Legal

Medical Disclaimer

⚠️ DRAFT — NOT LEGAL ADVICE — NOT FOR PUBLICATION
This document was prepared by a non-lawyer as preparatory material for a legal consultation. It has not been reviewed by a qualified lawyer, and it has not been reviewed by a qualified medical or dietetic professional either.
Do not publish this document, and do not rely on it, until a qualified lawyer admitted in the relevant jurisdiction has reviewed and approved it. A clinical review of the safety warnings in sections 5 and 6 is also recommended, because a disclaimer that omits a real risk is worse than no disclaimer.
All PLACEHOLDER markers must be completed before review. Clauses marked ⚠️ LAWYER need a specific decision.
Draft prepared: 2026-09-02.

Effective date: 2026-09-22 Applies to: Assay Grade — the web reader, the PDF, the tools and templates, the community, and everything published at https://assaygrade.com Published by: Bit State, MB, small partnership (mažoji bendrija), registration number 307056143, Šeduvos g. 29-14, Padubysio k., LT-83250 Pakruojo r., Republic of Lithuania Contact: hello@assaygrade.com

Before anything else

If you are having a medical emergency, stop reading and get help now. Call your local emergency number, or go to an emergency department. Do not use this Product, or any information product, to work out whether a situation is urgent.

Signs that mean call for help rather than read: chest pain, difficulty breathing, severe or sudden abdominal pain, fainting, confusion, signs of a stroke, a severe allergic reaction, severe dehydration, thoughts of harming yourself.

Emergency numbers: 112 in the EU and the UK. 911 in the US and Canada. 000 in Australia.

1. What this Product is

1.1. Assay Grade is an information product. It reviews and grades published scientific evidence about nutrition and inflammation, and it sets out a structured way to think about that evidence.

1.2. It is written for general education. It is not written for you specifically, and it cannot be, because we do not know anything about you.

1.3. It is not medical advice. It is not a diagnosis, a treatment, a prescription, a therapy, a care plan, or a substitute for any of those.

1.4. It is not dietetic advice, nutritional therapy, or a personalised nutrition plan. No qualified professional has assessed your situation.

1.5. It is not a medical device, and it is not intended to be used as one. It performs no diagnostic function and makes no individual assessment.

⚠️ LAWYER: confirm 1.5 against the borderline in Regulation (EU) 2017/745 (MDR) Art. 2 and Annex XVI, and the FDA's general wellness guidance. The risk rises sharply if the Product ever adds a symptom-input tool, a scoring questionnaire, a decision tree that outputs an individualised recommendation, or anything that adapts its output to a user's stated health data. Those features must be reviewed before they are built, not after.

2. No professional relationship

2.1. Reading the Product, downloading it, or joining the community does not create a doctor–patient, dietitian–client, or any other professional or clinical relationship between you and us, or between you and anyone connected with us.

2.2. We do not have your medical history. We do not know what medication you take, what conditions you have, what your blood work says, what you are allergic to, or what your doctor has told you.

2.3. We cannot assess you, and we do not. Nothing in the Product is an opinion about your case.

2.4. We will not give you individual advice, and you should not ask us for it. If you email us a question about your own health, we will tell you to talk to a qualified professional. That is not us being unhelpful — it is the only honest answer available to someone who cannot examine you.

3. Talk to a qualified professional

3.1. Before changing what you eat in any significant way, talk to a doctor, registered dietitian, or other qualified healthcare professional who knows your situation.

3.2. This matters most if any of the following is true — see section 5 for detail:

you are pregnant, trying to conceive, or breastfeeding;
you have a diagnosed medical condition;
you take prescription medication;
you have a history of an eating disorder or disordered eating;
you are making decisions about a child;
you have had bariatric surgery or another procedure affecting digestion;
you are under medical supervision for anything at all.

3.3. Never stop, start, delay, reduce or change a prescribed treatment because of something you read here. Talk to whoever prescribed it. If you disagree with your prescriber, that is a conversation to have with them, or with a second clinician — not a reason to act alone.

3.4. Never delay seeking care because you want to try a dietary approach first. If you have symptoms that worry you, get them looked at.

3.5. If something in the Product contradicts advice you have been given by a professional who has assessed you, their advice wins. They know things about you that we do not and cannot.

