Tuesday, September 18, 2012

The FDA On Warning Letters - They're Sure Not Final

Remember that case about ear candles?  Given the product, we had some fun with it in our earlier posts. Well, it turns out that the ear candling folks are nothing if not persistent. They appealed the second opinion, Holistic Candlers & Consumers Ass’n v. FDA, 664 F.3d 940 (D.C. Cir. 2012), to the Supreme Court. As our post indicated, this opinion turned (in part, but a large part) on the “finality” of an FDA warning letter.


The Supreme Court appeal has given the FDA the opportunity to state its formal opinion about how it views the “finality” of warning letters. See Brief for the Respondents [FDA] in Opposition, Holistic Candlers & Consumers Ass’n v. FDA, No. 11-1454, 2012 WL 3991471 (filed Sept. 11, 2012). To put it succinctly, they aren’t final at all.

Since it’s Friday and we’re lazy, we’ll simply quote for you some of the FDA’s reasoning on why its warning letters aren’t legal determinations of anything. Here’s what the FDA has told the United States Supreme Court:

If FDA believes that a person is violating the FDCA, the agency may issue a warning letter giving the person an opportunity to take voluntary corrective measures before the agency pursues enforcement action. Warning letters are “the agency’s principal means of achieving prompt voluntary compliance with the [FDCA].” FDA, Regulatory Procedures Manual, 4-1-1 (July 2012), http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManual/UCM074330.pdf A warning letter is “informal and advisory”; it “communicates the agency’s position on a matter” but “does not commit FDA to taking enforcement action.” Ibid.

FDA Holistic Candlers br. at *5.

[T]he warning letters here did not mark the consummation of FDA’s decisionmaking process. As FDA has explained, warning letters give “firms an opportunity to take voluntary and prompt corrective action before [FDA] initiates an enforcement action.” Regulatory Procedures Manual 4-1-1. An enforcement action - typically a seizure or an injunction - is not inevitable, and indeed, most warning letters do not result in enforcement action. See FDA, Enforcement Statistics Summary Fiscal Year 2011 (reporting 1720 Warning Letters, but only 15 seizures and 16 injunctions), http://www.fda.gov/downloads/ICECI/EnforcementActions/UCM285781.pdf. Violations identified in warning letters “may lead to enforcement action if not promptly and adequately corrected.” Regulatory Procedures Manual 4-1-1 (emphasis added). Consistent with the Regulatory Procedures Manual, the warning letters at issue here stated that “FDA will evaluate the information you submit and decide whether your product may be legally marketed.” Pet. App. 43 (quoting FDA warning letter) (emphasis and internal quotation marks omitted). Relatedly, the warning letters were not based on a formal and complete administrative record. At this stage, FDA’s statement that petitioners violated the FDCA was not “final and binding” on the agency or petitioners but rather remained “tentative [and] interlocutory [in] nature.”

Id. at *9-10 (emphasis original).

Nor did the warning letters finally determine the “rights or obligations” of petitioners with regard to the distribution of ear candles, or trigger “direct and appreciable legal consequences.” Bennett, 520 U.S. at 178. Rather, the letters “request[ed]” that petitioners “take prompt action to correct [the identified] deviations” from the FDCA, and cautioned that “[f]ailure to promptly correct these deviations may result in regulatory action.” Pet. App. 39. The letters served only to communicate FDA's position with regard to ear candles, and to warn recipients about the possibility of future enforcement action. See Regulatory Procedures Manual 4-1-1. The letters nonetheless remained “informal and advisory” and “[did] not commit FDA to taking enforcement action.” Ibid.

Id. at *10-11.

FDA warning letters trigger no legal consequences and are subject to further agency “evaluat[ion]” based on the recipient’s response. See Pet. App. 47. Such letters do not trigger any enlarged exposure to penalties for noncompliance with the FDCA, nor does their issuance preclude further agency consideration or review. Rather, the letters state FDA’s position on the facts available to it, encourage voluntary compliance with the FDCA, and alert the recipient of possible enforcement action by the FDA. If and when an enforcement action is brought, the agency’s claim is not that the recipient has “violated” the warning letter, but rather that it has violated the underlying requirements of the FDCA.

Id. at *14.

So there you have it, from the proverbial horse’s mouth. And what should be the consequences of the non-final nature of FDA warning letters. Here are a few − there may well be more, the more we think about this: (1) without enforcement they’re not admissible evidence, being considerably less than a bare criminal indictment; (2) any attempt to give a warning letter binding collateral estoppel effect would be a violation of Due Process, since such letters are not appealable; (3) warning letters are nothing like the enforcement actions mentioned in the concurrence in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), (4) as warning letters are not legally enforceable, they shouldn’t be the basis of an negligence per se action; and (5) being tentative and subject to change at any time, a warning letter should not be the type of evidence reasonably relied upon by experts in the field (assuming there is a “field” as to which expert testimony is permissible in the first instance).

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