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Today’s guest post is by Camille L. Fletcher and Joshua Kipnees, both with Patterson Belknap.  We actually sought out this guest post, which is rare.  We first saw it on one of Patterson’s in-house firm blogs, and it was one of those rare law firm posts that did more than describe a case, offer a couple of obvious observations, and end with an invitation to “contact your [fill in name of firm] lawyer for more information.”  Rather, this post contained what we like – good, solid legal research.  Since it also covered a topic, FDA warning letters, of interest to our readers, we invited the authors to send us a version as a guest post, and they graciously agreed. So here it is.  As always our guest posters deserve 100% of the credit (and any blame) for what they write.


Consumer class actions involving goods regulated by the Food and Drug Administration (“FDA”) coexist in parallel with FDA enforcement efforts.  Consumers have no private right of action to enforce the Food, Drug, and Cosmetics Act (“FDCA”)—the statute the FDA is charged with implementing—and attempts to use state consumer protection laws that interfere with the FDA’s regulatory regime are preempted.  Even so, private litigants often invoke FDA guidance, rules, and statements regarding labeling practices as evidence that a manufacturer’s marketing claims are—or are not—susceptible to challenge as deceptive advertising under state law.

Parties and courts in consumer class actions often rely on FDA warning letters for guidance on FDA interpretation of its rules and regulations.  FDA field offices issue warning letters to manufacturers it believes have violated the FDCA or its implementing regulations.  [Ed. note:  As discussed here, FDA warning letters are not even pre-reviewed by an FDA lawyer]  Issuance of a warning letter is not an enforcement action in and of itself; it is a predicate to the FDA’s enforcement process that affords the manufacturer a chance to comply voluntarily before action is taken.  When citing a manufacturer for advertising or labeling related-violations, the FDA will typically list in the warning letter examples of claims it identified, through its review of the manufacturer’s marketing, as improper.  Employing precatory language, the FDA advises the manufacturer that it “should take prompt action” to correct the violation, and that its failure to do so “may result” in regulatory action without further notice.  The FDA may ultimately take no further action, even if the manufacturer’s response to the warning letter is deficient; in fact, according to a 2013 analysis of the FDA’s enforcement activity, warning letters rarely precipitate further action on the FDA’s part.  See Jennifer L. Pomeranz, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, 39 Am. J.L. & Med. 617, 631-34 (2013).  Even the FDA’s own Guidelines recognize that such letters are only “informal and advisory” and “do[] not commit FDA to taking enforcement action.”  FDA Regulatory Processes Manual, § 4-1-1 (Apr. 2019).

For these reasons, courts have repeatedly held that FDA warning letters are too preliminary and informal for manufacturers to challenge in court.  See Holistic Candlers & Consumers Ass’n v. Food & Drug Administration, 664 F.3d 940, 944 (D.C. Cir. 2012); Cody Labs., Inc. v. Sebelius, 446 Fed. Appx. 964, 969 (10th Cir. 2011) (collecting cases and noting that every court to consider the question has held that an FDA warning letter does not constitute “final agency action” subject to judicial review).  [Ed. note:  see our prior posts on Holistic Candlers here and here]

But in suits between private litigants, parties often invoke FDA warning letters as bellwethers for the FDA’s stance on a particular type of labeling claim.

Several courts have found that the fact that the FDA has issued warning letters regarding the same or similar claims to support a preemption or primary jurisdiction defense, because it indicates the FDA’s intent to regulate a particular labeling practice.  E.g., Kelley v. WWF Operating Co., 2017 U.S. Dist. LEXIS 86971, *8-*18 (E.D. Cal. June 5, 2017) (finding that while positions the FDA had taken in its warning letters regarding soymilk labeling lacked coherence, the fact that FDA had issued them supported referral of the issue to the FDA on primary jurisdiction grounds); Hood v. Wholesoy & Co., 2013 U.S. Dist. LEXIS 97836, at *17 (N.D. Cal. July 12, 2013) (dismissing case on primary jurisdiction grounds because FDA issuance of warning letters and draft guidance helped to demonstrate the labeling claim at issue was “committed to the FDA’s expertise,” even though the FDA’s position was still “not settled”).  Reliance on FDA warning letters for this limited purpose is sensible and does not require giving weight to its analysis; that the FDA has chosen to speak on the issue is more germane than what it specifically has said.

On the other hand, some courts have construed statements in warning letters to reveal the FDA’s substantive position on the propriety of certain labeling claims.

For instance, in Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015), the plaintiffs alleged that the defendant had falsely labeled its vegetable oil-based buttery spread as containing “no trans fat,” when its product did contain some trans fat.  Only two years earlier, the Third Circuit—the only other US Court of Appeals to have considered the issue—had concluded, with respect to the very same product, that FDA regulations permit “no trans fat” labeling claims, even when a small amount of trans fats per serving is present; therefore, such claims were not misleading and, because they were preempted, could not be challenged as such.  Young v. Johnson & Johnson, 525 Fed. Appx. 179, 182-83 (3d Cir. 2013).

