Skrmetti (upholding Tennessee statute forbidding gender dysphoria treatments for minors) was the SCOTUS case that got the most publicity last week, but we drug and device lawyers will always perk up most when we see the High Court issue a ruling regarding the Food and Drug Administration (FDA).  That is probably one reason (though surely not the only reason) why at parties the people with whom we are chatting invariably dart their eyes around the room, desperately searching for a more interesting conversation companion. 

Food and Drug Administration v. R.J. Reynolds Vapor Co., 606 U.S. —- (June 20, 2025), is not a product liability personal injury case, but it offers an interesting (to us, anyway) perspective on challenges to FDA actions.  Both our clients and our opponents sometimes have an interest in pursuing such challenges.   Does the R.J. Reynolds Vapor case offer a blueprint, contrast, or cautionary tale?

The R.J. Reynolds Vapor case concerned the FDA’s denial of approval of tobacco vaping products under the Family Smoking Prevention and Tobacco Control Act (TCA).  21 U.S.C. section 387j. The FDA determined that the vapor product had not been demonstrated to be “appropriate for the protection of the public health,” as required by the TCA.  21 U.S.C. section 387(c)(2)(A).  (We will not hearken back to our tobacco-law days, at least not too much, when we point out that this policy decision by the FDA is a subject of theoretical majesty. You might think that tobacco vaping products pose risks, but what if they are alternatives to riskier products? Must perfection be the enemy of better?) The key questions in the R.J. Reynolds Vapor appeal would seem to center on standing and venue, but the High Court insisted on talking about zones of interests rather than standing, and ducked the most interesting venue issue. The former was an exercise in statutory interpretation, while the latter was a matter of “prudence.” 

In reality, R.J. Reynolds Vapor is a case about persons and places, and it is about choosing the right persons to get to the right places. (Interpret that word “right” however you please.) Per statute, challenges to FDA actions can be brought in the District of Columbia or the challenger’s residence/principal place of business.  But who can be a challenger?

Obviously, the disappointed applicant can bring a challenge.  If not them, then who? In this case the manufacturer was located in North Carolina, which is in the Fourth Circuit.  Accordingly, the manufacturer had the choice of filing its challenge in either the DC or Fourth Circuit.  But prospects for overturning the FDA’s denial did not look good in those courts. By contrast, the odds of overturning the FDA’s disapproval looked a lot better in the Fifth Circuit.  (With a little help from Google you can catch up on developments explaining why that is so.) 

The manufacturer then did something clever.  It challenged the FDA denial in a joint petition with a Texas-based retailer and a trade association in Mississippi. (Critics of the R.J. Reynolds Vapor opinion like to characterize the retailer as a gas station. So what? It is still a retailer. Plus, we remember that during the interminable Engle trial – speaking of tobacco litigation – the best retail local wine selection was at a Miami gas station.)  Texas and Mississippi are both in the Fifth Circuit.  Even aside from the FDA/vaping developments referenced above, if you are even remotely sentient you know that the Fifth Circuit is perceived to be the most conservative, pro-business, anti-agency, etc., jurisdiction in the country.  That image might be simplistic or overblown, but there it is. There has been some legal and political controversy about litigants filing cases in one-judge divisions within the Fifth Circuit so as virtually to guarantee a favorable outcome.  It is an extreme and relentlessly successful form of forum-shopping. But the issue in R.J. Reynolds Vapor was who could file a challenge to the FDA’s denial of approval of the vaping products, and where could they do so. The only reason for the case being in the Fifth Circuit was the involvement of the retailer and trade association. But did they have any business being in the case?

