For those wondering the status of the cigar industry’s lawsuit against FDA, not much has happened since the U.S. Food & Drug Administration (FDA) agreed to indefinitely delay the warning label requirements until after the resolution of the lawsuit.
The two sides—three cigar trade groups and FDA—have largely spent the last two months—at least according to paperwork—filing extensions to a joint status report, a document that lets the court know where the two sides stand on what the next steps are for the legal case.
That joint status report was filed yesterday and there’s one interesting note: attorneys for the cigar trade groups—Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR)—have asked FDA to delay its Nov. 8, 2019 deadline for the submission of data regarding harmful and potentially harmful constituents (HPHC) in cigars and pipe tobacco. In short, per current FDA deadlines, the agency expects every cigar manufacturer submit reports regarding the HPHCs found in every product a manufacturer sells.
The plaintiffs note that as part of the deeming regulations, FDA stated it would establish guidelines for how this testing should be done. So far it has not.
Furthermore, FDA has not even scheduled a date for when those guidelines would be published. And the plaintiffs argue that even if they were published yesterday, Dec. 13, it would not be enough time for cigar companies to collect the data FDA requires.
FDA hasn’t entirely ignored the subject. In late 2015, it 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.
HPHC testing is just one part of the larger compliance equation for cigars, though it’s likely the part where the industry knows the least about.
While HPHC testing in machine-made tobacco products like cigarettes is a common practice, cigarmakers have argued that their products would not be suitable for the same level of scrutiny. Whereas cigarettes are made with highly automated machines and are not made entirely of tobacco, cigars are made by hand and use only tobacco.
Cigarmakers have argued that because of this and other variances within the tobacco itself, even cigars that are made to be as identical as possible will like score with much greater variances than cigarettes.
In addition to providing guidelines about how to test for HPHCs, cigar makers are still waiting for FDA to provide a list of the HPHCs to actually test for. 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.
HPHC testing is also expected to be one of, if not the costliest one-time expense as part of the larger compliance process, though because FDA has not provided guidelines about said testing, the exact specifics remain unclear.
In the joint status report, plaintiffs for the attorneys indicate that unless an extension is granted, they will bring the issue before the court.
Elsewhere, the plaintiffs indicated they will provide a further update on their plans for the other part of the lawsuit on Jan. 14. For its part, FDA effectively no commented, stating that it will wait until it hears from the plaintiffs.