Like the radio stations of yore did with songs, we offer up two related posts back-to-back instead of the usual one.  We cannot offer a “favorite artist” as the source of consecutive songs, we offer two posts that relate to the legal implications of some of the typical things that FDA does and has been doing for quite some time.  As we and others have noted, the possibility of a decidedly atypical Secretary of HHS raised a specter that it may not be business as usual at FDA much longer.  For those of us whose legal practice focuses on cases related to FDA-regulated products, we cannot help but consider the impacts on litigation, both in terms of the kind of cases that get brought and how courts treat them.  (Our unwieldy double title above also makes us think about episode titles for the old Rocky & Bullwinkle show.)

First up is a little ditty called “Express Preemption Based on an OTC Drug Monograph.”  Over the years, we have written many posts on over-the-counter drugs and the express preemption provisions of 21 U.S.C. § 379r.  As a brief recap, that portion of the FDCA has an even stronger express preemption provision than others because it also covers state requirements that are “otherwise not identical with” federal requirements, but it does not apply to product liability claims.  The reality, though, is that plaintiff lawyers do not always push product liability claims in litigation they manufacture over these products largely because product liability claims almost always require physical, not merely subclinical or economic, injuries and class actions for physical injuries tend not to get certified.  (Product liability class actions for “no injuries” also tend not to get certified and many consumer protection statutes do not cover physical injuries from products.)  That means the preferred vehicle for plaintiff lawyers to bring cases against the manufacturers of OTC drugs is a proposed class action for economic damages based on a range of non-product liability theories, which they try to frame to avoid express preemption.  Also, consistent with a relatively recent trend we have seen for prescription drugs and devices, the assertions often seem to focus on risks allegedly posed by some contaminant, additive, or trace degradation product even though those risks did not lead to any physician injuries for which compensation is sought.  That is quite a tricky little dance based on scare tactics.

Many of the commonly used OTC products that are regulated as drugs based on their active ingredients are not products that many consumers may view as drugs, such as sunscreen and toothpaste.  Therapeutic or medicated shampoos, by contrast, sound more like OTC drugs, which they are depending on the active ingredient.  Eisman v. Johnson & Johnson Consumer, Inc., No. 2:24-cv-01982-ODW (AJRx), 2025 U.S. Dist. LEXIS 9493 (C.D. Cal. Jan. 17, 2025), addresses a motion to dismiss on preemption as to a proposed class of uninjured purchasers of two particular therapeutic shampoos with Coal Tar as the active ingredient.  The alleged issue was the presence of benzene in the Coal Tar, which was not disclosed in labeling that complied with the FDA’s monograph on therapeutic shampoos containing Coal Tar.  Alleged contamination by benzene has popped up in a number of the OTC cases we have seen recently, like in acne medications here and sunscreen here, but Eisman is a little different in that Coal Tar naturally has thousands of chemical compounds in it and benzene has been known for more than four decades (based on the decision itself) to be one of those.  So, it seemed likely that Eisman would join the list of proposed OTC class actions dismissed early on based on express preemption.  See here, here, here, and here, among many more.  Even though it was brought under California law and decided by a California federal court, Eisman did not disappoint.

After starting with a recap about the breadth of express preemption under § 379r, Eisman looked at the many requirements for active ingredients, labeling, etc., under the monograph for the control of dandruff, seborrheic dermatitis, and psoriasis under 21 C.F.R. §358.701 et seq.  2025 U.S. Dist. LEXIS 9493, *5-8.  Plaintiff’s broad allegations fit generally into the categories of 1) alleged omissions about benzene from product labeling and 2) alleged adulteration or misbranding based on the undisclosed presence of benzene in the products.  Any liability imposed under any of plaintiff’s theories would have imposed a requirement that was “different from or in addition to, or that is otherwise not identical with” the FDA requirements, which clearly did not require any disclosures about what makes up Coal Tar.  Id. at *9-10.  In this context, benzene was not an ingredient that should have been on the labeling, because it was not a “purposefully added component of the drug.”  Id. at *11.  Plaintiff’s allegations that the products needed to have benzene removed so that they were not considered adulterated was “fundamentally as odds with the FDA’s monograph.”  Id. at *12 (citing Howard v. Alchemee, LLC, No. 2:24-cv-01834-SB (BFMc), 2024 U.S. Dist. LEXIS 169359 (C.D. Cal. Sept. 19, 2024), which we discussed here).  Because the monograph was approved, FDA was clearly aware of the presence of small amounts of benzene in the Coal Tar and still “approved OTC Coal Tar drug products as generally safe and effective, and not adulterated, with the understanding that they would contain some level of benzene.” Id. at *13.  That meant all of plaintiff’s claims were expressly preempted.  The court also wisely denied leave to amend because it would have been futile.

