Claims, evidence and regulation by market
British VitaTech, a Leicester contract manufacturer of custom supplements for premium wellness brands, checks supplement claims, novel food status and labelling for the UK, EU and US while each product is developed.
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Supplement claims for the UK, EU and US, from one formula
Every custom and private label supplement we develop and make in Leicester for premium wellness brands has its supplement claims built in, market by market. A claim fixes the dose the formula must deliver, the form of each ingredient, the words on the label and what a brand can say in advertising, so we check claims, novel food status and labelling for the UK, EU and US while your product is developed. You receive a claims matrix for every market, the evidence review behind every claim, labels drafted for each market from one formula and, for the US, structure/function claim files with a draft FDA notification for your brand to file.
As of October 2026, health claims in Great Britain and the EU must be authorised under Regulation (EC) No 1924/2006 and listed on the GB nutrition and health claims register or the EU Register. Claims awaiting a decision, such as botanical claims, may continue under transitional rules: Article 28(5) and (6) of that regulation in the EU, and the Department of Health and Social Care's list of on-hold claims in Great Britain. The European Court of Auditors reported in 2024 that 2,078 health claims for plant substances were on hold, pending since 2010. The GB register added no authorised claims in 2025 or 2026, only non-authorised ones.
Why each health claim sets the dose and the exact wording
The test every claim must pass
EFSA's guidance for claim applicants asks three questions. Is the food or constituent sufficiently characterised? Is the claimed effect defined, and is it a beneficial physiological effect? Is a cause and effect relationship established for the target population under the proposed conditions of use? A claim needs a favourable answer to all three. Human efficacy studies are central; animal, in vitro and mechanistic studies only support them. In Great Britain, the UK Nutrition and Health Claims Committee asks the same three questions under its own framework and found in August 2024 that "a cause-and-effect relationship has not been established" between creatine and improved cognitive function, as EFSA did in December 2024; the EU refused that claim in May 2026 (Commission Regulation (EU) 2026/1118).
Conditions of use decide the formula
Three claims, quoted exactly from the registers, with their conditions of use as of October 2026:
| Claim | Conditions of use |
|---|---|
| "Creatine increases physical performance in successive bursts of short-term, high intensity exercise" | "The claim may be used only for food which provides a daily intake of 3 g of creatine." The consumer is told the effect comes with 3 g a day, and the claim is only for foods targeting adults performing high intensity exercise. |
| "Magnesium contributes to a reduction of tiredness and fatigue" | Food that is at least a source of magnesium, as defined for the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] in the Annex to Regulation (EC) No 1924/2006 |
| "Biotin contributes to the maintenance of normal hair" | Food that is at least a source of biotin, on the same definition |
A source condition depends on what the product delivers, so our stability and shelf life testing sets overages that keep each claim true to the last day.
Exact wording, every time
Wording with the same meaning for consumers as an authorised claim is allowed, under the same conditions of use (recital 9 of Regulation (EU) No 432/2012). CAP Code rule 15.1.1, in the UK advertising code, likewise allows only authorised health claims "or claims that would have the same meaning to the consumer". In October 2026, the Advertising Standards Authority upheld a complaint against a paid social media advert, finding that "Clinically backed to support muscle strength" did not share the meaning of either authorised GB creatine claim. We use the register's exact wording on labels and in the copy we draft, which ends the argument. Rule 15.2 adds that references to general benefits for overall good health or health-related well-being need a specific authorised claim alongside.
Botanical claims and the 2025 EU court ruling
As of October 2026, botanical claims remain on hold in GB and the EU. In case C-386/23 (judgment of 30 April 2025), the Court of Justice of the EU ruled that, until the Commission completes its examination of claims for botanical substances, advertising for a botanical food supplement may not use claims describing or referring to psychological or behavioural functions, or refer to general benefits for overall good health without a specific claim from the authorised lists, unless Article 28(6) of Regulation (EC) No 1924/2006 permits the claim. Our labels go further: each botanical is described by species, plant part, extract ratio and standardised marker, and an authorised nutrient claim carries the health message.
Novel food checks in GB and the EU
A food not consumed to a significant degree in the EU or the UK before 15 May 1997 is a novel food and needs authorisation before sale under Regulation (EU) 2015/2283, which Great Britain keeps as assimilated law. EU decisions made after 1 January 2021 do not apply in Great Britain (FSA). We screen every ingredient in-house against the FSA's register of authorised novel foods, the EU's Union list and the Commission's novel food catalogue, because status turns on source, part and use. As of October 2026:
- L-theanine extracted from green tea is not novel in EU food supplements; other sources are novel.
- Lion's mane fruiting body and its water extracts are not novel in the EU; dehydrated mycelium powder is.
- Magnesium L-threonate is authorised in the EU and, since 5 March 2026, in GB, but only the applicant's material can be used until 7 November 2029 in the EU and March 2031 in GB.
