West Virginia Record

Monday, January 20, 2020

Judge dismisses four claims in FDA vaping lawsuit

By Kyla Asbury | Oct 23, 2017


CHARLESTON – A federal judge has dismissed four of five claims against the Food and Drug Administration in a lawsuit challenging the legality of the FDA regulating e-cigarettes and vaping devices.

On May 10, 2016, under the authority conferred upon it by Congress, the FDA issued the final rule deeming several new products, including vaping devices, as “tobacco products” subject to the Food, Drug & Cosmetic Act.

Larry Faircloth raised five claims for relief in his 2016 complaint, asserting that the FDA lacks the statutory authority to deem vaping devices as tobacco products under the FDA; that the rule is arbitrary and capricious because the premarket approval process for new tobacco products imposes an extraordinary burden on manufacturers; that the FDA’s cost-benefit analysis “erroneously concludes the rule’s benefits outweigh its costs” and fails to recognize the “severe regulatory burdens” placed on manufactures; that the rule violates Faircloth’s First Amendment rights; and that the rule violates the 10th Amendment.

The defendants, which include the FDA; Dr. Scott Gottlieb, the commissioner of the FDA; and Thomas Price, the secretary of Health and Human Services,  moved to dismiss the entire action for lack of jurisdiction and alleging that Faircloth lacked standing to challenge the deeming rule as a consumer of vaping devices and that his challenge is unripe.

“Mr. Faircloth is not directly regulated as a consumer of vaping devices and e-liquids,” the order states. “Similarly, he has not been prohibited or otherwise outright prevented from obtaining his vaping products. Furthermore, his future harms are not sufficiently imminent to have standing to bring Counts I-III against defendants.”

Faircloth theorizes that the costs imposed upon the vaping industry will reduce product diversity and increase prices to such an extent that he will inevitably return to using tobacco cigarettes, resulting in increased healthcare costs for the remainder of his life. This injury is squarely the type of “conjectural or hypothetical” future injury that fails to give plaintiff standing as to Counts I-III of his claims, according to the order.

Faircloth does not have standing to challenge the deeming rule as Counts I through III of his complaint, nor does he have standing to challenge the deeming rule under the 10th Amendment, which was Count V.

The court decided that Faircloth has proper standing to assert his First Amendment claim, according to the order.

Faircloth claimed in his complaint that by operation of the deeming rule’s limitation on the availability of vape and e-liquid products, he will likely return to more dangerous tobacco products, which will result in healthcare costs to him of approximately $35 per pack of cigarettes.

The plaintiff smoked two packs of cigarettes per day prior to use of vape products. The effect of the defendant’s action will increase the plaintiff’s healthcare costs by $766,500 over the next 30 years.

Faircloth claims the defendants have usurped the power of the states to shift residents from more dangerous tobacco products to the healthier alternative of vape and e-liquid products.

Faircloth is seeking for the court to vacate and set aside the deeming rule; and to declare that the deeming rule is contrary to and exceeds FDA’s statutory authority, that it is arbitrary and capricious, that it’s cost-benefit analysis is unlawful and that it violates his First and 10th Amendment rights. He is being represented by Patrick Lane of The Lane Law Firm.

U.S. District Court for the Southern District of West Virginia case number: 2:16-cv-05267

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U.S. Food and Drug Administration (FDA)U.S. District Court for the Southern District of West Virginia Charleston Division