Clinical Standards

How We Build Formulas

Most supplement brands ask: "What ingredients could we legally claim?"
Moana asks: "What does the evidence actually support?"

Three Reformulation Principles

The rules we follow before any ingredient enters a Moana formula.

01

EFSA-First Formulation

We consult EFSA's approved claims database before selecting any ingredient. If an ingredient lacks EFSA approval, we don't claim it — even if it's popular. We include it transparently, with its science clearly disclosed, and make no claim beyond what's authorized.

02

Clinical Dosing

We dose ingredients according to published clinical trials, not minimal legally-defensible amounts. Underdosing is legal. It is not honest.

  • Glucomannan: 3g/day (EFSA minimum for weight management claim)
  • Zinc: 5.5mg/day (EFSA minimum for cognitive function)
  • DHA: 250mg/day (EFSA minimum for brain health)
03

Proactive Compliance

We monitor EFSA regulatory updates quarterly and reformulate before restrictions arrive — not because we are forced to. This means no supply gaps, no surprise label changes, no compliance scrambles. You are always on the right side of EU regulation.

How We Verify Every Ingredient

Four filters. Every ingredient passes all four before entering a formula.

01

EFSA Journal Search

Does the ingredient have an EFSA-approved health claim? If yes, we confirm the exact claim wording and conditions (dose, form, frequency).

02

Clinical Trial Review

If not EFSA-approved, are there 3+ RCTs in peer-reviewed journals? We assess study quality, population, dose, and effect size.

03

Safety Dossier Check

5+ years of post-market safety data? Any adverse event reports? EU pharmacovigilance records reviewed.

04

Dose Validation

What dose did clinical studies use? We match or exceed that dose — never use minimal amounts that are legally defensible but therapeutically useless.

Ingredients We Don't Use — And Why

Transparency means explaining what is not in our formulas, not just what is.

IngredientStatusWhy We Exclude / Disclose
NMNNovel Food (EU-restricted)Legally defensible in the US, prohibited as a food supplement ingredient in the EU. We use nicotinamide (Vitamin B3) instead — EFSA-approved precursor to NAD+.
BerberineArticle 8 procedure (restriction expected)Proactively removed from MTS-01 three months before its expected restriction (March 2026). Zero supply interruption for customers.
Lion's Mane (claims)Insufficient EFSA substantiationWe include Lion's Mane at clinical doses in NDO-X because the research is promising — but we make zero health claims for it. EFSA has not approved claims for this ingredient.
Resveratrol (claims)Insufficient EFSA dataIncluded in SirtCore™ 01 at clinical dose. We claim nothing for it beyond its role as a characterising ingredient. Approved EFSA claim is for Nicotinamide.
High-Dose Niacin (standalone)EFSA claim conditions applyWe use nicotinamide at doses that align with EFSA-approved claim conditions for energy metabolism support.

Reformulation History

A public record of every formula change, why it was made, and when.

Jan 2026
MTS-01 / Gut-Metabolic AssistProactive

Berberine → Sinetrol® XPur

Removed berberine from MTS-01 approximately three months before EFSA's expected Article 8 restriction (March 2026). Replaced with Sinetrol® XPur — backed by 3 published RCTs, EU GMP-certified, full EFSA safety dossier. Zero supply gap for customers.

Ref: EU Novel Food Regulation (EU) 2015/2283 • Article 8 Procedure

Launch
SIRT-01 / SirtCore™ 01By Design

NMN excluded — Nicotinamide used instead

NMN is classified as a Novel Food in the EU and cannot be legally sold as a food supplement ingredient. SirtCore™ 01 launched with Nicotinamide (Vitamin B3), the EFSA-authorized NAD+ precursor, at clinical dose. Same metabolic pathway. Full EU compliance from day one.

Ref: EU Novel Food Regulation (EU) 2015/2283 • EFSA Journal 2010;8(10):1757

Our Transparency Promise

Every Ingredient

Clinical dose listed on the label. EFSA claim linked where approved. Source and manufacturer disclosed.

Every Change

All reformulations are logged publicly here. We explain what changed, why, and when — before customers ask.

Every Batch

Third-party tested for heavy metals, microbial contamination, and potency. Results linked from each product page.

Food Supplements. Our products are not intended to diagnose, treat, cure, or prevent any disease. All health claims comply with EFSA Regulation 1924/2006 and EU Regulation 432/2012. Manufactured in the EU under GMP conditions. Individual results vary.