Structure/function claims can help dietary supplement brands explain what an ingredient does in the body. But a claim can cross the line into a disease claim when its wording or context suggests that the product diagnoses, treats, cures, mitigates, or prevents disease.
FDA does not pre-approve ordinary structure/function claims. However, manufacturers must have substantiation that the claim is truthful and not misleading, provide the required disclaimer, and notify FDA within 30 days after first marketing the product with the claim.
Here are 10 types of phrases that can create significant regulatory risk.
1. “Treats inflammation”
Risky: “Treats chronic inflammation.”
The word “treats” strongly suggests a therapeutic purpose. Depending on context, inflammation-related claims can imply treatment of a disease or health condition.
Safer direction: “Supports a healthy inflammatory response.”
The overall context still matters, including surrounding claims and product positioning.
2. “Prevents diabetes”
Risky: “Helps prevent diabetes.”
Diabetes is a disease, so a claim that a supplement prevents or treats diabetes is not an ordinary structure/function claim.
Safer direction: Keep the claim focused on a normal body function rather than disease prevention.
3. “Lowers blood pressure”
Risky: “Naturally lowers high blood pressure.”
This identifies a disease-related condition and suggests a therapeutic effect.
A structure/function claim should instead describe a normal physiological function without connecting the product to treatment of hypertension.
4. “Fights infections”
Risky: “Fights infections and harmful bacteria.”
FDA guidance explains that claims suggesting a supplement enhances the body’s ability to fight disease can be disease claims.
Claims involving “antiviral,” “antibacterial,” or similar disease-fighting language therefore require careful review.
5. “Relieves arthritis pain”
Risky: “Relieves arthritis pain.”
The reference to arthritis connects the product directly to a specific disease.
Even if the ingredient has evidence relating to joint function, the wording can turn a permissible structure/function concept into an implied disease claim.
6. “Replaces your medication”
Risky: “A natural alternative to prescription medication.”
FDA considers claims that a supplement is a substitute for a therapy used to treat disease to be implied disease claims.
Comparing a supplement directly with a prescription drug can therefore create substantial regulatory risk.
7. “Reduces cholesterol”
Risky: “Reduces high cholesterol.”
A claim about cholesterol can become problematic when it is presented as reducing a disease-related risk or treating an abnormal condition.
Before using cholesterol-related language, companies should evaluate the exact wording, evidence, and regulatory category.
8. “Boosts immunity against viruses”
Risky: “Boosts immunity against viruses.”
The issue is not simply the word “immune.” The problem is the connection between the claimed effect and disease prevention.
FDA specifically identifies claims such as supporting the body’s ability to resist infection or antiviral capabilities as potentially disease claims.
9. “Heals ulcers”
Risky: “Heals stomach ulcers naturally.”
“Ulcers” identify a specific medical condition, while “heals” communicates a therapeutic effect.
Changing only one word may not solve the problem if the overall context still communicates disease treatment.
10. “Cures anxiety”
Risky: “Cures anxiety naturally.”
This is a straightforward example of a disease or disease-related claim because it represents the supplement as curing a health condition.
FDA has repeatedly taken enforcement action when dietary supplements are marketed with claims to treat or prevent diseases. For example, FDA issued warning letters to companies making cardiovascular disease treatment claims in 2022.
What Makes a Structure/Function Claim Safer?
A compliant claim generally focuses on the normal structure or function of the body, rather than diagnosing, treating, curing, or preventing disease.
For example:
Higher risk: “Treats joint inflammation.”
Potentially more appropriate: “Supports healthy joint function.”
Higher risk: “Prevents heart disease.”
Potentially more appropriate: “Supports cardiovascular health.”
However, simply replacing one word is not enough. FDA evaluates the overall context of the labeling, including product names, images, surrounding claims, testimonials, and other representations.
The Compliance Checklist
Before publishing a structure/function claim, ask:
- Does the claim mention a disease or recognizable symptom?
- Does it suggest treatment, cure, mitigation, or prevention?
- Does the product name create an implied disease claim?
- Do testimonials or website content change the meaning of the claim?
- Do you have adequate substantiation?
- Is the required DSHEA disclaimer properly presented?
- Was the structure/function claim notification submitted to FDA within 30 days after first marketing?
Remember that the disclaimer does not convert a disease claim into a permissible structure/function claim. The underlying claim itself must comply with the law.
Bottom Line
Structure/function claims can be valuable for supplement marketing, but the line between a permissible claim and a disease claim can be narrow.
The safest approach is to review the exact wording + scientific substantiation + surrounding marketing context before a product goes to market.
JJCC Group can help supplement companies review structure/function claims, evaluate substantiation, prepare FDA notifications, and identify disease-claim risks before they become an enforcement issue.
