Fighting Back! E-Liquid Maker Halo Sues the FDA

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.”