As promised, the U.S. Food and Drug Administration (FDA) is taking a closer look on how to regulate flavored tobacco. Today the agency announced an Advanced Notice of Proposed Rule Making (ANPRM) to solicit input into how this should be done. While aimed at cigarettes and e-cigarettes, premium cigars are very much a part of the equation.
The ANPRM process opens up a period of public comment for stakeholders to provide data, research, and information that the FDA can incorporate into the rules it is developing around flavored tobacco.
Last year, U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb announced the plan to develop a comprehensive plan to reduce nicotine levels down to non-addictive levels. As a part of that program, Dr. Gottlieb announced that the question of if and how premium cigars should be regulated would be re-opened. Last week, the FDA announced there would be three Advanced Notice of Proposed Rule Making initiatives. The first of the three was announced last week and was concerned with regulations around setting a maximum nicotine level in tobacco products. The second is today’s announcement around how flavored tobacco products should be regulated. The third will be specific to premium cigars and will re-solicit input on how premium cigars as a whole should be regulated.
Last week’s ANPRM around nicotine levels asked the question whether or not premium cigars should be regulated differently than other tobacco products or even regulated at all. This time there was no such distinction made for premium cigars. Specific items being addressed in the ANPRM include:
- The role that flavors play in initiation and patterns of tobacco use, particularly among youth and young adults;
- The role that flavors may play in helping some adult cigarette smokers reduce cigarette use and/or switch to potentially less harmful tobacco products;
- The role that flavors in non-combusted tobacco products may play in quitting combusted tobacco products, quitting all tobacco use or starting to use more than one type of tobacco product;
- Consumer perceptions of health risks and addictiveness of flavored tobacco products;
- Whether certain flavors used in tobacco products present potential adverse health effects to users or others; and
- The impact of local, state and international efforts to restrict the sale or marketing of flavored tobacco products.
Much of the rationale here is that the FDA is claiming that flavoring in tobacco products is a leading reason for younger people using them. The agency is saying the flavoring could mask the tobacco taste and ultimately lead to addiction to tobacco use. The ANPRM did include specific references to cigars. In the ANPRM, the FDA claims 65.4% of cigar users said their first time using a cigar was with a flavored product. However, the use of cigars is a loaded term as it later states “2017 Monitoring the Future data show that among 8th, 10th, and 12th grade students, 60 percent of current little cigar users reported using flavored little cigars (Ref. 40). In addition, data from the PATH Study show that among current filtered cigar users, 79.3 percent of young adults aged 18-24 years and 56.2 percent of adults aged 25 years and older report current flavored use.” In the cigar industry’s battle with the FDA, one of the arguing points by the industry is that premium hand-made cigars compared to “little cigars” and “filtered cigars” do not fall under that definition and that premium hand-made cigars are not marketed to children.
The words “exemption for premium cigars” were not something mentioned in the ANPRM in regards to flavored tobacco. It is anticipated the third ANPRM will re-open the question of exempting premium handmade cigars. How this will fit in with flavored tobacco is an unknown.
The public comment period opens up on March 21, 2018 – the date when this proposal hits the Federal Register. Following publication, the period for providing public comment is 90 days long, ending June 19, 2018.