Courts could overrule US FDA decisions after Chevron deference overturned

The US Supreme Court has overturned the Chevron doctrine, which held that courts should defer to the interpretations of expert federal agencies regarding ambiguous laws the agencies are required to implement, as long as the agency’s interpretations are reasonable.

The ruling – based on the 1984 decision in Chevron vs Natural Resources Defense Council that established an important principle in administrative law, known as “Chevron deference” – may have an impact on the tobacco and nicotine industry, as it could open the doors for the courts to potentially overrule US Food and Drug Administration (FDA) decisions. The ruling was issued last week, with the six conservative justices in the majority and the three liberals in dissent.

“Chevron is overruled,” wrote chief justice John Roberts in the decision that overturned the doctrine. “Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA [Administrative Procedure Act] requires.”

Justice Elena Kagan, writing a dissent joined by the court’s two other liberals, said that, with the overturning of Chevron, “a rule of judicial humility gives way to a rule of judicial hubris”.

“In one fell swoop, the majority today gives itself exclusive power over every open issue – no matter how expertise-driven or policy-laden – involving the meaning of regulatory law,” Kagan wrote. “As if it did not have enough, the majority turns itself into the country’s administrative czar.” She also pushed back against the majority’s suggestion that overruling the two-step Chevron doctrine would introduce clarity into judicial review of agency interpretations.

 

Impact on FDA’s authority

 

Interviewed by ECigIntelligence, US lawyer Sean Griffin, partner at law firm Sidley Austin, said this decision is likely to have an impact on the FDA’s authority across all tobacco and vaping products. He highlighted that courts have previously found parts of the Tobacco Control Act (TCA) to be ambiguous and have upheld the FDA’s interpretation based on reasonableness under step two of the Chevron doctrine – for example, in Cigar Association of America vs FDA, deferring to the FDA’s interpretation of the phrase “component or part”.

“Now, that is no longer a permissible result,” Griffin said, “now the court would have to determine what the best understanding of the statute is. And we may get an example of the new approach from the Supreme Court next term.”

 

Appeal petitions on hold

 

Griffin said the court also just granted certiorari (agreed to hear the appeal) in the Wages and White Lion case and placed several other certiorari petitions involving electronic nicotine delivery systems (ENDS) products on hold, pending the resolution of that case. “And I would expect to see increased litigation around the FDA’s implementation of the key statutory terms,” he added, “for example, how to apply the PMTA [premarket tobacco product application] authorisation standard ‘appropriate for the protection of the public health’ and whether the term ‘nicotine’ can include nicotine analogues.”

In FDA vs Brown & Williamson Tobacco in 2000, the Supreme Court cited the Chevron doctrine in relation to the tobacco industry. However, according to ECigIntelligence analysts, that does not mean that every regulation involving tobacco would raise this issue – the type of policy needs to have an impact of national significance, such as a total ban.

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    In an amicus curiae brief (where a person or group not party to a legal case is allowed to offer the court information) submitted to the Supreme Court last year by a group of vaping businesses and trade organisations, lawyers representing the industry explained that the FDA “has applied a one-size-fits-all approach which has swung the pendulum far to one side, in effect banning all non-tobacco flavoured (for example, mint and fruit) ENDS products, and in the process focusing its attention largely on underage use at the expense of adult smokers”.

    “FDA implemented this de facto ban,” they said, “not by asking Congress to amend the TCA or by promulgating a tobacco product standard via public notice and comment rulemaking, as required by APA, but rather through a statutory interpretation that is not grounded in the TCA’s text, structure, and context.”

     

    ‘Significant threat’

     

    Cliff Douglas, CEO of Global Action to End Smoking, said the Supreme Court’s decision to overturn the Chevron deference represents a “significant threat to public health, as well as a wide array of environmental and consumer protections”.

    “FDA has left much to be desired in its regulation of tobacco products,” Douglas said. “The current PMTA process is opaque, expensive and cumbersome, and the agency has essentially created a de facto ban on novel, risk-minimising nicotine products that millions of consumers have turned to as life-saving options. Even with the recent, welcome decision to authorise a handful of menthol-flavoured e-cigarettes, these products make up only a minuscule fraction of the total e-cigarette market, most of which is illicit.” Douglas added that the “solution is not to weaken the FDA’s authority”.

    Likewise, Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said that, while disappointing, the Supreme Court decision overturning the Chevron deference should not impact the FDA’s clear authority, granted by Congress, to regulate tobacco products.

    “This principle has long helped ensure that healthcare and other laws are interpreted and implemented appropriately by expert federal agencies,” she said.

     

    Legal challenges

     

    Tony Abboud, executive director of the Vapor Technology Association (VTA), welcomed the decision, blaming the federal agency for overstepping its authority when it chose to implement a ban on flavoured e-cigarettes in its deeply flawed implementation of the PMTA process.

    “There is no question that the FDA violated the Administrative Procedure Act by implementing what the Fifth Circuit Court of Appeals called a ‘de facto ban on flavoured e-cigarettes’ through its shifty implementation of the PMTA regulation,” Abboud said, “by imposing new requirements on products after applications were already filed, ultimately ensuring their application’s demise.” He added that the ruling puts the agency’s misregulation of flavoured e-cigarettes “in serious jeopardy and raises real legal challenges for the FDA’s serial and en masse rejection of e-cigarettes, which the FDA continues to reject without proper review of the science”.

    This week, the Supreme Court also agreed to consider whether the federal agency acted unlawfully in rejecting flavoured vaping products, which are rising in popularity among teenagers.

    – Antonia Di Lorenzo ECigIntelligence staff

    Antonia Di Lorenzo

    Assistant news editor/senior reporter
    Antonia is a member of the editorial team and holds a masters degree in Law from the University of Naples Federico II, Italy. She moved in 2013 to London, where she completed a postgraduate course at the London School of Journalism. In the UK, she worked as a news reporter for a financial newswire and a magazine before moving to Barcelona in 2019.

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