Cigar News: FDA Acknowledges their Huge Workload for Substantial Equivalence Reports and Offers Possible Deferment

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Save the Leaf

On August 5th 2020, just 4 years after the FDA’s deeming regulations on the the cigar industry took effect, the U.S. Food and Drug Administration submitted a court filing which essentially proposed a program that will allow manufacturers to request a deferral on submitting substantial equivalence reports. Essentially it allows premium cigar manufacturers to apply to the FDA for it to consider exercising FDA discretion to defer the submission of substantial equivalence reports.

Sounds like a lot of legal mumbo jumbo to me. In the letter, the FDA acknowledges what many in the cigar industry have been saying, with regards to how problem full the substantial equivalence process in the industry. The FDA though, did not offer any clear path forward for the premium cigar industry and they did not address the serious defects in the regulations when they are applied to the premium cigar business. However, they did note that premium cigars “remain the FDA’s lowest priority for premarket review.”

Now, four years to the day, when the Premium Cigar Industry protested on the US Capital grounds, the issuance of the regulations, the FDA said they will be issuing guidance as to how premium cigar manufacturers and importers may apply for the deferral from the pre-market review process. Four years in the making to come to this conclusion?

In fact, the FDA plans on opening a “new research effort” focused on premium cigars which is planned to evaluate public health associated issues. Didn’t we see this movie before? And they want the industry help to assist in that research!

In a note to the industry PCA Executive Director Scott Pearce stated today;

“This is an important indication by the FDA that they do not have the capacity or resources to regulate premium cigars for premarket review. However, the industry needs further clarity and is hopeful that the Trump Administration will take definitive action in support of the small businesses across the country and go a step further. We cannot operate businesses in regulatory uncertainty and the FDA’s action further complicates the situation especially without their definitive release of guidance on the topic.”

Cigar Rights of America (CRA) Executive Director Glynn Loope added:

“While this letter is a welcomed recognition that premium handmade cigars warrant regulatory relief, it is concerning that the industry will be asked to submit, yet again, analysis to demonstrate what has already been proven – premium handmade cigars are unique and lack the adverse public health impact some seem determined to claim. This letter also recognizes that the agency has higher priorities. It is time for the FDA to provide the premium cigar industry and its family owned businesses permanent relief from this unjustified regulatory scheme, rather than this uncertain potential process.”

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So here we are once again, with new rules, more paperwork, and no resolution. There has been plenty of money spent by manufacturers and brand owners to submit substantial equivalence reports in time for the original September 9th submittal date. Now, more legal expenses seem to be required to submit more paper. All I can say is, keep writing to your representatives and maybe we can win this war.

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