FDA Seeks Comments on Potential Tobacco Regulations

    The industry needs to comment on proposed rules that would impact nicotine levels, flavored products and more.


    The FDA is requesting studies, data or information regarding the role of flavors (other than tobacco flavor) in tobacco products. This role includes the use of flavored products in the initiation of tobacco use, the appeal of flavors in tobacco products, patterns of flavored tobacco use by youth (individuals under the age of 18), flavors and perception of harm and likelihood of tobacco product use, flavors and progression to regular use of tobacco products, flavor preferences of youth and young adults (individuals ages 18-24), and adult use of flavored tobacco products.

    The ANPRM asks whether there are any specific flavors the FDA should reduce or eliminate in tobacco products and why. The ANPRM also seeks to determine whether the FDA should set a maximum amount of a flavor in a tobacco product, establish a minimum amount or prohibit a flavor outright. If certain flavors were restricted or prohibited, to which types of tobacco products should the standard apply (combustible, noncombustible or both) and why? Regarding menthol, the agency is asking for additional data or new information about the role of menthol in those just starting to smoke and whether smokers would switch to another tobacco product or start dual use if a tobacco product standard limiting or prohibiting menthol in cigarettes was adopted.

    The final topic in the flavors ANPRM is whether the FDA may consider restrictions on the sale or distribution of flavored tobacco products. A possible regulation could restrict the advertising and promotion of tobacco products with flavors. However, the First Amendment to the U.S. Constitution protects free speech, and the U.S. Supreme Court has ruled that free speech extends to commercial speech, which includes advertising, and that tobacco advertising, in particular, is a protected form of free speech. This means the FDA is prohibited from adopting a rule or regulation that restricts the freedom of advertising flavored tobacco products.

    Premium Cigars: On March 26, 2018, the FDA published an ANPRM regarding premium cigars that focuses on a definition of what constitutes a premium cigar, use patterns of premium cigar smokers and public health considerations associated with premium cigars. Specifically, in terms of a definition, the FDA is inquiring about cigar size, tobacco fillers, the wrapper and binder composition, presence or absence of a filter, rate of production (machine-made or handmade), flavors, nicotine content, packaging size and retail price.

    Regarding patterns of use, the FDA is asking for information about the role of premium cigars on tobacco use initiation compared to other kinds of cigars; the dual use of premium cigars and other tobacco products; the frequency and intensity of use (number of cigars smoked per day and the depth of smoke inhalation); the impact of premium cigar labeling, advertising and marketing on patterns of use; and whether smokers would switch to premium cigars if the FDA exempted premium cigars from regulation or regulated premium cigars differently than other kinds of cigars.

    Should Comments be Submitted? Industry members may want to know whether submitting comments to the FDA makes a difference in the regulatory process. The most simple and direct answer is yes. The FDA is required to seek public comments on an ANPRM and proposed regulations. It is very important that retailers, their customers, wholesalers and manufacturers all submit comments to the FDA.

    Comments can be submitted to the FDA at www.regulations.gov until June 14 for lowering nicotine under Docket No. FDA-2017-N-6189; until June 19 for flavors in tobacco products under Docket No. FDA-2017-N-6565; and until June 25 for premium cigars under Docket No. FDA-2017-N-6107.

    – Contributed by Thomas A. Briant, executive director of the National Association of Tobacco Outlets (NATO)

    This story first appeared in the May/June 2018 issue of Tobacco Business magazine. Members of the tobacco industry are eligible for a complimentary subscription to our magazine. Click here for details.