Specifications & Testing Programs for Supplements, NHPs & Foods

When it comes to supplement and functional food compliance, specifications and testing are the backbone of product quality. They determine whether your products are safe, properly labeled, and legally marketable. The FDA, Health Canada, and CFIA expect brand owners — not just manufacturers — to establish and maintain product specifications. Without them, you’re operating blind.

At Blue Ocean Regulatory, we help brands build complete specification and testing programs tailored to their products, manufacturing partners, and sales channels. We create documentation that meets FDA/Health Canada expectations, protects your brand during audits, and ensures that your customers get what the label promises.

Why Specifications Matter

  • Regulatory Requirement (U.S.): Under 21 CFR 111, every dietary supplement brand must establish specifications for identity, purity, strength, composition, and contaminants. Manufacturers must test against these specs before releasing product.

  • Canadian Requirements: Health Canada requires Natural Health Products (NHPs) to meet specifications aligned with NNHPD monographs or approved evidence. Both medicinal and non-medicinal ingredients must be covered. For foods, the CFIA enforces Nutrition Facts accuracy and contaminant limits.

  • Retailer Expectation: Amazon, Whole Foods, Loblaws, and other retailers increasingly ask for Certificates of Analysis (COAs) and proof of testing programs. Missing documentation often results in rejections or delistings.

  • Liability: If you don’t have specifications, your brand nor your manufacturer knows what to test for and how to best engineer your product. That leaves you exposed to variabilities in testing, legal issues with conflicting results, recalls, and consumer lawsuits.

What Our Service Covers

We don’t just hand you templates, we build customized specifications and testing programs for your specific products, customers, and supply chain.

1. Finished Product Specifications

  • Identity, strength, purity, and composition for each product.

  • Nutrient testing aligned with Supplement Facts or Nutrition Facts panels.

  • Limits for heavy metals, pesticides, solvents, and microbiological contaminants.

  • Requirements for packaging components and branded materials.

  • Shelf-life expectations supported by stability testing (when applicable).

2. Testing Program Development

  • Mapping of which tests must be performed at incoming, in-process, and finished product stages.

  • Third-party lab qualification and approved methods (e.g., ICP-MS for heavy metals, HPLC for actives).

  • Sampling plans (composite vs. individual lot testing).

  • Microbial and allergen testing programs tailored to risk.

  • Bracketing and matrix approaches for stability studies.

3. Documentation & Recordkeeping

  • SOPs for specifications, testing, and release.

  • Finished Product Certificate of Analysis templates.

  • Record retention and audit-ready filing systems.

  • Guidance on integrating specs with your QMS.

Common Issues We Catch

Brands often think “the manufacturer has this handled.” But audits and enforcement show otherwise. Typical problems include:

  • Finished product COAs missing required contaminants testing.

  • Labels declaring nutrients not actually tested at release.

  • Confusion between client labels and what is formulated.

  • Food products using Supplement Facts testing approaches (or vice versa).

  • Inconsistent microbial testing — skipping testing or relying on outdated methods.

  • Lack of written specifications entirely, leaving brands exposed in FDA inspections.

Our Approach

We start with a gap analysis of your current specifications and testing practices. From there, we build:

  • Practical specifications matched to your products.

  • Testing programs scaled to your risk profile (no wasted money on unnecessary tests, no missed essentials).

  • Audit-ready documentation to satisfy FDA, NNHPD, CFIA, and retailer requests.

And because we know many founders don’t have a scientific background, we present everything in plain language so you understand exactly what’s required and why.

Why Brands Work With Blue Ocean Regulatory

We bridge technical compliance with brand reality. Our consultants have worked across dietary supplements, functional foods, and Canadian NHPs — giving us the perspective to design programs that satisfy regulators without overwhelming your operations.

Our expertise has 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 choose us because we provide compliance infrastructure that’s practical, defensible, and scalable.

Next Steps

If your brand doesn’t have documented specifications and a formal testing program — or if your COAs don’t cover all regulatory requirements — now is the time to act. Regulators, retailers, and consumers are demanding proof of compliance earlier than ever.

Schedule a Specifications & Testing Program Review with Blue Ocean Regulatory today. We’ll create the specifications, design the testing, and give you the documentation you need to confidently launch and scale your products.