Fighting Back! E-Liquid Maker Halo Sues the FDA

The first vapor industry legal challenge to the FDA's deeming ban

Halo Lawsauit

The vape industry has returned fire. The first legal action against the FDA’s deeming ban came Tuesday as e-liquid maker Halo’s parent company Nicopure Labs, LLC, filed suit in the US District Court for the District of Columbia. The lawsuit claims that “the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution.”

The mostly small- and medium-sized companies that make up the American vaping industry are still reeling from the announcement of the FDA’s so-called deeming regulations, which were published Tuesday in the Federal Register.

Ninety days from now, on August 8, the first restrictions begin — including freezing the market in place. After that day, no new products may be introduced for sale unless they have undergone the expensive pre-market tobacco application process.

The government’s role is not to regulate for the sake of regulation”

Vaping advocates are united in opposing the FDA’s regulations. As Dr. Michael Siegel said in his excellent analysis of the burdens of the application process, “these regulations will decimate the e-cigarette industry.“ The only hope for vape businesses is to change the law, either in Congress or the courts. This lawsuit is the first concrete action taken by a vaping company to fight back against the coming ban.

“Today we turn to the justice system to protect our rights and the rights of our customers because we believe in its fairness”, said 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.”

“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. “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.”

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Jeremy

    Gotta love Halo!

  • Chris

    I’m afraid they should have worked with the vaping colaition rather than striking out on their own. If they lose, legal precedence will prevent the coalition from filing their own lawsuit, and will singlehandedly eliminate legal avenues for the rest of the industry.

    • Jim McDonald

      This is a complicated thing with a lot of moving parts. There are multiple grounds on which lawsuits may be filed, and they may be filed in multiple jurisdictions. Additionally, whatever the result of this suit may be, it will most likely be appealed.

      So, while I’m certainly not a lawyer, the comments I’ve seen from lawyers don’t seem to indicate that any preliminary result in this case would necessarily affect other efforts.

  • EvilWoodchuck

    Still legal to make it yourself… Make sure to order lots of nic before this happens

    • Ignas P.

      You can also make your own liquid from tobacco.

  • Blood Bath

    I have plenty to make my own have been for years now. ,,l,, FDA

  • Henrik Ringtved

    This is just great Halo

  • Hans Olav Pedersen

    You go on HALO. We support you and all the VAPERS in the USA from VAPERS in Norway.

  • Mark

    Please other companies follow Halos lead. Don’t roll over and be shut down. Show the Feds this industry will not be simply wiped away by ridiculous unconstitutional regulations.

  • John Adams

    Buy Halo e-juice to show your support. This has to be an expensive endeavor for them.