Last week, the International Premium Cigar & Pipe Retailers Association (IPCPR) noted that the U.S. Food & Drug Administration (FDA) had updated a March 2015 document titled Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions to include a new footnote regarding an “Interim Enforcement Policy” regarding new tobacco products.
Fortunately for cigar manufacturers, those “new tobacco products” are only products that are currently regulated by FDA, which means there is no immediate legal change regarding bringing new cigars to the market.
“FDA does not have jurisdiction over non-regulated products until the deeming rule is finalized and enacted,” said Kip Talley, senior director of legislative affairs for IPCPR, in a statement to halfwheel. “The FDA continues to review comments related to the regulation of premium cigars and pipe tobacco. We expect this process could be finalized over the summer.”
The FDA is currently debating between two regulatory paths for premium cigars.
Under Option 1, the FDA would treat premium cigars like most other tobacco products meaning that all products introduced after the new rules go into effect would require pre-approval by FDA before any new cigar were to come to market. But any product being marketed prior to Feb. 15, 2007 would be largely exempt from rules. Products introduced in between Feb. 15, 2007 and the day the rules went into effect would have two years to apply for approval, but would be able to stay on the market until FDA rejected a particular application.
Under Option Two, FDA itself would exempt “premium cigars” based off of a multi-part definition Among the requirements for exemption: a $10 retail price, no added flavorings and only “primarily” longfiller cigars. Public comments on the matter were accepted until last summer.
(For more information about the FDA’s proposed regulations for premium cigars, visit our microsite, halfwheel.com/fda)