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    Categories: FDA/Deeming RegulationsNews

CAA, CRA & IPCPR Petition for Summary Judgement in FDA Lawsuit

Yesterday, attorneys representing the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers Association (IPCPR) filed a motion for summary judgement as part of the three organizations joint lawsuit against the U.S. Food & Drug Administration.

Summary judgement is a legal procedure where one side of a case asks a judge to rule on all or parts of the case regarding legal issues surrounding a case. A summary judgement is centered around questions of law instead of questions of fact. In this case, the plaintiffs are arguing the court rule that Deeming Rule and user fee rules are “must be vacated as arbitrary, capricious, and contrary to the (Administrative Procedure Act) and the Constitution.”

The summary judgement petition focuses on nine issues:

  1. FDA Improperly Interpreted the Family Smoking Prevention and Tobacco Control Act — The argument here is that the agency opted to impose all parts of the Tobacco Control Act to cigars. The plaintiffs argue that the Tobacco Control Act was not designed to treat cigars and pipe tobacco similar to cigarettes. The Tobacco Control Act was approved by Congress in 2009. It gave FDA the authority to regulate other tobacco products including cigars and pipes.
  2. FDA’s Substantial Equivalence Procedure is Unclear — The plaintiffs argue that FDA violated the law when it enacted the rule without clearly establishing a substantial equivalence process.
  3. FDA Decided Against Allowing Pending Applications to Remain on the Market — This is a two-part argument. First, the plaintiffs argue that FDA will not be able to rule on all pending applications with 30 months of Aug. 8, 2016—a deadline FDA has set up for itself. Furthermore, it argues that in the case of cigarette regulations, FDA allowed for any pending applications to remain on the market, some of those products are still on the market with applications pending. The plaintiffs argue this treatment is unfair because it punishes cigars in a stricter manner than cigarettes—and potentially much stricter if FDA does not meet its 30-month deadline.
  4. FDA Rejected Option 2 — The plaintiffs argue that FDA’s decision to not exempt premium cigars from FDA control via Option 2 is “the height of arbitrary and capricious rulemaking” given that a recent FDA-funded study found no statistically significant youth use of premium cigars and there is no evidence “premium cigars present any public health threat.”
  5. FDA Isn’t Charging User Fees to E-cigarettes — Currently cigars and pipes—along with four other categories of tobacco—are subject to FDA user fees; e-cigarettes are not. For what it’s worth, FDA has previously stated that it does not believe it has the authority to charge e-cigarette user fees. The plaintiffs dispute this
  6. FDA Did Not Perform Adequate Cost-benefit Analysis — The plaintiffs cite previous D.C. Circuit Court rulings which have invalidated rules because of lack of cost-benefit analysis. FDA admitted that it did not perform some of the studies about potential impacts including basic procedures such as how many cigars are on the market.
  7. Large Warning Labels are Unconstitutional — The plaintiffs argue that smaller warning labels would be just as sufficient, but perhaps more importantly, FDA did not establish why larger warning labels were needed.
  8. Pipe Tobacco Retailers Registering as Manufacturers is Wrong — The argument here is that FDA realized retailers who blend their own pipe tobacco would likely need to be registered as manufacturers in order to have e-cigarette retailers blending their own vape liquids also register as manufacturers.
  9. FDA Didn’t Identify Why Pipes are a Public Health Risk — FDA deemed pipes as a “component” meaning anyone manufacturing pipes would need to register with FDA. The plaintiffs argue there’s no reasonable explanation as to why pipes should be a component and doing so will destroy the pipe making industry.

A hearing on the lawsuit is scheduled for July 28, 2017.

You can read the original complaint here.

Charlie Minato: I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.