Not quite a year ago we had a little fun commenting on the Daubert dismissal of a suit involving something called an “ear candle.” As we said back then:
[W]e never thought about lighting a candle in our ear. That seems a little strange. Maybe even a little risky. We can’t think of a good reason to plant a candle in an ear, and we can think of a pretty good reason not to: hot wax. That might hurt.
Apparently the FDA had similar qualms. We’ve just learned from reading Holistic Candlers & Consumers Ass’n v. FDA, ___ F.3d ___, 2012 WL 5831 (D.C. Cir. Jan. 3, 2012), that: (1) those who make candles for people to shove in their ears (at least 15 different entities) and set on fire actually have their own lobbying group (that’s scary – are UFO believers next?); (2) some people actually believe shoving a lit candle in your ear is a healthy thing to do (that’s scarier); and (3) the FDA is on the case (that’s probably good, although one might wonder about the Agency’s enforcement priorities).
So why do we care about people who stick lit candles in their ears?
Because – aside from keeping a straight face – the Court of Appeals makes a point about FDA warning letters that needs to be kept in mind whenever such things surface in product liability litigation. Such letters, including the 15 issued in this case, don’t mean squat as supposed statements of FDA regulatory positions:
FDA’s warning letters . . . neither mark the consummation of the agency’s decisionmaking process nor determine the appellants’ legal rights or obligations. The letters plainly do not mark the consummation of FDA’s decisionmaking. . . . FDA warning letters . . . giv[e] firms an opportunity to take voluntary and prompt corrective action before [the FDA] initiates an enforcement action. . . . Nor do the letters represent a decision determining rights or obligations, or one from which legal consequences flow. . . . [A] Warning Letter is the agency’s principal means of achieving prompt voluntary compliance with the [FDCA]. Although a warning letter communicates the agency’s position on a matter, it is only informal and advisory and does not commit FDA to taking enforcement action. . . . In short, an FDA warning letter compels action by neither the recipient nor the agency.
Holistic Candlers, 2012 WL 5831, at *2-3 (citation to the FDA’s regulatory procedures manual and quotation marks omitted).
This discussion of FDA warning letters was important in Holistic Candlers because, due to their preliminary nature, “FDA warning letters do not represent final agency action subject to judicial review.” Id. at *4. Thus, the litigation was snuffed.
To us it’s important because FDA warning letters don’t even rise to the level of a criminal indictment, let alone a conviction. An indictment is at least the “initiation of an enforcement action,” whereas an FDA warning letter isn’t even that. It might even be less than a DOJ target letter (we say “might” because we’re not criminal lawyers, and don’t claim to know all the implications of a target letter). If mere criminal charges not leading to conviction are not admissible evidence, then a fortiori an FDA warning letter should not be admissible in similar circumstances. This isn’t the first time we’ve made this point about FDA warning letters, but it’s a point that bears repeating.