Formulation Compliance & Claims Substantiation

A winning formula isn’t just about great ingredients — it’s about evidence that matches your dose, your delivery form, and your target consumer, expressed in claims that meet FDA and FTC expectations in the U.S. and Health Canada/NNHPD standards in Canada. Done right, substantiation protects you with regulators and retailers while giving your marketing team confident, high-performing claim language. Done poorly, it invites FDA/FTC attention, litigators and competitor enforcement, retailer rejections, and consumer complaints.

Blue Ocean Regulatory helps brands build safe, compliant, and credible formulas — and the claims to match. We audit your formula against known regulatory limits, map each proposed claim to human evidence, and craft claim language that sells without crossing the disease-claim line.

Why Substantiation Matters (U.S. & Canada)

  • United States (FDA + FTC): The FDA governs labeling (e.g., structure/function claims and the FDA disclaimer) while the FTC enforces advertising truthfulness. The FTC’s standard is “competent and reliable scientific evidence”—often human clinical studies of the specific ingredient, dose, and population relevant to your claim.

  • Canada (NNHPD/Health Canada): NHPs require pre-market approval (NPN). Claims must align with NNHPD monographs or be supported by acceptable evidence. Dose, route, and cautions must match what’s approved.

  • Conventional Foods: When your product is a food (bars, RTDs, protein powders positioned as foods), claims are different. You’ll use Nutrition Facts and are limited to permitted nutrient content and certain function claims(with CFIA/FDA criteria), not supplement-style claims.

Where AI Gets It Wrong (and How We Fix It)

AI is useful for ideation—but it often misreads the fine print that regulators and retailers care about. Common failure points we correct:

  • Wrong form or standardization: Mixing results from magnesium oxide studies to support magnesium glycinateclaims, or ignoring extract standardizations (e.g., withanolides in ashwagandha) and branded ingredient differences.

  • Dose mismatches: Citing studies at 600–900 mg while your label delivers 150 mg/day, without a valid dose-bridging rationale.

  • Population & duration gaps: Applying results from diseased populations to healthy consumers, or from 3-day trials to lifetime benefit claims.

  • Surrogate vs. clinical endpoints: Extrapolating biomarker shifts to outcome claims (e.g., “lowers anxiety”) without human-perceived endpoints.

  • Animal/in vitro creep: Using cell/rodent data to justify human benefit language.

  • Study quality & limitations: Ignoring issues like open-label designs, tiny sample sizes, lack of replication, conflicts of interests, or high heterogeneity in meta-analyses.

  • Regulatory category confusion: Recommending supplement ingredients it a conventional food product.

  • Retailer reality: Missing Amazon wording restrictions or Whole Foods/Loblaws ingredient bans when proposing claims.

We prevent these errors by reading the full studies (where available), verifying ingredient identity/standardization, checking dose equivalence, and documenting limitations so your claim language stays strong and defensible.

What Our Service Includes

1) Formula Compliance Audit

  • Verify daily dose vs. regulatory limits (ULs, NNHPD maximums, age/pregnancy cautions).

  • Assess ingredient identity (botanical Latin binomial, part used, standardization, trademarked actives).

  • Confirm category fit: Supplement Facts vs Nutrition Facts vs NHP.

2) Evidence Mapping & Gap Analysis

  • Build an evidence table (human RCTs, crossover trials, systematic reviews/meta-analyses, monographs).

  • Match your exact dose, form, and population to the literature; identify where only surrogate endpoints exist.

  • Highlight limitations (sample size, duration, risk of bias) and practical implications for claims.

3) Claim Crafting (U.S. & Canada)

  • Draft structure/function claims for U.S. labels and FTC-safe ad copy; apply the FDA disclaimer where required.

  • Propose NNHPD-compatible claims for Canadian NPN submissions, with evidence citations.

  • For foods, provide nutrient content and eligible function claims compliant with FDA/CFIA wording.

4) Substantiation Dossier

  • A reviewer-ready substantiation file: study summaries, citations, dose-bridging rationale, and risk statements.

  • Supporting studies (where available) are provided..

5) Propose Supplement Facts/Formula

  • Propose a formula/supplement facts of which you can then use with your contract manufacturer.

  • Identify key hero ingredients vs supporting ingredients so that you can better adjust your formula for costs.

Our Standards for “Competent & Reliable” Evidence

We prioritize human clinical data that matches your product’s reality—dose, form, population, timing. We weigh:

  • Study design quality (randomization, blinding, control, power).

  • Endpoint relevance (clinically meaningful vs surrogate).

  • Consistency & replication (independent labs, multiple trials).

  • Applicability (healthy adult population if you market for general wellness; athletes only if you sell to athletes).

When the evidence is mixed or thin, we downgrade claim strength, propose softer phrasing (“supports,” “helps maintain”), or recommend formula or dose changes to meet the desired claim.

Common Pitfalls We Fix

  • Claims that imply disease treatment/prevention.

  • U.S. claims reused in Canada without NPN-approved wording.

  • Branded-ingredient claims used with non-equivalent generics.

  • Substantiation files that don’t match the label dose.

  • Food products using supplement-style claims (wrong facts panel + claim class).

Why Brands Trust Blue Ocean Regulatory

We combine deep regulatory knowledge with practical brand experience. Our work and 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. You get plain-language, defensible claims and a dossier that stands up to retailers, regulators, and platforms.

Next Steps

If you’re planning claims for a new launch—or if a retailer or platform has asked for substantiation—let’s get your formulation and claims aligned with the science. We’ll build the dossier, craft compliant copy, and keep your team on the right side of FDA, FTC, and Health Canada.