Zyla Life Sciences L.L.C., v Wells Pharma of Houston, L.L.C.[1]

Ralph F. Hall[2]

Why It Made the List

Any case that opens the door to state law oversight of medical products and private entity-based enforcement of FDA-related obligations is worthy of attention.

Over the past century of FDA law, two, often interrelated, questions have arisen, died down, and then reappeared, often with a vengeance. Zyla now presents these questions in a way that may dictate a more final resolution.

The first question is what role, if any, does state statutory or state common law have in regulating products and conduct within the scope of the Federal Food, Drug, and Cosmetic Act (FDCA)[3] or otherwise within FDA’s jurisdiction.

The second question involves when, how, and even whether private entities or individuals can seek to enforce FDA-related obligations.

These state actions can be direct actions to enforce FDCA-type obligations (often using state statutory structures that mimic or parallel the FDCA). Zyla’s lawsuit against Wells for marketing a product without the necessary FDA approval and the recent action brought by Texas against the makers of Tylenol for allegedly inadequate warnings are examples of this type of case. A private action such as a product liability case to obtain compensation or other redress under state common law or non-FDCA specific statutory systems is an example of this type of case.

Zyla is a 2025 case that directly addresses both of the aforementioned questions. Zyla demonstrates the evolving, sometimes seemingly inconsistent, nature of the case law in this area. It also is a fascinating example of the innovative use of state law by a private entity to challenge conduct by a competitor.

Regulated industry, patients, other stakeholders, and practitioners need to understand this evolving landscape both for offensive uses and to be prepared defensively if a client is subject to some litigation based on state law claims.

The importance of this issue is underscored by the fact that the Supreme Court is currently considering a petition for a writ of certiorari in this exact case[4] and has invited the Solicitor General to file a brief expressing the views of the United States on this question.[5][6]

Discussion

Facts and Case Status

In this case, Zyla sued Wells in federal court (under diversity jurisdiction) for allegedly selling a “new drug” (as defined in 21 U.S.C. § 321(p)) without having an approved New Drug Application (or other equivalent marketing authorization). Wells was selling a compounded version of a drug for which Zyla had FDA marketing authorization.[7] Zyla asserted that this conduct violated the laws of six states that have state statutory systems that parallel the FDCA.[8] Wells filed a motion to dismiss under FRCP 12(b)(6) asserting that Zyla’s claims were barred by preemption and the FDCA. The District Court agreed and granted the motion to dismiss.

Zyla appealed and the Fifth Circuit reversed. The Fifth Circuit ruled that the claims presented by Zyla were not precluded by the terms of FDCA and were not preempted. Wells has filed a (still pending) petition for a writ of certiorari.[9]

Role of State Law

Analysis of State Law Claims

To understand Zyla and its importance (and implications) one needs to understand the environment within which this recent case exists.

Many practitioners have long believed that only the federal government has the authority to enforce FDCA obligations or requirements. (Product liability cases are efforts to enforce non-FDCA based claims.)

The obvious basis for this belief starts with the FDCA itself. 21 U.S.C. § 337 specifically states that all actions to enforce the FDCA must be brought “in the name of the United States.”[10] (The Supremacy Clause and the Interstate Commerce Clause are the foundational constitutional provisions upon which § 337 is based.) A plain reading of this section is that the power to enforce the FDCA is reserved solely to the federal government (i.e., the Department of Justice) and not to states or private litigants.

The statutory language reserving to the federal government the sole right to bring enforcement actions for violations of FDCA obligations is supported by the Supreme Court in the well-known decision in Buckman.[11] In Buckman, the Supreme Court prevented a private party from bringing a case asserting that the defendant had committed fraud on FDA.

Various cases following Buckman have supported this interpretation. In Nexus Pharmaceuticals, Inc., v. Central Administrative Pharmacy Services, Inc. (“Nexus”),[12] the Ninth Circuit upheld the dismissal of claims that the defendants were illegally marketing a new “drug” in violation of FDCA requirements. While Buckman involved allegations that the defendant had violated the federal statute (the FDCA), the plaintiff in Nexus asserted that the defendants had violated various state laws that prohibited the sale of an unapproved new drug (essentially state law provisions that were parallel to, or identical to, the FDCA).[13] The Nexus court utilized a preemption analysis to justify the dismissal of the case.