That was all pretty straightforward and, from our perspective, correct.  The going-forward concern is that challenges to FDA decisions on the safety and efficacy of a product or category of products, including decisions that have remained unchanged for decades, will not be viewed as a hard stop should those decisions start getting reversed based on, shall we say, re-thinking of established science.  Even though the focus in a proper preemption analysis will be on what the manufacturer could have done in the past—in Eisman, the plaintiff bought the monograph-compliant shampoo back in February 2021—it is not hard to imagine how regulatory changes in the future could affect liability for alleged failures in the past.  Among other things, when a manufacturer elects to discontinue the sale of a product in response to regulatory actions, that decision almost always affects the analysis of liability related to the sale and use of the product several years earlier.  We will be watching how this all develops.

* * * * * * *

Our second shot is called “The Delaney Clause and Personal Injury Litigation— FDA Delists Color Additive Red No. 3, but Will It Be Enough to Attract Even Dyed-in-the-Wool Plaintiffs Lawyers?” and it is a guest post from Justin Kadoura, a Holland & Knight litigation associate and Blog devotee.  As always, all credit and blame for a guest post—even one embedded within a two-fer—goes to the guest poster.  Despite very different regulatory schemes, the issues discussed below clearly fit with those discussed above.  Both fit with the sort of scare tactics about trace or theoretical exposures that plaintiffs like to feature.

On January 15, 2025, FDA granted a citizen petition submitted by the Center for Science in the Public Interest and others to repeal the approval of color additive Red No. 3 in foods based on the Delaney Clause of the 1958 Color Additive Amendments to the Food, Drug & Cosmetics Act.  The Delaney Clause prohibits approval, and requires the delisting, of food and color additives that have been shown to cause cancer in humans or animals.  The Red No. 3 petition cited to “multiple regulatory conclusions that FD&C Red No. 3 is carcinogenic in male rats, which are based on some in vivo studies”—studies which had not prompted any action in the thirty-seven years since they were published in 1987.  The FDA stated in its decision that although “Red No. 3 has been found to ‘induce cancer when ingested by . . . animals,’” and is thus subject to the Delaney Clause, “Red No. 3-induced thyroid tumors in male rats are of limited relevance to humans.”  “FD&C Red No. 3 is likely not genotoxic” and “appears to induce thyroid tumors in male rats through a key event—an increase in circulating TSH—and rodents show much higher sensitivity to such perturbations compared to humans.” 

Often, when FDA or another agency revokes approval for a substance used by consumers based on safety concerns, personal injury litigation follows.  Consequently, apart from having to reformulate (or discontinue) their Red No. 3-containing products, companies may fear that they face a risk of litigation from consumers who ingested those products and developed cancer.  Historically, however, FDA’s use of the Delaney Clause to delist a product has not resulted in significant tort litigation.  For example, FDA used the Delaney Clause to delist Red Nos. 2 and 4 in 1976.  Although that ban resulted in some patent litigation due to the potentially increased value of Red No. 40, see Warner-Jenkinson Co. v. Allied Chemical Corp., 567 F.2d 184, 185 (2d Cir. 1997), and even a seizure of adulterated roe by the government, see United States v. An Article of Food Consisting of 12 Barrels, More of Less, Labeled in Part: (Barrel) Lumpfish Roe 100 Kg Net Colored Black, 477 F. Supp. 1185 (S.D.N.Y. 1979), it did not initially result in significant tort litigation.  But see De Coursey v. Murad, LLC, 673 F. Supp. 3d 194 (N.D.N.Y. 2023) (alleging that manufacturer’s cosmetics contained color additives, including Red No. 4, long after they were delisted by the FDA); Morales v. Kraft Foods Grp., Inc., No. 14-cv-4387, 2014 WL 12597034, at *1 (C.D. Cal. Oct. 23, 2014) (alleging that manufacturer’s advertising that cheese was “natural” was deceptive because it contained food additives, including Red. No. 2).  In 2018, FDA delisted several synthetic flavor additives in response to a petition.  Although those additives have been subject to some environmental tort litigation, that litigation often does not reference (and in some instances predates) FDA’s 2018 action.

The history and purpose of the Delaney Clause shed some light on why substances banned under the Delaney Clause have not frequently been the subject of tort litigation.

