Market Access Intelligence for Nutraceuticals.
The claim is the product. The same claim can be allowed in one market, banned in another and pending in a third. Know exactly what you can claim, where, and the moment it changes.
See how it works ↓Market Access Intelligence for beverages: one living view of the taxes, thresholds, sweetener rules, caffeine limits, label laws and claim trends that decide whether a drink reaches the shelf, and stays on it.
What is Market Access Intelligence? →Few health claims are authorised, and the rules differ across EU member states.
health claims authorised in the EU, out of roughly 44,000 submitted. Almost nothing clears the bar, and what does is precise.EU Register of nutrition & health claims / EFSA
botanical health claims have been "on hold" in the EU since 2010, with no final decision.EU pending botanical claims list
EU member states each set their own maximum vitamin and mineral levels and borderline calls. There is no single EU answer.EU Food Supplements Directive (levels not harmonised)
global supplements and functional-foods market, and its growth depends on claims that differ by market.Industry estimates
Your best-selling claim in one market can be an illegal claim in the next.
The same ingredient, same dose, can carry an authorised claim in one market, a pending claim in another, and none in a third, while a neighbour caps the dose or calls it a medicine. A correct claim drives sales. A wrong one leads to withdrawn labels or delisting.
An EFSA-authorised wording, a US structure/function claim and a "traditional use" botanical claim can describe the same benefit. Each follows its own regime, wording and evidence bar.
Botanical claims on the EU on-hold list are neither approved nor rejected. You sell in that grey zone and need to know when one moves.
Each EU member state sets its own vitamin and mineral caps. A dose that is legal in one country can be over the limit in the next.
Food supplement or medicine? A dose, a claim, or a form can tip you across the line, and reclassification means a different regulator, a different licence, or no market at all.
Spiked sports products, mislabelled botanicals and undeclared actives often start with a supplier COA. They can end in a regulator's warning letter.
Many new actives are novel foods. They need pre-market approval before you can sell them or make a claim.
The Prodeen platform catches each claim ruling, max-level revision and borderline decision and filters it to your actives, doses and markets. Your team gets a next step it can act on and corrects labels the same day.
See the signal in actionThe claim carried the brand. Then the EU rejected the botanical claim it rested on, and the hero line on four SKUs became non-compliant overnight. In the US the same claim was fine. That morning, the team had to know exactly which labels, markets and sentences had to change.
Your team found it before a competitor or a regulator did.Everything that decides if your claim survives, tracked before it breaks.
One claim ruling reaches Regulatory, Scientific Affairs, Quality, R&D and Marketing, each with its next step. Prodeen tracks the five domains below and turns each signal into an action.
One loop, from a claim ruling to a corrected label.
| EU | US | UK | AU | |
|---|---|---|---|---|
| Botanical claims | ||||
| Vitamin max levels | ||||
| Novel food status | ||||
| Borderline risk |
Six claim jobs, from entering a market to replacing a claims database.
Find out what you can claim there
Before you enter, know which of your claims survive, which need re-wording, and where the dose caps and borderline calls bite.
See the use case → Launching a productBuild the claim in from day one
Substantiate the claim, confirm the novel-food route and lock the compliant wording for every launch market before the pack is printed.
Managing a live portfolioKeep every claim standing
Prodeen routes every ruling, max-level change and borderline update to the SKUs and markets it touches, as it happens.
Preparing for an auditProve every claim is substantiated
Keep a signed, current substantiation file for each claim and market, so you can answer an audit or regulator query in hours.
Replacing a legacy subscriptionSwap a claims database for live intelligence
Stop cross-referencing a static register by hand. Get claim changes routed to your products and markets automatically.
Not sure yet?Bring us one claim
Send us one active, one dose, one claim and two markets. We will send back a sample report on where the claim stands.
Test us →Answers your experts can put their name to.
From a claim ruling or max-level change to a validated answer your team can act on, with every source named.
Of incoming signals filtered out as noise before they ever reach your team.Illustrative, based on a typical supplement portfolio.
Prodeen flags a claim the day it is rejected, and your team re-words it that day.
Built by the team behind Selerant and DigiComply. This is our third time in your world.