- According to the FDA, a supplement may describe how an ingredient affects the body's normal structure or function, like "calcium builds strong bones." It may not claim to diagnose, treat, cure or prevent any disease.
- A claim like this on the label needs the FDA disclaimer, and the manufacturer notifies the FDA no later than 30 days after it starts marketing with it. The FDA doesn't approve these claims.
- On the product page the FTC's guidance applies too: claims online are advertising, you need proof before you publish, and the disclaimer doesn't fix a misleading claim.
- Answer from your own facts: ingredients, how to take it, how long a bottle lasts, shipping, returns and subscriptions. Send questions about conditions, medicines, pregnancy and children to the label and a doctor or pharmacist.
- These are US rules, and other countries have their own. This guide isn't legal advice.
What can you say on a supplement product page?
Under US Food and Drug Administration (FDA) rules, a dietary supplement may describe how a nutrient or ingredient affects the normal structure or function of the body. This is called a structure/function claim. The FDA's examples: "calcium builds strong bones," "fiber maintains bowel regularity" and "antioxidants maintain cell integrity."
What you can't do: claim that the supplement diagnoses, treats, cures or prevents any disease. According to the FDA, only a drug can legally make that claim. And every structure/function claim comes with three rules:
- The FDA doesn't approve the claim in advance. The manufacturer must have evidence that the claim is truthful and not misleading.
- The label needs a disclaimer saying the FDA hasn't evaluated the claim, and that the product isn't intended to diagnose, treat, cure or prevent any disease. The exact wording is below.
- The manufacturer notifies the FDA of the claim's wording no later than 30 days after it starts marketing the supplement with it.
There are two more kinds of these claims, and the same three rules apply to them. A general well-being claim describes the general well-being that comes from taking a nutrient or ingredient. And a claim about a nutrient deficiency disease, like vitamin C and scurvy, is allowed only if it also says how common that disease is in the United States. Source: FDA, Structure/Function Claims, content current as of March 2024.
If you resell another brand, its label and the claims on it come from the brand. The words you add on your product page and in your FAQ are yours.
These are US rules. Israel, the European Union and other countries have their own. This guide isn't legal advice: before you write a health claim, check with a lawyer or with the regulator in the country you sell to.
Which words turn an answer into a disease claim?
Any word that suggests the supplement affects a disease, a sign of a disease, or its treatment. Context decides: according to the FDA's guide, even words like restore, support, maintain, raise and lower can suggest a disease, depending on what's around them. These are examples from the guide, shortened:
| Topic | Disease claim, not allowed | Allowed wording |
|---|---|---|
| A sign of a disease | Reduces cholesterol | Maintains cholesterol levels that are already in the normal range |
| The body's response to disease | Supports the body's ability to resist infection | Supports the immune system |
| Memory and aging | Alzheimer's disease or senile dementia | Mild memory loss associated with aging |
| The menstrual cycle | Severe depression associated with the menstrual cycle | Mild mood changes, cramps and edema associated with the menstrual cycle |
| Skin | Cystic acne | Noncystic acne |
| An effect on a disease | Protects against the development of cancer, reduces the pain and stiffness of arthritis | None: any effect on a disease is a disease claim |
| The product name | A name that suggests the product treats a disease, like CircuCure or CarpalHealth | A name that doesn't suggest a disease. Even Soothing Sleep could be read as a claim to treat insomnia, unless other wording on the product makes clear it is about occasional sleeplessness |
| Pictures and symbols | A heart symbol, in most cases. An EKG tracing, or a picture of an unhealthy organ | A picture of a healthy organ |
| Side effects of a treatment | Maintains the intestinal flora in people on antibiotics | A claim about a side effect that isn't itself a disease, such as countering a drug's depletion of a nutrient |
A study citation can be a disease claim too, if it suggests the supplement treats or prevents a disease. It depends on the context: where the citation appears, for example on the label itself, and how prominent it is. And note the source's age: the guide was issued in 2002, and its page on the FDA's site shows content current as of November 2017. Source: FDA, Small Entity Compliance Guide on Structure/Function Claims, January 2002.
