Dr. Scott Gottlieb, commissioner of the U.S. Food & Drug Administration (FDA), announced “major policy goals” for the agency in 2018 and reevaluating the regulation of premium cigars is one of them.
Gottlieb wrote the agency will issue an Advance Notice of Proposed Rulemaking (ANPRM) in 2018 regarding the regulation of premium cigars.
An ANPRM is a document published in the Federal Register that an agency publishes soliciting comments from the public and industry about proposed changes to regulations. It can precede a Notice of Proposed Rulemaking (NPRM), a process where the government details planned changes and gives the public a short period of time to respond before the rules are finalized.
Just because FDA will issue an ANPRM doesn’t mean it will change rules, or even get to the point of issuing an NPRM. However, given the current regulations, if FDA were to begin evaluating regulations for premium cigars specifically, it seems likely the changes, if any, would be favorable to the premium cigar industry.
“FDA will be issuing an Advance Notice of Proposed Rulemaking to solicit information that may inform regulatory actions FDA might take with respect to premium cigars,” wrote Gottlieb. “Asking certain questions related to how we might define and regulate ‘premium cigars,’ taking into consideration the health effects of these products and their patterns of use.”
Flavored tobacco products will also be subject to an ANPRM as part of the agency’s efforts to address “the nicotine addiction crisis.”
It’s likely to result in stricter rules if any changes are brought about. Last year, the agency tried to introduce harsher restrictions on flavored tobacco products, including not allowing products with “characterizing flavors” to be grandfathered, as part of its deeming regulations. Those efforts were struck down by the the White House Office of Management and Budget (OMB) before FDA’s draft was formally unveiled.
Gottlieb’s letter noted the agency is concerned about the appeal of flavored tobacco products towards youth, but also that the products can be helpful in reducing individual’s nicotine consumption.