Law360 (February 20, 2020, 5:41 PM EST) -- A group of Democratic U.S. senators are demanding an explanation from U.S. Department of Health and Human Services Secretary Alex Azar after he said some vape products will be exempt from a court-ordered deadline on applications for U.S. Food and Drug Administration approval.

Eleven senators — including Democratic presidential candidates Elizabeth Warren, D-Mass., and Amy Klobuchar, D-Minn. — sent Azar a letter on Thursday in response to comments he made on an Ohio radio show on Jan. 21.

Any new tobacco product requires FDA approval before it can go to market. But the FDA gave the vaping industry until 2022 to get their premarket applications in — an extension that a federal judge later shortened to May 2020.

In the letter, the senators said they are concerned that Azar's comments mean the FDA and HHS intend to inappropriately cut some vaping products a break on a deadline that should apply to the industry broadly. The FDA's own rules on what constitutes a tobacco product apply to a variety of things, including any "electronic nicotine delivery systems" and their accompanying parts, the senators said.

"It is incredibly alarming that while youth e-cigarette use is skyrocketing, the Trump administration continues to focus on ideas that would delay and diminish long-overdue steps to hold tobacco companies accountable," the senators said.

On the radio show in January, Azar responded to host Scott Sands' questions about vaping regulation by saying that the May 12 deadline for premarket tobacco approval applications only applies to e-cigarettes, not all vaping products.

Azar also said the Trump administration is working with businesses and vaping advocates to create "pathways that would streamline approval for the open-tank, small vape shop-based products."

Open-tank vaping systems allow the user to mix their own flavors, which is typically done in a vape shop.

"Really what we're focused on are the cartridges in the systems with kid-attractive flavors," Azar said.

The senators' letter tells Azar that the regulations apply to all "new tobacco products," which would include the open-tank products. It asks Azar to clarify what he meant by March 5, and confirm that regulators will be reviewing applications from open-tank vaping products.

HHS representatives did not respond to a request for comment on Thursday.

The deadline has been the subject of extensive litigation across multiple states, but as of now, it remains in place.

In 2018, the American Academy of Pediatrics and several other public health groups sued the FDA and HHS, saying the agencies had violated the Administrative Procedure Act when they gave the vaping industry an extension on the applications.

U.S. District Judge Paul Grimm agreed and vacated the FDA's extension, saying the agencies had overstepped their authority. The health groups urged him to set a 120-day deadline, while the FDA suggested a 10-month deadline, according to court records.

In July, Judge Grimm chose the 10-month timeline, setting a deadline for May 2020.

That ruling has been appealed to the Fourth Circuit, where it is still pending, court records show. But the FDA has said it will adhere to the May deadline regardless of how the case ends up.

The vaping industry has argued that the deadline is unreasonable and could force many businesses to close.

In addition to the appeal, the industry has also fought back in separate litigation. The Vapor Technology Association, a vaping trade group, sued the FDA to stop the deadline in Kentucky federal court last year.

But in January, the Kentucky judge said the group had no standing to sue the FDA, because the deadline was set by the Maryland court.

Democratic Senators: 

--Additional reporting by Sam Reisman, Emily Field and Hailey Konnath. Editing by Nicole Bleier.

 

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