Shelf-Life & Stability Studies for Supplements, NHPs & Foods

Every supplement, Natural Health Product (NHP), and functional food sold in the U.S. or Canada must carry an expiration date or best-before date. But regulators, retailers, and consumers expect that date to mean something. It’s not just a guess.

That’s where shelf-life and stability studies come in. These studies provide evidence that your product maintains potency, safety, and quality over its intended shelf life. Without them, you risk FDA or Health Canada citations, retailer rejections, and consumer trust issues.

At Blue Ocean Regulatory, we design and oversee shelf-life and stability programs tailored to supplement and food brands. We help you build data-driven expiration dating that withstands regulatory and retailer scrutiny — and keeps your brand protected.

Why Stability Studies Matter

  • FDA Requirement (U.S.): Under 21 CFR 111, dietary supplement expiration/best-before dates must be supported by stability data. Unsupported dating is considered misbranding.

  • Health Canada Requirement (NHPs): NPN applications require evidence of stability to support shelf-life and recommended storage conditions.

  • CFIA (Foods): Best-before dates must be truthful, and claims like “no preservatives” raise additional stability expectations.

  • Retailers: CVS,, Whole Foods, and Costco may request stability documentation before approving or continuing to list products.

  • Liability: If your product doesn’t meet requirements before its expiration date, you could face recalls, lawsuits, and regulatory action.

What Our Shelf-Life & Stability Services Cover

We build programs that balance regulatory expectations with practical business needs.

1. Study Design

  • Real-time stability protocols (gold standard).

  • Accelerated stability studies to support faster launch timelines.

  • Bracketing and matrix approaches to reduce testing burden across multiple SKUs.

  • Tailored protocols for dosage forms (capsules, powders, gummies, liquids).

2. Testing Parameters

  • Potency: Key actives tested at T=0, 3, 6, 9, 12 months (or longer as needed).

  • Microbial: Total plate count, yeast/mold, pathogens.

  • Physical: Color, odor, appearance, dissolution, moisture.

  • Packaging integrity: Impact of bottles, sachets, or stick packs on stability.

  • Contaminants: Heavy metals, rancidity (oils), or other time-sensitive risks.

3. Lab Qualification & Oversight

  • Selection of qualified third-party labs.

  • Verification of methods (e.g., HPLC, ICP-MS, validated microbiology).

  • Review of COAs and raw data for accuracy.

4. Documentation & Reporting

  • Shelf-life justification reports aligned with FDA and NNHPD expectations.

  • Stability summaries formatted for NPN applications.

  • Audit-ready records for FDA inspections or retailer reviews.

  • Recommendations for label updates based on stability outcomes.

5. Ongoing Support

  • Annual program reviews.

  • Updates when formulas, suppliers, or packaging change.

  • Integration of stability data with your Quality Management System (QMS).

Common Pitfalls We Prevent

Brands often underestimate the complexity of stability testing. Typical mistakes include:

  • Unsupported expiration dating: Putting “2 years” on labels without any stability data.

  • Accelerated-only testing: Using 3–6 month accelerated studies without confirming with real-time data.

  • Ignoring packaging: Testing bulk powder but not finished product in bottles, sachets, or blister packs.

  • Under-testing actives: Testing a single vitamin or mineral while ignoring botanicals or probiotics that degrade faster.

  • No microbiological checks: Assuming “dry powders” are stable without confirming microbial growth risk.

  • Mismatched formats: Submitting stability data from a different dosage form or formulation to Health Canada.

  • Lost data: Not integrating stability studies into recordkeeping systems, leaving brands unprepared for audits.

Our Approach

We make stability studies practical and defensible:

  • Design studies proportionate to your risk profile and product category.

  • Align testing parameters with your claims, regulatory expectations, and retailer requirements.

  • Provide audit-ready reports that stand up to FDA, Health Canada, or retailer review.

  • Communicate findings in plain language so founders understand how shelf-life decisions are made.

Why Brands Work With Blue Ocean Regulatory

We’ve worked with brands across supplements, NHPs, and foods — from startups validating their first capsule to established companies with dozens of SKUs across multiple categories.

Our insights have been featured in NutraIngredients USA, we’ve been invited to guest speak at events hosted by the Council for Responsible Nutrition, and we’ve appeared on The Nutracast Podcast.

Brands trust us because we combine technical accuracy with practical solutions. We don’t overcomplicate stability studies — we design programs that get your products to market faster while keeping you compliant.

Next Steps

If your products are carrying expiration dates without supporting stability data — or if you’re preparing a new NHP submission in Canada — now is the time to act.

Schedule a Shelf-Life & Stability Review with Blue Ocean Regulatory today. We’ll design the right protocol, oversee testing, and provide the defensible documentation you need to launch and scale with confidence.