Premium Cigars Receive Historic Relief from FDA Regulations
Premium Cigars Receive Historic Relief from FDA Regulations
Federal court strikes down the premarket review/substantial equivalence process.
Today, the U.S. District Court for the District of Columbia struck down the FDA’s premarket review process for premium cigars known as substantial equivalence. In a lengthy opinion, Judge Amit P. Mehta explained that the FDA’s actions violated the Administrative Procedure Act. As substantial equivalence was the most onerous and costly component of FDA regulation, today’s decision will provide significant and long-awaited regulatory relief for premium cigars.“This is a historic day for America’s premium cigar industry,” said Drew Newman, general counsel and fourth-generation owner of J.C. Newman Cigar Co. “Since the FDA first proposed regulating premium cigars in 2014, we have been extremely worried about how to scientifically prove that a cigar rolled today is ‘substantially equivalent’ to one from 2007.”In the 2016 “Deeming Rule,” FDA expanded its authority to include all tobacco products, including premium cigars. In doing so, FDA decided that any cigar first sold after 2007 – nine years earlier – must be approved by FDA using an exhaustive process developed for cigarettes. Because the FDA had not finalized how this approval process would work for cigars, the agency had repeatedly extended the filing deadline before Judge Mehta struck it down today.“From the beginning, the premarket review process has never worked for premium cigars,” said Newman. “Just as sunlight, wind, and rain cause grapes used to make fines wine to vary from year to year, the same is true with premium cigar tobacco. Like wines, premium cigars also change and get better with age. It would have been impossible to demonstrate that a cigar rolled today is the same as one from 2007.” (A longer explanation on why the premarket review process was so difficult for premium cigars is below.)Judge Mehta concluded that FDA “arbitrarily failed to consider a streamlined substantial equivalence process for premium cigars” and that its “cursory response [to comments submitted by the premium cigar industry] is not reasoned decision-making.” As a result, he is requiring FDA to “consider whether a streamlined substantial equivalence process is appropriate for premium cigars” and has struck down the September 9 deadline for filing premarket review applications for premium cigars.“Judge Mehta’s decision defined ‘premium cigar’ narrowly and includes only premium cigars that are entirely handmade,” said Newman. “This definition inadvertently excludes cigars that we roll in our 110-year-old American cigar factory in Tampa using hand-operated, antique cigar machines. In the months ahead, we will ask FDA to include those historic, handcrafted cigars as well.”With today’s decision, the three most onerous and costly parts of FDA regulation have been set aside. In addition to today’s decision striking down premarket review of new cigars, last month the U.S. Court of Appeals for the D.C. Circuit struck down the massive new health warning labels proposed by the FDA. Previously, the FDA agreed to indefinitely delay expensive product testing until a reliable method for testing cigars is established.
Premium cigars will still be subject to other FDA regulations, including minimum purchase age, product listing, facility registration, and ingredient reporting. The FDA can continue to inspect cigar factories and warehouses and take action against products that are harming public health. In addition to the FDA, cigars will continue to be regulated by the Alcohol and Tobacco Tax and Trade Bureau, U.S. Customs and Border Protection, and other agencies. “We are very grateful for the tremendous support of U.S. Senator Marco Rubio and Congresswoman Kathy Castor for their bipartisan leadership and tireless advocacy on behalf of Florida’s historic premium cigar industry,” said Newman. “We also appreciate the leadership of the Cigar Association of America, Premium Cigar Association, and Cigar Rights of America for litigating this case.”“My family has been rolling premium cigars in the United States for four generations and 125 years,” said Newman. “Our one goal is to continue our family tradition for another century. The regulatory relief provided by today’s decision will help us to achieve this goal.”
Background Information on Premarket Review of Premium Cigars
The FDA’s premarket review process for cigars presumes that manufacturers and the FDA can scientifically compare a premium cigar rolled today with one made 13 years ago in 2007 to determine if they are “substantially equivalent.” This process may be appropriate for mass-market products that are chemically standardized and are produced in mass quantities. However, because premium cigars are handcrafted, rolled in small batches, and subject to great natural variation, the same, expensive process does not work for premium cigars. Although the FDA has not issued the required form and content for premarket review applications for cigars, various statements, presentations, and other informal guidance suggests how this process was to apply to premium cigars. Premarket review would have been extremely difficult for the premium cigar industry to complete for the following reasons:
- The FDA has requested voluminous amounts of scientific information about premium cigars, including draw resistance, tobacco rod density, moisture content, and wrapper porosity. The premium cigar industry does not collect the wide range of information that the FDA is requesting.
- The FDA has also requested premium cigar manufacturers to submit detailed testing data for both new and predicate products even though standards for testing cigars are still being developed and attempts to test premium cigars to date have proven unreliable.
- Additionally, the FDA has requested detailed information about product packaging, including inks in cigar bands and wood in cigar boxes and explanations of differences between those used today and in 2007.
- The agency has requested detailed Environmental Assessments discussing “Air quality, Water resources, Land use and zoning, Biological resources, Geological features and soils, Socioeconomics and environmental justice, Solid Waste and hazardous Waste, Floodplains, wetlands and coastal zones, Regulatory compliance, Cumulative Impacts of above, Mitigation of the impacts when necessary.”
In comments filed with the FDA last year, Cigar Rights of America reported that the tremendous amount of information that the FDA is seeking in premarket review would take 1,000 hours and cost $50,000 to prepare per cigar. Because many of the 51,000 different premium cigar products presently sold in the United States would need to go through the premarket review process, the total cost of premarket review for the premium cigar industry would exceed $1 billion. As premium cigars are boutique products made in small batches by small businesses, the premium cigar industry could not absorb these high costs.