Scientific substantiation for the actives on your label

We read the studies behind every active in your formulation and tell you what they’ll support in GB and the EU

Scientific Substantiation Review

Supplement brands and investors · UK · EU · US

Does the research match what’s in your product?

We appraise the published research behind the actives your product contains and join it to what the rules let you say. You’ll know which parts of your story the science supports. Where it doesn’t, we’ll tell you what to say instead, before any claim, pack or campaign depends on it.

Book a call about your formulation

A 20-minute call. We’ll follow it with a written scope and proposal.

Why it matters

The evidence usually arrives as a summary. The risk sits in the detail.

Most of the science behind a supplement reaches the brand second-hand: a supplier dossier, a white paper, a trade presentation, a list of references on a spec sheet. It’s written for formulators and buyers, and it’s legitimate in that setting. The trouble starts when a technical statement is lifted into consumer copy and becomes a claim the underlying study was never designed to support.

The studies themselves are rarely the problem. They were run at a different dose, on a different grade of the ingredient, in a capsule rather than a powder, or in people that do not represent your customer. Each difference seems small, but together they decide whether the evidence belongs to your product at all.

The authorised claims registers take care of the vitamins and minerals. On one recent formulation of almost thirty actives, the register answered well over half of them, and the ones it couldn’t answer were the ones on the front of the pack. That’s usually how it goes, because what makes a product different is what the register hasn’t caught up with, and that’s where your own evidence has to do the work.

And that evidence tends to be read properly for the first time when someone else asks for it: an ad platform, a retailer’s technical team, a competitor’s complaint to the Advertising Standards Authority (ASA), or an investor’s due diligence. We’d rather you read it first.

The claims register tells you what you’re allowed to say. This review tells you what your own evidence lets you say about everything the register doesn’t cover.

What we check

What a scientific substantiation review covers

We start by screening every active against the Great Britain Nutrition and Health Claims Register (GBNHCR) and the EU Register of nutrition and health claims. Anything already answered by an authorised claim at your dose and form is set aside, and the review concentrates on what’s left. For each of those actives we look at:

  • The full text of every study, never the abstract, the supplier summary or the press release
  • How each study was designed, who took part and how many
  • The dose, the ingredient form or branded grade, the delivery format and how long it ran
  • What was actually measured, and whether the effect was large and consistent enough to build a message on
  • Who funded the work and what conflicts were declared
  • Whether it matches your product: your dose, your grade, your format and your customer
  • What the evidence will carry, and what it won’t
  • What you can say instead where the intended message doesn’t hold
  • Where each finding lands in GB and the EU, including CAP Code exposure and any mandatory statement attached to a claim you’re relying on

If we spot something outside this scope while we’re in the formulation, such as a permitted-form question or a dose close to a legal limit, we’ll flag it so the right review can pick it up.

It’s critical appraisal, done to the standard a pharmaceutical team would expect, then translated into language your marketing team can use.

What you get

A substantiation file you can hand to anyone who asks

A VJM report written to be read by your marketing, technical and leadership teams alike, with no statistics background needed. It contains:

  • A one-page summary. What can be said for each active, what can’t, and the two or three findings that change a commercial decision. It’s the page that gets forwarded, so it carries the whole argument.
  • The register screen. Every active, its dose and form, and where it stands on the GB and EU registers.
  • An assessment card for every study. Design, population, numbers, dose, form, format, duration, outcomes, funding and conflicts, on one card.
  • A comparability check. Your formulation against the studies, active by active. This is where most findings live.
  • A verdict in two halves. What the evidence supports, then what it doesn’t. Never only the second half.
  • The alternative. For every message that doesn’t hold, what the evidence does support and what the rules permit instead.
  • A substantiation file index. The papers named, numbered and filed, ready for the next time a retailer, marketplace or regulator asks what backs a claim.

Every compliance ruling in the report is signed off by our compliance lead before it reaches you.

In practice

What a review turns up

Three patterns we see repeatedly. Chances are, one of them applies to your product.

The trials were run on something else

A supplier’s headline trials are sometimes run on a related grade, a different extract ratio or a different form of the ingredient. When that happens, the evidence doesn’t automatically carry across to your product. We check what the grade you actually hold has been tested for, where it has its own evidence, then build the message on that instead.

