It will be several months before the premium cigar industry gets to plead its case against several points of contention with new regulation by the U.S. Food and Drug Administration, as this week it was announced that a court date of July 28, 2017 has been set.
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.
“After a thorough and detailed legal review, we are challenging this unlawful regulatory action in federal court to protect the statutory and constitutional rights of our industry and its members,” said Mark Pursell, ceo of the IPCPR at the time of the filing. “The fact that all three of our organizations are acting in once voice speaks to the urgency and seriousness of this action.”
Nine counts were listed in the lawsuit, challenging a variety of parts of the rule, including:
- The application of the Feb. 15, 2007 grandfather date
- The additional user fees only being applied to cigars and pipes, not to electronic cigarettes
- The decision to make warning labels 30 percent of the packaging
- The classification of retailers who blend their own pipe tobacco as “manufacturers”
- FDA’s decision to not include financial impact analysis for small business
- FDA’s regulation of pipes as an accessory
FDA has previously issued its thoughts on some of these issues within the various documents it published in early May after it announced the deeming regulations. In late October, FDA filed a response in D.C. District Court, a 26-page document that contained little in the way of specifics.
The agency largely turned to three responses in its reply:
- 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.
However, FDA did offer three defenses that it will seek to combat the lawsuit:
- This Court lacks subject matter jurisdiction over this action.
- The complaint fails to state a claim upon which relief can be granted.
- 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.
FDA has previously stated that it will seek to enforce all parts of the rule it can despite any legal challenges. In the event a court where to grant injunctive relief for a specific part of the rule, FDA would enforce all other parts of the rule.
District Judge Amit P. Mehta has been assigned to the case. Earlier this year, he ruled against FDA 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. However, he also upheld FDA’s rule that changing a product quantity–i.e., the number of cigars in a box–would constitute a new product under the Tobacco Control Act.
The original complaint is posted below, followed by the response from FDA.
For more information about the regulation of cigars by FDA, visit halfwheel.com/fda.