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.
“… at this time, FDA is not finalizing the proposed SE rule with respect to “premium” cigars. Rather, FDA will take appropriate action once it has further considered the comments submitted to the deeming rule docket that suggested FDA create a streamlined SE process for “premium” cigars…”
The Final Rule reflects targeted efforts by Premium Cigar Association (PCA) and Cigar Rights of America (CRA) over many years to educate FDA, CTP, and White House officials with category specific data on premium cigars as they relate to public health risk for youth and nicotine addiction and urging them to exclude premium cigars from regulations that are ill-suited to the category. The Final Rule also builds upon the federal court ruling that FDA failed to fully evaluate the comments it had received during its proposed rulemaking on premium cigars before taking action to regulate the category.
Yesterday’s release notes, “As discussed in section V.C.1 of this final rule, we are adding the Cigar Ass’n of Am. court’s definition of “premium” cigars to § 1107.12. That definition is:
“Premium” cigars means a type of cigar that: (1) is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) 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); (4) 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); (5) has no filter, nontobacco tip, or nontobacco mouthpiece; (6) does not have a characterizing flavor other than tobacco; (7) contains only tobacco, water, and vegetable gum with no other ingredients or additives; and (8) weighs more than 6 pounds per 1,000 units.”
This is an important victory for the associations and will provide a formative definition for future use at both the federal and state levels in the legislative and regulatory process.
“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. “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. “
UPDATE: January 22, 2021
On January 20, 2021, following the change from the Trump to Biden administration, the Chief of Staff to President Biden issued a Memorandum for the Heads of Executive Departments and Agencies, which directs agencies to immediately withdraw any rule that has been sent to the Office of the Federal Register but not formally published pending review and approval by a department or agency head appointed by the President. Such actions are typical of incoming administrations and are generally aimed at preventing last-minute “midnight rulemaking.”
On January 21, 2021, the Office of the Federal Register withdrew both the final SE and PMTA rules from public inspection that were initially slated to be published on January 27th.