FDA plans to require cigars—except those grandfathered—to undergo testing to determine the level of harmful and potentially harmful constituents (HPHCs) within the cigar.
The process will involve a machine on one end of the cigar simulating a human smoking a cigar and then probes and other testing equipment to monitor the specific levels of select HPHCs within the smoke itself.
This data was expected to be turned over to FDA in November 2019 but in March 2019 the agency indefinitely delayed this deadline until six months after FDA announces its testing protocol.
There are many different HPHCs, but only a small fraction will be tested—how many and which ones are still unknown.
For example, there are over 6,000 chemicals within cigarette smoke, though FDA opted to only focus on 20 HPHCs—instead of the full list of 93—for cigarettes. FDA requires smokeless tobacco t be tested for seven HPHCs, roll-your-own tobacco gets tested for six, although not all of those six are included on the 20 HPHC list for cigarettes.
No one knows how many will be required for cigars and which ones and that will play a big role in the time it takes to test and the costs. Furthermore, it's not just cigars that will be subjected to new HPHC testing, pipe tobacco, hookah and shisha tobacco and e-cigarettes/vaping products will only be subject to the testing for the first time.
In late 2015, FDA announced it was looking to procure “cigar smoking machine(s),” though it’s unclear what the status of those machines are or if FDA ever actually procured machines.
Some cigar trade groups and companies have argued that the machines to test cigars do not exist, while at least one lab has said that they have done HPHC testing for premium cigars.
A common claim from the cigar industry against testing is that the variance in cigars is so great that the data derived from testing will be unusable. Some companies who claim to have tested for at least some HPHCs in cigars say that the data shows over a 50 percent variance between one cigar to another from the same box.
There is an established testing protocol through CORESTA that would account for many of the variables like humidity, temperature and weight, but even that seems unlikely to ever produce results that would be as understandable as data from cigarettes.
Unlike cigarettes, which contain far more chemicals than tobacco, cigars are made entirely of tobacco. Furthermore, the products are rolled by hand and the tobacco is, scientifically speaking, not even fermented. In short, even if a cigar maker tried to make two cigars nearly identical it would not be able to come close to the production of a cigarette.
One lab told halfwheel that testing a cigar for the same HPHC panel used for cigarettes will cost roughly $18,000 per cigar. That number changes depending on how long it takes for the cigar to be smoked and it would also increase if the cigar was a unique shape that required special molds to be made.
Given FDA's previous financial estimates about how much product approval would cost, it's unclear whether the agency expected testing to be this expensive.
There's also the question of time. That same lab said that it would only be able to test 25 cigars per week per machine and that it was unlikely that they would purchase a second machine. Furthermore, they expected only a few labs to purchase machines for testing.
FDA's timeline for HPHC testing is that it would be due six months after the guidelines were announced. If four machines worked seven days per week, it would only result in 3,600 SKUs being tested, far less than the number that would likely apply for testing.
Last Updated: May 23, 2019.