The FDA recognises three claim types for dietary supplements: health claims, structure/function claims (including general well-being and classical nutrient deficiency claims), and nutrient content claims. Structure/function claims must be notified to the FDA within 30 days of first marketing and carry the required disclaimer. Even then, your advertising must still meet the FTC’s evidence standard, because FDA notification does not replace it.
TL;DR:
- Wording that says a supplement maintains healthy joint function describes normal function, while claiming it relieves joint pain can make it an unapproved drug.
- Review the full presentation shoppers see, including testimonials, product names, images, hashtags, and alt text, because context can turn acceptable wording into a disease claim.
- Stating that a serving provides 20% of the Daily Value creates a nutrient content claim, subject to set criteria and possible Supplement Facts requirements.
- Keep a record for each claim that names supporting studies, product dose, and studied population, then revisit it whenever the formula or dose changes.
- If regulators flag a claim, pause affected ads and pages, remove or revise the wording, gather evidence, and seek legal review for borderline disease language.
What do the three FDA claim types actually mean?
The FDA groups label claims into three primary categories, and each follows a different regulatory route. Classifying your copy first saves most of the later trouble.
- Health claims link a substance to reducing the risk of a disease. They generally need FDA authorisation through a petition or similar process, and a supplement seller cannot simply write one.
- Structure/function claims describe an effect on normal body structure or function, such as “supports immune health”. They need substantiation and a notification under section 403®(6) of the Federal Food, Drug, and Cosmetic Act. General well-being and classical nutrient deficiency claims sit in the same family.
- Nutrient content claims state or imply the level of a nutrient. They are strictly defined in 21 CFR 101 Subpart D, and words like “high” or “good source” have set numeric criteria and may require a Supplement Facts panel.
Qualified health claims exist too. They use qualifying language when evidence falls short of the standard for a full health claim.
How do you tell a structure/function claim from a disease claim?
A structure/function claim is about keeping normal function going. A disease claim says you will prevent, treat or cure something, which makes the product an unapproved drug. The FDA’s small entity guide notes that one word can flip the category: “maintains healthy joint function” is acceptable, while “relieves joint pain” is not.
Run each line of copy through these checks:
- Read the verb. Words such as “supports”, “maintains” and “promotes” may describe normal function. “Prevents”, “treats”, “cures” and “reduces the risk of” can point to a disease claim.
- Look for disease names or symptoms. Mentioning arthritis, flu or high blood pressure usually turns the claim into a disease claim.
- Check the context. Review testimonials, product names, imagery and hashtags alongside the headline, since the full presentation matters when assessing a claim.
- Check for therapy comparisons. Review comparisons with medication carefully, since wording and context can affect how a claim is understood.
- Ask what the claim describes. Claims about normal function differ from claims that refer to a disease or abnormal condition.
Pro Tip: Review the whole page as a shopper sees it, including reviews, titles and image alt text. A compliant claim can be undone by a customer quote you republish.
What does the 403®(6) notification require, and what is the disclaimer?
Under section 403®(6), you must notify the FDA no later than 30 days after first marketing a product with a structure/function, general well-being or classical nutrient deficiency claim. The claim must also be truthful and not misleading. The FDA does not pre-approve these claims.
- What to include: the exact text of the claim, the product it appears on, and who is making the notification.
- The disclaimer: certain structure/function and related claims must carry the required statutory disclaimer. Check the FDA’s guidance for the applicable requirements.
- Other claim types: authorised health claims and nutrient content claims follow their own petition or regulatory routes rather than this notification, so check the FDA’s claims overview before assuming one process fits all.
How much evidence do you need, and what does the FTC expect?
The FDA’s substantiation guidance recommends evidence proportionate to the claim, human intervention studies where possible, and support for every reasonable interpretation of your wording. Think of it as the totality of the evidence, not one cherry-picked paper.
The FTC runs a separate track for advertising. Its health products guidance applies a “competent and reliable scientific evidence” standard, requires no pre-approval, and treats FDA notification as no substitute for that support.
