First Lawsuit Filed Over FDA ‘Deeming’ Regs

Electronic-cigarette company argues ‘government’s role is not to regulate for the sake of regulation’

By 
Melissa Vonder Haar, Freelance Writer

tobacco in court

TAMPA, Fla. -- The first legal challenge to the U.S. Food and Drug Administration’s (FDA) “deeming” regulations on cigars, pipe tobacco and electronic cigarettes has been filed, less than a week after the agency announced the final rules. This Tuesday, e-liquid manufacturer Nicopure Labs LLC filed suit in the U.S. District Court for the District of Columbia.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness," said Patricia Kovacevic, Nicopure’s general counsel and chief compliance officer. “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.”

In the lawsuit, Nicopure claims the FDA’s rulemaking process violated the Administrative Procedure Act and the deeming rule violates the First Amendment.

“Through one voice, Nicopure Labs has taken a stand to ensure the voices of all vapers are heard and that vapers are treated fairly and not with a single stroke of a broad brush by the FDA,” Jeff Stamler, Nicopure’s CEO and co-founder, said in a press release. “We fully support reasonable regulation that protects consumers, accomplishes the public health priority to reduce the grave harm caused by conventional cigarette smoking, and allows businesses to survive and innovate for a greater public health vision for our society as a whole.”

“FDA’s rule does not protect the consumer from low quality products,” added Jason del Giudice, the company’s CTO and co-founder. “Instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves.”

When asked about the lawsuit by The National Law Journal, an FDA spokesman declined to comment, citing the pending litigation.