NATO outlines the FDA’s request for information and how retailers can participate.
The U.S. Food and Drug Administration (FDA) is seeking input from the public and the tobacco industry on proposed rule making related to flavors in tobacco products, according to a report by the National Association of Tobacco Outlets (NATO).
On July 28, 2017, the FDA announced a new comprehensive approach to tobacco regulation.
As reported by NATO, as a part of this new approach, on March 21, 2018, the FDA published an advanced notice of proposed rulemaking (ANPRM) to obtain information from the public and the tobacco industry related to the role that flavors play in tobacco products. In the ANPRM, the FDA stated that the agency is seeking this information to decide what regulatory actions the “FDA might take with respect to tobacco products with flavors.” These “potential regulatory actions include, but are not limited to, tobacco product standards and restrictions on [the] sale and distribution of tobacco products with flavors.”
NATO outlined the FDA’s request as follows:
The FDA is seeking comments, evidence and other information on the following topics related to flavors in tobacco products.
Role of 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 appeal of flavors in tobacco products, patterns of flavored tobacco use by youth (youth are those 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 adult (young adults are those individuals ages 18-24), and adults’ use of flavored tobacco products.
Flavors and Initiation and Patterns of Use of Combustible Tobacco Products: The FDA is also seeking information on whether flavors play a role in the initiation of tobacco use and the patterns of use of combustible tobacco products. The studies, data and information sought by the FDA include: (1) how youth and young adults begin using flavored tobacco products, (2) whether flavored tobacco products result in reduced cigarette use or cause a switch to potentially less harmful flavored tobacco products, (3) will the use of non-combustible flavored tobacco products cause consumers to stop using combustible tobacco products, (4) will consumers begin to use both flavored tobacco products and other combustible tobacco products (i.e., “dual use”), and (5) will the use of flavored tobacco products delay consumers from quitting the use of tobacco products.
Tobacco Product Standard: Another topic in the ANPRM asks questions about the kind of product standard that the FDA should consider establishing. One question is whether there are any specific flavors, which the FDA should reduce or eliminate in tobacco products and why. A second question is what level of a product standard should the agency adopt? That is, should the FDA set a maximum amount of a flavor in a tobacco product, establish a minimum amount of a flavor, or prohibit a flavor outright. Third, the FDA asks if the agency were to prohibit or restrict certain flavors, to which types of tobacco products should the standard apply (combustible, non-combustible, or both) and why?
Fourth, while the FDA has received a significant amount of information relating to the use of menthol in cigarettes, the agency is asking for additional data or new information about the role of menthol in initiating smoking and would smokers switch to another tobacco product or start dual use of another product if a tobacco product standard prohibiting or limiting menthol in cigarettes was adopted. Also, the FDA is requesting information on what role, if any, menthol plays in the use of tobacco other than cigarettes, including in cigars and electronic cigarette/vapor products.
Sale or Distribution Restrictions: The final topic in the ANPRM is whether the FDA may consider restrictions on the sale or distribution of flavored tobacco products. Possible restrictions could include restrictions on the advertising and promotion of tobacco products with flavors.
Other potential restrictions that the agency could consider include regulations on access to flavored tobacco products and restrictions on the labeling or packaging of flavored tobacco products. These latter restrictions could include requirements for warnings or disclosure statements on product packaging.
Should Comments Be Submitted to the FDA? NATO 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 just like it is doing now on whether a product standard(s) should be proposed regarding flavors in tobacco products. Moreover, FDA staff members have indicated to NATO and publicly stated that they read every comment that is submitted. It is very important that members of the tobacco industry, including retailers, their customers, wholesalers and manufacturers all submit comments to the FDA. NATO will be submitting formal comments to the FDA on this ANPRM.
When and How to Submit Comments to the FDA: Comments on this ANPRM can be submitted either electronically or in writing to the FDA and are due by June 19, 2018. During the first part of April, NATO will be sending out a follow up NATO News Bulletin with specific instructions on how NATO members can submit comments to the FDA.