensive and transparent regulatory process, it is worth noting that an ANPRM does not compel FDA to implement any tobacco product regulation by any specific deadline.

ASTHO reviewed the rulemaking notices from a population health perspective, looking specifically for instances where information about states’ efforts can help inform the FDA’s regulatory activities. Keep reading for a summary of these insights below.

Opportunities for States

There is reason for public health stakeholders to be encouraged by, but also critically attentive to, this series of announcements. Since any of the rules resulting from FDA’s notices would impact how tobacco products can be manufactured, marketed, and/or sold across the country, state health departments and other public health stakeholders are encouraged to submit comments on these proposals. Due to their own experiences regulating tobacco products, state health agencies have a wealth of information that can be used to inform the FDA’s regulatory efforts. This input will help ensure that any forthcoming regulatory decisions by FDA are based on strong evidence in the interest of promoting public health.

Summary: FDA’s Three Notices of Proposed Rulemaking Yield Mixed Public Health Impact

Reducing Nicotine Content in Combustible Cigarettes

This ANPRM is seeking comments and data on many topics related to a potential product standard for nicotine in cigarettes. Establishing a maximum nicotine level in cigarettes to make them non-addictive or minimally addictive would almost certainly have significant population health benefits by discouraging cigarette use. A simulation model published by FDA researchers in the New England Journal of Medicine projects that a median of 13 million smokers would stop smoking combustible cigarettes within five years of them becoming non-addictive and, that by 2060, approximately 1.6 percent of American adults would smoke combustible cigarettes if no other policies were changed from the present. This projection represents a significantly reduced death, disease, and economic burden resulting from all tobacco use in the United States. Comment period closes: June 14

Implementing New Flavor Restrictions in Combustible and Electronic Tobacco Products

This ANPRM is calling on stakeholders to share data and information that can inform FDA’s process for examining the role that flavors, including menthol, play in initiation, use, and cessation of tobacco products. Several different tobacco flavoring regulations could have a positive public health impact, as well. Recent research has confirmed that candy and fruit flavors make e-cigarettes more appealing to youth. Menthol cigarettes continue to be smoked disproportionately by young people and African Americans, contributing to health disparities resulting from tobacco use. Forbidding these flavorings, preventing products that contain them from being advertised, and/or making it harder for youth to access these products would likely reduce nicotine addiction, the initiation of tobacco products, and the disparity gap between non-smoking and smoking populations.

This ANPRM recognizes that in non-combustible products, like e-cigarettes, it is possible for the flavors to do both harm and good. For example, e-cigarette flavors may also encourage adults to switch from combustible tobacco products to e-cigarettes in the interest of harm reduction. A National Academy of Sciences, Engineering, and Medicine systematic literature review found that e-cigarettes have a mixed impact on population health. The consequences of making flavored e-cigarette products available to adult consumers and appealing to adult combustible tobacco product users must be considered alongside the health impacts of these products appealing to youth. Any positive impacts tied to encouraging adult cigarette smokers to switch to e-cigarette products could be outweighed by the number of young people that could become addicted to nicotine. Comment period closes: June 19

Changing Regulations on Premium Cigars

In 2016, FDA brought additional tobacco products, including all cigars, under the agency’s oversight to help better protect Americans from the dangers of tobacco use. This ANPRM is seeking comments and information related to the patterns of use and resulting public health impacts from products commonly referred to as “premium cigars.” There is reason for the public health community to be skeptical, however. This ANPRM could potentially result in a rollback of existing cigar regulations. For example, FDA could decide that written health warnings are no longer required on the packaging of premium cigars. Because no definition of premium cigar is provided, the public cannot be assured at this time that the categorization would exclude all flavored and relatively affordable cigar products used by youth and more frequently preferred by racial and ethnic minorities.

It is important to note that, in some states, premium cigars are already incorporated into the tobacco regulatory framework. States like Maine define premium cigars based on weight, while Minnesota’s definition includes a minimum price of two dollars. Also, just this year, the Colorado Senate passed a measure to define premium cigars, which emphasizes the handmade nature of premium products. These definitions have significant implications for the administration, implementation, and enforcement of tobacco control policies that can be shared with the FDA. Comment period closes: June 25