The U.S. dietary supplement industry continues to face mounting legal scrutiny as consumer class action lawsuits expand in scope and complexity. Allegations now range from inaccurate labeling and noncompliant disclaimers to misleading ingredient claims. While regulatory frameworks such as the Federal Food, Drug, and Cosmetic Act (FDCA) and the Dietary Supplement Health and Education Act (DSHEA) guide product labeling, most lawsuits are brought under state consumer protection laws—allowing plaintiffs to challenge claims that appear deceptive to the “reasonable consumer.”
Labeling and Disclaimer Challenges
One of the most significant trends involves challenges to structure/function claim disclaimers required under 21 CFR § 101.93. Plaintiffs allege that some supplements omit the mandated FDA disclaimer or fail to place it on the same panel as the related claim, misleading consumers into believing products are FDA-approved. Although the FDA has rarely enforced this provision, plaintiff attorneys have capitalized on the gap between regulatory practice and technical compliance. Companies can mitigate risk by ensuring disclaimers appear near each structure/function claim and by using clear symbols or asterisks to direct consumers to explanatory text.
Ingredient and Testing Discrepancies
Class actions increasingly allege that labeled ingredient amounts are inaccurate or unsubstantiated. These suits often cite laboratory testing that shows lower-than-declared levels of active ingredients such as magnesium glycinate or berberine. Under FDA rules, dietary supplements must generally contain 100 percent of the labeled amount of each ingredient (21 CFR § 101.36). Even when testing differences are marginal, plaintiffs argue that under-labeling or overstatements mislead consumers. Brands should confirm label accuracy through validated analytical methods and document testing protocols to defend against such claims.
The Reasonable Consumer Standard
Courts continue to apply the reasonable consumer standard as a key defense. Several recent Ninth Circuit decisions—Moore v. Trader Joe’s Co., McGinity v. Procter & Gamble Co., and Whiteside v. Kimberly-Clark Corp.—reinforced that labeling must be evaluated in context. Qualifiers, disclaimers, and back-panel details can clarify ambiguous front-label claims, often leading to early dismissal of cases. These precedents highlight the importance of contextual, well-qualified labeling and transparent communication with consumers.
Emerging Allegations
Beyond labeling, new claims allege “greenwashing,” misleading sustainability messaging, and undisclosed synthetic ingredients. Some lawsuits challenge “natural” or “clean” representations when trace levels of microplastics or processing agents are present. Others target slack-fill packaging or inaccurate protein content declarations. As consumer awareness of ingredient sourcing grows—spurred by health initiatives and social media—supplement manufacturers should proactively review product claims for potential misinterpretation.
Conclusion
The evolving landscape of dietary supplement litigation underscores the need for strong compliance and transparent marketing. While FDA alignment remains critical, companies must also evaluate how an average consumer interprets label claims. Routine label audits, evidence-based substantiation, and clear disclaimers can significantly reduce exposure to class action risk.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
U.S. Food and Drug Administration. Food Labeling: Structure/Function Claims, Small Entity Compliance Guide. 21 CFR § 101.93 (2024).
Moore v. Trader Joe’s Co., 4 F.4th 874 (9th Cir. 2021).
Federal Trade Commission. Health Products Compliance Guidance. December 2022.
