First vapor rules suit filed against FDA

Let the litigation begin. The first of what is expected to be a plethora of companies has filed suit against the U.S. Food and Drug Administration (FDA) challenging its recently released deeming rules for the vapor industry.

Florida-based Nicopure Labs, represented by the international law firm of Covington & Burling, filed suit in the U.S. District Court for the District of Columbia in response to new FDA regulations that would subject e-cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act.

In its court filing, Nicopure Labs argues that the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the Constitution of the United States.

“Once the Deeming Rule goes into effect on August 8, 2016, the overwhelming majority of Nicopure’s products—including hundreds of products that are neither made nor derived from tobacco nor intended for human consumption—will be subject to the premarket approval, reporting, record-keeping, inspection, labeling, manufacturing, testing, and other requirements imposed by the Act,” the suit states. “Such regulation will severely burden Nicopure and its operations— costing millions of dollars. The Deeming Rule’s premarket approval requirements will force Nicopure to discontinue existing product lines and will also prevent Nicopure from introducing new product lines after the Rule’s effective date.”

Nicopure Labs general counsel and chief compliance officer Patricia Kovacevic, said the company felt it had no other options other than to turn to the justice system to protect its rights and the rights of its customers. “The government’s role is not to regulate for the sake of regulation,” she said. “Regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”

Jeff Stamler, CEO and co-founder of Nicopure Labs, said that since 2009, Nicopure revolutionized the way e-liquid was manufactured and packaged, forever changing the vapor industry as few knew it. “Today, Nicopure Labs is again at the forefront of the industry as revolutionaries … 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,” he said  “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, CTO and co-founder of Nicopure Labs, said the company is committed to responsible manufacturing based on superior product standards and stringent quality requirements. “[The] FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies,” he said.