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Vaping Company Sues FDA Over New Regulations

Launch Time: 2016-05-11 Views: 1266 Rely: 0 Started by:

On Tuesday, the U.S. Food and Drug Administration officially published new rules regulating vaping products. Not wasting any time, a company that sells the devices and manufactures the “e-liquid” used in them fired a lawsuit early Tuesday claiming the agency overstepped its authority.


In one of the first, if not the first, lawsuits filed in response to the rules, Nicopure Labs LLC, represented by Covington & Burling, argued that the breadth of the regulatory regime’s reach is “staggering.”

“The net effect of the Deeming Rule is a regime that arbitrarily frustrates innovations and advances in public health while preserving the status quo that existed in 2007, i.e., a market dominated by cigarettes,” Nicopure’s lawyers wrote in the complaint, filed in the U.S. District Court for the District of Columbia.

Nicopure says that although some of its e-liquid products contain nicotine derived from tobacco, some don’t. They accused the FDA of discounting evidence that vaping is safer than consuming cigarettes and other traditional tobacco products, and argued that the reporting, testing and other requirements included in the regulations would “severely burden Nicopure and its operations—costing millions of dollars.”

Nicopure also lodged a constitutional claim, arguing that the rules violate the First Amendment because they block the company from making “truthful and nonmisleading statements” about vaping and “engaging in other forms of protected expression,” such as distributing free samples.

An FDA spokesman declined to comment, citing the pending litigation.

Covington partner Benjamin Block, a lead attorney for Nicopure, referred a request for comment to Nicopure. In a statement, the company's general counsel and chief compliance officer, Patricia Kovacevic, said: “The government’s role is not to regulate for the sake of regulation; regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”