Courts in the US, the FDA, and the end of ‘Chevron deference’: a dissenting view

There has been jubilation in the US e-cigarette industry, especially vocally from some of the trade organisations, over the demise of the legal doctrine of “Chevron deference”. But many commentators outside the sector itself have expressed reservations, and they are right to do so: this is a case where the devil you know may well be the better choice.

The 40-year-old doctrine was overturned by the Supreme Court in a decision not directly related to vaping (although a concurring opinion by one of the justices does quote Francis Bacon on “the vapours and fumes of law”). But it has direct and quite possibly immediate relevance to the Food and Drug Administration (FDA) and the frequent lawsuits brought against it by the industry, because “Chevron deference” said – in essence – that the courts could not overrule a reasonable agency interpretation of the law.

Under Chevron, even if the courts disagreed with the agency’s interpretation, they couldn’t do anything about it unless it was clearly unsupported by any reasonable argument.

 

Easier for courts to reverse FDA decisions

 

For the vape industry, this meant that when companies tried to challenge the FDA’s handling of the premarket tobacco product application (PMTA) process in court, the court’s hands could be tied. Chevron could mean that the FDA’s interpretation of the law had to stand.

Now, however, the binning of Chevron should make it easier for courts to reverse FDA decisions (though the outcomes of previous cases where Chevron was involved are not, and won’t be, automatically changed).

As the Supreme Court’s summary (or “syllabus”) of its ruling says, courts now should “exercise their independent judgment in deciding whether an agency has acted within its statutory authority, and courts may not defer to an agency interpretation of the law simply because a statute is ambiguous”. It adds that “delegating ultimate interpretive authority to agencies is simply not necessary to ensure that the resolution of statutory ambiguities is well informed by subject matter expertise”. In other words, a court is just as able as the FDA to decide exactly what Congress meant when it framed federal tobacco law.

 

Courts don’t have the expertise agencies do

Subscribe to our Newsletter

Join in to hear about news, events, and podcasts in the sector

    See more

     

    On the face of it, this does indeed sound like good news for the industry. The very basis of any FDA decision can be challenged in court without the FDA being able to fall back on ultimate authority. FDA marketing denial orders against flavoured products on the basis of potential youth appeal could possibly be overturned, for example, or the requirements for scientific evidence supporting PMTAs could be ruled unfair.

    But what’s easy to overlook amid the rejoicing is that giving greater power to the courts cuts both ways. While it is true that the FDA has not exactly been the industry’s best friend since it took over regulation of e-cigarettes in 2016, a future FDA might be more sympathetic. For example, the agency has just approved some menthol vape products for the first time; it is not difficult to imagine a situation where the FDA slowly starts authorising more flavoured products, an anti-tobacco organisation takes it to court, and (with the FDA unshielded by Chevron) a vape-sceptic court orders the authorisations to be withdrawn.

    For, in a country where the reputation of vaping has endured so many onslaughts and confusion between smoking-related harms and nicotine itself is so widespread, there are bound to be unfriendly courts as well as friendly ones. As a dissenting justice in the Supreme Court wrote, “agencies have expertise in [technical] areas; courts do not”.

     

    Could it all backfire?

     

    Persuading the FDA of reduced-risk nicotine products’ merits might not be easy, but it is going to be easier than educating every individual judge, and dislike of the FDA’s handling of the PMTA process to date shouldn’t blind us to the fact that Congress gave interpretive powers to specialist agencies in the first place precisely because they are likely to be better at it than generalist courts.

    Equally, making it much easier to get an FDA decision overturned through the judicial process will do nothing to bring consistency to the marketplace, or to level the regulatory playing field between small companies and bigger ones. It could just mean that the deep pockets already required to fund a PMTA will now have to be even deeper in order to fund the subsequent litigation. There will be individual winners, sure, but will the industry as a whole be any better off?

    Be careful what you wish for.

    – Barnaby Page ECigIntelligence staff

    Photo: Greg Willson

    Barnaby Page

    Editorial director
    Before joining ECigIntelligence in early 2014 as one of its first employees, Barnaby had a 30-year career as a reporter and editor for newspapers, magazines and online services, working in Canada, the US and the Middle East as well as his current British location. He has edited publications covering fields including technology and the advertising industry, and was launch editor of the first large daily online news service in the British regional media. Barnaby also writes on classical music and film for a number of publications. Barnaby manages the editorial and reporting teams and works closely with the analyst teams, to ensure that all content meets high standards of quality and relevance. He also writes for the site occasionally, mostly on science-related issues, and is a member of the Association of British Science Writers.