The U.S. Food and Drug Administration has issued the agency’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions. This Agenda includes regulatory actions that the FDA plans to consider taking in the next twelve months. In the Agenda, the FDA has published Regulatory Identification Number (RIN) 0910-AI28 that would propose a new tobacco product standard for characterizing flavors in cigars. A tobacco product standard is a power granted to the FDA by Congress through the Family Smoking Prevention and Tobacco Control Act (TCA) that allows the agency to limit or ban an ingredient or constituent in a tobacco product or tobacco smoke.

In the original deeming regulations that extended the FDA’s authority to cigars, pipe tobacco, electronic cigarettes/vapor products, and hookah tobacco and which went into effect on August 8, 2016, the FDA stated that “[t]o address concerns with the growing flavored cigar market and its impact on youth and young adult initiation with tobacco products, FDA is announcing here that it intends to issue in the future a proposed product standard that would prohibit characterizing flavors in all cigars, including cigarillos and little cigars.” The new Fall 2018 Unified Agenda that includes RIN 0910-AI28 is an announcement from the FDA that it plans to consider a proposed regulation that bans the use of characterizing flavors in all cigars. To read the actual RIN 0910-AI28, click on the link below:

Link: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AI28

In the TCA, characterizing flavors are described as an “herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee.” However, since a proposed regulation banning the use of characterizing flavors in cigars has not yet been drafted or issued by the FDA, the exact flavors that a proposed regulation would ban are not yet known.

There are a number of steps that the FDA would need to take in order to finalize a regulation that would ban the use of characterizing flavors in all cigars. These steps include drafting a proposed regulation, having the proposed regulation reviewed by the White House Office of Management and Budget (OMB), requesting the public to submit comments on the proposed regulation, reviewing the public comments, drafting a final regulation, seeking final OMB review and approval, and publishing the final regulation with an effective date. NATO will monitor any newly proposed FDA regulations and alert its members to such proposed rules and how to submit comments to the proposed restrictions.