Structure/Function Claims vs Disease Claims: Examples for Supplement Brands

Supplement brands can say how a product supports the body’s normal function, such as “supports healthy digestion.” That is a structure/function claim. They cannot say a product treats, cures, or prevents a disease unless the FDA has approved that specific claim. That is a disease claim, and the FDA treats a product that makes one as a drug. To use a structure/function claim, you need proof it is true, you must tell the FDA within 30 days, and your label must carry a standard disclaimer.

One wrong word can turn a compliant supplement page into an unapproved drug claim. “Supports joint health” sits in safer territory. “Reduces arthritis pain” does not.

This guide shows where the line sits, with plain-English examples and safer rewrites. It is educational, not legal advice. Have a qualified regulatory attorney review your claims before launch.

1. What is a structure/function claim?

A structure/function claim describes the role a nutrient or dietary ingredient plays in the body’s normal structure or function. It can also describe the documented mechanism behind that role, or general well-being. The FDA allows these supplement claims without pre-approval.

Congress created the category in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The same law lets supplements make claims about classic nutrient-deficiency diseases, such as vitamin C and scurvy. Other disease claims need FDA authorization.

2. What is a disease claim?

A disease claim says or hints that a product can treat, cure or prevent a disease. It can also say the product can diagnose or ease one.

The FDA defines a disease as damage that stops part of the body from working properly. It also counts health states that lead to that damage. Heart disease and high blood pressure both count.

There is one exception. Diseases caused by a lack of a nutrient, like scurvy from too little vitamin C are allowed. Supplements can make claims about those.

The stakes are high. Under FDA guidance, a supplement that carries a disease claim is regulated as a drug, unless the claim is an authorized health claim.

An explicit claim names the disease. An implied claim describes the disease state or its characteristic symptoms. Both count.

3. How do you tell a structure/function claim from a disease claim?

Ask whether the claim, in context, suggests the product acts on a disease. The FDA admits there is not always a bright line. It tells marketers to weigh objective evidence across the entire label.

The FDA uses 10 criteria. In plain English, your claim is likely a disease claim if it:

1. Names a disease or class of diseases, or describes the disease state.
2. Claims an effect on characteristic signs or symptoms of a disease.
3. Targets a condition tied to a natural process like aging or menopause, when that condition is uncommon or can cause serious harm.
4. Implies disease through the product name, ingredients, images or symbols.
5. Claims to belong to a disease-treating product class, such as antibiotics or antivirals.
6. Claims to substitute for a disease therapy.
7. Claims to augment a disease therapy.
8. Claims a role in fighting disease or infection.
9. Claims to treat side effects of a disease therapy, when that side effect is itself a disease.
10. Otherwise suggests an effect on disease.

Words are not magic. The FDA says terms like “support,” “maintain” and “promote” can still create an implied disease claim when the context points to disease. Terms like “prevent,” “treat” and “cure” are disease claims when they point to disease.

4. What are examples of compliant structure/function claims?

Compliant claims describe normal body functions or general well-being without naming diseases or their symptoms. These examples fit the FDA’s criteria on their face. They still need evidence, the disclaimer and a 30-day notification.

• “Supports healthy digestion.” It names a normal function, not a condition.
• “Supports joint health.” Same logic. Keep it away from pain, stiffness or inflammation language tied to arthritis.
• “Supports the immune system.” The FDA calls this too general to imply disease prevention. See our guide to everyday habits that support immune health.
• “Helps maintain cholesterol levels already in the normal range.” The “already normal” context removes the disease inference.
• “Helps with occasional sleeplessness.” “Occasional” signals a non-disease state.
• “Helps with mild memory lapses that come with aging.” The FDA treats mild age-related memory loss as acceptable.
• “Helps you unwind after a stressful day.” Stress alone is not a disease unless the context links it to one.
• “Helps relieve temporary water weight.” “Temporary” keeps it in structure/function territory.

Context can change any of these. Review each claim inside its full page, not in isolation.

5. What are examples of disease claims to avoid?

Disease claims name a disease, describe its symptoms, or imply treatment or prevention. Here are common traps, with safer rewrites.

• Avoid: “Reduces pain and stiffness from arthritis.” Why: It names a disease. Try: “Supports joint health.”
• Avoid: “Lowers cholesterol.” Why: The FDA says cholesterol reduction is so tied to cardiovascular disease that it implies a disease claim. Try: “Helps maintain cholesterol levels already in the normal range.”
• Avoid: “Boosts your body’s ability to fight infection.” Why: Infection-fighting language is a disease claim under the FDA’s criteria. Try: “Supports the immune system.”
• Avoid: “Restores gut flora while you take antibiotics.” Why: The FDA treats maintaining intestinal flora in people on antibiotics as a disease claim. Try: “Supports digestive health.”
• Avoid: “A natural alternative to your prescription.” Why: Claiming to substitute for a disease therapy implies the same purpose. Try: Describe the nutrient’s role in the body, with no drug comparison.
• Avoid: “Cures insomnia.” Why: It names a disease and uses “cure.” Try: “Helps with occasional sleeplessness.”

One more trap: general statements that your product prevents disease. The FDA treats these as disease claims because they imply the product itself does the preventing.