4. What we do not promise

4.1. We do not promise any outcome. Not weight change, not symptom improvement, not reduced inflammation, not better blood markers, not more energy, not disease prevention, not anything else.

4.2. We do not claim the Product will cure, treat, prevent, mitigate or diagnose any disease or condition. It will not.

4.3. Individual variation is real and it is large. People differ in genetics, gut microbiome, medication, sleep, stress, activity, existing conditions, age, and dozens of factors nobody has measured. Two people doing exactly the same thing routinely get different results. Any result reported by anyone else — including in any research we cite — is not a prediction about you.

4.4. Population-level research describes averages. You are not an average. A finding that a group improved on average tells you very little about whether you will.

4.5. We do not publish testimonials or before-and-after claims, and we do not have a transformation story to sell you. That is deliberate. It is also why this section is short: there is nothing to walk back.

5. Specific situations that need professional input

This is not a complete list, and it is not meant to frighten you. It is the list of situations where general nutrition information is most likely to be wrong for a particular person.

5.1. Pregnancy, trying to conceive, and breastfeeding

Nutritional needs change substantially during pregnancy and lactation, and some approaches that are unremarkable otherwise are not appropriate. Certain restrictions, fasting patterns, and elimination approaches are specifically not advised. Some supplements are contraindicated, and some are essential. Talk to your midwife, obstetrician, GP or a prenatal dietitian before making changes. Do not use this Product as a pregnancy nutrition guide.

5.2. Existing medical conditions

If you have a diagnosed condition, dietary change is a clinical matter, not a lifestyle one. This applies in particular — but not only — to:

diabetes (types 1 and 2), where carbohydrate change can require insulin or medication adjustment and can cause hypoglycaemia;
kidney disease, where protein, potassium, phosphate and fluid intake may be restricted;
liver disease;
inflammatory bowel disease, coeliac disease, and other GI conditions;
autoimmune conditions;
cardiovascular disease;
thyroid conditions;
cancer, during or after treatment, where nutritional status directly affects outcomes;
immunosuppression of any kind.

Talk to the clinician who manages your condition before you change anything.

5.3. Prescription medication — interactions are real

Food and supplements interact with medication. This is not a theoretical concern. Well-documented examples include:

warfarin and other anticoagulants — vitamin K intake, and some supplements, affect clotting;
grapefruit and related citrus, which affect the metabolism of a long list of drugs including some statins and immunosuppressants;
thyroid medication, whose absorption is affected by timing, calcium, iron and soy;
MAOIs and tyramine-containing foods;
diabetes medication and insulin, where dietary change alters dose requirements;
antibiotics, some of which are affected by calcium and other minerals;
lithium, which is sensitive to sodium and fluid intake.

This list is illustrative, not complete. If you take any prescription medication, ask your pharmacist or prescriber before making dietary changes or starting any supplement. Pharmacists are usually the fastest and most accessible source for this specific question, and asking them costs nothing.

5.4. History of an eating disorder or disordered eating

Please read this before going further.

Structured eating rules, food categorisation, elimination protocols, tracking, and "good food / bad food" framing can trigger or worsen anorexia, bulimia, binge eating disorder, ARFID and orthorexia. This is true of a great deal of nutrition content, including careful and evidence-based content.

If you have a history of an eating disorder or disordered eating, or if you are currently in treatment or recovery:

talk to your treatment team before using this Product, and consider whether it is right for you at all;
if reading it makes you anxious about food, increases restriction, or makes you feel you must follow rules perfectly, stop and speak to someone;
our voluntary 30-day refund guarantee applies without question in this situation, and you do not need to explain yourself to us.

We take this seriously enough to say plainly: for some people, the right decision is not to read this Product. Support is available — in the US, the ANAD helpline; in the UK, Beat; anywhere else, Find A Helpline.

⚠️ LAWYER / CLINICAL: 5.4 should be reviewed by someone with eating-disorder expertise. Also decide whether a lighter version of this warning belongs on the sales page itself, before purchase, rather than only after. There is a reasonable argument that it does.

5.5. Children and adolescents

Do not apply anything in this Product to a child or adolescent without input from a paediatrician or paediatric dietitian. Children have different nutritional requirements, they are growing, and restriction carries risks in childhood and adolescence that it does not carry in adults. The Product is written for adults making decisions about themselves.

