FDA Extends Two Deadlines For Cigar Companies Affected By Hurricanes
- October 18, 2017 |
- By Andrew Nagy
Cigar manufacturers and importers located in areas impacted by Hurricanes Harvey and Irma or the recent wildfires have been granted a six-month extension to comply with two provisions outlined in the Final Deeming Rule, the U.S. Food & Drug Administration announced today.
“The FDA is aware that tobacco manufacturers and importers in the affected areas are dealing with extraordinary circumstances and may need additional time to meet certain requirements,” the FDA said in a press release. “As a result, the FDA is extending the compliance deadlines for the ingredient listing and health document submission requirements by an additional six months for manufacturers and importers of deemed products in the areas affected by these recent natural disasters.”
The list of areas that the FDA recognizes as affected by the natural disasters includes Caribbean Island nations as well as many counties in Florida, California and Texas that have been designated by the Federal Emergency Management Agency as disaster areas.
In particular to premium cigars, the extension includes the Dominican Republic, a major cigar-producing country, as well as the Florida counties of Broward, Miami Dade and Pinellas, where the majority of U.S. cigar importers are headquartered.
According to the announcement, the new deadline for larger cigar manufacturers to file their Ingredient Listings is May 8, 2018, while small-scale manufacturers have until November 8, 2018 to submit. (The FDA defines a small-scale manufacturer to be a company that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5 million or less.)
As part of the FDA’s controversial Final Deeming Rule, cigarmakers are required to file an ingredient list for each different cigar brand introduced after February 15, 2007, including brand extensions, so long as the cigar was made using no chemical additives or substances other than water. (Flavored cigars must submit a much more detailed ingredient list.)
The FDA requires at least the following information be included in a premium cigar ingredient submission:
• The type of tobacco (burley, bright, oriental, etc.)
• The variety
• The curing method (e.g. flue, fire, sun, steam, air) and, if applicable, the heat source (e.g. propane, wood)
• A description of any recombinant DNA technology used to engineer the tobacco
Additionally, cigarmakers are required to specify the "expected function" of each ingredient, such as whether the tobacco leaf will be wrapper, binder or filler, as well as quantify how much of an ingredient was used in the cigar.
The announcement also extended the deadline for Health Documents, which, according to the FDA, relate to the “health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.”
While the deadline for larger cigar manufacturers to submit their Health Documents was February 8, 2017, small-scale manufacturers now have until May 8, 2018 to turn in theirs.
Additionally, the FDA said in its announcement that it is still determining what actions to take regarding retailers who may have been impacted by the natural disasters. The agency hinted that it may temporarily suspend enforcement activities for tobacconists located in the natural disaster areas.