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 were 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 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.
Because FDA is still updating it policies regarding the main approval pathway, as well as developing its testing protocols, the exact cost of this process unknown.
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:
- In 2017, 4.31 cents per cigar
- In 2018, 4.74 cents per cigar
- In 2019, 5.15 cents per cigar
Last Updated: May 23, 2019.
FDA's decision to regulate all cigars centers around three core arguments:
- FDA believes all cigars pose serious negative health risks
- FDA does not believe that premium cigars sufficiently reduce health risks
- FDA believes premium cigars are used by youth and young adults
FDA suggests that 9,000 lives have been ended early because of cigar smoking. While it does not specify whether or not those are premium cigars, the agency argues it does not have to. Rather, because it does not accept any study on the healthy affects solely premium cigars to be valid—largely due to small sample sizes—it chooses to ague that all cigars are a danger to public health.
FDA's explanation for underage individuals smoking premium cigars is perhaps less grounded. It cites a study that indicates that 3.8 percent of youth aged 12 to 17 indicated they smoked premium cigars, but then discusses in detail, smoking rates for two legal age groups 18 to 25 and 18 to 29. (Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act…, 187-188)
It then states "FDA does not believe it necessary for the definition of premium cigars in this study to match exactly the definitions in the NPRM in order to draw inferences about the use of different types of cigar products... (These data) clearly indicate that youth and young adults are using premium cigars." (Ibid.)
FDA makes it clear that it believes its mandate calls for not only special focus towards underage, illegal tobacco use, but also legal use amongst young adults.
As explained throughout the rest of this guide, all cigars will now be subject to a variety of regulatory measures, including: