FDA taken to court over slow course of action currently taken

May 22, 2019

to enact any kind of regulation, because you know governments are great at doing things quickly.  In the latest challenge against vaping, the Food and Drug Administration is being forced by a federal court to abandon it's previous industry guidance and begin expediting the process of regulating such products.

United States District Judge Paul W. Grimm of the district of Maryland ruled in the case of American Academy of Pediatrics et al v. FDA that due to lack of action taken on deemed tobacco products such as e-cigarettes, eLiquids, and vaporizers under the FDA’s current interpretation of the Tobacco Control Act, the public health regulator must act in expediting regulatory requirements.  That's right, the suit is contesting that a federal regulating agency should, perhaps, actually regulate something that falls in the agencies purview. 

Judge Grimm’s decision forces the FDA to give up the 2017 guidance delaying pre-market tobacco applications for e-cigarettes and vape products to a later date. The agency utilized its discretionary power as the enforcing agency to implement the deadline for PMTA applications and similarly allowed products that would be technically deemed as non-compliant to remain on the market during the interim. Courts typically allow enforcing agencies to determine compliance policies under their specific federal statutes, and the public health organizations suing as the plaintiff class were able to challenge precedence in this case.

The American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, and the Truth Initiative and five individual pediatricians, made up the plaintiff class.

In the initial complaint filed in 2018, the plaintiffs accused specifically former FDA commissioner Scott Gottlieb, his agency, and the Department of Health and Human Services of failing to live up to statutory requirements.  Kind of makes sense why Scott was in such a hurry to vacate the head spot of the FDA at the end of March.

In the 2017 compliance policy that was issued in August of that year, the FDA extended the compliance deadlines for filing PMTA submissions for Deemed Products to August 8, 2021, for combustible products and to August 8, 2022, for other noncombustible products.

The plaintiffs allege that this guidance exceeds the FDA’s authority as the enforcing agency and that its implementation was “arbitrary and capricious” and that it violates the U.S. Constitution’s Take Care clause that requires the president and his administration to faithfully enforce the law due to the delay in the pre-market review process for tobacco and deemed products. Additionally, it was alleged that the FDA also violated provisions of the Administrative Procedure Act (APA) that requires a public comment period for any new regulations promulgated from the agency as the enforcing entity. 

Litigation persisted until March of this year when Gottlieb’s FDA issued that month’s revision to the compliance policy. The court issued a stay on the case due to the implementation of the guidance that is still under review by the FDA. The plaintiffs were able to convince Judge Grimm to issue a summary judgment mandating the implementation process for PMTA requirement to begin before the deadline dates. Under the March guidance, the compliance deadlines were again amended.

The plaintiffs managed to argue that as public health advocacy groups that are likely to be involved in the public comment period of any proposed regulation, then they are entitled to all information on the safety and the efficacy of these products under a declaration of informational injury. Grimm ruled that the public health groups faced injury for not having immediate access to information related to any regulatory action or rule making.  Basically passing the buck back and forth until the FDA actually does something about their regulatory statutes. 

With regards to the oncoming regulatory implications there's quite a bit to speculate on.  Grimm ordered: “Plaintiffs will submit additional briefings regarding a remedy, in fifteen pages or less, within fourteen days of the date of this Memorandum Opinion. Defendants will have fourteen days to respond, in fifteen pages or less, and Plaintiffs will have five business days to reply, in ten pages or less.”

FDA likely to appeal

Tony Abboud, the executive director of the Vapor Technology Association, had this to say about the situation; "It appears that the court misunderstood the underlying facts and both misunderstood and misapplied the applicable law.”  Continuing; “Based on our initial review, we believe there exists a reasonable likelihood of reversal should FDA appeal the decision. Importantly, because this decision goes to the heart of FDA’s authority to exercise enforcement discretion with respect to pre-market review and other legal requirements, we anticipate that FDA will appeal this decision.”

If FDA declined to appeal this ruling, the precedence set would adversely impact the regulatory power the agency maintains.  It would also mean the entire destruction of our industry.  Vaping would probably fall straight into the hands of tobacco giants and there'd be nothing but menthol and tobacco flavors available, depending on how harshly they chase after the DIY and mom and pop markets. 

Despite the promises by the FDA, the agency has still yet to finalize critical documents that the industry needs to file pre-market applications. In order to protect adult access to less harmful alternatives to cigarettes and stop somewhere around one hundred thousand Americans from becoming unemployed, FDA should definitely appeal this ruling.

What do you think? Are these nonprofits really acting in their do-good intent to get the truth about vaping out there, or are they also trying to kill the whole vape world?  Has the FDA been sitting on it's hands far too long?

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