FTC vs Quincy Bioscience: What Supplement Brands Must Learn
Supplement claims are one of the most heavily scrutinized areas of the industry. Whether you’re promising “better memory,” “detox,” or “stronger bones,” the words you choose—and the science behind them—determine your legal exposure. A recent high-profile case, FTC vs Quincy Bioscience (makers of Prevagen), highlights just how complex the substantiation standard can be.
In this post, we’ll break down the lawsuit, explore what the FTC considered sufficient evidence, and review key lessons supplement brands must apply when making claims.
What the Case Was About
The FTC challenged Prevagen’s advertising on multiple fronts. Claims included:
“Prevagen improves memory.”
“Prevagen improves memory within 90 days.”
“Prevagen reduces memory problems associated with aging.”
“Prevagen provides other cognitive benefits.”
“All benefits are clinically proven.”
These statements combine two high-risk elements: strong verbs (“improves,” “reduces”) and time-bound promises(“within 90 days”). Both elevate the level of substantiation required.
The FTC argued that claims like “clinically proven” were misleading without robust human clinical trials. Quincy, meanwhile, pointed to animal studies, expert testimony, and mechanistic data suggesting their active ingredient (apoaequorin) could cross the blood-brain barrier.
The FTC’s Standard for Substantiation
The FTC requires that supplement claims be backed by “competent and reliable scientific evidence.” While the law itself does not specify clinical trials, the FTC’s interpretation has consistently pushed for:
Randomized, controlled human clinical trials (RCTs).
Sufficient sample sizes.
Objective, reliable endpoints.
Results that are relevant to real-world use.
This high bar is designed to prevent exaggerated or unproven claims. The FTC’s position: animal studies or mechanistic data are not enough when a brand promises a measurable consumer benefit.
Quincy’s Defense
Quincy argued that the law provides flexibility: animal research, mechanistic evidence, and other forms of scientific analysis can reasonably support a claim, depending on the context. They pointed out that no regulation explicitly mandates RCTs for supplements.
Their position reflects a common industry view—that “competent and reliable scientific evidence” should consider the totality of available data, not just clinical trials.
The Jury’s Verdict
The outcome was paradoxical:
The jury found that Quincy’s claims lacked competent and reliable scientific evidence.
Yet six out of eight claims were deemed not materially misleading to consumers.
In other words, consumers may not have been deceived, but the science still didn’t meet the FTC’s evidentiary standard. This gray area highlights the difficulty of navigating claims compliance.
Key Takeaways for Supplement Brands
1. Watch the Trigger Words
Words like improves, reduces, boosts, and clinically proven raise substantiation requirements. Use them only if you can defend them with strong evidence.
2. Broad Claims Create Risk
General statements like “provides cognitive benefits” may feel safe, but their vagueness leaves room for regulators (or competitors) to interpret them in the harshest way possible.
3. “Clinically Proven” Is a High Bar
If you use “clinically proven,” regulators will expect published, well-designed RCTs directly supporting your claim. Safer alternatives: clinically studied or scientifically supported, provided the evidence is clear.
4. Substantiation Is Flexible—But the FTC Favors RCTs
While the law doesn’t explicitly demand clinical trials, the FTC has made them the practical expectation for high-risk claims. Brands should prepare as if RCTs are the standard.
5. Competitors and Class-Action Lawyers Are Watching
Even if the FTC doesn’t come knocking, competitors or law firms may challenge your claims. Amazon and retailers are also tightening their standards, especially for high-risk categories like brain health, weight loss, and immunity.
Q&A: Common Claim Questions
Q: Can I say my supplement is “clinically proven”?
Only if you have high-quality, human clinical trials that directly support your claim. Otherwise, you expose your brand to significant legal risk.
Q: Are animal studies enough to support claims?
No. Animal or in vitro data may add context, but FTC expects human clinical evidence for efficacy claims.
Q: What’s safer language to use?
“Supports healthy memory” or “helps maintain cognitive function” are examples of lower-risk structure/function claims—if backed by adequate substantiation.
Q: Do all ingredients need to be at clinical doses?
Not always. FTC focuses on whether the formula, as a whole, can deliver the claimed benefit. But under-dosed “hero ingredients” raise red flags.
Final Thoughts
The Quincy case underscores why claim language is never just a marketing decision—it’s a compliance decision. Even seemingly modest claims can invite scrutiny if they aren’t backed by evidence that regulators and competitors recognize as credible.
For supplement startups, the safest path is to build a substantiation file early, pressure-test claim language, and plan formulations with compliance in mind. Doing so reduces legal risk and builds long-term brand value.
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About Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and functional food brands launch and scale compliance. Core specialties include FDA/FTC label & claims review, substantiation dossiers, cGMP programs, manufacturer vetting, test & shelf-life strategies, and retailer/investor readiness. Our goal: build brands that last—and pass.