Cigars vs FDA – The Lawsuit Has Been Filed

Today, the International Premium Cigar and Pipe Retailers Association (IPCPR), Cigar Association of America (CAA) and Cigar Rights of America (CRA) have filed a joint lawsuit against the Food and Drug Administration (FDA) and their Commissioner Robert Califf jointly and separately along with the Department of Health and Human Services (HHS) and their Secretary Sylvia Burwell.

This multiparty suit was filed on behalf of the members of all three organizations, IPCPR, CAA and CRA (the plaintiffs) for the benefit of their members, in unity, and for the purpose that others would not have to file separately. Some manufacturers may also choose to file separately anyway on their own behalf, some have already done so, including Global Premium Cigars and others plan to still do so in the near future, sources tell The Cigar Authority.

As for this litigation, the plaintiff’s lawsuit lies in the FDA Final Rule of the “Deeming Regulations” against cigars, pipes and pipe tobacco which were announced on May 5, 2016 which go into effect on August 8, 2016. The plaintiffs claim The Final Rule is legally defective and contrary to the Tobacco Control Act and Congressional intent in several respects including that it incorrectly subjects cigars, pipes and pipe tobacco to stricter regulatory restrictions than originally regulated products such as cigarettes.

Nine counts were filed which include;

Count I: FDA’s Actions Regarding the Predicate Date and the Substantial Equivalence Process Are Arbitrary, Capricious, an Abuse of Discretion and Not in Accordance With Law, and Exceed FDA’s Regulatory Authority.

Count II: The Final Rule’s User Fee Provisions are Arbitrary, Capricious, and Not in Accordance with the Tobacco Control Act, and Exceed FDA’s Regulatory Authority.

Count III: The Final Rule’s User Fee Provisions Violate Plaintiffs’ Members’ Right to Due Process and Equal Protection.

Count IV: FDA’s Failure to carry out a Proper Cost-Benefit Analysis Violates the Regulatory Flexibility Act and Unfunded Mandates Reform Act of 1995.

Count V and VI: FDA’s Treatment of Premium Cigars and Failure to Consider Option Two is Arbitrary and Capricious.

Count VII: The Final Rule’s Warning Label Requirements Impermissibly Restrict Free Speech.

Count VIII: Regulation of Tobacconists Who Blend Finished Tobacco as “Manufacturers” is Arbitrary, Capricious, and Not in Accordance with the Tobacco Control Act, and Exceeds FDA’s Regulatory Authority.

Count IX: Regulation of Pipes as “Components” Rather Than as “Accessories” is Arbitrary, Capricious, and Not in Accordance with Law.

The suit asks for relief by vacating and setting aside the final rule as unlawful, arbitrary, capricious , and an abuse of discretion, and otherwise not in accordance with law, and in excess of FDA’s authority. They ask for a permanent injunction restraining Defendants from implementing or enforcing the Final Rule.

So what does all this mean?

For one, it means that all 3 cigar organizations (IPCPR, CAA and CRA) have agreed to join together, united for strength. This is a good step forward for our industry creating a glimmer of hope for the future. That being said, the wheels of justice move very slowly so it will be as written by the FDA for now. No one knows exactly what the future holds, but that will be up to the courts to decide.

To read the official press release please visit: http://thecigarauthority.com/ipcpr-caa-cra-file-lawsuit-versus-fda/

The Lawsuit:

Lawsuit Vs FDA