5.6. Older adults

Appetite, absorption, medication load and the risk of unintentional weight loss and sarcopenia all change with age. Restriction that is harmless at 35 may not be at 75. Involve a clinician.

5.7. Allergies and intolerances

The Product does not know what you are allergic to. You are responsible for checking every ingredient against your own allergies and intolerances. If you have a diagnosed severe allergy, treat any general food guidance — ours included — as something to check, not something to follow.

6. This Product does not replace medical care

6.1. The Product is a supplement to healthcare, not a replacement for it. It does not replace consultation, examination, diagnosis, testing, monitoring or treatment.

6.2. Do not use it to self-diagnose. Symptoms overlap. Conditions with similar symptoms have completely different treatments, and some of them are serious.

6.3. Do not use it to self-treat a diagnosed condition in place of the treatment you have been prescribed.

6.4. Nutrition can be part of managing many conditions. It is rarely the whole of it, and deciding what part it plays in your case is a clinical judgement.

7. How our evidence grades work — and what they do not mean

Grading is the main thing this Product does, so it needs to be explained honestly here rather than only in the marketing.

7.1. Every substantive claim in the Product carries a grade from A to D. The grade describes how strong the published evidence is for that claim, based on the study designs available, their quality, their consistency, and their limitations. The full method is set out in our Evidence and Editorial Policy.

7.2. In outline:

Grade	What it means
A	Strong, consistent evidence from well-conducted human research
B	Moderate evidence; the direction is reasonably clear, with real limitations
C	Weak or mixed evidence; plausible but not established
D	Very weak evidence, or evidence mainly from animal, cell or short-term surrogate studies

7.3. A grade is a statement about the research. It is not a promise about you.

7.4. Specifically, an A grade does not mean:

that it will work for you;
that it will work in your circumstances, with your conditions or medication;
that the effect will be large enough to notice;
that it is safe for you personally;
that you should do it.

An A grade means only that the published evidence supporting the claim is strong. A strong average effect can be zero for an individual.

7.5. A D grade does not mean something is false or useless. It means the evidence is weak. Weak evidence is not the same as evidence of absence, and it may improve later.

7.6. Grades change. When new research arrives, grades move — in both directions, including downwards. What you read today may be graded differently in a year. The web reader is the current version; a PDF you downloaded may be out of date.

7.7. The Product contains an explicit chapter on what the evidence does not support. That chapter exists because the honest answer to many popular nutrition claims is "this is not established", and we would rather say so than quietly leave it out. Read it. It is arguably the most useful part.

7.8. Grading is a judgement exercise. Reasonable, well-informed people grade the same literature differently. We publish our method so you can disagree with it, and we publish our sources so you can check them yourself. Please do check them.

7.9. Grades are not endorsements, recommendations or instructions. They are a map of the evidence, and you still have to decide where to walk with a professional who knows you.

8. Third-party content and the community

8.1. The Product cites and links to third-party research, articles and resources. We do not control them, we are not responsible for them, and a citation is not an endorsement of everything the source says.

8.2. The community is not a clinic. Members are not your clinicians. Anything posted there by another member is that person's own view. It has not been verified by us, and it is not medical advice.

8.3. Do not ask the community to diagnose you, and do not diagnose anyone else. Do not recommend that anyone change or stop their medication.

8.4. Members sometimes share what worked for them. That is one person's experience, not evidence, and it is not a recommendation for you.

9. Where you are, and what this Product is not claiming there

This section is a jurisdictional statement. It is here so there is no ambiguity about what is being claimed.

9.1. Assay Grade is offered as general educational information in every country where it is available. It is not offered as a therapeutic product, a health product, a medicine, or a medical device anywhere.

9.2. United States. No statement in the Product has been evaluated by the Food and Drug Administration. The Product is not intended to diagnose, treat, cure or prevent any disease. It makes no disease claims and no structure/function claims about any specific product.

9.3. United Kingdom. The Product is not a medicinal product within the meaning of the Human Medicines Regulations 2012, and it is not a medical device. It makes no therapeutic claim.

