In court filings last night, the FDA announced a potential new program relating to the requirement that premium cigar manufacturers submit substantial equivalence reports for a decade’s worth of products. Therein, the FDA explained a potential program for premium cigar manufacturers to apply to the FDA for it to consider exercising its discretion to defer the submission of substantial equivalence reports.
The letter clearly reflects subjecting premium cigars to the substantial equivalence process is a significant problem. The letter, however, falls short in addressing the serious defects in the regulatory scheme as applied to premium cigars and in providing a secure, permanent, and predictable path forward.
Specifically, the agency is right to recognize that America’s youth are not attracted to premium cigars. And the agency is right to note that the FDA’s “top priority” are deemed products such as e-cigarettes and associated products, and that premium cigars “remain the FDA’s lowest priority for premarket review.”
The agency will be issuing guidance as to how premium cigar manufacturers and importers may apply for the deferral from the premarket review process, although it is unclear whether that path will meaningfully be available to manufacturers before key regulatory deadlines. The agency provided a modified definition of premium cigar that closely mirrors that put forth in pending legislation that has been requested by the Premium Cigar Association and Cigar Rights of America.
The agency intends to reopen a “new research effort” specifically on premium cigars, that will again evaluate public health associated issues. This will be the second time the industry has been asked to engage in a public comment or related fact-finding approach by the FDA. The industry contends that the burden of proving regulatory necessity should lie with the agency and has been punted to the industry yet again.
PCA Executive Director Scott Pearce notes, “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.”
CRA Executive Glynn Loope comments , “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.”