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August 23, 2017

First Lawsuit Filed Over FDA’s E-Cigarettes Regulations


The first legal challenge to the United States Food and Drug Administration’s (FDA) deeming regulations on cigars, pipe tobacco and electronic cigarettes has been filed, 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. Patricia Kovacevic, Nicopure’s general counsel and chief compliance officer stated:

Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness.. 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 rule-making process violated the Administrative Procedure Act and the deeming rule violates the First Amendment to the United States Constitution prohibiting the making of any law respecting an establishment of religion, impeding the free exercise of religion, abridging the freedom of speech, infringing on the freedom of the press, interfering with the right to peaceably assemble or prohibiting the petitioning for a governmental redress of grievances.Jeff Stamler, Nicopure’s CEO and co-founder, said in a press release:

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, 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, the company’s CTO and co-founder stated:

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.

Currently, FDA spokesmen have declined to comment, citing the pending litigation.

About Nicopure Labs, LLC

Operating since 2009, Tampa-based Nicopure Labs, LLC is an industry leading e-liquid manufacturer with operations in the U.S. and Europe. Nicopure Labs has recently upgraded its 110,000 sq. ft. manufacturing and distribution operations in Gainesville, Florida to include a 10,000 sq. ft. ISO 7 Clean Room. Distributing to over 90 countries worldwide, Nicopure Labs has also expanded its presence with the recent addition of a European headquarters in the Netherlands and offices in England.


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