The dose that looks right on the spec sheet

Claim conditions are set on the nutrient, not on the compound that supplies it. One authorised calcium claim needs at least 400 mg of calcium per portion, but calcium carbonate is only 40% calcium, so 400 mg of carbonate delivers just 160 mg. The product looks as though it meets the condition on paper but misses it by more than half, and the same arithmetic applies to plenty of other actives.

The same applies across the different forms of creatine. Monohydrate is about 88% creatine, so weighing out the 3 g the authorised claims require as monohydrate leaves a product around 12% short, and some creatine salts contain closer to 60%.

The test that can’t change the answer

A test is only worth commissioning if its result could change what you’re allowed to say. A small trial, for instance, can’t make an unauthorised health claim usable in the UK or EU, because that still needs a formal authorisation application. The same applies to some laboratory testing, where the product’s composition has already settled the result. Collagen is a good example: it contains almost no tryptophan, so a protein quality test on a collagen-based product can only ever confirm a low score.

Before anything is commissioned, we check whether any possible outcome would change the position. Where it wouldn’t, the budget may be better spent elsewhere.

Who does the work

Science and compliance, worked from both ends

VJM is a two-person studio, and the review is built alongside the compliance work rather than bolted onto it, so every finding arrives with its regulatory consequence already worked out.

Richard Metzger, pharmacologist and co-founder of VJM Writing Services

Richard Metzger

Co-Founder & Science Lead

12 years in Pharma r&D

A pharmacologist and published researcher with twelve years in pharma and biotech, including AstraZeneca and GSK. He reads every study in full, as a regulator would.

Victoria Metzger, former NHS dietitian and co-founder of VJM Writing Services

Victoria Metzger

Co-Founder & Compliance Lead

8 years as an nhs dietitian

A former NHS dietitian of eight years and a specialist in UK, EU and US claims regulation. She rules on every compliance question the review raises and signs off the report.

Where the review points to further work, the same two people pick it up with the evidence already in hand:

Read more about us

Getting started

Start with a call.

Every review is scoped to the formulation and set out in a written proposal, with a fixed fee and a timeline, before any work begins. The fee is set by the actives that need appraising, not the length of the ingredient list, so anything the register already answers doesn’t add to it.

1. Book a call. Twenty minutes on the formulation, the evidence you hold and where you’re selling.

2. We scope it. We look through the formulation and the evidence and work out which actives need appraising.

3. You get a proposal. Scope, deliverables, fee and timeline in writing. Work starts when you’re happy with it.

Book a call about your formulation

Prefer email? Send your formulation and any studies to info@vjmwritingservices.com. We’re happy to sign an NDA before you send anything.

FAQ

A few we get asked.

Founders preparing to launch, who want to know what their formulation can support before they commit to packaging, a website or an ad campaign. Brand teams at established supplement companies, whether that’s NPD, technical, regulatory or marketing, launching a formulation, reformulating, entering a new market or answering an ad rejection or a retailer’s questions. It’s also used by investors and acquirers who want to know, before they commit, how much of what a brand says about its products is backed by the evidence and the register.

No. Laboratories use “claim substantiation” to mean analytical testing, confirming what’s in an ingredient or a finished product. Scientific substantiation is the other half: appraising the published clinical evidence and what it lets you say. If your claims need an assay as well, we’ll tell you.

No. In the UK and EU a health claim has to be authorised and on the register before anyone can use it, and that runs through a formal application rather than a consultant. The review tells you where each active stands. For the actives the register doesn’t cover, it tells you which studies you can reference, whether a statement such as “at a clinically studied dose” holds, and how far the science can be described before it becomes a claim you’re not allowed to make.

Tell us, and we’ll tell you exactly what to ask the supplier for. We only build findings from full papers, and how a supplier answers a request for the full text is useful to know in itself.

That’s a bigger question than one review can answer fairly. What we tell you is what the evidence shows at your dose, in your form and format, and what can be said about it. Where it won’t carry the message you had in mind, we find what it does support.

No. Where a study is the right next step, we’ll say what it would need to test to be worth the money. We don’t sell trials, which keeps our read of your evidence independent.

The UK and EU are covered as one scientific substantiation review, because the evidence is the same and only the regulatory side differs. The US works to a different standard again, so US work is scoped around what you need, on its own or alongside the UK and EU. Pet supplements aren’t covered by this review at present.

Yes, as a separate piece of work. Product pages, ads and launch content are reviewed on the compliance side of the studio, and the review gives that work a head start.

Yes. We never publish client work, and we’re happy to sign an NDA before you share anything. The examples on this page are patterns drawn from across the category.