It didn’t take long, but the first legal challenge to the U.S. Food and Drug Administration (FDA)’s Deeming Rule on Tobacco products has been filed. On May 10th, 2016 it was announced that Nicopure Labs LLC, a manufacturer of e-liquids for vaping devices filed suit in the U.S. District Court in the District of Columbia against the FDA. It is expected that this will be the first of many and could be a sign of things to come from the premium cigar end.
In a press release from Nicarpure Labs LLC the company said the court filing contents “the FDA’s rulemaking process violated the Administrative Procedure Act, and the deeming rule violates the First Amendment to the Constitution.
The court filing is significant because when the FDA regulations were released last week, vaping products and electronic cigarettes were lumped in with premium cigars and pipe tobacco.
“Back in 2009 Halo revolutionized the way e-liquid was manufactured and packaged, forever changing the Vape industry as few knew it. Today Nicopure Labs is again at the forefront of the industry as revolutionaries, as Nicopure Labs leads the way in defense of our constitutional rights and for the future of the entire vaping industry and the American right to choose. 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,” said Jeff Stamler, CEO and co-founder of Nicopure Labs 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.”
Jason del Giudice, CTO and co-founder, also stated: “We are committed to responsible manufacturing based on superior product standards and stringent quality requirements. FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies such as ourselves, who are determined to drive the industry to the highest standards of quality and innovation.”
“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness”, added Nicopure Labs General Counsel and Chief Compliance Officer, Patricia Kovacevic. “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.”
Nicapure Labs LLC, who contends they are not affiliated with any tobacco company was founded in 2009 and has operations in both the United States and Europe. Based out of Gainesville, Florid, the company has been in operation since 2009, putting it in the crosshairs to have its products regulated by the FDA.