However, the case law is open to different interpretations. In Bubak v. Golo,[14] the Ninth Circuit permitted a state law-based claim to proceed. The Bubak court distinguished this case from Nexus because the state statute at issue in Bubak did not explicitly incorporate the FDCA. The plaintiff in Bubak asserted its claims under the California Unfair Competition Law,[15] while the claims in Nexus were state statutes that explicitly incorporated the FDCA. Interestingly, the court focused on the legal basis for the cause of action and not on the factual basis. In many ways, the same type of conduct existed in both cases with the difference being the legal basis for the plaintiff’s claims.

There is also a plethora of product liability cases addressing preemption (in all of the different forms or types of preemption). Product liability cases almost universally involve state law-based claims (generally, negligence, failure to warn, manufacturing defect, or state-specific product liability statutes). Absent express or conflict preemption, many of these cases are permitted to proceed. See, e.g., Medtronic v. Lohr, 518 U.S. 470 (1996); Wyeth v. Levine, 555 U.S. 555 (2009).

In Nexus, the court utilized a classic preemption analysis. Using § 337, Buckman, and the Supremacy Clause, the court concluded that the state law-based cause of action intruded into the federal realm. The same type of conduct was addressed in both statutory systems.

However, in Zyla (and Bubak), the court concluded that § 337, Buckman, and its progeny did not apply to bar the application of state laws that are parallel to, and consistent with, the FDCA. The defendant’s reliance on § 337, Buckman, Nexus and similar cases to argue for preemption was to no avail.

The Zyla court concluded that the preemption or overbreadth doctrine was not applicable to this case. To win on preemption, the defendant would need to establish that the state law in question imposed new or additional requirements on the defendant. In conducting its analysis along these lines, the court relied on cases such as Kansas v. Garcia, 589 U.S. 191 (2020), which help define the federal/state relationship.

The court in Zyla determined that the state statute in question was identical to, and incorporated, the FDCA, and thus found that it was not preempted. The court did not conduct a detailed analysis of the “sole power” language in § 337 once it found as such.

The court relied particularly on California v. Zook, 336 U.S. 725 (1949). Zook involved a question of whether certain conduct was permitted under the Interstate Commerce Clause and does not directly involve the FDCA. The Supreme Court in Zook held that the California law at issue in that case was not preempted. Using Zook, the Zyla court held that the mere “fact of identity” between the federal and state statutory schemas did “not mean the automatic invalidity of the state measures. . . .”[16] The Zyla court reinforced the interest the state has in addressing violative conduct even if the federal system also prohibits such conduct.

In addition to the classic preemption and statutory interpretation arguments, the defendant in Zyla argued that permitting a state law-based cause of action would effectively negate the congressional intent expressed in § 337 that the federal government (and only the federal government) be the enforcement mechanism for FDCA claims. The Zyla court rejected this argument (which the court in Nexus seemingly accepted). The Zyla court had no problem with both federal law and (parallel) state law being the basis for enforcement actions. The court emphasized federalism, the historical role of states in protecting its citizens, the benefit of leveraging federal enforcement resources and cases such as Zook.

The federal government, the court noted, had also filed a brief supporting such dual enforcement possibilities in another Supreme Court case, Athena Cosmetics, Inc. v. Allergan, Inc., 576 U.S. 1054 (2011).

The Zyla court explicitly reminded everyone that the federal government has limited resources and that state centric enforcement actions would help address these resource constraints. “Thus it [the federal government] often welcomes state aid in enforcing shared legal norms.”[17] The court also was concerned that rejecting state law-based claims would undermine the role of states in protecting its citizens.

It is interesting that the court seemed to accept, without much debate, that the federal government would value or appreciate this state-based enforcement action and that such a state-based action would aid the overall purposes of the FDCA.

