FDA Opens Public Comment on Nicotine, Flavors and Cigars

Agency publishes three new notices of proposed rulemaking

LAKEVILLE, Minn. -- On July 28, 2017, the U.S. Food and Drug Administration (FDA) announced a new comprehensive approach to tobacco regulation. As part of this new approach and in a span of three weeks’ time in March 2018, the FDA published three separate advanced notices of proposed rulemaking (ANPRM). These separate notices each solicit a litany of information from the public and stakeholders regarding proposed regulations on three pending issues:

  1. Whether a product standard or standards should be proposed regarding flavors in tobacco products.
  2. How to regulate premium cigars.
  3. Whether to set maximum nicotine levels in cigarettes.

What is an ANPRM and a product standard?

A federal agency is required to follow a nine-step process in considering, drafting and adopting a new federal regulation. Issuing an ANPRM is part of the third step in this nine-step process. The first step in initiating a proposed rulemaking action involves an agency considering priorities and legislative requirements. The second step is a determination by an agency whether a new regulation is needed. In the third step, a proposed rule is drafted, but as a part of this step, an agency can first ask the public and an affected industry for information about a possible regulation before a regulation is actually drafted. (This is known as an ANPRM.)

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. This means that the FDA has the authority to draft and enact a new rule or regulation that includes a product standard limiting or prohibiting flavors in tobacco products or setting a maximum level of nicotine in cigarettes.

Nicotine Levels in Cigarettes
The FDA is seeking comments, evidence and other information on five topics related to setting a maximum level of nicotine in cigarettes, including the scope of the regulation; information on the merits of setting maximum nicotine levels in cigarettes at 0.3, 0.4 and 0.5 milligrams of nicotine; implementation; technical achievability; and possible countervailing effects.

Flavored Tobacco Products
The FDA is seeking comments, evidence and other information on four topics related to flavors in tobacco products, including the role of flavors in tobacco products, flavors and initiation and patterns of use of combustible-tobacco products, the kind of tobacco-product standard that the FDA should consider establishing, and any sales or distribution restrictions.

Regulation of Premium Cigars
The FDA is seeking comments, evidence and other information on three primary topics related to the regulation of premium cigars, including the definition of premium cigars, the use patterns of premium cigars, and public-health considerations regarding the required warning statements associated with the marketing of premium cigars, which will be required to appear on cigar packaging and advertising in the near future. In addition, the FDA is soliciting any comments on the definition of “premium cigar,” “youth” and “young adult” used for studies, information or views provided in response to this ANPRM. 

Should comments be submitted to the FDA?
Interested parties 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 just like it is doing now on whether a product standard or standards should be proposed regarding flavors in tobacco products, how to regulate premium cigars and information on setting maximum nicotine levels in cigarettes. Moreover, FDA staff members have indicated publicly that they read every comment that is submitted. For this reason, it is very important for anyone who feels they have a stake in this conversation to submit comments to the FDA. To electronically submit comments on these ANPRMs to the FDA, visit and type the word “cigar” into the search box. This will automatically take you an option to select each ANPRM listed above. You then click the “Comment now” button next to the desired ANPRM to write and submit your comments.

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