What claims turn a dietary supplement into an illegal drug?

A dietary supplement may make structure/function claims — statements about how an ingredient supports the normal workings of the body. It may not make disease claims, which say the product treats, prevents, or cures a disease. A disease claim makes the supplement an unapproved new drug, regardless of what the label calls it.

What is the difference between a structure/function claim and a disease claim?

A structure/function claim describes an effect on normal structure or function — “supports a healthy immune system,” “helps maintain healthy joints.” A disease claim says or implies that the product treats, prevents, mitigates, or cures a disease. That is the line, and crossing it changes the product’s legal category rather than just the wording on the panel.

Which phrases cross the line?

Anything naming a disease or a diagnosable condition and pairing it with an effect: lowers blood pressure, fights cancer, cures anxiety, reverses diabetes. Implication counts too. Images, a product name, before-and-after photos, and republished customer testimonials can all establish a disease claim even when the label text is careful.

Who enforces this, and what do they do?

Both FDA and the FTC act in this space, frequently together. Warning letters are routine and public. Beyond letters, the consequences can include product seizures, injunctions, and private lawsuits — including class actions built on the same claim language.

What does compliant claim language look like?

Replace the disease language with a structure/function claim, and carry the disclaimer required by the Dietary Supplement Health and Education Act stating that the claim has not been evaluated by FDA and the product is not intended to diagnose, treat, cure, or prevent any disease. The disclaimer does not rescue a disease claim. It supports a claim that was already lawful.

What records should you keep?

Substantiation for every claim, on file, before the claim goes live. If your only support for a claim is that a competitor makes it, you do not have substantiation.

Video Transcript

Does your supplement label say it treats, cures, or prevents a disease?

That single phrase can turn your product into an illegal drug in the eyes of the FDA. Here is the rule.

Supplements are allowed to make structure/function claims, which are statements about how an ingredient supports the normal workings of the body.

They are not allowed to make disease claims, which say the product treats, prevents, or cures a disease.

A disease claim makes your supplement an unapproved new drug. Why does this matter?

Phrases like lowers blood pressure, fights cancer, or cures anxiety cross the line.

So can certain images, product names, and customer testimonials.

The FDA and the FTC send warning letters for this regularly, and the consequences can include product seizures, injunctions, and lawsuits.

So what should you do? First, review every claim on your labels, website, Amazon, and social media for disease language.

Second, replace those with compliant structure function claims, like supports a healthy immune system, and add the disclaimer required by the Dietary Supplement Health and Education Act.

Third, keep substantiation on file for every claim you make. Want a second set of eyes on your claims? Contact us today.

Frequently Asked Questions

Q: Does the DSHEA disclaimer make any claim legal?
A: No. The disclaimer is required for structure/function claims. It does not convert a disease claim into a permitted one.

Q: Do customer reviews on my own site count as my claims?
A: They can. Selecting, curating, or republishing testimonials that make disease claims can make them attributable to you.

Q: What about Amazon listing copy and A+ content?
A: It is treated the same as your website. Marketplace copy is one of the most common places disease claims are found.

Q: Is a claim about a symptom the same as a claim about a disease?
A: Not always, but symptom claims tied to a recognizable disease state are frequently treated as disease claims. This is a case-by-case judgment worth getting reviewed.

Q: What if my ingredient really does have clinical support?
A: Evidence supports substantiation, but it does not change the category rules. A supplement with excellent data still cannot claim to treat a disease.

Talk to an FDA compliance attorney before a problem becomes a recall, a hold, or a lost contract. Contact Capote Law Firm today.

Related video: Avoiding FDA Trouble: Navigating Supplement Claims Safely
Related video: Customer Reviews & Testimonials as Illegal Drug Claims
Service page: Supplement Claims and Labeling Review