On Aug. 8, 2016, the U.S. Food & Drug Administration's deeming regulations went into effect. While it marked the first day that FDA was formally regulating cigars, most of the specific rules in regulations did not actually go into effect on Aug. 8 as the deadlines are spread out over many years.
The deeming regulations affect nearly every facet of how cigars are made and sold in America, but their impacts can largely be divided into three main areas.
As part of the deeming regulations, FDA will require warning labels to be placed on every box (or bundle) and advertisement for cigars sold in the U.S. Because of the ambiguous nature of how FDA defines—or doesn't define—advertising, this could mean large warning labels on the website of every online cigar retailer and catalog, social media posts for events and other areas that may not traditionally be thought of as advertising.
At this moment, these regulations are not in effect.
By far, the costliest part of the regulations in both time and money are new rules regarding how companies may introduce new products.
FDA will require that companies submit applications for approval before selling any new cigars after Aug. 8, 2016. Furthermore, all existing cigars will need to find approval via one of three main pathways.
At this time, this rule is not in effect.
FDA's regulation of tobacco products is funded by the tobacco products themselves.
The Center for Tobacco Products' budget is paid for by user fees, which are now paid by all cigar companies selling cigars in the U.S. These user fees are added to the wholesale cost of cigars.
User fees vary due to both the volume of cigars sold and the cost of those cigars, but halfwheel has estimated the maximum user fees to be:
Last Updated: May 23, 2019.