Note that in § 337 (b) Congress created an explicit process for states to enforce certain food-centric FDCA provisions but only after prior notice to the United States. The court did not explicitly address whether this provision demonstrated congressional intent to limit state enforcement. Whether adding a provision permitting a state to seek enforcement powers is the right tool for state-based efforts to enforce FDCA provisions is for Congress to decide. And it must be noted that, as currently codified, the § 337(b) requirements apply to FDCA-based causes of action although one can imagine such provisions being expanded to cover parallel state statutory systems.

Zyla involved some complex pharmaceutical compounding questions (often quite fact-specific). Because the case was at the motion to dismiss stage under Rule 12(b)(6) of the Federal Rules of Civil Procedure (FRCP), the court could not conclude or decide that the state law in question would, in fact, impose new, additional, or conflicting requirements on the defendant as compared to existing federal requirements.

Analytical Approach

Given this arguably inconsistent, or at least confusing, case law, how should these cases be viewed and analyzed?

It may be helpful to think about this in a three-step approach focusing on the nature of the claim.

• What is the nature of the state law claim being asserted? Is it an FDCA-type provision?
• Is the state law preempted by federal law? Is the state provision inconsistent with, or in addition to, FDCA obligations?
• Does a private person have the authority or right to assert the state law claim?

Step one:

First, an explicit claim of an FDCA violation (a Buckman type claim) would seem to fail given § 337 and Buchman itself. This is the easiest analytical pathway with highly predictable results given the current state of the law.

Step two:

Assuming the claim satisfies step one, if the claim at issue is explicitly based on a state law equivalent to the FDCA, then the Nexus line of analysis would seem to apply and, under § 337, the claim might likely fail. If Nexus applies, the claim fails.

The key question asked in step two is whether the state law at issue is preempted under an express preemption analysis, an implied preemption analysis, or a conflict/field preemption analysis. (One can argue that field preemption is included in one of the other types of preemption.) A claim can satisfy step one and still be excluded under step two.

The California “Sherman Law”[18] is an example of a state statute that directly incorporates or repeats provisions of the FDCA. Under Nexus, state law claims based exclusively on the California Sherman Law may well fail based on a preemption analysis. (This conclusion may be open to debate or further refinement given other recent case law.[19])

The basis for the Nexus line of analysis is that if there are state laws identical to the FDCA, then § 337 is directly applicable and Congress, as a policy matter, has vested the United States with the sole right to enforce such provisions. The state requirements being imposed and the interests protected would seem to be the same as the federal requirements and thus would be preempted.[20]

Clearly, if the state law being asserted actually conflicts with, or creates different requirements than, the FDCA in some substantive way, then, under any preemption approach, the claim is probably preempted and the case cannot proceed. Remember that in Zyla the court proceeded along these lines and determined that, based on the status of the case as being a dismissal under FRCP 12(b)(6), there was no demonstrated conflict and no preemption.

Step three:

Third, if the state law claim is not a direct FDCA-type claim, then the claim could pass steps one and two, and the analysis would move to step three. This is the Zyla situation[21] in which the explicit cause of action was based on the state’s unfair competition law, not a provision that is exclusive to FDA regulated products or otherwise mimics the FDCA. These types of cases can include the traditional product liability cases as these generally assert non-FDCA state law claims (e.g., failure to warn claims).[22]

A preemption analysis (along the lines of step two) is still critical. If the state law claim is contrary to federal requirements or if there is otherwise express preemption (see, e.g., Medtronic v Reigel[23] and § 379a), the case still fails.

Private Causes of Action

The next question is who can bring such an action. Can such an action be brought by a state entity (the Texas Tylenol case, for example) or by a private citizen (the Zyla situation)?

If it is a federal law claim, then cases such as Buckman and the plain language of § 337 make it clear that actions to directly enforce the FDCA are barred. Only the federal government can enforce the FDCA. So, if the action is an effort by a state entity or a private citizen to enforce the actual FDCA, the result is clear, the case cannot proceed.