The FSA is preparing to implement a UK and EU sanitary and phytosanitary (SPS) agreement, still under negotiation, in summer 2027; GB authorisations would then cease and an EU authorisation would be needed, with very limited exceptions (FSA Board, September 2026). Until it is concluded it is a proposal, so we screen GB formulas against EU status now.
US structure/function claims
US supplements can carry structure/function claims under the Dietary Supplement Health and Education Act of 1994. As of October 2026, 21 CFR 101.93 sets the terms for claims:
- Notification. FDA is notified no later than 30 days after first marketing, in a notice signed by a responsible individual who certifies that the firm has substantiation that the statement is truthful and not misleading.
- Disclaimer. "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." It sits next to the claim or is linked to it by a symbol, is boxed where it is not adjacent, and appears in bold type no smaller than one-sixteenth of an inch.
- Substantiation. The FTC's Health Products Compliance Guidance (December 2022) expects competent and reliable scientific evidence, which for health benefit claims generally means randomised, controlled human trials.
Grading the evidence, and building it when it falls short
How we review the evidence
Our evidence review asks one question per claim: does the human evidence for this ingredient, in this form and at this dose, support this wording in this market?
- Define. Source, plant part, extract ratio and standardisation, dose, duration, population and outcome.
- Search. Peer-reviewed human studies, systematic reviews and regulators' opinions, with safety limits checked in the same pass.
- Grade. Randomised controlled trials and systematic reviews carry the most weight.
- Match. We record how closely each study fits your form, dose and population. A trial on a standardised extract does not transfer to a raw powder of the same plant.
- Conclude. For each market: the claim wording, the condition the formula meets and the evidence behind it, or the gap. Together these form the claims matrix behind your labels.
When evidence is thin, we build it
When promising data stop short of the claim a brand wants, we arrange a human study with our clinical research partners, designed to the standard regulators apply:
- Randomised and placebo-controlled, double-blind wherever the product allows
- Run in the population the claim targets, at your product's own dose, form and duration
- One primary outcome, validated and fixed in advance, with the sample size set by a power calculation
- Approved by an independent ethics committee and registered on a public trial registry before the first participant enrols
- Reported to the CONSORT standard for randomised trials
The results support US structure/function substantiation, an application for a new authorised claim in GB or the EU, and the evidence file of a branded ingredient. As the European Commission's register notes, a claim authorised on proprietary data can be restricted to the applicant's use for five years.
Four products, their claims and what each formula must deliver
| Product | GB and EU wording | What the formula must do | US route |
|---|---|---|---|
| Creatine gummy | "Creatine increases physical performance in successive bursts of short-term, high intensity exercise" | Deliver 3 g of creatine a day for adults performing high intensity exercise; no cognition wording | Structure/function claim with substantiation, disclaimer and notification |
| Magnesium and botanical evening blend | "Magnesium contributes to normal psychological function" | At least a source of magnesium; botanicals named without health claims | Structure/function claims for botanicals where human evidence supports them |
| Probiotic capsule | "Vitamin D contributes to the normal function of the immune system", from added vitamin D | At least a source of vitamin D; strains named in the ingredients list, because GB advertising guidance and the Commission regard "probiotic" as a health claim | Live microbials declared by weight, with a CFU count as FDA's 2018 draft guidance allows |
| Hair gummy | "Biotin contributes to the maintenance of normal hair" | At least a source of biotin; no claims for ingredients without one | Structure/function claim with disclaimer |
Nutrition claims follow the same discipline. As of October 2026, "sugar-free" allows no more than 0.5 g of sugars per 100 g in GB and the EU (Regulation (EC) No 1924/2006) and less than 0.5 g per reference amount and per labelled serving in the US (21 CFR 101.60), which shapes the sweetener system in our flavour development and taste masking work.
Claims move with markets. A UK pouch brand, a client since 2023, grew into Europe, the USA and Mexico; we guided it through the regulatory and compliance checks for each market, and our R&D team proposes formula updates when ingredients improve or market conditions shift. In the brand's words: "They've felt less like a supplier and more like a partner in the business."
Claims work in five steps, plus label rules for each market
Claims work runs through our research and development process from the brief:
- Brief. Markets, channels and the message you want to make.
- Screen. Novel food and new dietary ingredient status, permitted forms and maximum amounts for every ingredient, including those in our ingredient library.
- Evidence and formulation. The claims matrix, then doses that meet each claim's conditions to the end of shelf life.
- Labels and release. Labels drafted for each market from one formula, then verified on every batch as the critical control point in our HACCP study.
- Watch. Our supplement regulation watch tracks rule changes each quarter, and we propose updates when the rules or the evidence move.
