FDA Responds to Joint CAA/CRA/IPCPR Lawsuit

Yesterday, the U.S. Food & Drug Administration (FDA) responded to the lawsuit filed by three cigar industry trade groups.

In July, the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR) filed a joint lawsuit in federal court as a response to new rules enacted by FDA to regulate premium cigars. Since then, not much has happened in the lawsuit other than a handful of summons sent to various FDA officials as part of the lawsuit.

At least until yesterday, when a 26-page response was filed by FDA in the D.C. District Court.

There’s very little in the response in the way of new revelations. In it, FDA responds to each claim made in the lawsuit, though almost none of it is done with specifics. In fact, most of the responses are one of three statements repeated throughout the document:

• Denied.
• This paragraph contains argument and conclusions of law, not allegations of fact, and thus no response is required. 
• Defendants specifically deny any characterization of that analysis, which speaks for itself, and respectfully refer the Court to that analysis for a complete and accurate statement of its contents.

FDA does present three defenses that it will seek to combat the lawsuit:

1. This Court lacks subject matter jurisdiction over this action.
2. The complaint fails to state a claim upon which relief can be granted.
3. Defendants’ actions did not violate the U.S. Constitution, the Administrative Procedure Act, the Federal Food, Drug, and Cosmetic Act, the Tobacco Control Act, or any other statutory or regulatory provision.

The first two responses would seek to have the lawsuit thrown out over basically procedural grounds, while the third is a claim of innocence.

Presiding over the case is Amit P. Mehta, the same judge who ruled against FDA earlier this year in a case regarding whether changing the label of a product would make it a new product under the Tobacco Control Act, the law that allows FDA to regulate various types of tobacco products. In that ruling, Mehta did uphold FDA’s rule that changing a product quantity would constitute a new product under the Tobacco Control Act.

As for the cigar lawsuit, FDA did respond to one contention with some specificity.

In the lawsuit, the plaintiffs (CAA, CRA, IPCPR) argued that FDA has not adequately responded to substantial equivalence reports, i.e. the legal application companies submit for product approval from FDA. The lawsuit said that since 2011 there has “consistently been over 3,500” pending substantial equivalence reports needing response from FDA.

FDA’s response said that it had resolved 1,193 of 2,029 (59 percent) of the regular substantial equivalence reports submitted as of Nov. 30, 2015. It should be noted, the two sides are comparing apples and oranges with the numbers. The 3,500 number likely refers to all types of substantial equivalence reports while FDA references just one type.

The response from FDA is below, followed by the original complaint.

For more information about the regulation of cigars by FDA, visit halfwheel.com/fda.

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 have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.