The Delaney Clause was passed in 1958 as part of the Food Additives Amendment in response to the explosion of new techniques in food processing, including the introduction of hundreds of new preservatives and flavorings.  Before the Delaney Clause was passed, FDA had limited ability to prevent the use of potentially harmful additives before they were marketed to consumers.  Under the FDCA, substances that are already generally recognized as safe for their intended use are not considered “food additives.”  21 U.S.C. § 321(s).  Novel ingredients, however, generally require premarket approval from FDA, which in turn requires showing “reasonable certainty in the minds of competent scientists that the substance is not harmful under conditions of its intended use.” 21 C.F.R. § 170.3(i).  The Delaney Clause provides that both food additives are automatically “unsafe” and cannot be approved “if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal.”  21 U.S.C. § 348(c)(3)(A).  Although “color additives,” such as Red No. 3, are exempted from the definition of “food additives,” the Color Additives Amendment of 1960 nonetheless subjects color additives to the premarket approval process, including their own Delaney Clause.  21 U.S.C. § 379e(a), (b)(5)(B); 21 CFR 70.3(i). 

The test set out in the Delaney Clause is not dose-dependent, does not require human cohort or epidemiology studies before an additive is banned, and does not allow FDA to consider other factors in determining an additive’s safety profile.  This strict prohibition is premised on Congress’s belief at the time that no additive that posed a risk of cancer could be determined to be safe, particularly given the less-advanced scientific understanding of cancerous substances in the 1950s.  Indeed, despite FDA’s initial attempts to limit the use of the Delaney Clause in situations where the risk of cancer was de minimis, courts held “that the Delaney Clause of the Color Additive Amendments does not contain an implicit de minimis exception for carcinogenic dyes with trivial risks to humans” and “that Congress adopted an ‘extraordinarily rigid’ position, denying the FDA authority to list a dye once it found it to ‘induce cancer in . . . animals’ in the conventional sense of the term.”  Public Citizen v. Young, 831 F.2d 1108, 1122 (D.C. Cir. 1987); see also Lee v. Reilly, 968 F.2d 985, 988 (9th Cir. 1992).  But see Scott v. FDA, 728 F.2d 322, 325 (6th Cir. 1984).

In light of the de minimis showing required to delist a substance under the Delaney Clause, it is unsurprising that such delisting to not often result in wide-spread tort litigation.  Successful tort claims typically require evidence of dose dependence and human studies that are not required under the Delaney Clause.

Moreover, the fact that the Delaney Clause can be used to deny approval to an additive before it reaches the market limits the pool of potential plaintiffs with any injuries.  And, despite the D.C. Circuit’s holding in Public Citizen, FDA continues to use the Delaney Clause to delist additives that are already on the market only sparingly—giving plaintiffs’ lawyers very few additives to target, especially over the last few decades when toxic tort litigation has expanded rapidly.

Even when FDA delists an additive under the Delaney Clause, it sometimes does so with reservations.  Indeed, FDA has other, more nuanced tools to evaluate and delist additives that have bad safety profiles without relying on the blunt instrument of the Delaney Clause.  In 1981, the U.S. General Accounting Office (“GOA”) issued a report to Congress evaluating the public and scientific opinions of the Delaney Clause, stating that it “is a source of controversy, an emotional issue, and a target for change.”  Among the GOA’s proposed alternatives was to repeal the Delaney Clause and allow FDA to regulate allegedly cancer-causing additives under the general safety provisions of the FDCA.  Accordingly, when FDA used the Delaney Clause to delist certain synthetic flavor additives in 2018, FDA stated that “[a]lthough we are amending our food additive regulations for these synthetic flavoring substances in accordance with the Delaney Clause, FDA’s rigorous scientific analysis has determined that they do not pose a risk to public health under the conditions of their intended use.  The synthetic flavoring substances that are the subject of this petition are typically used in foods available in the U.S. marketplace in very small amounts and their use results in very low levels of exposures and low risk,” but “the petitioners provided evidence that these substances caused cancer in animals who were exposed to much higher doses.”  These types of reserved statements would make it difficult for plaintiffs’ lawyers to effectively use FDA’s regulatory action as a sword in litigation.  Cf. Wilson v. ColourPop Cosmetics, LLC, No. 22-cv-5198, 2023 WL 6787986 (N.D. Cal. Sept. 7, 2023) (holding that plaintiff lacked standing to bring claim arising from purchase of cosmetics that contained unreasonably dangerous ingredients, including Red No. 4, because, among other things, the “claims ultimately depend on the existence of violations of federal law—the Court can’t make a decision the FDA itself did not make” and “the FDA has not made a scientific determination that the additives that are not ‘specifically’ approved for the eyes are likely to cause injuries”).

Nonetheless, the night is young, and substances that are initially delisted based solely on the Delaney Clause could later be revealed, through further testing, to pose actual risks of cancer.  Given the wide publicity given to FDA’s recent action taken on Red No. 3, manufacturers and distributors could be subject to litigation a few years down the road if the science becomes more developed.