E-Cigarette Manufacturer Challenges New Fed Rule

(CN) — An e-cigarette manufacturer claims in court that a federal rule regulating its products is unconstitutional and will cost the company millions if allowed to stand.

Nicopure Labs LLC sued the Food and Drug Administration and commissioner Robert Califf, as well as Health and Human Services Secretary Sylvia Mathews Burwell, in D.C. Federal Court Tuesday, challenging the departments' plan to regulate of vaping devices and e-liquids with the same level of scrutiny as that applied to tobacco products.

The Trinity, Fla.-based vape distributor takes issue with a rule "deeming tobacco products to be subject to the federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act; restrictions on the sale and distribution of tobacco products and required warning statements for tobacco products."

The rule, which the FDA released on May 5, "dramatically expands FDA's exercise of its regulatory authority under the Tobacco Control Act, a statute enacted in 2009 that is designed to address the 'cancer, heart disease, and other serious adverse health effects' associated with use of 'tobacco products,'" the complaint says.

Nicopure says the rule "concludes that vaping devices (or the constituent parts or components of vaping devices) are 'tobacco products' subject to the Act's provisions, even though vaping devices (or their parts) are not made or derived from tobacco or intended for human consumption." (Parentheses in original).

"The breadth of the deeming rule's purported reach is staggering," the complaint continues. "Indeed, the rule classifies as 'tobacco products'—and thus asserts regulatory authority over—inter alia, 'programmable software,' 'batteries,' 'digital display/lights,' and 'glass or plastic vial[s].'"

The rule will cost Nicopure millions, according to the complaint.

"Once the deeming rule goes into effect on Aug. 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, recordkeeping, inspection, labeling, manufacturing, testing, and other requirements imposed by the Act," the complaint states.

The plaintiff claims that the 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 will be forced to redirect resources from day to day business operations and research and development to compliance with the deeming rule's premarket approval, reporting, recordkeeping, inspection, labeling, manufacturing, and other requirements.

"Even if the court ultimately sets aside the deeming rule, Nicopure will suffer irreparable harm from its promulgation due to the immediate and irreparable consequences of being subject to unlawful regulation, including the unlawful deprivation of Nicopure's constitutional rights," the complaint continues.

The four-count complaint asserts violations of the Administrative Procedure Act and the First Amendment and seeks declaratory and injunctive relief.

Nicopure is represented by Benjamin Block and Kevin King with Covington & Burlington in D.C.

Justice Department spokesman Wyn Hornbuckle declined to comment on the ruling Thursday.

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