9.4. European Union and EEA. The Product is a work of information. It is not a foodstuff, food supplement, medicinal product or medical device, and it is not a commercial communication about any food product. It makes no nutrition or health claim within the meaning of Regulation (EC) No 1924/2006 in relation to any food we supply, because we do not supply food.

9.5. Canada. The Product is not a natural health product, a drug or a medical device under the Food and Drugs Act. It makes no therapeutic claim, and no statement in it has been evaluated by Health Canada.

9.6. Australia. The Product is not a therapeutic good within the meaning of the Therapeutic Goods Act 1989, and nothing in it is intended as a therapeutic claim. It has not been evaluated by the Therapeutic Goods Administration.

9.7. Local law governs. If the law where you live gives you rights or protections beyond this notice, those apply and this notice does not reduce them.

⚠️ LAWYER: section 9 is the most jurisdiction-sensitive part of the document and needs verification country by country. Specific points:

The US wording in 9.2 is modelled on the DSHEA disclaimer, which is designed for supplement labels rather than information products. Confirm whether including it helps or whether it invites the inference that we are making structure/function claims. The bigger US exposure is FTC substantiation under s.5 of the FTC Act and the Health Products Compliance Guidance, not FDA.
AU: confirm the TGA "therapeutic goods" analysis for an information product, and whether the advertising rules bite on the sales page rather than the content.
CA: confirm the Health Canada and Competition Bureau positions.
EU: the research file concludes Regulation 1924/2006 does not apply to us because we are not a food business operator and supply no food, but flags that this changes the moment affiliate links to food or supplements are added. If affiliate revenue is ever introduced, 9.4 becomes false and must be rewritten.
Confirm that the disclaimer does not itself contain anything that reads as a therapeutic claim under Annex I(17) of Directive 2005/29/EC.

10. Limitation of liability

10.1. To the fullest extent permitted by law, we are not liable for any loss, injury or harm resulting from your use of, or reliance on, the Product, including any decision you make about your diet, health or treatment.

10.2. You are responsible for your own health decisions, including the decision to consult a professional or not to.

10.3. This section does not limit or exclude:

(a) liability for death or personal injury caused by our negligence; (b) liability for fraud or fraudulent misrepresentation; (c) any liability that cannot lawfully be excluded or limited; or (d) any of your statutory rights as a consumer.

10.4. Section 15 of our Terms of Service ("Your statutory rights are not affected") applies to this disclaimer in full.

⚠️ LAWYER: section 10 is deliberately short because the operative limitation lives in section 14 of the Terms of Service. Confirm the two are consistent and that the carve-out in 10.3(a) is prominent enough. A disclaimer that appears to exclude liability for personal injury is both unenforceable and, in some jurisdictions, itself an unfair commercial practice.

11. Accepting this disclaimer

11.1. By buying or using the Product you confirm that you have read this disclaimer, that you understand the Product is information and not medical advice, and that you are responsible for consulting a qualified professional about your own situation.

11.2. If you do not accept this, do not use the Product. Our 30-day satisfaction guarantee means you can get your money back, without explanation. See the Refund Policy.

11.3. This disclaimer forms part of our Terms of Service.

12. Contact

Questions about this disclaimer: hello@assaygrade.com.

Questions about your own health: your doctor, your pharmacist, or a registered dietitian. Not us. We mean this literally, and we will say the same thing if you write to us.

Open questions for the lawyer

Country-by-country verification of section 9, especially the US framing (FDA disclaimer vs FTC substantiation) and the AU therapeutic goods analysis.
Whether a short-form version of this disclaimer must appear before purchase on the sales page, and whether the eating-disorder warning in 5.4 in particular belongs there.
Whether the medical warnings in section 5 should be reviewed by a clinician, and whether that review should be documented as part of the substantiation file.
Whether the evidence-grading explanation in section 7 creates any implied warranty about the accuracy of the grades.
Where and how the disclaimer must be surfaced — sales page, checkout, first login, the PDF's opening pages, and the community rules — and whether acknowledgement should be recorded.
Whether the community's health discussion between members creates any duty for us as moderator, and how that interacts with the platform liability rules in the Digital Services Act.
Whether 11.1 ("by using the Product you confirm...") is effective, or whether an express acknowledgement at checkout is needed.