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US FDA’s authority over the vaping industry could face further challenges

US FDA’s authority over the vaping industry could face further challenges

Legal experts have given the vaping industry hope that the US Food and Drug Administration’s (FDA’s) authority to regulate e-cigs could face further legal scrutiny, reports ECigIntelligence

In early June the US Supreme Court recently refused to review a challenge initiated by a vape shop.

As the court did not reject the challenge outright, but simply declined to review it, legal experts believe this leaves the door open for other lower courts to issue conflicting rulings that could push the matter back onto the Supreme Court’s agenda.

“The court generally does not do well on an issue that they have dealt with in a prior term, but we will see,” J Gregory Troutman, a lawyer in Louisville, Kentucky, who represents vape shops and trade groups in legal matters across the US, told ECigIntelligence.

The Supreme Court is approaching the end of the period in which it selects cases to hear in the upcoming term, and by the time it considered the challenge to FDA regulation of vaping products its “docket was already pretty full”, according to lawyer Jerad Najvar of Houston, Texas, who represented Mississippi-based Big Time Vapes, the plaintiff in the recently denied review petition.

And Najvar emphasised that the ruling was “not a precedential decision” and the matter could potentially be raised at the highest legal level again.

“It is the end of the road for Big Time Vapes vs FDA, but that’s not to say the same argument could not be litigated elsewhere,” he said. “That’s not in our plans at the moment but we are looking at other things” – including possible litigation regarding the specifics of how the FDA is implementing its authority.

According to Najvar, the FDA is “not living up to their obligations under several statutes”.

A second, still-pending case before the Supreme Court involves the FDA’s delegation of authority to government bureaucrats, who petitioners argue are not constitutionally permitted to make such decisions.

While court watchers acknowledge it could face the same fate as the recently rejected review petition, Troutman pointed to the credentials of the petitioning lawyers as a reason for the challengers to remain optimistic. “It is easier to argue a more narrow, focused issue than it is a broader issue,” he said.

Other experts say the likeliest route for changing the regulatory authority over e-cigarette products may be through the FDA itself.

The Small Business Administration (SBA) recently wrote to acting FDA commissioner Janet Woodcock requesting an extension of the one-year moratorium on enforcement actions against manufacturers who submitted premarket tobacco product applications (PMTAs) by the 9th September 2020 deadline.

The SBA also called on the federal agency to “reverse its policy of reviewing submitted PMTAs by market share to keep small manufacturers’ products on the market”.

What This Means:

Although one big door has closed with the Supreme Court decision not to review the Big Time Vapes case, other small cases focusing on specific issues of the regulation could potentially make it to court.

Legal experts, we spoke to believe that after the legal scrutiny undertaken against the FDA’s authority by some in the industry there is “widespread optimism” that the agency could eventually relent in its regulations.

ECigIntelligence is the leading provider of the detailed global market and regulatory analysis, legal tracking, and quantitative data for the e-cigarette, heated tobacco, and combustible-alternatives sector worldwide.

We offer the necessary tools to navigate the complex market and regulatory landscape of this sector through independent, analytical and actionable data insights, in-depth country reports, regulatory trackers, and legal analysis. In addition, we offer customized research and consultancy support.

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