In a win for implied preemption, the Ninth Circuit recently affirmed dismissal of supplement marketing claims under California’s Unfair Competition Law (UCL).  The case, Bubak v. Golo, LLC, No. 24-492 (9th Cir. Oct. 9, 2025), held that the plaintiff’s UCL claim was impliedly preempted because it depended entirely on alleged violations of the federal Food, Drug, and Cosmetic Act (FDCA), which may be enforced only by the federal government.

Plaintiff asserted a UCL claim premised entirely on allegations that Golo violated the FDCA—which is incorporated into California’s Sherman Food, Drug, and Cosmetic Law (Sherman Law)—by representing that its dietary supplement can mitigate or prevent a disease.  The Ninth Circuit held that claim was impliedly preempted because it “necessarily requires litigating the alleged underlying FDCA violation,” and “the plain text of the FDCA leaves that determination in the first instance to the FDA’s balancing of risks and concerns in its enforcement process.”  The Ninth Circuit noted that its decision in Bubak was consistent with its prior holding in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022).

Notably, the Ninth Circuit declined to extend its more recent decision in Davidson v. Sprout Foods, Inc., 106 F.4th 842 (9th Cir. 2024), which we previously covered here.  In Davidson, a split panel broke with the logic underlying Nexus by holding that the FDCA does not preempt Sherman Law claims that are fully parallel with the FDCA.  The Bubak court distinguished by stating that the claim in Davidson did not “require litigating questions that are reserved for the FDA, because the violation was plain” in that case.  Here, however, as in Nexus, “further analysis is needed to determine whether Golo’s marketing actually violated the FDCA.”

In a separate concurrence, Judge Callahan suggested that Davidson should be overruled.  Judge Callahan noted that Davidson created an intra-circuit split and argued that the FDCA does not carve out a “plain violation” exception to its bar on private enforcement.  Even if it did, there is no meaningful distinction between the violations in these cases, each of which required examining the marketing at issue to determine if it violates FDA regulations. 

While unpublished, Bubak underscores the continuing uncertainty in the Ninth Circuit after Nexus and Davidson.  Helpfully, however, both the memorandum opinion—which narrows Davidson to “plain” violations—and the separate concurrence—which openly calls for the court to revisit Davidson—lay the groundwork for advocating for a broader view of preemption in future cases.

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Photo of Alyssa McGraw Alyssa McGraw

Alyssa McGraw is a litigator whose practice focuses on complex civil litigation and government investigations. She represents clients in the consumer brands, technology, and financial services industries, with experience defending clients in class actions, regulatory enforcement proceedings, and internal and government investigations, including…

Alyssa McGraw is a litigator whose practice focuses on complex civil litigation and government investigations. She represents clients in the consumer brands, technology, and financial services industries, with experience defending clients in class actions, regulatory enforcement proceedings, and internal and government investigations, including in related litigation.

Alyssa also maintains an active pro bono practice.

Photo of Andrew Soukup Andrew Soukup

Andrew Soukup serves as co-chair of the firm’s Class Action Litigation Practice Group. He specializes in representing heavily regulated businesses in class actions, multidistrict litigation, and other high-stakes disputes.

Praised for achieving “big wins in his class action practice,” Andrew has defeated a…

Andrew Soukup serves as co-chair of the firm’s Class Action Litigation Practice Group. He specializes in representing heavily regulated businesses in class actions, multidistrict litigation, and other high-stakes disputes.

Praised for achieving “big wins in his class action practice,” Andrew has defeated a variety of advertising, consumer protection, privacy, and product defect and safety claims, with exposure ranging from millions to billions of dollars. Based on his “proven record,” Andrew has been recognized as an “attorney you want on your side in a bet-the-company case.”

Andrew’s clients include those in the consumer products, life sciences, financial services, technology, automotive, gaming, and media and communications industries. He has consistently helped his clients prevail in litigation in federal and state courts across the country against putative class representatives, government agencies, state attorneys general, and commercial entities.

With a long history of representing companies subject to extensive federal regulation and oversight, Andrew has a unique ability to help courts understand the complex environment that governs clients’ businesses. Clients turn to Andrew because of his successful outcomes at all stages of litigation, his responsiveness and attention to their matters and his deep understanding of their businesses.

Andrew’s recent successes include:

Leading the successful defense of several of the world’s leading companies and brands in class actions accusing them of engaging in deceptive marketing or selling defective products, including claims brought under state consumer protection and unfair deceptive acts or practices statutes.
Defeating claims against one of the nation’s leading consumer products companies in industry-wide, multidistrict class-action litigation challenging the company’s marketing and advertising of over-the-counter medicine containing allegedly ineffective ingredients, which earned Andrew recognition by American Lawyer as a “Litigator of the Week.”
Delivered wins in multiple nationwide class actions on behalf of leading financial institutions related to fees, disclosures, and other banking practices, including defending several financial institutions accused of violating the Paycheck Protection Program’s implementing laws, which contributed to Covington’s recognition as a “Class Action Group of the Year.”
Represented several consumer product and life sciences companies from lawsuits seeking economic damages arising out of the sale of products that allegedly caused personal injuries.
Helping several of the world’s most prominent companies from ESG-related claims accusing them of misrepresenting their practices.

Andrew has also achieved favorable outcomes for clients in commercial and indemnification disputes involving contracts, fraud, and other business tort claims. He helps companies navigate contractual and indemnification disputes with their business partners. Additionally, he provides guidance on arbitration agreements and has helped numerous clients avoid multi-district and class-action litigation by enforcing their arbitration agreements.

As a recognized thought leader on issues impacting class action litigation, Andrew regularly contributes to the firm’s blog, Inside Class Actions, and was recently featured in an interview with Litigation Daily on class-action litigation issues. In recognition of his achievements, he has been recognized by The American Lawyer as a Lawyer of the Week, and the Daily Journal recently included him on their list of Leading Commercial Litigators (2025).

Watch: Andrew shares insights on class action litigation, as part of our Navigating Class Actions video series.

 

Photo of Steve Petkis Steve Petkis

Steve Petkis is a partner in the firm’s Washington, DC office, where he represents a variety of clients in their most sensitive, complex, and high-stakes litigation matters in both state and federal court. He regularly defends life sciences clients and other regulated entities…

Steve Petkis is a partner in the firm’s Washington, DC office, where he represents a variety of clients in their most sensitive, complex, and high-stakes litigation matters in both state and federal court. He regularly defends life sciences clients and other regulated entities against class action and mass tort claims that span jurisdictions.

Steve handles cases from pre-litigation planning through appeal, with a proven record of delivering victories at all stages. He was a member of the trial team that secured a complete defense win for McKesson in a landmark public nuisance case involving prescription opioid medications. In addition, his briefing strategies, fact and expert depositions, and courtroom stand-up have helped steer a number of other clients to highly-favorable resolutions that eliminate billions of dollars in potential exposure.

Steve previously served as a law clerk to Judge Katherine B. Forrest on the United States District Court for the Southern District of New York. He maintains an active pro bono practice focused on civil rights and criminal justice issues.