The FTC’s rule of thumb: you need a reasonable basis for a claim before you publish it, not after a complaint arrives.
Practical evidence mapping, especially when you publish at scale:
- Keep one record per claim, listing the studies, the product dose and the population studied.
- Match the strength of the wording to the strength of the evidence.
- Re-check records when you reformulate or change a dose.
- Store the evidence outside any content tool, so it is available if a regulator asks.
Which wording works, and which should you avoid?
Pair every phrase you plan to use with a “never” version so writers can see the line.
- Immune support: “Supports immune health” works. “Helps prevent colds and flu” does not.
- Joint support: “Maintains healthy joint function” works. “Relieves arthritis pain” does not.
- Digestion: “Supports digestive comfort” works. “Treats irritable bowel syndrome” does not.
- Sleep: “Supports restful sleep” works. “Cures insomnia” does not.
Numbers change the category. Stating that a serving gives “20% of the Daily Value” or calling it “high in” a vitamin makes it a nutrient content claim with numeric criteria and Supplement Facts consequences. Put the disclaimer in a fixed template block under the claim so it never gets dropped. For SEO and consistency, our guide to product description SEO explains why repeating standard blocks helps.
Pro Tip: Draft the disclaimer once as a reusable template line, then lock it so edits to the description cannot remove it.
What happens if regulators challenge your claims?
The FTC can pursue enforcement over advertising claims. The FTC’s Notice of Penalty Offenses on claim substantiation raises the stakes for repeat problems, and its business blog stresses potential civil penalties.
If a claim is flagged:
- Pause the ads and pages carrying it.
- Remove or reword the claim.
- Gather the substantiation you hold.
- File or update a notification where one applies.
- Have a lawyer review any borderline disease-related language.
Why automation needs a legal gate
Automation gives you consistent copy, but it does not lower the evidence bar. Our rule for any team publishing supplement pages is to use a gate with an evidence map for each claim, a legal check, a notification workflow, a locked disclaimer template, and a final human read. Review both the copy and the science behind it on a schedule, because formulas and studies change. Our guide to editing AI-generated descriptions covers that human pass, and a good persuasive copy guide helps writers sharpen wording without crossing into disease claims.
— Jamie Moss
How can we help you publish consistent, traceable product pages?
MerchUp AI is an AI product manager for Shopify stores, and we built it to take the repetitive work out of listings while you keep control of the claims.
- We generate full Shopify listings from a photo or barcode.
- We write descriptions into designed templates, so you can include a standard disclaimer in your product descriptions.
- We do all your SEO in one click: MerchUp AI reads your store’s Google Search Console data and live Google results, picks keywords, writes meta titles, descriptions and image alt text, checks rankings on live Google, and pushes everything to your store.
We do not replace legal substantiation. You must keep your own evidence for every health-related claim our AI writes. See our pricing plans, starting with a free plan, or follow the tutorial to test the workflow on a few products today.
This article is general information, not a substitute for advice from a qualified lawyer. Consult a qualified legal professional about your own circumstances before acting on anything here.
FAQ
What are the three types of claims the FDA allows?
The FDA recognizes health claims, structure/function claims and nutrient content claims for dietary supplements. Each has its own rules, and structure/function claims need a 30-day notification plus the disclaimer, as the FDA’s label claims page explains.
Are supplement claims regulated?
Yes, but not pre-approved. Firms are responsible for making sure their products are not misbranded, and structure/function claims need substantiation and the required disclaimer, according to the FDA’s supplement Q&A. The FTC separately polices advertising claims.
Are GNC supplements FDA regulated?
Like every dietary supplement, products sold at national retailers are subject to the same labelling, truthfulness and substantiation rules. Being stocked in a big chain does not mean the FDA has approved the claims on the label.
What are the FDA’s new regulations for 2026?
The FDA lists targeted publication goals for proposed and final rules on its Foods Program regulations page. Check that page for current dates, since targets can shift.
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