How ProSupps Got Sued: The Hidden Labeling Mistake Every Supplement Brand Must Avoid

Intro

What if a simple “0 g carbohydrates” claim could land your supplement brand in court? The ProSupps lawsuit proves it can. This case highlights how even small oversights—often made in good faith—can spiral into major legal and financial fallout.

This article breaks down what the ProSupps HydroBCAA case teaches every supplement brand owner about label accuracy, testing, and compliance responsibility. You’ll learn practical ways to verify your product data, how to structure claims defensively, and why “poker face” labeling can keep you out of a courtroom.

Key Takeaways

• Even basic nutrition claims like “0 g carbohydrates” can trigger lawsuits.
• One tested sample can now be enough to move a misbranding case forward.
• You—not your manufacturer—are responsible for label accuracy.
• Adopt a “poker face” approach to minimize risky language.
• Consistent third-party testing is cheaper than litigation.

1. What the ProSupps Lawsuit Reveals About Labeling Risk

In 2022, ProSupps was sued over its HydroBCAA product. The label claimed “0 g carbohydrates,” but independent testing allegedly found 5.68 g per serving.

At first, ProSupps caught a break: the plaintiff had tested only one sample. A district court dismissed the case, noting that FDA guidance typically requires 12 samples for label claim verification. But the victory was short-lived. In June 2025, the Ninth Circuit Court reversed that decision—ruling that even a single test could be enough to reopen a misbranding case.

The message is clear: even a seemingly minor discrepancy can put your brand’s integrity, finances, and focus on trial.

Pro tips:
– Never assume “simple” claims are safe—treat every statement as legally binding.
– Avoid absolute terms like “zero,” “sugar-free,” or “fat-free” unless verified.
– Review FDA’s 21 CFR 101.9 rounding and nutrient declaration rules before printing.

2. Why Following the Manufacturer’s Label Template Isn’t Enough

Most supplement brands rely on their manufacturer to generate the Supplement Facts panel, trusting that the values are correct. But manufacturers often use automated formulation software that defaults to “0 g” when no carbohydrate or fat data is entered.

That placeholder becomes your liability. If the lab never measured those nutrients, your label becomes a misrepresentation—whether intentional or not.

In the eyes of regulators and courts, you are the responsible party. Not your manufacturer. Not your graphic designer. Your brand owns the label and the claims printed on it.

Pro tips:
– Request raw nutrient calculations or lab data from your manufacturer before sign-off.
– Validate every “0 g” or “sugar-free” statement with test data.
– Keep an audit trail of who approved each label version and when.

3. Adopt a “Poker Face” Labeling Strategy

In poker, champions win by staying unreadable. They reveal nothing—no tells, no emotions. Your supplement label should do the same.

Keep it clean, minimal, and free of unnecessary claims. Every word you add is a potential target for litigation. Terms like “natural,” “clean,” or “pure” are common triggers for lawsuits, as they lack consistent regulatory definitions.

Think of your label as a legal document that must survive adversarial scrutiny. Less flash, fewer adjectives, more clarity.

Pro tips:
– Eliminate marketing buzzwords with vague meaning.
– Separate promotional claims (for your website) from factual declarations (on your label).
– Focus front-panel text on compliance-safe elements: brand name, count, form, and net quantity.

4. Verify Label Accuracy Through Testing, Not Assumptions

Testing costs money—but lawsuits cost far more. The ProSupps case shows that skipping verification testing is like driving uninsured.

Each production lot should be tested for key label nutrients—not just active ingredients. Pull samples from multiple parts of the batch, not one bottle. Keep records of who performed the tests, when, and how.

Beware of “Certificates of Analysis” that list only “N/A” or generic pass/fail statements. These often indicate that no actual nutrient test was performed.

Pro tips:
– Test at least 12 samples from across the batch to mirror FDA expectations.
– Use ISO 17025-accredited labs with validated methods.
– Archive all test reports with lot traceability for at least 2 years.

5. Design Labels That Look Sharp and Compliant

Visual precision matters. Sloppy formatting, inconsistent fonts, or incorrect disclaimers make your brand look careless—and signal vulnerability to lawyers.

A professional, compliant label reflects operational maturity. Misaligned panels or inconsistent French/English text (a common mistake on U.S. products) raise red flags instantly. Just as an ill-fitting suit undermines confidence, a poorly formatted label undermines trust.

Your label should project competence before anyone reads the fine print.

Pro tips:
– Have every label reviewed by a regulatory expert before printing.
– Check formatting requirements under 21 CFR 101.36 (dietary supplements).
– Confirm that all structure/function claims include the DSHEA disclaimer verbatim.

FAQ

Q1. Why was ProSupps sued if the manufacturer produced the label?
Because FDA and FTC hold the brand owner accountable for label accuracy, regardless of who printed or formatted it.

Q2. How accurate do nutrient values have to be?
Generally, declared nutrients must be within ±20% of the actual tested value (21 CFR 101.9).

Q3. Can one failed test trigger a lawsuit?
Yes. As the Ninth Circuit ruled in 2025, even one sample can be enough to move a case forward.

Q4. Should small brands invest in their own testing?
Absolutely. Testing is an insurance policy—protecting you from costly claims and damaged credibility.

Q5. What’s the best way to avoid label disputes?
Keep labels clean, test your products, and document everything. Simplicity and transparency are your strongest defenses.

Next Steps

1) Book a 1:1 regulatory consult (startups & first-time launches)
Get a rapid-read on feasibility, classification, claims, and manufacturing path. Deliverables: prioritized risk list, draft claims, and next-step plan.

2) Join SSET — Supplement Startup Essentials Training (& Pair It With A Consult)
A step-by-step program covering FDA/FTC fundamentals, manufacturer vetting, testing plans, claims/substantiation, and Amazon/Retail readiness.

3) Established brands: contact us to scope support
Already in market and scaling? Let’s tailor a plan for your needs: e.g., multi-country labeling, stability programs, QA audits, recall SOPs, claims reviews, retail submissions.

Compliance Note

This article provides educational guidance under U.S. FDA/FTC dietary supplement regulations and does not constitute legal advice. Always verify requirements before market entry.

© Blue Ocean Regulatory
Blue Ocean Regulatory helps supplement and natural health brands navigate FDA, FTC, and Health Canada requirements—building trust that fuels growth instead of red tape.