Earlier this week, the Food and Drug Administration dropped almost 500 pages of regulations sure to wipe out the nascent e-cigarette industry. A potential victim of the industry-crippling regulations, Nicopure Labs LLC, has filed suit against the FDA and its regulations.
One of the new rules is a requirement (the “deeming rule”) that all products on the market as of February 17, 2007, go through the Premarket Tobacco Application process (PMTA). Almost every product on the market hit the shelves after that date, so all businesses and products are subject to the new rules.
The PMTA is an extraordinarily expensive, time-consuming affair that costs millions of dollars for each individual product and involves a staggering 1,700 hours of paperwork. Companies that sell e-juice have a variety of flavors and blends for sale. The cost to go through the approval process will just put them out of business.
Nicopure is fighting back and claiming that the FDA violated the “Administrative Procedure Act” when devising its regulations. The company also claims the FDA is violating the First Amendment.
“The net effect of the Deeming Rule is a regime that arbitrarily frustrates innovations and advances in public health while preserving the status quo that existed in 2007, i.e., a market dominated by cigarettes,” said Nicopure’s lawyers.
The National Law Journal writes, “Nicopure also lodged a constitutional claim, arguing that the rules violate the First Amendment because they block the company from making ‘truthful and nonmisleading statements’ about vaping and ‘engaging in other forms of protected expression,’ such as distributing free samples.”
Said Jeff Stamler, CEO and co-founder of Nicopure Labs, about the suit: “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.”
The company went on to criticize the regulatory overreach of the FDA.
“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,” said Jason del Giudice, Nicopure’s CTO and co-founder.
The lead attorney for Nicopure seems to have really hit the nail on the head: “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,” the company’s general counsel and chief compliance officer, Patricia Kovacevic, said.
Amen. I hope more victims of the FDA fight back and sue the agency.