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Nicopure Sues FDA Over Deeming E-Cigarette Regulations

Ed Oswald
by · May 16, 2016

Nicopure Sues the FDA Over RegulationsIt didn’t take long, but the first lawsuit aiming to stop the FDA’s deeming regulations on e-cigarettes is on the books. Tampa Florida-based e-juice manufacturer Nicopure filed suit against the agency last week, claiming the regulations violate federal law as well as the First Amendment.

Nicopure produces several juice lines, including the popular Halo e-juice brand. The company says that as written, the potential regulations place far stricter limits on electronic cigarettes than traditional tobacco products under the Tobacco Control Act.

“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,” CEO and co-founder Jeff Stamler said in a statement.

More About the Lawsuit

The suit was filed Tuesday in the U.S. District Court for the District of Columbia, which is the court that handles litigation against government agencies. It is the first suit to be filed by any company in the industry, and as far as we can tell the only suit in progress that attempts to stop the regulations from taking effect.

We should mention that Nicopure does support “reasonable regulation” on the industry, something that other e-juice makers, device manufacturers, and even local store owners publicly support. However, in all cases, these companies have looked at it from the perspective of keeping low quality juices off the market, which arguably is an even bigger threat to public health than vaping itself.

“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,” Nicopure legal counsel Patricia Kovacevic argues.

That doesn’t appear to be happening from an early read of the nearly 500-page document, according to legal experts.

Rather than focus on regulation of juice quality — which the FDA’s deeming regulations actually ignore completely — the law is set to ban an estimated 95 percent of all e-cigarette devices on the market. It also makes e-juice production — and the approvals now required — so difficult to get that it’s likely only big tobacco companies who’ve cashed in on the vaping trend would remain.

Violations in FDA Regulations

Specifically, Nicopure contends that the looming regulations violate the Administrative Procedure Act. This 70-year-old law guides the government in how it can draft new regulations, and requires the agency make the process public and allow for citizen’s participation in the process itself.

The claims in the lawsuit of First Amendment violations, however, are a little harder to decipher. The First Amendment states that

Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the government for a redress of grievances.

Nicopure might see the FDA’s deeming regulations as curtailing the rights listed in the latter part of the First Amendment, but it’s not completely clear that such an argument could be successful considering the deeming regulations are currently in mandatory 30-day public comment period required under Federal Law.

Then again, Nicopure could feel its own First Amendment rights are being violated. “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,” CTO Jason del Giudice said.

We’ll continue to follow the case and report on any developments, but it’s clear that the FDA will not go unchallenged when it comes to e-cigarette regulation.

Here is an overview directly from Nicopure:

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