Taking the FDA to Court

Posted by Mitch Clarke on 16th Nov 2016

In a landmark lawsuit filed in the District Court of Washington DC, NicoPure Labs moved for summary judgment against the United States Food and Drug Administration regarding their latest regulations on e-cigarettes. This motion calls into question not only the legality of the Agency’s latest rules deeming e-cigarettes -- which includes all relevant parts and components -- strictly as tobacco products, but also raises concerns over the FDA’s claimed exempt status from review by an external court, thanks to the Administrative Procedure Act. 

Shortly after submission, NicoPure’s suit was consolidated with a similar motion filed by the E-Vapor Coalition, a collection of organizations such as the Right to Be Smoke-Free Coalition, the American Vaping Association, the Electronic Vaping Coalition of America, and eight other pro-vaping groups; this consolidated case  to have both sides provide their oral arguments on October 17 th to the Honorable Judge Amy Berman Jackson, a district judge appointed last year by the Obama administration, though this schedules date was quickly moved up to the 11th of that same month.

The lawsuit filed originally by NicoPure against the FDA names specifically as defendants Dr. Robert M. Califf, the current FDA Deputy Commissioner and known for being a vocal advocate in support of direct collaboration between Big Pharm and the Food & Drug Administration, as well as Sylvia Mathews Burwell, who not only serves as the Secretary of Health and Human Services, but also regularly gives speeches in Washington D.C. and writes informative blog posts, both activities covering topics she believes to be beneficial to the public. 

On August 16 th, the defendants, with assistance from the Department of Justice, filed a cross-motion calling for a denouncing summary judgment from Judge Jackson, citing their own reasons for doing so in a 102 page document that does little but repeat the Administration’s official opinions on the matter, this time doing so with 116 previous court cases supporting their claims referenced throughout the motion. Shortly thereafter, with the support of the E-Vapor Coalition, NicoPure submitted a joint memorandum replying to the defendants’ opposing cross-motion – this document outlined in great detail the points raised in the plaintiffs' original motion and backed these points with numerous statutes and previous court cases, similarly to the defendants’ own cross-motion.

For three hours on October 11th, representative counsel from both sides of the lawsuit met with Judge Amy Jackson to present their arguments supporting and opposing the FDA’s recently implemented regulations, as well as answer any of the presiding judge's questions in order to help her more easily reach an informed and fair ruling. Thankfully, Judge Jackson had many relevant questions for both sides of the aisle, including those touching on points called into question by both the FDA’s and NicoPure’s cross-motions, a good sign that Judge Jackson isn't rushing into this case and intends to keep an open mind to the facts. Such questions, among many others, included the legality of prohibiting modified exposure claims such as “no smoke” or “free of [a certain substance]”, the court’s undertaking of an Administrative Procedure Act review of the deeming rule, and the Administration’s choice to not adjust the 2007 predicate date.

To no one’s surprise, similar cases against the FDA are popping up in the district courts of popular e-liquid manufacturer home states such as California. For instance, Lost Arts Liquids, a prominent e-liquid manufacturer, filed a motion denouncing the same FDA regulations, even though it could not be consolidated with the NicoPure et al. motion because it was filed in the District Court of California. Another such motion came mere hours after the announcement of Judge Jackson’s presiding: several cigar-oriented associations such as The Cigar Rights of America, the Cigar Association of America, and the International Premium Cigar and Pipe Retailers Association banded together to file in the same Federal Court a declaratory injunction to "vacate, set aside and enjoin the enforcement of the final [FDA e-cig regulations]."

Without making assumptions about the nature of Judge Jackson’s questions or stance, optimism is extremely high in the camp of pro-vaping advocates. With such fair proceedings preceding the presiding Judge’s final decision, which will most likely be deferred until sometime next year, supporters of the right to vape are positive that the bright and shining marriage between justice and facts will be more than enough to illuminate the murky methodology and dark motives of the Food and Drug Administration.