What disclaimer does a supplement claim need?
Every structure/function claim on the label needs this disclaimer, word for word:
- For one claim: "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."
- For several claims: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
In plain words: the FDA hasn't checked the claim, and the product isn't meant to diagnose, treat, cure or prevent any disease. Where it goes:
- Right next to the claim, with nothing in between. Or linked to it by a symbol, such as an asterisk, at the end of each claim.
- On every panel or page that has a claim.
- In a box, if it isn't right next to the claim.
- In bold type, with letters at least one-sixteenth of an inch tall, about 1.6 mm.
These rules are written for the label and for labeling, such as pamphlets and catalogs. Our suggestion: if your product page repeats a claim from the label, put the same disclaimer with it, with the same asterisk. And the disclaimer doesn't make a disease claim allowed: it goes with the claims the rules allow, and a disease claim isn't one of them. Source: 21 CFR 101.93, as published by Cornell Law School's Legal Information Institute, checked 26 October 2026.
Do the rules apply to your product page and FAQ?
Yes. In the US, the FDA has primary responsibility for claims on the label and in labeling, and the Federal Trade Commission (FTC) has primary responsibility for claims in all forms of advertising. In its December 2022 guidance for health products, advertising includes what's on the internet and in other digital content, in social media and in influencer marketing. So an answer in your FAQ that says what the supplement does is an advertising claim too. What the guidance says:
- Proof before you publish. You need a reasonable basis for a claim before you publish it. For health claims, the FTC expects competent and reliable scientific evidence, generally randomized, controlled human clinical testing.
- Implied claims count. A marketer is just as responsible for a claim the answer suggests as for one it states outright.
- The disclaimer doesn't fix a misleading claim. The guidance says the disclaimer the law requires on the label won't cure an otherwise deceptive ad.
- A customer's word isn't proof. Advertisers are liable for the misleading use of endorsements, and the guidance says stories of individual customers' experiences are never enough to prove a claim about a health product. So when a shopper asks whether it works, don't answer with a quote from a customer who says it cured them.
Source: FTC, Health Products Compliance Guidance, December 2022.
What about Shopify Payments?
Shopify Payments' list of prohibited businesses and products includes pseudo pharmaceuticals: pharmaceuticals and other products that make health claims not verified by a local or national regulatory body. Shopify says the list isn't exhaustive and varies by region, and a store that isn't eligible can add a third-party payment provider. So a health claim on your page can affect how you take payments too. Source: Shopify Help Center, Shopify Payments eligibility, checked 26 October 2026.
Which shopper questions should you answer, and which not?
Answer the practical questions from your own facts: the label, the product page and your policies. Send questions about a health condition, a medicine, pregnancy or a child to the label and to a doctor or pharmacist.
| Question | Where the answer comes from |
|---|---|
| What's in it, and how much of each? | The Supplement Facts panel and the ingredient list on the label |
| How and when do I take it? | The directions on the label, word for word |
| How long does a bottle last? | The servings per container and the serving size. For example, 60 capsules at 2 a day: 30 days |
| Is it vegan? Does it contain gluten? | Only what the label says, or what the maker has stated in writing. If it isn't written, don't guess: check with the maker |
| When will it arrive? | Your shipping policy, in days |
| Can I return an opened bottle? | Your returns policy, in one sentence |
| How do I pause or cancel a subscription? | Your subscription terms: how often it ships, how to skip, and how to cancel |
More on writing the answers themselves: product page FAQ.
Questions to send to a doctor or pharmacist
- A health condition: will it help my migraines?
- Medicines: can I take it with my medication?
- Pregnancy and breastfeeding, children, and a planned surgery.
