WASHINGTON -- The time clock for a decision on whether cigars should have flavors appears to have begun as the U.S. Food and Drug Administration (FDA) recently released an agenda of items it will act on over the next year, according to a tobacco-retailing association.
The FDA has issued the agency’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions, which includes regulatory actions that the agency plans to consider taking in the next 12 months, according to Lakeville, Minn.-based NATO. 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.
Officials with NATO said the FDA has congressional authority to limit or ban an ingredient or constituent in a tobacco product or tobacco smoke, an authority that encompasses flavors.
Within the federal rules that apply, NATO officials said flavors are described as an “herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee.” Since a proposed regulation banning the use of characterizing flavors in cigars has not yet been drafted or issued by the FDA, however, the exact flavors that a proposed regulation could ban are not yet known, NATO officials said.
But before the FDA can move forward with a standard or any potential ban, NATO officials said the agency must go through a number of steps. These would include the following:
- 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.
- Publishing the final regulation with an effective date.
NATO officials said they will monitor any newly proposed FDA regulation and alert its members to such proposed rules and how to submit comments to the proposed restrictions.