Whether a state or private entity can bring a case under state law, regardless of the statutory structure (whether akin to the FDCA, a more general state law, such as the state unfair competition law at issue in Zyla, or state common law causes of action), seems a matter of state law.

However, there may be a complexity if the cause of action is a state law parallel to the FDCA. An action to indirectly enforce the FDCA would seem to be a claim in which the rights or responsibilities at issue are based on, or derived from, the provisions in the FDCA (or implementing regulations). In such a case, if a state or private citizen can sue, then the prohibitions in § 337 are bypassed. A state or private citizen may have greater ability to bring an action based on a general state obligation, such as through a general unfair completion law or a product liability claim. Premeption is still an issue. This difference between these types of claims helps explain the different results in Nexus and Zyla.

If the cause of action is not based on the FDCA, but the defendant raises FDCA compliance as a defense (a common strategy in product liability cases), the case would seem to be best judged under standard preemption law and there would be no limitations outside of general state law on the nature of the plaintiff legally entitled to sue. Raising FDCA compliance as a defense should not automatically convert the case into a Buckman type case.

Assuming that only state law claims are raised, deciding whether a private entity can enforce a state-based FDCA equivalent statute starts with reviewing the actual language of that statute. Does the state statute permit or preclude private enforcement? If the statute (or common law) permits such an entity to bring an action, then the other analytical points discussed above, principally preemption, become relevant as to the viability of the claim, but the legal right to bring the claim has been established.

Open Legal and Policy Issues and Challenges

As evidenced by the pending petition for a writ of certiorari, there are a number of open questions for practitioners and others to ponder.

First, how does one determine whether the claim is an FDCA-centric claim? It is easy if the stated cause of action is based on the FDCA or on interactions with FDA (see Buckman). It is also relatively easy if the claim is based on a state statute that is identical to the FDCA. (Often this is done via incorporation of the FDCA into state law.) This is the Nexus fact pattern.

The analysis gets more complex if the plaintiff does not directly assert FDCA-type requirements. How central must the FDCA aspects be before the § 337/Buckman type of limitations applies?[24]

In Zyla, for example, the key to the plaintiff’s case is the allegation of marketing of an unapproved product—clearly an FDA question. But the actual legal claim is under a state unfair competition law. If the defendant wins the FDA approval question (the product either was, in fact, approved or did not legally require some FDA approval), the unfair competition claim does not survive. Is this connection to the FDCA so close that the limitation of FDCA enforcement to the federal government applies? The court in Zyla did not think so, but we are awaiting possible Supreme Court action.

Contrast this situation with the standard product liability case. In these cases, the FDCA issues are more peripheral to the case. There may be preemption issues but those are more in the nature of a defense. These cases seem to be generally outside of the § 337/Buckman/fraud on the FDA type of limitations (recognizing, of course, the case-specific preemption issues that might exist and provide a complete defense).

However, the question about non-federal enforcement of FDCA matters might arise in a product liability case if the plaintiff asserts a negligence per se claim based on assertions that the defendant violated some relevant and material provision of the FDCA.[25] If there has been a final determination that the defendant had, in fact, violated the FDCA, the analysis is easier. If the federal government has not made a legally binding, final determination that the defendant had, in reality, violated a relevant and material provision of the FDCA, we may be back to the situation of mere allegations of FDCA violations and the § 337/Buckman type of limitations become more relevant.[26]

There are obvious concerns that permitting states or private entities to pursue enforcement of FDCA obligations undercuts the congressional policy that enforcement of FDCA obligations is the sole responsibility of the federal government. For example, an action finding that a particular product violates the laws of six to eight states, including California and Florida, may have the practical impact of being a national determination. Good lawyers likewise can usually find some non-FDCA-specific law such as an unfair competition law to assert claims otherwise falling within the FDA regulatory framework. Zyla is such a case. The plaintiff was upset that a competitor was (allegedly) selling a competing product without the needed FDA approval. For whatever reasons, the United States was not addressing this concern. So Zyla sues under state unfair competition law. The § 337/Buckman type of limitations are not deemed applicable. As a result, private parties were litigating actual FDCA questions.

