A group of anti-tobacco groups led by Campaign for Tobacco-free Kids have gleefully announced that they are suing the FDA. They demand that the FDA reverse the decision to delay implementation of the near-ban of vapor products, from the original deadline later this year until 2022. There is little doubt that the lawsuit will fail. So the interesting question is why are they doing it.
When the FDA asserted authority over vapor products and cigars, they set an August 2018 deadline for manufacturers to apply for “new product” approval, which they later delayed until 2022. The research and legal work needed for such an application, to have any hope of success, costs in the seven-figure range, meaning that only manufacturers with a top-selling closed-system will even try. The rest of the market, including all open-system products, will be banned when that deadline arrives, unless there are major changes in the way the FDA regulates tobacco products. Moreover, it is not entirely clear that any product can get approval.
If the plaintiffs get what they are asking for, all vapor products would be banned as soon as the decision was handed down. But there is basically no chance they will prevail.
First, it seems almost certain that the suit will be dismissed on the grounds that the plaintiffs do not have standing. This basically means that they cannot sue over a policy that has no material impact on them. Just as being an entitled busybody with opinions about how others should live does not make someone a stakeholder, it also does not give them standing to sue. As previously reported, a federal judge ruled unequivocally that this same coalition did not have standing to intervene in a manufacturer lawsuit against the FDA that focused on warning labels. They actually had slightly better (though still hopelessly weak) arguments for standing in that case; they argued that relaxing warning label requirements would “force” them to spend more to “educate” the public. In the present case, their only available claim is that they are busybodies.
Second, in the extremely unlikely event that the suit is not dismissed based on standing, prevailing on the merits seems equally hopeless. The lawsuit contends that the FDA exceeded its authority when it changed the deadline. But the original deadline was an arbitrary choice by the FDA, and there is no basis for suggesting it is somehow a better date than any other. The reasons the FDA cited for the delay are solid and reasonable. Courts almost never second-guess an agency’s decision under such circumstances. In addition, though it is hardly worth thinking about given the vanishingly small probability, if a court did find in favor of the plaintiffs, it would not move the deadline back to the original. That would make it literally impossible to comply. The deadline would be set far enough after the decision to be practical, which would be a year or two later, given how onerous these applications are. In other words, the deadline would be basically unchanged from the current plan.
The plaintiffs undoubtedly know all this. So what is the purpose of filing the suit? It must be some combination of signaling and propaganda. The suit is not so newsworthy that the general public could be the target audience. Thus it has got to be about the FDA itself. The possible stories fall into two categories: supporting FDA plans, and signaling antagonism toward the FDA and their possible plans.
Taking the latter first, one story is the plaintiffs trying to punish the FDA for making a decision they did not like, hoping that their scolding glares, the press releases and the cost of legal action will make FDA think twice before doing it again. This seems rather unlikely. The FDA completely eclipses anti-tobacco groups in terms of influence and funding. Alternatively, it could be a threat to the FDA about approving any vapor products as “new products” when the deadline comes. In this story, the plaintiffs are using a pointless lawsuit to signal that they will also sue over any approvals later. Unlike the present one, those cases would be ugly for the FDA if allowed to proceed. The plaintiffs would claim that the approval was arbitrary and capricious, and they could make that case. All of the FDA’s approval decisions about tobacco products are arbitrary and capricious. FDA has not created rules that applications must follow (or can follow) to earn approval, and thus all of the decisions are ad hoc.
That threat might well be about one particular product line. The media blitz from CTFK and their followers emphasized the popularity of Juul products and the supposedly widespread underage use. At first blush this is rather ironic, given that bestsellers like Juul are the only products that could survive past the deadline. They would become more profitable, more widely available and more accessible to minors. While this might just represent ironic cluelessness, it might be a specific signal that these groups want to make sure that Juuls in particular are denied approval and that they will fight the FDA if the agency approves the devices.
The weakness in all of these stories is that the anti-tobacco groups are dependent on the FDA to further their prohibitionist agenda, and the agency is giving them almost everything they want. Although the FDA is not likely to bother being too spiteful, attempts to twist their arms via lawsuit, intimidation or mobilization could backfire. Tobacco product manufacturers, who are also dependent on the FDA’s whims, also sue the agency. But they do so with a clear agenda and a credible case, not to lash out. Presumably everyone sees it as “just business” rather than confrontational games.
That leaves the possibility that this lawsuit is intended as a gift to the FDA. A suit that is doomed to quickly fail cannot hurt the agency. But the FDA can pretend otherwise, using it as an excuse for restrictive policies. It is a perfect setup for “bothsidesism.” With the FDA’s existing policies and current proposals, the U.S. is on a path to having the most extreme anti-tobacco measures of any relatively free country. But even this extremism can be spun with, “hey, we are finding a fair middle-ground; both sides are suing us, so we must be striking a balance.” If this is the story, it is not likely to have happened without the FDA indicating their support for the lawsuit, at least at a nudge-wink level.
Whatever the explanation, vapers should not worry much about the lawsuit forcing FDA action. It is the actions that the FDA itself chooses that threaten vapers. The only concern about the lawsuit and the extremists behind it is that they could encourage the FDA to cause even more harm than the agency already plans.