Yet the Ninth Circuit in Reid reached a different result, relying in large part on FDA warning letters issued to manufacturers not involved in the litigation for labeling their products as “no trans fats” and “trans-fat free.”  Reid, 780 F.3d at 962.  The panel regarded the FDA warning letters as “materials establishing the legal principles governing [the] case,” which it found it could consider without taking judicial notice of their contents.  Id. at n.4.  Although acknowledging that the warning letters were “informal and advisory,” the panel announced it would “defer to the FDA’s interpretation of its own rules, even if the product of an informal and non-final process, unless its interpretation is clearly erroneous.”  Id. at 962.  Accordingly, the panel reasoned, “given that the FDA has indicated in warning letters that claims like ‘No Trans Fat’ are not authorized,” the defendant could not “shield itself from liability with the FDA’s regulations.”  Id. at 967.

The Ninth Circuit recently reaffirmed Reid in Hawkins v. Kroger, 906 F.3d 763, 771 (9th Cir. 2018), holding that “0g trans fats” was interchangeable with a “no trans fats” claim, and therefore, was an unauthorized nutrient-content claim.  Despite reciting Reid’s analysis at length and opining that “Reid squarely controls here,” the Kroger panel noticeably omitted any mention of FDA warning letters addressing “no trans fat” claims and their influence on the outcome in Reid.  Id. at 771-72.

Last year, a federal judge in the Southern District of New York—the first court in the Second Circuit to address the question—followed Reid in holding that state law claims based on “no trans fat” statements were not authorized by the FDA, and thus, not preempted.  Bowling v. Johnson & Johnson, 2018 U.S. Dist. LEXIS 52142, at *4-*13 (S.D.N.Y. Mar. 28, 2018).  Unlike in Reid, the Bowling court appeared to recognize that it could only consider FDA warning letters regarding “no trans fat claims” if it could properly take judicial notice of their contents, thus implicitly rejecting Reid’s determination that the letters articulated “‘legal principles governing [the] case’” available for consideration on a motion to dismiss.  Bowling, 2018 U.S. Dist. LEXIS 52142, at *9 n.3 (quoting Reid, 780 F.3d at 962 n.4).  But despite acknowledging that, ordinarily, “’communications with the FDA are not public records of agency actions’” subject to judicial notice, the Bowling court construed the warning letters as “publicly available evidence of agency actions” and took notice of their contents.  Bowling, 2018 U.S. Dist. LEXIS 52142, at *12.  Accordingly, the court relied on these letters as “support” for its conclusion that the FDA’s “regulations do not authorize ‘no trans fat’ claims.”  Id. at *13.

It is curious that a court’s determination of the lawfulness of a manufacturer’s labeling under FDA regulations should turn on isolated FDA warning letters to other companies, which may have resulted in no actual enforcement action.  Indeed, given courts’ recognition that warning letters merely contain “conclusions by subordinate officials of the FDA” and that the positions taken in such letters may subsequently be revoked or modified through the administrative process, there is little justification to imbue them with the force of law – much less as “governing” legal principles that dictate the interpretations of FDA rule on a motion to dismiss.  Biotics Research Corp. v. Heller, 710 F.2d 1375, 1378 (9th Cir. 1983).  And it is a particularly unfair result that manufacturers should be bound by the contents of warning letters when they are simultaneously told such letters are too informal to challenge in court.

Judicial reliance on FDA statements in warning letters is far from universal, and several courts, unlike Reid and Bowling, have declined to infer a labeling claim is unlawful merely because it has been identified in a warning letter.  See Caudill Seed & Warehouse Co. v. Jarrow Formulas, Inc., 2017 U.S. Dist. LEXIS 160827, at *29-*33 (W.D. Ky. Sep. 29, 2017) (finding that the FDA warning letter was not entitled to deference because it was “informal and advisory and not a final statement of an agency as to legality”); Craig v. Twining N. Am., 2015 U.S. Dist. LEXIS 14839, at *17-*19 (W.D. Ark. Feb. 5, 2015) (declining to defer to FDA’s statements in warning letter issued to different manufacturer regarding similar claim because, in part, warning letters “do not mark the consummation of the FDA’s decision making”); Gitson v. Trader Joe’s Co., 2013 U.S. Dist. LEXIS 144917, at *23-*24 (N.D. Cal. Oct. 4, 2013) (finding that plaintiffs “place too much reliance on the FDA warning letters” as evidence that soymilk labeling statement is false and misleading and “simply do not bear weight” on whether a reasonable consumer would be deceived).  [Ed. note:  see our own (less current) case list, here]  This approach, in our view, more faithfully corresponds with the limited role and significance of warning letters in the FDA’s enforcement process.   According only minimal weight to such letters, commensurate with their purpose as informal advisory tools, not only removes a thumb on the scale against manufacturers in class actions, it also shows due regard for the FDA’s jurisdiction and rulemaking process by declining to attribute to the FDA a formal position it did not necessarily intend to assume.  The FDA should be taken at its word that it considers its letters to be “informal and advisory,” and nothing more.