On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new comprehensive approach to the regulation of tobacco products and recently published three advance notices of proposed rulemaking (ANPRMs) to obtain information from the public and the tobacco industry on setting a maximum level of nicotine in cigarettes, the role that flavors play in tobacco products and potential regulations on premium cigars.
Specifically, the FDA is considering drafting a product standard rule lowering the allowable amount of nicotine so that cigarettes are minimally addictive or nonaddictive. In addition, the agency is seeking information to decide whether to limit or ban flavors in tobacco products and whether or how to regulate premium cigars.
What is an ANPRM? A federal agency is required to follow a nine-step process in considering, drafting and adopting a new federal regulation. The first step in initiating a proposed rulemaking involves an agency considering priorities and legislative requirements. The second step is a determination by an agency as to whether a new regulation is needed. In the third step, a proposed rule is drafted, but as a part of this third step, an agency can first ask the public and an impacted industry for information about a possible regulation before one is drafted (this is known as an ANPRM).
What is a Product Standard? In the Family Smoking Prevention and Tobacco Control Act, which is the federal law that authorized the FDA to regulate tobacco products, Congress gave the FDA the power to enact product standards. Under a product standard, the FDA can limit or ban an ingredient in a tobacco product or a constituent in tobacco smoke.
Lowering Nicotine: In its ANPRM on potentially lowering the level of nicotine in cigarettes, the FDA asks for a broad range of studies, data and information regarding whether smokers would use other combustible tobacco products in place of cigarettes to maintain their dose of nicotine or engage in dual use of cigarettes and other tobacco products. For this reason, the FDA is asking for comments on whether a product standard setting an allowable level of nicotine should apply to roll-your-own tobacco, some or all cigars, pipe tobacco and water pipe tobacco. Note that the FDA is not asking whether a nicotine level should be set for electronic cigarettes or vapor products.
The FDA is requesting information on whether large and/or premium cigars should be excluded from a possible nicotine level product standard due to different patterns of use and whether large and/or premium cigars could be used in place of or as a dual use product. In addition, the FDA wants to better understand whether current smokers would switch to premium cigars if cigarette nicotine levels were lowered.
The FDA has reviewed studies of very low nicotine content cigarettes that estimate that lowering nicotine levels to 0.5 mg or lower per rod (the tobacco in a cigarette) would minimize addictiveness. In particular, the FDA is asking for comments on setting maximum nicotine levels in a cigarette at 0.3 mg, 0.4 mg and 0.5 mg of nicotine. According to the ANPRM, conventional cigarettes made in the United States contain approximately 10 mg to 14 mg of nicotine per cigarette. Also, a product standard by the FDA could propose either a single maximum nicotine level in cigarettes where the nicotine is reduced all at once or a stepped-down approach where the nicotine is reduced gradually over time through a sequence of lower levels at various implementation dates.
The agency is considering a proper time frame for implementing a possible nicotine level product standard to allow adequate time for the industry to comply. Manufacturers are being asked to submit comments on whether a two-year, four-year or six-year time frame would be appropriate.
Flavors in Tobacco Products: On March 21, 2018, the FDA issued an ANPRM to obtain information related to the role that flavors play in tobacco products to decide what potential regulatory actions to take regarding product standards and restrictions on the sale and distribution of flavored tobacco products. This means the FDA has the authority to draft and enact a new regulation that includes a product standard limiting or prohibiting flavors in tobacco products.
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.