Structure/Function Claims in Supplements: What the Prevagen Case Teaches (and What to Do Now)
Key takeaway:
Words like “improves,” “reduces,” “boosts,” “within 90 days,” and “clinically proven” raise the bar on evidence. The FTC’s “competent and reliable scientific evidence” standard is rigorous and—practically—often interpreted as requiring well-designed randomized controlled human trials for efficacy claims, particularly around memory and cognition. The Prevagen (Quincy) litigation shows how ambiguous language and thin substantiation invite scrutiny—even when a jury finds claims not “materially misleading.”
Introduction
Structure/function claims promise support for normal bodily functions—memory, bone strength, performance, detox, and more. They are attractive to marketers and risky for brands. The FTC v. Quincy Bioscience (Prevagen) enforcement and trial illuminate where brands get in trouble: high-promise language, clinical proof assertions, and studies that don’t translate to real-world outcomes. This article distills the case discussion into practical guidance you can use immediately.
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Why Certain Claims Attract Scrutiny
Some categories and phrases are lightning rods:
Cognitive & memory claims: Historically high litigation and enforcement interest.
Trigger verbs: “Improves, reduces, boosts, increases, decreases.” These imply a promised effect, not mere support.
Time-bound promises: “Within 90 days” increases evidentiary expectations.
Vague breadth: “Other cognitive benefits” is overly broad and invites contrary interpretations.
Proof language: “Clinically proven” or even “clinically shown” signals human clinical data that is directly relevant, well-designed, and meaningful.
None of these words are automatically prohibited—but every one of them raises the substantiation bar.
What “Adequate Substantiation” Really Means
The FTC requires competent and reliable scientific evidence. In practice, that means:
Evidence conducted and evaluated objectively by qualified experts.
Methods that are generally accepted to yield accurate, reliable results.
For health-related benefits, the practical expectation is randomized, controlled human clinical testing aligned to the specific population, dose, form, and outcome claimed.
Animal, in vitro, or weak human data may be considered but typically don’t carry the claim alone—especially when claims are strong (e.g., “improves memory in 90 days”).
Design details matter: endpoints, statistical plan, blinding, placebo control, sample size, washout, population matching, and whether outcomes are clinically meaningful (not just statistically significant by a trivial margin).
Inside the Prevagen Dispute (On the Substantiation Question)
Quincy’s position: “Competent and reliable evidence” is flexible; totality of evidence counts; not every claim requires an RCT by law. The defense cited expert testimony and non-human data suggesting mechanistic plausibility (e.g., blood–brain barrier crossing).
FTC’s position: For claims like “improves memory” (and especially with a time promise), well-designed human RCTs are the appropriate standard. Selective reporting, subgroup fishing, or tiny effects that don’t translate to real life are insufficient.
Jury outcome (high level): The jury found all eight statements lacked competent and reliable scientific evidence, yet six of eight were not materially misleading. The paradox underscores a tough reality for brands: you can lose on substantiation even if messaging isn’t deemed misleading, and that gap doesn’t protect you from enforcement risk or follow-on challenges.
Practical Guardrails for Safer Claims
Dial the verb to match your evidence
Safer: “Supports memory,” “Helps maintain cognitive performance.”
Higher bar: “Improves memory,” “Reduces memory problems,” “Increases performance.” If you keep them, expect RCT-grade evidence.
Avoid ambiguous catch-alls
Replace “other cognitive benefits” with specific, supported endpoints (e.g., working memory, processing speed), and cite the population aligned to your product.
Be cautious with time promises
“Within 90 days” requires studies showing the effect on that timeline, in a like population, at the same dose and form.
Treat “clinically proven/shown” as a commitment
If you say it, be ready to produce direct, well-designed human clinical data matching your product and claim. When in doubt, remove “proven” and use precise, qualified language grounded in your evidence.
Translate statistics to consumer reality
If a study shows a minuscule change on a cognitive test, ask: Does it matter to a consumer? Message only what is material and meaningful.
Document your rationale
Maintain a substantiation dossier: search strategy, study selection, quality grading, applicability to your product (dose, form, matrix), endpoint mapping to claims, and limitations.
Think beyond FTC
Expect competitor NAD challenges, retailer reviews (and evolving Amazon scrutiny), and plaintiff baractivity. Build claims that withstand multiple forums, not just a single regulator.
Claim Language Checklist (Quick Use)
Replace absolute promises with qualified support language when evidence is preliminary.
Tie the claim to specific outcomes rather than broad “cognitive benefits.”
Match population, dose, form, timing between studies and product.
Avoid disease claims and implied disease treatment.
Keep a claim matrix linking each claim to evidence and risk level.
Have compliance and scientific review sign-off before publishing.
Key Takeaways
Memory and cognition claims sit in a high-risk zone; words like “improves” and “clinically proven” invite RCT-level expectations.
The Prevagen litigation shows how brands can fail substantiation even when messaging isn’t found materially misleading.
The safest path is specific, supported, and qualified language anchored in relevant human data and documented in a defensible dossier.
Proactive claim design during formulation and copywriting is far cheaper than defending an aggressive claim later.
FAQ
Are structure/function claims allowed to say “improves”?
Yes, but using “improves” typically requires stronger human evidence than “supports/helps maintain.” Choose verbs that match the strength of your data.
Can animal or in vitro studies substantiate a claim?
They may contribute to biological plausibility but rarely suffice for efficacy—especially for high-promise claims in humans.
Is “clinically proven” safer than “clinically shown”?
Both imply human clinical data. “Proven” suggests stronger, reproducible findings. If studies are limited or not directly applicable to your product, avoid both.
How do we reduce risk without killing performance marketing?
Narrow the claim to specific, supported outcomes, use qualified language, and reinforce credibility with transparent substantiation rather than broad, absolute promises.
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About Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and functional food brands launch and scale compliantly. Core specialties include FDA/FTC label & claims review, substantiation dossiers, cGMP programs, manufacturer vetting, test & stability strategies, and retailer/investor readiness. Our goal: build brands that last—and pass.