The state of Texas’ lawsuit against the manufacturers of Tylenol under Texas state law for allegedly false and misleading labeling is, likewise, simply a backdoor way to address specific FDCA labeling issues that FDA has declined to address.

A key issue for litigating these cases is whether a state or private entity should be able to circumvent the § 337/Buckman limitations on private causes of action.

Impact on Enforcement Discretion

A core justification used by courts in cases such as Zyla is that the federal government has limited resources (certainly true) and that the United States doesn’t know about many violations of FDCA-related requirements (also true). The courts conclude that having states or private entities be able to bring enforcement actions (or suits based upon a failure to satisfy FDCA requirements) is simply a tool to fill gaps left by limited FDA/DOJ resources or knowledge.

However, the courts have not analyzed the impact on FDA policy decisions of permitting states and private entities to bring FDCA-related cases. The decision whether to bring an enforcement action is often a policy decision, not just a simple resource question. Vesting enforcement power solely in the federal government preserves the government’s ability to control FDCA-related policy.

FDA has on many occasions formally set forth a policy of enforcement discretion applicable to certain matters. There are many examples of the use of enforcement discretion as a policy making tool including:

• Drug importation rules
• Software oversight (particularly wearables and general wellness products)
• Regulatory requirements during drug shortages
• Regulatory oversight of laboratory developed tests.
• Hand sanitizer oversight during COVID
• COVID diagnostic tests
• AI oversight
• Relaxed requirements for access to products treating rare diseases
• Permitting companies to continue marketing products in the face of a warning letter, asserting that the product in question is “adulterated or misbranded” and thus violative

Very recently, FDA announced that it was exercising enforcement discretion for certain aspects of labeling of color additives.

The agency sent a letter to industry providing notice of FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.[27]

What should happen if a state brings an action under an FDCA state law clone seeking to enforce some color additive requirement for which FDA has announced that it will exercise enforcement discretion and not bring any action?

FDA’s ability to utilize enforcement discretion is clear. In the face of efforts to mandate enforcement, courts have explicitly recognized the power of FDA to exercise such enforcement discretion. Notably, the Supreme Court in Heckler v. Chaney, 470 U.S. 821 (1985) recognized this inherent power. And Congress has explicitly given FDA the authority not to bring enforcement actions for “minor” violations. See 21 U.S.C. § 336.

Further, in § 337, Congress has given states a limited role to enforce FDCA requirements, but only after providing prior notification to FDA. One can see litigants arguing that Congress knew how to empower states (and by implication private entities) to enforce FDCA obligations when Congress so desired. As a matter of statutory interpretation, the inclusion of these specific provisions might be the exclusion of state enforcement empowerment in other contexts. [28]

While FDA may formally state that it is going to exercise enforcement discretion, these pronouncements are rarely binding. Does the fact that these pronouncements are non-binding impact these questions? Can there be preemption or a statutory bar based on non-binding FDA pronouncements?

FDA also routinely utilizes enforcement discretion in individual case determinations. These are rarely announced publicly but are important tools for FDA to advance public health and its policy decisions. Again, can a state law-based action brought by a state or private entity be used to override FDA’s enforcement discretion? And how would the court and the litigants even know? Can FDA intervene to take control of the litigation?[29] These questions raise statutory authority questions, reliance questions, and preemption questions—all currently without a clear answer.

There is a gray area between some state or private action directly seeking to enforce FDCA obligations (perhaps via a state statute that incorporates the FDCA) and a cause of action such as a product liability case in which the plaintiffs’ claims are based on classic state law such as a failure to warn.[30]

One can think of several different fact patterns in which this question may come up:

• FDA has a formal, public enforcement discretion position.
• FDA has knowledge of the specific situation and has knowingly decided not to bring an action for policy reasons.
• FDA has knowledge of the specific situation and has knowingly decided not to bring an action due to resource constraints.
• FDA has no prior knowledge of the specific facts or situation.

Courts have not analyzed these different fact patterns and there may be different results for different situations.

