In July, the Cigar Association of America (CAA), Cigar Rights of America (CRA) and International Premium Cigar and Pipe Retailers Association (IPCPR)—the three largest cigar trade groups—filed a lawsuit against the U.S. Food & Drug Administration regarding the deeming regulations.
The lawsuit was centered around nine counts, including:
In March, FDA requested a delay of 60 days in the lawsuit, arguing that its new staff needed more time to prepare for the lawsuit. Ultimately, the two sides agreed to a 30-day delay, but the three cigar trade groups made it clear that if FDA were to ask for another delay, they would request an equal delay in the implementation of regulations.
Less than two months later, the two sides agreed to delay both the lawsuit and the regulations by 90 days.
A much more important delay announcement came less than 90 days late when FDA announced that it would push the substantial equivalence requirements from May 2018 to Aug. 8, 2021.
In short, FDA hadn't developed a policy regarding substantial equivalence and came to the conclusion that it would be unreasonable for cigar companies to comply with the requirements less than one year later.
It's worth noting that FDA hasn't put substantial equivalence on hold, the agency posted a document outlining how it believes a manufacturer could have new product approved under the substantial equivalence pathway, however until FDA determines its testing requirements for cigars, it seems unlikely a product could be approved under this pathway.
More info about substantial equivalence can be found here.
FDA won all claims, except for one regarding whether retailers who blend pipe tobacco must register as manufacturers. Judge Metha agreed with the cigar industry that FDA may not have enough scientific data to conclude that premium cigars warrant the warning labels the agency requires, but he believed that the court could not rule in the cigar industry's favor due to the way the law is written.
Requiring the premium cigar industry to incur substantial compliance costs while the agency comprehensively reassesses the wisdom of regulation, before the warnings requirements go into effect, smacks of basic unfairness. In the court’s view, the prudent course would be for FDA to stay the warnings requirement as to premium cigars... The court’s displeasure with the FDA’s handling of the status of premium cigars, no doubt, provides little consolation to the industry. But the court can do no more. Its hands are tied by both the law and the posture of the case.
In June, the cigar groups filed an appeal of the D.C. court ruling, specifically over the implementation of warning labels. The appeal was expected, particularly because the warning label requirements were set to take effect on Aug. 10, 2018 and despite the loss in the courtroom in May, the cigar industry was far from done exhausting its legal avenues.
On July 5, 2018, Metha agreed and delayed the warning labels indefinitely. More specifically, the warning label requirements cannot go into effect until at least 60 days after an appeal had been decided by the U.S. Court of Appeals for the D.C. Circuit.
The delay was specific to the warning labels, both the ones on boxes and advertisements.
In February, the cigar industry formally filed an appeal of the D.C. lawsuit. The 163-page document argues that a recent ruling by the Supreme Court, National Institute of Family and Life Advocates v. Becerra, changed the measuring stick by which the government must prove its warning labels are necessary for products.
The appeal also highlighted arguments made in the Texas Lawsuit, such as whether FDA's warning labels uniquely devalued luxury items like cigars and how much speech was limited by the new rules.
The joint D.C./Texas lawsuit scored its largest victory in early 2020 when Mehta ruled that the warning labels that were set to be required for cigars were unconstitutional, a follow-up to his 2018 ruling. This ruling meant that not only were warning labels not required for premium cigar boxes but also for advertisements. The latter is key as it also means that premium cigar companies and retailers will not have to submit 12-month warning label plans.
Yes, but nothing permanent.
As a result—directly or indirectly—of the D.C. lawsuit, FDA has delayed a variety of deadlines.
In short, the three cigar trade groups have agreed to evenly split the costs of the regulations: the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipes Retailers Association (IPCPR).
There was a dispute between the CAA and the CRA/IPCPR about some costs related to the lawsuit.
First, six health groups asked to be named co-defenants alongside FDA. Their theory was they could more aggressively defend the regulations. Ultimately, the court rejected their attempt to be named as co-defendants. Various groups have filed amicus briefs, i.e. statements to the court, in the D.C.-based deeming lawsuit.
Second, those same groups along with one other group and five pediatricans filed a lawsuit in Maryland suing FDA for not moving fast enough with regulations. This is a common practice by health groups regarding tobacco regulation.
Last edited: April 29, 2020.