On the last night of the Trump Administration being in office (January 19, 2021), the U.S. Food and Drug Administration (FDA) and Center for Tobacco Products (CTP) released rules about Substantial Equivalence (SE) and Premarket Tobacco Product Application (PMTA). Regarding premium cigars, the FDA did not apply the rules at this time. This is the result of the August ruling by the DC delaying FDA Enforcement of SE and PMTA when it involved premium cigars.
SE is a mechanism the FDA is providing to tobacco and alternative tobacco companies as a mechanism to bring new products to market. In order for a new tobacco product to be found substantially equivalent, the FDA must determine either that it has the same characteristics as a predicate tobacco product, or that it has different characteristics than the predicate tobacco product but does not raise different questions of public health. PTMA is a more costly option that does not involve the SE process. Most premium cigar companies have been expected to go the SE route to bring products to market.
Back in August, Judge Amit P. Metha of the DC Circuit Court ruled, “In issuing the Final Deeming Rule, the FDA arbitrarily failed to address commenters’ requests for a streamlined substantial equivalence process for premium cigars undergoing premarket review. Accordingly, the court remands the Final Deeming Rule for the limited purpose of considering that issue anew and enjoins enforcement of the premarket review requirements against premium cigars during that time. In all other respects, however, Defendants’ actions were lawful, reasonable, and adequately explained.”
Yesterday’s announcement essentially documented regulations for SE and the more costly PTMA, but complied with Judge Metha’s ruling and did not apply them to premium cigars. It did not provide any additional victory for the premium cigar industry but essentially put things in writing for now. The rule will become official once published to the Federal Register on 1/27/21.
Last night, the Food & Drug Administration (FDA) and the Center for Tobacco Products (CTP) released the Final Substantial Equivalence (SE) and Premarket Tobacco Product Application (PMTA) Rules to address deemed products. While the rules apply regulations to a wide variety of products, FDA stopped short of applying the new regulations to “premium cigars” acknowledging that the agency is evaluating industry comments and its own research on the category.
A definition of a premium cigar was also documented in the regulations – something that has been an on-going debate for several years. The definition is based on the one used in the joint industry lawsuit filed by the Cigar Association of America (CAA), Cigar Rights of America (CRA), and the International Premium Cigar and Pipe Retailers (IPCPR – now PCA). The definition is:
- is wrapped in whole tobacco leaf
- contains a 100 percent leaf tobacco binder
- contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar)
- is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling)
- has no filter, nontobacco tip, or nontobacco mouthpiece
- does not have a characterizing flavor other than tobacco
- contains only tobacco, water, and vegetable gum with no other ingredients or additives
- (weighs more than 6 pounds per 1,000 units.
“This is the result of a continued effort in the courts and educating lawmakers and regulators about our industry by the PCA and CRA teams,” said Scott Pearce, Executive Director of the Premium Cigar Association in a press release. “How this industry is defined ultimately determines how it is regulated and the public health risk data for premium cigars simply doesn’t compare to that of other deemed products.”
Robert Levin, Chairman of CRA, added, “The release of the Final Rule is a culmination of years of advocacy work in Washington that laid the groundwork for a specific and distinct definition of premium cigars that is now part of a federal definition. “
The FDA is expected to go back to the drawing board and produce a more streamlined process around SE, but no timetable has been issued.