6. Do product names, images, and citations count as claims?

Yes. The FDA looks at the whole label and labeling, so names, pictures, symbols, and study citations can all imply a disease claim.

• Product names: The FDA gives “CarpalHealth” and “CircuCure” as implied disease claims. A name like “Soothing Sleep” can imply insomnia unless the labeling makes clear it means occasional sleeplessness.
• Images and symbols: Heart symbols and EKG tracings are ordinarily implied disease claims. Pictures of healthy organs are fine. Pictures of diseased tissue are not.
• Study citations: A citation with a disease in its title can become a disease claim if its placement or prominence implies treatment. A balanced bibliography is safer.
• “Rx” and “prescription”: These can mislead shoppers into thinking the product is a prescription drug.

Check your product name, hero image, and icons before you check your adjectives.

7. What does a structure/function claim need before you publish it?

Three things: substantiation, an FDA notification, and a standard disclaimer. The FDA’s guide says you need substantiation before you make the claim.

1. Substantiation. You must have evidence that the claim is truthful and not misleading.
2. Notification. You must notify the FDA within 30 days of first marketing the product with the claim. It is a filing, not an approval. An FDA response, or silence, is not a statement that your product meets other legal requirements.
3. Disclaimer. The claim must carry this statement, prominently displayed and in boldface: “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.” The wording and placement rules sit in 21 CFR 101.93.

8. Does the FDA or the FTC regulate supplement marketing claims?

Both do. The FDA oversees labeling, claim notifications, and disclaimers. The FTC polices advertising for truthfulness and substantiation, and the two agencies share jurisdiction over supplements.

The FTC does not require pre-market approval of health claims in advertising. It also has no notification requirement like the FDA’s, according to its Health Products Compliance Guidance. That does not make advertising a free-for-all. A claim can satisfy the FDA’s structure/function rules and still fail the FTC’s evidence standard.

The FTC issued the guidance on December 20, 2022. It replaced the agency’s 1998 supplement advertising guide and, as law firm summaries note, covers health-related claims beyond supplements.

9. How much evidence does the FTC expect behind a claim?

The FTC expects “competent and reliable scientific evidence.” Law firms reading the 2022 guidance say that generally means randomized, controlled human clinical trials.

McDermott’s summary adds that animal studies, in vitro studies, observational studies and anecdotes are generally not enough. It also notes there is no exemption for botanical or traditional-use products.

Be careful with references to outside studies. The same summary says claims implied by third-party literature must meet FTC standards. Keep a substantiation file for every claim you publish.

10. How do you write compliant structure/function claims?

Start from the evidence, name the body function, strip disease language, add context, and get a review. Here is the workflow.

1. Start with your substantiation. Write only what your evidence supports.
2. Name the function, not the condition. Write “supports digestion,” not “relieves IBS.”
3. Check every element against the 10 criteria. That includes the product name, images, testimonials, and citations.
4. Add context where words are ambiguous. Phrases like “occasional” and “already in the normal range” do real work.
5. Add the disclaimer and file the notification. Do both within the 30-day window.
6. Get a regulatory review. Meta and Google add their own rules for health claims in ads, so check those too.

Then build the page around the approved claim. Our guide to creating authentic wellness brand content shows how to earn trust and stay compliant. Use a headline that stops the scroll and a clear call to action. Compliant copy can still persuade.

Frequently Asked Questions

Does the word “supports” make a claim safe?

No. The FDA says words like “support,” “maintain,” and “promote” can create an implied disease claim when the context points to disease.

Does the disclaimer make a disease claim legal?

No. A supplement with a disease claim is regulated as a drug unless the claim is an authorized health claim. The disclaimer accompanies structure/function claims only.

Does the FDA approve my structure/function claim?

No. You notify the FDA within 30 days of first marketing the product with the claim. The FDA’s response, or lack of one, is not a statement that your product is compliant.

Can I say a product supports the immune system?

Often, yes, if you can substantiate it. The FDA’s guide calls “supports the immune system” too general to imply disease prevention. A claim about resisting infection is a disease claim.

Do testimonials and third-party studies count as claims?

Yes. The FTC’s guidance still covers testimonials and endorsements. Claims implied by third-party literature must also meet FTC standards.

Final Word

The line between structure/function and disease claims is about context. Describe normal body function. Back every claim with evidence. File the notification and add the disclaimer.

Then write for your reader’s goal. Digesting comfortably, feeling steady, and sleeping well sells without crossing the line.

Not sure a specialist is worth it? Read why wellness brands need a professional copywriter.

Want copy that converts and passes review? Start your project.

About the Author

Patrick Mumo is a freelance copywriter for health and wellness brands. He writes compliance-aware landing pages, emails, ads, and SEO content that convert, pass ad review, and get cited by search engines and AI assistants. Learn more about Patrick, explore his services, or visit patrickmumo.com.

Related Posts

• Words to Avoid in Supplement Marketing (and What to Write Instead)
• How to Write Meta Ads for Supplements That Pass Review
• FTC Health Claims Rules for Supplement Marketing: A Plain-English Guide
• Why Wellness Brands Need a Professional Copywriter
• How to Create Authentic Wellness Brand Content

Further reading on patrickmumo.com: Why High-Converting Sales Copy Matters, How to Hire a Copywriter, and The 10 Copywriting Formulas That Never Go Out of Style