E-Cigarette Retailer Battles Regulators at Sixth Circuit

A man exhales while smoking an e-cigarette in Portland, Maine, in August 2019. (AP photo/Robert F. Bukaty)

(CN) — An e-cigarette and vapor technology retailer argued before the Sixth Circuit on Wednesday that the Food and Drug Administration’s deadlines for regulation of its vaping products are arbitrary and violate the Administrative Procedure Act.

Vapor Stockroom LLC and the Vapor Technology Association, or VTA, sued the FDA in August 2019, claiming the agency exceeded the scope of its authority when it established a 10-month deadline to complete regulatory filings for new vapor and nicotine products.

Originally, the FDA had imposed a deadline of Aug. 8, 2022, for the registration of “noncombustible products,” but was forced to change the date after it was sued by a group of physicians and public health organizations in Maryland federal court.

The judge in that case established the 10-month deadline currently challenged by the VTA. The trade group called the amended deadline “a transparent attempt at regulation by litigation.”

U.S. District Judge Karen Caldwell, an appointee of George W. Bush, sided with the government agency and granted its motion to dismiss in January.

Caldwell ruled the plaintiffs failed to establish causation in their lawsuit, specifically because their alleged injuries are “the result of the independent action of some third party not before the court.”

“As the District Court for the District of Columbia held in a recent, similar suit brought by cigar industry plaintiffs,” Caldwell said, “‘the predicament in which plaintiffs find themselves … was caused not by any action or inaction by the [FDA]; rather, it is entirely a function of a judicial ruling.’”

The VTA argued that the FDA’s suggestion of a 10-month deadline during the Maryland litigation established causation and granted it standing to pursue APA and due process claims, but Caldwell disagreed.

“Contrary to plaintiffs’ characterizations,” she said, “the government argued to the Maryland court that the ‘bedrock principles of administrative law constrain [that] court’s authority’ to enforce a specific deadline, and that the court should, instead, remand to the FDA.”

The judge added, “Even if the government had vigorously argued for the ten-month deadline, courts are not ‘motivated’ by parties to rule in a certain way. For example, this court, after considering defendants’ and plaintiffs’ arguments on justiciability, is now dismissing plaintiffs’ suit, but not because it has been ‘motivated’ to do so by defendants; rather, because that is what it has determined the law requires.”

Vapor Stockroom was the only party to challenge Caldwell’s decision on appeal, and attorney Eric Heyer of the Washington firm Thompson Hine argued on its behalf Wednesday morning before a panel of Sixth Circuit judges.

Heyer told the panel that “two separate legs” now support the accelerated deadline, referring to both the Maryland district court decision and a set of guidance filings established by the FDA after the ruling.

U.S. Circuit Judge Raymond Kethledge, an appointee of George W. Bush, asked the attorney why his client has not filed a separate suit to challenge the FDA’s guidance filings. He told Heyer the Cincinnati-based appeals court would have trouble granting relief regarding the decision of the Maryland court.

Heyer said his client has been “backed into a corner” and admitted that “we’ve had the ground shift under our feet” following the passage of the guidance filings.

“We can’t enjoin a completely independent agency action,” Kethledge told the attorney.

Heyer disagreed, telling the panel the “court’s inherent equitable powers” could be used to prevent enforcement of the deadline against his client.

Attorney Lindsey Powell argued on behalf of the FDA and disputed her opposing counsel’s claim regarding the appeals court’s authority.

“The guidance,” she said, “is an exercise of agency discretion not subject to review.”

Powell asked the panel to uphold Judge Caldwell’s decision regarding causation and disputed the “cat’s paw” theory advanced by Heyer and his client, who claimed the FDA urged the Maryland court to adopt the filing deadline.

“We’re not pulling one over on the district court,” Powell said.

In his rebuttal, Heyer reminded the panel he is not asking for relief on a broad spectrum, but instead only seeks an injunction to prevent enforcement of the deadline against his client, a single entity.

Senior U.S. Circuit Judge John Rogers, another George W. Bush appointee, and U.S. Circuit Judge John Nalbandian, an appointee of President Donald Trump, joined Kethledge on the panel.

No timetable has been set for the court’s decision.

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