Novi Times

A potentially precedent-setting case centering on the issuance of federal regulations is scheduled for oral arguments before the U.S. Court of Appeals, District of Columbia Circuit, in September.

In Moose Jooce, et al., v. Food and Drug Administration, et al, the plaintiffs argue the FDA violated the Constitution by letting a mid-level employee write rules for the vaping industry, the application of which have far-reaching implications.

“Because FDA continues improperly to allow employees to issue rules, Plaintiffs will almost certainly be subject to additional unconstitutional regulations,” attorneys with the Pacific Legal Foundation (PLF) wrote in a June 23 reply brief.

The courthouse of the U.S. Court of Appeals, District of Columbia Circuit | https://www.cadc.uscourts.gov/internet/home.nsf

In 2016, the FDA began regulating vaping materials under provisions of the Tobacco Control Act, even though the products do not contain tobacco. Yet the regulation did not come from Congress, nor from the heads of the FDA or Health and Human Services.

As it turns out, it was authorized and signed by Leslie Kux, an unappointed, unelected FDA employee.

The PLF maintains that under the Constitution’s Appointments Clause, only specially appointed officials are able to release regulations or similar governmental actions.

The lower court ruled that Kux’s regulation stands because it was later signed by proper FDA officials.

“The biggest issue in our case is when the Constitution is violated you get a remedy,” Jonathan Wood, PLF Senior Attorney, told the Novi Times. “The District Court took a different approach because the then-FDA Commissioner wrote a letter about it, but the court sort of took that and said the rule would have been the same.”

“That’s a really dangerous approach to take to Constitution,” Wood said.

While this is the first case targeting the FDA, there is a similar litigation against the National Marine Fisheries Service, Wood said.

“What we’ve seen is all agencies take the same approach. If sued, they’ll submit a letter to get rid of the case and don’t fix the underlying problem. This is the first case to keep going.”

The hope is the appellate court overturns the lower court’s ruling in the FDA case and sets the precedent that affects all other agencies, Wood said.

“Even if inferior officers have the power to issue the Deeming Rule, Ms. Kux was not properly appointed,” the reply brief states. “The Appointments Clause requires that Congress ‘by Law’ expressly establish the power to appoint inferior officers. U.S. Const. art. II, § 2, cl. 2. Congress has not done so here.”

A PLF study, “But Who Rules the Rulemakers?” found the practice prevalent at the HHS, leading to questions of democratic accountability.

The appeal also asserts the vaping rule violates the First Amendment.

“One of our challenges is vaping companies like my clients’ are not allowed to talk about their products, unless they prove to the FDA that it’s truthful and in the public interest. This is the kind of restriction on speech that I don’t think would be tolerated in any other context,” Wood said.

“It’s critically important, if the government says you can’t speak unless your speech is ‘good,’ that completely turns the First Amendment on its head,” he said.

Moreover, Wood noted, the vaping rule is public policy that threatens to shutter thousands of small businesses by imposing regulations that complicate the method by which they can improve and repair their products.

“I pray that they listen to it and not just come down on the side of the FDA,” Kimberly Manor, who owns Moose Jooce in Lake Station, told the Novi Times. “It’s a matter of public health. I quit smoking the first time I tried vaping, I have helped over 2,000 people quit smoking, but the FDA doesn’t like to give up control.”

The matter should have been handled at the Legislative level, not by an unappointed employee, Manor said.

“Because vaping looks like smoking, everybody has pushed that connotation with it. I feel 100% better since I quit smoking, but I can’t tell [customers] my personal story, I can’t grab them and say its 95% better for you than smoking, that vaping saves lives. I have to stand there and listen to them give me information that they have gotten from our government and HHS.”

“I’m so proud of what I do,” Manor added. “This is more than a job, it’s a calling.”