In many cases, permitting a state or private entity to bring an enforcement action targeting conduct for which FDA has exercised enforcement discretion will undercut FDA’s policy decisions. Whether and how courts will take this into account is an open question.

Summary

As demonstrated above, there are many different fact patterns presenting differing challenges to FDA’s authority.

The analysis of these questions should begin with a straightforward statutory interpretation process applying known rule sets such as using the “plain meaning” of the statute, Loper Bright, the “Major Questions Doctrine,” and past precedent. Depending on the results of the statutory interpretation process, there might be constitutional questions under the Supremacy Clause and the Interstate Commerce Clause.

Courts will also need to deal with the relationship between the state law-based cause of action to the FDCA. In some cases, this will be through a direct connection such as state statutes that incorporate the FDCA. Other cases have more attenuated connections to the FDCA. Along this spectrum, you have cases such as Zyla in which the conduct upon which the state case is directly based on FDCA requirements (in Zyla the requirement under the FDCA is to have some premarket approval). The actual cause of action, however, sounds in state unfair competition law. Further along the spectrum, one finds cases based on classic state laws such as product liability law.[31] Here, FDA’s oversight role may be relevant as a defense, thus triggering preemption questions.

Courts will need to address the authority question, preemption, and, in some cases, the right of a private entity to bring suit. As part of this assessment, courts should consider the impact on FDA policy making of permitting state law-based claims to be pursued by the state or by private entities.

Impact

The law on state-based causes of action is clearly still evolving. The robustness of the case law varies across areas with product liability case law being the most developed. Cases such as Lohr, Levine, Mensing, and Reigel provide a level of certainty. (Recognizing, of course, that there are specific factual and legal questions in each case and potential judicial and statutory changes.)

Cases such as Zyla, Bubok, and Nexus demonstrate that in other types of cases such certainty does not exist. Here we see some important differences between the cases. Nexus provides insights into situations involving state law provisions incorporating the FDCA. Zyla involves FDCA-centric issues (premarket approvals), but the actual cause of action is a non-FDCA-specific state law such as the California Unfair Competition Statute.

Practitioners need to be alert to these key factual and legal differences in both the underlying conduct and in the specific basis for the cause of action being asserted.

Importantly, Zyla also opens the door for private litigants to use FDCA-related requirements to advance commercial or policy objectives.

Until the Supreme Court (perhaps in Zyla) or Congress definitively resolve these questions, stakeholders and practitioners will need to consider the possible offensive use of state laws to address perceived FDCA violations not otherwise addressed by FDA. For example, companies could use state laws to challenge competitors if the plaintiff believes that the defendant’s FDCA compliance (or lack thereof) has given the defendant some material competitive advantage.

States or private litigants may also consider using state law to address what they perceive to be mistaken government policy decisions or priorities. The Texas Tylenol lawsuit is such an example. These cases could seek to challenge product approvals, indications for use, warnings, or whatever.

Conversely, industry and other potential defendants need to be prepared to face state law-based claims (asserted either by the state itself or by private litigants) challenging their actions. While industry has long faced such claims in the product liability context, these new claims could directly attack the product, the company’s compliance, and regulatory decisions. In the past, a company might just complain to FDA or Congress about the premarket approval (or lack thereof) of a competitor’s product. Now, if Zyla is the law, rather than just complaining, the company could sue the competitor for its failure to have the proper premarket approval using one of a number of state law-based claims. And this risk is not limited to just premarket approval issues. Such claims could arise from alleged failures to file adverse event reports, not doing recalls, lack of proper quality systems, or conducting improper/inadequate clinical studies.

Finally, FDA should consider how it should address such cases. Will such cases undercut FDA’s policy? How should FDA address such challenges? Will FDA seek to intervene in cases or seek congressional clarity?

Time will tell the development of the law in this area and its impact on stakeholders. Practitioners should be monitoring this development, considering how to best use the evolving law offensively and defensively and addressing the policy issues raised by these cases.

 

[1]   Zyla Life Sciences v. Wells Pharma (“Zyla”), No. 23-20533 (5th Cir. 2025).

