The U.S. Food & Drug Administration (FDA) announced that it will be unveiling a new comprehensive tobacco policy, which amongst other things will delay the deadline for substantial equivalence from May 2018 until to Aug. 8, 2021.
It’s a three-year delay only to the approval deadline for substantial equivalence, a process by which manufacturers would submit for product approval based on reports that the cigar in question is substantially equivalent in its threat to public health, i.e. it is no more harmful than an already approved product.
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FDA has previously stated that it estimates as many as 30 percent of cigars to apply for some form of substantial equivalence, with approximately 60 percent applying for grandfather status, a process expected to be far easier and cheaper and one that four cigar manufacturers have already received approval for.
Today’s announcement does not affect any of the other FDA-related deadlines such as warning plans and ad requirements, the first of which would go into effect on Aug. 10, 2017, though sources have told halfwheel they expect FDA to delay those deadlines by another three months as the agency and the Department of Justice request another three-month delay in lawsuit brought against FDA by three cigar trade groups: the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR).
In a press release, Dr. Scott Gottlieb, commissioner of FDA, indicated the agency would open a comment period for public and scientific comments regarding how consumers use cigars, the potential health effects of smoking cigars and how cigars should be tested for harmful and potentially harmful constituents (HPHCs).
While FDA has announced it will issue much more detailed substantial equivalence, it remains unclear when that guidance will come as the agency announced no specific dates other than the 2021 date and an Aug. 8, 2022 date for e-cigarettes and vapor products to submit for premarket tobacco product application (PMTA).
Earlier this month, Tobacos Mundial, a Houston-based warehouse that is also handling FDA compliance for a variety of its clients, received a letter from FDA as part of a substantial equivalence process for a product from Jas Sum Kral, one of its clients.
According to Andrew Wood of Tobacos Mundial, the 10-page response listed a variety of data FDA wanted as part of the substantial equivalence filing including the levels of nicotine, carbon monoxide, tar, pH and nitrocomine within the smoke put off by a cigar.
The agency also wanted to know the ingredients used, including those in the bands, boxes and cellophane as well as the weight and weight to surface area ratio for each tobacco component.
While the letter was problematic in the sense of being able to reply to it, many saw it is as a win to prove just how egregious FDA’s process would be. As part of the lawsuit, the three trade groups have argued that FDA did not fully or accurately evaluate the costs and the letter sent to wood would back that up. The agency estimated that a full substantial equivalence report, of which it predicted only 5 percent of cigars would be subject to, would cost $22,787.
It might be possible that FDA’s estimates would be close to the actual costs; Wood told halfwheel because of the delay to 2021 he is waiting to actually test the cigars. It’s likely the estimate about 5 percent of cigars is way off.
As part of today’s announcement, there were no dates given for when FDA will open the comment period, close the comment period, or announce a regulatory framework for substantial equivalence, meaning it could be a few years before any of that is announced. In the mean time, any cigars that were on the market prior to Aug. 8, 2016 will be allowed to remain on the market, so long as the comply with other regulations such as the ban on free samples, which is already in effect, and warning label restrictions, which will go into effect at some point in the future, likely before 2021.