The Food and Drug Administration released its “deeming” rule in 2016. The 499 pages of regulation touch nearly every aspect of the cigar industry. The Cigar Association of America, the International Premium Cigar and Pipe Retailers Association and the Cigar Rights of America, have all joined to file suit against the United States Federal Drug and Food Administration relating to the Deeming Rule.
The FDA’s new rule deems all tobacco products, including premium cigars, subject to the agency’s regulatory authority. The rule is long and complex. In many ways, it raises more questions than answers. Unfortunately, the FDA chose to apply a one-size fits all regulatory framework regulating all tobacco products, including cigars of any size, in the same manner.
The rule took effect on August 8, 2016. Most provisions of the rule will become effective at various points over the next eighteen months. Below are several key dates and deadlines. Continue to check back for more updates.
Key Dates & Deadlines
FDA has extened all the deadlines set for May 10, 2017 or later by 90 days, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.
FDA cites ongoing litigation and the need for new leadership to review issues raised by the final rule for the deferral. The full release can be seen here.