Don't answer them from the store, because the answer depends on the person. According to the FDA, certain supplements can change how a medication is absorbed, metabolized or excreted. For example, drugs for HIV/AIDS, heart disease and depression, treatments for organ transplants, and birth control pills, are less effective when taken with St. John's wort. And the prescription blood thinner warfarin, as well as ginkgo biloba, aspirin and vitamin E, can each thin the blood, and taking them together may raise the risk of internal bleeding or stroke.
The FDA advises talking with a health care professional before taking supplements, and notes that before surgery your health care professional may ask you to stop taking supplements two or three weeks ahead. So the answer to these questions is a fixed one: what the label says, and a request to ask a doctor or pharmacist and show them the label. Source: FDA, Mixing Medications and Dietary Supplements Can Endanger Your Health, content current as of June 2022.
AI-written answers: what to check before shoppers see them
AI can turn a fact into a disease claim with a small change of words, such as writing "reduces cholesterol" instead of "maintains cholesterol levels that are already in the normal range." So every answer should come only from your label, product page and policies, and someone should read every word. What to check:
- A source for every fact. Every answer comes from the label, the product page or a policy. If it isn't written there, write it there first, or don't answer it.
- Search for disease words: cure, treat, prevent, relieve, lower, fight, and the names of diseases and symptoms. Check each one against the table above.
- A structure/function claim only if it's on the label, in the same words, and with the disclaimer.
- One fixed answer for questions about conditions, medicines, pregnancy and children: the label, and a doctor or pharmacist.
- No customer quotes about an effect on a disease.
- Read the answers again when the label or the formula changes.
What happens when AI gives shoppers a wrong answer, and who is responsible: the risk of wrong AI answers.
Example: five answers for an invented magnesium supplement
The product, its label and its claim here are invented, for the example. Each answer gives a fact from the label, or sends the shopper to a doctor or pharmacist. In a store that sells in the US, the disclaimer appears in its exact English words, as it does here.
How do I take it?
Two capsules a day, with food, as the label says. Don't take more than the serving on the label unless your doctor tells you to.
How long does a bottle last?
There are 60 capsules in a bottle. At two a day, it lasts 30 days.
What does it do?
According to the label, magnesium supports normal muscle function.* *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.
Will it help my migraines?
We can't say it treats or prevents any condition. The label lists what's in each capsule. Please ask your doctor whether it's right for you.
Can I take it with my medication?
Some supplements can change how medicines work. So before you start, show the label to your doctor or pharmacist.
Where BOOX fits
BOOX fits when shoppers stop on a supplement page over a practical question, like what's in it, how to take it, shipping, returns or a subscription, and the answer is already written on the product page or in your policies. We make BOOX, so here are the details.
- What it does: BOOX shows a popup on the product page with three questions and answers for each product. It writes them with AI from the product page and the store's policies, and you can edit any of them.
- In a supplement store, read every answer. An answer written from your page can repeat what the page says, including a claim you shouldn't make. So fix the page first, then go through each product's three answers with the checklist above, and edit what needs it.
- You choose when it shows: after time on the page, after a scroll, or after an add to cart with no checkout, with separate rules for computers and phones. It opens by itself at most once per visit, and never blocks scrolling.
- Every answer ends with an add-to-cart button that takes the shopper to the store's own buy button. Your data shows, per product and per question, how many saw the popup, how many answered, and how many bought after answering.
- Free for up to 50 answers a month. Premium, unlimited: $10 a month, with a 14-day free trial.
When it doesn't: BOOX doesn't check answers against FDA or FTC rules, and doesn't add a disclaimer for you. That's your job, or your advisor's. It doesn't give a shopper personal medical advice either. If your shoppers mostly ask whether the supplement suits their health, they need a doctor or pharmacist, not a fixed answer. And if you don't have time to read every answer that gets written, no tool that writes with AI suits a supplement store, BOOX included. A comparison of all the ways: ways to answer shoppers.