As expected, the U.S. Food & Drug Administration (FDA) has announced that it has delayed the requirements for cigar manufacturers to submit data regarding the amount of harmful and potentially harmful constituents (HPHCs) from November 2019 to six months after the agency publishes its final guidance regarding HPHC testing.
Of note, small scale manufacturers, an FDA defined term for companies that generate less than $5 million in revenue and have less than 150 employees, will be given nine months from the date of the publication of the final guidelines.
No one knows when the agency plans on publishing that guidance, so this delay is in some ways an indefinite delay.
Over the last few months, attorneys for three cigar trade groups have indicated that they would ask the court for an order delaying the HPHC testing requirements if it couldn’t come to an agreement with FDA. Two weeks ago, sources told halfwheel that FDA had privately given indications it would delay the requirements on its own.
A delay in HPHC testing was an almost certainty given it’s unlikely that cigar manufacturers could comply with the Nov. 8, 2019 deadline. HPHC testing is widely believed to be the most damaging and costly part of the 2016 deeming regulations. One lab recently told halfwheel it estimates that if cigars are required to use the same HPHC panel as cigarettes, which is not known, it would cost upwards of $18,000 per SKU.
But none of that is known right now as FDA has said almost nothing on HPHC testing since 2016, other than that it will announce its guidelines at a later date.
While testing cigars the same as cigarettes is probably the best-educated guess, FDA’s history with HPHC testing would suggest it’s probably more likely that the panel is slightly different. For example, cigarette companies have stated 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. Furthermore, HPHC testing for smokeless tobacco focuses on only seven HPHCs, while roll-your-own tobacco is subject to only six, though the smaller lists include HPHCs that aren’t part of the 20 required for cigarettes.
FDA will also likely have to develop different HPHC panels for the various deemed products: cigars, pipe tobacco, hookah and shisha and e-cigarettes and vaping products.
Beyond the cost, there’s a very real likelihood that the labs won’t be able to test all the cigars under this timeline.
For examples, that same lab said that it would only be able to test 25 cigars per week. That means if there were four labs all working seven days per week, FDA’s six-month extension would mean that only 3,600 SKUs would be able to be tested from the time the final guidelines are published until the deadline.
Even the 90-day deadline for small scale manufacturers would limit the number of HPHC tested cigars to 5,400, with four labs testing seven days per week.
It’s unclear how many labs will acquire the appropriate machines to test cigars; there’s a lively debate within the cigar industry about whether the machines actually exist to do the test.
And then there’s the question of how reliable the test actually is, as explained by Drew Newman, general counsel of J.C. Newman Cigar Co., in a statement to halfwheel:
Although we will await FDA’s guidance, I remain very skeptical about whether it is possible to reliably test premium cigars because making premium cigars is an inherently unscientific process. Because premium cigars are handcrafted, they are subject to great natural variation. We know that the amount of sunlight, rain, and wind affects the characteristics of premium cigar tobacco just as the size of tobacco leaves and where they are grown on a plant. As cigar makers, we harness this natural variation to create unique and interesting blends. A recent study that tested showed this. In it, researchers tested the same premium cigar brand in two different years and found that variances upwards of 50%.
We are very grateful to Cigar Rights of America, the International Premium Cigar and Pipe Retailers Association, and the Cigar Association of America for their continued leadership and efforts to seek much needed relief for the premium cigar industry.
When FDA announced plans for the deeming regulations the agency estimated between 10-50 percent of the cigars on the market could be eliminated due to regulation.