Juul Files Appeal Against ‘Unlawful’ FDA Vape Ban

Juul Lab’s e-cigarette products have become “tobacco non grata” as federal regulators ordered the company to pull all its vape products from shelves and stop selling its wares Thursday. Just one day later, the vape company filed a last ditch effort to stop themselves from going up in smoke.

The U.S. Food and Drug Administration announced Thursday that Juul failed to show enough evidence that their products won’t impact public health in its premarket tobacco product application. The agency further claimed the company’s studies provided “insufficient and conflicting data.”

Juul filed an appeal against the decision in federal appeals court Friday asking for a temporary hold. In its appeal, Juul called the FDA’s marketing ban “extraordinary and unlawful” and that “at every turn, FDA singled [Juul] out” while not allowing them to resolve “largely technical concerns.”

In a statement yesterday, Juul’s chief regulatory officer Joe Murillo said they would be seeking this stay, but the speed of this move shows just how brutal the FDAs decision is for the company. Juul’s appeal also complained about how the news of the FDA’s decision was first leaked to the press Wednesday. The company seems to think that the agency was targeting them with an “arbitrary and capricious” decision.

In the agency’s original release announcing the move, FDA Commissioner Robert Califf said his agency dedicated “significant resources” to companies like Juul that hold wide sway over sectors of U.S. markets. He further said that Juul holds “a significant part of the available products and many have played a disproportionate role in the rise of youth vaping.”

Murillo said in yesterday’s statement the company’s toxicological data “meets the statutory standard of being ‘appropriate for the protection of the public health.’”

Juul has been held under the lens of regulators for several years following multiple allegations the company targeted young children with its vaping products. The FDA previously banned sweet-tasting candy or fruit pod flavors for all vape products and left just tobacco or menthol flavors allowed for sale. The agency said Thursday that while regulators did not have info to suggest there were immediate hazards with the use of Juul’s vapes, there was not enough data provided to assess the total toxicological risks.

This is compared to competitor e-cig brand Vuse, which gained FDA approval last year. Insider cited legal experts who said this latest move might be the starting gun for a much broader regulatory push against industries like vapes.

Juul Lab’s e-cigarette products have become “tobacco non grata” as federal regulators ordered the company to pull all its vape products from shelves and stop selling its wares Thursday. Just one day later, the vape company filed a last ditch effort to stop themselves from going up in smoke.

The U.S. Food and Drug Administration announced Thursday that Juul failed to show enough evidence that their products won’t impact public health in its premarket tobacco product application. The agency further claimed the company’s studies provided “insufficient and conflicting data.”

Juul filed an appeal against the decision in federal appeals court Friday asking for a temporary hold. In its appeal, Juul called the FDA’s marketing ban “extraordinary and unlawful” and that “at every turn, FDA singled [Juul] out” while not allowing them to resolve “largely technical concerns.”

In a statement yesterday, Juul’s chief regulatory officer Joe Murillo said they would be seeking this stay, but the speed of this move shows just how brutal the FDAs decision is for the company. Juul’s appeal also complained about how the news of the FDA’s decision was first leaked to the press Wednesday. The company seems to think that the agency was targeting them with an “arbitrary and capricious” decision.

In the agency’s original release announcing the move, FDA Commissioner Robert Califf said his agency dedicated “significant resources” to companies like Juul that hold wide sway over sectors of U.S. markets. He further said that Juul holds “a significant part of the available products and many have played a disproportionate role in the rise of youth vaping.”

Murillo said in yesterday’s statement the company’s toxicological data “meets the statutory standard of being ‘appropriate for the protection of the public health.’”

Juul has been held under the lens of regulators for several years following multiple allegations the company targeted young children with its vaping products. The FDA previously banned sweet-tasting candy or fruit pod flavors for all vape products and left just tobacco or menthol flavors allowed for sale. The agency said Thursday that while regulators did not have info to suggest there were immediate hazards with the use of Juul’s vapes, there was not enough data provided to assess the total toxicological risks.

This is compared to competitor e-cig brand Vuse, which gained FDA approval last year. Insider cited legal experts who said this latest move might be the starting gun for a much broader regulatory push against industries like vapes.