[2]   Professor of Practice (retired), University of Minnesota Law School; Hall Strategies, LLC

[3]   21 U.S.C. § 201 et seq. We recognize that FDA also has responsibility for certain statutes not technically part of the FDCA. For convenience, these will be combined with references to the FDCA.

[4]   Petition for Writ of Certiorari, Zyla, No. 25-257.

[5]   As of the date of writing this article, the Supreme Court has not ruled on the petition for a writ of certiorari. It may well be that this case is the subject of another article next year if the Supreme Court acts.

[6]   In addition to judicial activity, Congress and state legislators may be asked to consider how to address these claims. Congress might want to consider changes to the FDCA to clarify what roles states and private parties should have in enforcing claims within the scope of the FDCA and the jurisdiction of FDA.

[7]   The specific issues around compounding drugs are not the subject of this article.

[8]   States with such parallel state provisions are: California, Colorado, Connecticut, Florida, South Carolina, and Tennessee.

[9]   Wells has been supported in this petition by the Americans for Access to Compounded Medication.

[10]  Section 337(b) sets forth some limited situations in which a state may bring actions in its name under a limited number of food-related obligations. There is a process for prior notice to FDA of such an intent. It seems that this exception is limited to actions brought by the state. In any event, this provision is not relevant to the facts in this case.

[11]  Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001)

[12]  48 F.4th 1040 (9th Cir. 2022). The Ninth Circuit muddied up these waters in Davidson v. Sprout Foods, Inc.,106 F.4^th 849 (9th Cir. 2024), in finding certain food labeling claims not preempted.

[13]  While Zyla listed six states with laws identical o the FDCA, the court in Nexus also listed Arizona and Pennsylvania as states prohibiting the sale of an unapproved new drug. Nexus, at 9.

[14]  Bubak v. Golo., No. 24-492, (9th Cir. October 9, 2025). It is critical to note that this case is “Not for Publication.” As such, its use as precedent in limited. The case is included here as an example of a case permitting a state law cause of action to be prosecuted.

[15]  Cal. Bus. & Prof. Code §§ 17200, 17204.

[16]  Zyla, at 8.

[17]  Zyla, at 11.

[18]  Cal. Health & Safety Code § 110987 et seq.

[19]  See Davidson, supra note 12.

[20]  Remember that, in certain circumstances, a state may enforce such provisions if statutorily permitted. See, e.g., § 337.

[21]  Remember that a petition for a writ of certiorari is pending as of this writing.

[22]  Grafting an FDCA claim onto a product liability claim would be covered by Buckman and thus not stand. “Fraud on the FDA” directly addresses the interests and prerogatives of the United States. As such, the United States, as the “aggrieved party,” should have enforcement rights and responsibilities.

[23]  Medtronic v Reigel, 552 U.S. 312 (2008).

[24]  Remember that the “jurisdiction” question—does the plaintiff have the authority or ability to pursue the claim—is related to, but not identical to, preemption issues.

[25]  The existence of a negligence per se claim based on a violation of federal law is a matter of state law and there can be differences between the states.

[26]  Remember that warning letters, untitled letters, 483s, etc. are not final agency actions. Likewise, guidances are not technically binding.

[27]  FDA Takes New Approach to “No Artificial Colors” Claims, U.S. Food & Drug Admin. (Feb. 5, 2026), https://www.fda.gov/news-events/press-announcements/fda-takes-new-approach-no-artificial-colors-claims.

[28]  One can think about analogies to the False Claims Act under which the federal government is given prior notice and the opportunity to intervene.

[29]  There is precedent for authorizing the federal government to take control (often via intervention) of litigation if federal interests are involved. See, e.g., the False Claims Act. See 31 U.S.C. § 3730.

[30]  There also may be some analogies to classic drug product liability cases under a failure to warn cause of action against the pioneer drug in which the defendant asserts that it could not make the proposed label change as FDA had rejected the company’s request for such a change.

[31]  Cases such as Buckman (fraud on the FDA) or cases asserting a negligence per se claim based on violations of the FDCA seem closer to the Nexus type of claim.