Supplement label requirements in the UK, EU and US
| As of October 2026 | Great Britain | European Union | United States |
|---|---|---|---|
| Name | "Food supplement" | "Food supplement", in each member state's required languages | "Dietary supplement", or a term such as "calcium supplement", in the statement of identity |
| Mandatory statements | Daily portion, a warning not to exceed it, a varied diet statement and out of reach of young children | The same, under Directive 2002/46/EC | Supplement Facts panel; iron warning on solid forms where it applies |
| Claims | Authorised GB register claims, or wording with the same meaning | Authorised EU Register claims, or wording with the same meaning | Structure/function claims with FDA's disclaimer and notification |
| Business named | A UK, Channel Islands or Isle of Man address for the food business or its importer | The EU operator, or the importer into the EU | Name and place of business, plus a domestic address or phone number for serious adverse event reports |
| Date mark | Best before | Best before | No federal requirement; FDA expects data behind any date used |
Our pages on supplement manufacturing for EU brands and custom supplement manufacturing for US brands cover each market's notifications and registrations. R&D, including the claims review, is a paid stage, included with an order of the right size. Your formula is yours, and so is its evidence file. British VitaTech is ISO 9001, HACCP and GMP certified by BSI, and FDA registered. Start your project.
References: Regulation (EC) No 1924/2006 on nutrition and health claims (2006); Commission Regulation (EU) No 432/2012, list of permitted health claims (2012); Regulation (EU) 2015/2283 on novel foods (2015); Directive 2002/46/EC on food supplements (2002); Court of Justice of the EU, case C-386/23, Novel Nutriology (2025); Commission Regulation (EU) 2026/1118 refusing a health claim (2026); 21 CFR 101.93, statements for dietary supplements (1997); EFSA, general scientific guidance for stakeholders on health claim applications (2021).
Where this is going
To 2030
Up: claims-led marketing constrained in Europe; evidence-backed branded ingredients favoured
To 2036
Tightens: botanical claims resolved or lost
What to watch
Industry calls for a regulated third category between supplements and medicines, with wider claims, could loosen the rules
Questions brands ask
Which health claims can a supplement make in the UK and EU?
Authorised claims from the GB nutrition and health claims register in Great Britain and the EU Register in the EU, each with its conditions of use. As of October 2026, both registers rest on Regulation (EC) No 1924/2006, and claims still awaiting a decision, such as botanical claims, may continue only under transitional rules. We quote each claim in the register's exact wording, for example "Magnesium contributes to a reduction of tiredness and fatigue", for food that is at least a source of magnesium.
Can we make health claims about botanical ingredients?
Not on our labels. As of October 2026, botanical claims remain on hold in GB and the EU, usable only within the limits of transitional rules. In case C-386/23 (April 2025), the Court of Justice ruled that until the Commission completes its examination, EU advertising for a botanical supplement may not use claims on psychological or behavioural functions unless Article 28(6) of Regulation (EC) No 1924/2006 permits them. We describe each botanical precisely and let an authorised nutrient claim carry the message.
What does a US structure/function claim need?
Substantiation, a disclaimer and a notification. As of October 2026, 21 CFR 101.93 requires FDA to be notified no later than 30 days after first marketing, in a notice certifying that the firm has substantiation that the claim is truthful and not misleading. FDA's disclaimer sits next to the claim or is linked to it by a symbol, in bold type at least one-sixteenth of an inch high. The FTC expects competent and reliable scientific evidence behind every claim.
How do you check whether an ingredient is a novel food?
We screen every ingredient in-house against the public registers before formulation. As of October 2026, that means the FSA's register of authorised novel foods for Great Britain, the Union list and the European Commission's novel food catalogue for the EU, and new dietary ingredient status for the US. Status can turn on the part used: lion's mane fruiting body is not novel in the EU, while its dehydrated mycelium powder is. We settle the status before the formula is fixed.
What happens when the evidence for our ingredient is thin?
We build it. Our evidence review shows where the human data fall short of the claim you want, and we arrange a human study with our clinical research partners: randomised and placebo-controlled, in the target population, at your product's dose and form, ethically approved and registered before recruitment. The results support US structure/function substantiation and an application for a new authorised claim in GB or the EU, where a claim based on proprietary data can be restricted to the applicant for five years.
Do labels differ between the UK, EU and US?
Yes, and we draft each market's label from one formula. As of October 2026, GB and EU labels say "food supplement", give the daily portion with the mandatory warnings and carry authorised claims. GB labels need a UK, Channel Islands or Isle of Man address for the business or its importer, and EU labels name the EU operator or importer. US labels say "dietary supplement", carry a Supplement Facts panel and use structure/function claims with FDA's disclaimer.
Why do you quote claims word for word?
Because rewording is where disputes start. Wording with the same meaning as an authorised claim is allowed, under recital 9 of Regulation (EU) No 432/2012 and CAP Code rule 15.1.1, but in October 2026 the Advertising Standards Authority ruled that "Clinically backed to support muscle strength" did not share the meaning of either authorised GB creatine claim. Using the register's exact wording, with its conditions met by the formula, removes that argument before a label or advert goes live.
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