A divided panel of the Fifth Circuit held that the retailer and trade association could bring the challenge and that, therefore, venue in the Fifth Circuit was proper.  The FDA filed for certiorari (a recent episode of the Advisory Opinions podcast entertainingly shows the remarkably different ways that word is pronounced by the Justices), and thus we have the SCOTUS opinion. Remember that while trial courts decide cases/controversies, SCOTUS decides legal questions. Here is the question teed up by the parties:  Whether a manufacturer may file a petition for review in a circuit (other than the U.S. Court of Appeals for the District of Columbia Circuit) where it neither resides nor has its principal place of business, if the petition is joined by a seller of the manufacturer’s products that is located within that circuit.  The majority decision in R.J. Reynolds Vapor was authored by the always intriguing Justice Barrett and the opinion affirmed the Fifth Circuit ruling. Justice Jackson, joined by Justice Sotomayor, dissented.  (It is interesting that Justice Kagan was with the majority on this case. Besides probably being the best writer on the Court, the former Harvard Law dean is wicked smart on procedural issues.  Recall that she dissented in Mallory. There is some speculation that Justice Kagan sided with the conservatives on recent cases in order to do some horse-trading on others.  That seems unlikely, but perhaps we shall see.)

The TCA is the main statute at issue in this case, along with the Administrative Procedure Act (APA). The TCA  sets forth the statutory zone of interest by permitting challenges to adverse FDA action by “any person adversely affected” by the FDA’s denial.  21 U.S.C. §§ 387l(a)(1).  That is the same language used in the APA, and the High Court majority interprets it the same way – to include anyone even “arguably” aggrieved by the action.  Therefore, it is not only the applicant who can sue, but in this case so can any retailers that could have sold the product for a profit.  They literally have “business” being in the case. We are all textualists now, right?  The Court cites A. Scalia & B.Garner, Reading Law (2012).  If you do not have that book on your shelf, you might want to get it. The Court points out that it would be passing strange to read the word “any” to mean “only one.”  If Congress had meant to limit standing to the applicant, it would have said so, as it has in other contexts. (More on that later.).   

The Court did not decide the interesting question of whether each petitioner must be in the correct venue. The FDA argued to the Supreme Court that even if the retailer and trade association can sue in the Fifth Circuit, a manufacturer from the Fourth Circuit should not be allowed to join in on the fun. But the FDA did not argue that position below, and SCOTUS would prefer to have that issue fleshed out below before deciding it. Too bad. There is a bit of a parallel between what happened in this case and the utilization by plaintiffs of (okay, we’ll say it: fraudulent) joinder of local defendants, often retailers, to steer a case away from federal court. There is real force to the FDA’s argument in this case, which was picked up by the dissent, that forum shopping is afoot.

While this action involves potential sellers of vaping products, could it also just as easily involve persons desiring to distribute drugs or vaccines or any other product (e.g., Ivermectin) that the FDA might refuse to approve for a particular use in the future? After all, just as with vaping products, there are retailers of drugs and vaccines who might realize profits.  What about PBMs?  What about patients who feel aggrieved by the unavailability of certain products? We plodding bloggers probably would have thought of those questions on our own but, to be honest, it was one of our faithful readers who first broached them to us.  And then he came up with a decent answer: it comes down to the relevant drug/device/vaccine language regarding standing to sue over approvals/rejections. The APA language is broad and, as the R.J. Reynolds Vapor majority points out, “not especially demanding.”  But it is likely not the only language at issue in any given case.  If the governing statute turns out to be the same as the TCA, you can expect the same answer. Find “any person adversely affected” by the denial, apply the “arguably” standard to determine who was adversely affected, and you’re off to the races. But first you must compare the governing language to what the Court construed here.  Notably, the opinion in R.J. Reynolds Vapor indicates that more narrow TCA statutory language applies to orders that a product be withdrawn, so withdrawals may not support such broad standing, er, zone of interest. The statutory language matters. It is, in fact, dispositive. 

To take just one example, for challenges to denial of a New Drug Application (NDA) under the Food, Drug, and Cosmetic Act, after exhaustion of administrative process, an “appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application under this section.  Such appeal shall be taken by filing in the United States court of appeals for the circuit wherein such applicant resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit….”  Section 505(h) (emphasis supplied by your friendly blogger). That “applicant” language is considerably narrower than “any person adversely affected.” Sorry, but there is no substitute for flipping through the statutes.