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

A structure/function claim describes how a nutrient or ingredient affects the normal structure or function of the body, such as 'supports bone health' or 'promotes digestive regularity.' A disease claim states that a product can diagnose, treat, cure, or prevent a disease, such as 'prevents osteoporosis' or 'treats arthritis.' Supplements may make structure/function claims but cannot make disease claims. Disease claims make a product an unapproved drug under federal law.

Do I need to notify the FDA about structure/function claims on my supplement label?

Yes. Under DSHEA, you must notify the FDA within 30 days of first marketing a product with a structure/function claim. Submit the notification to the FDA's Office of Dietary Supplement Programs. You must also include the disclaimer: '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 notification is not an approval process. FDA does not review or approve the claim.

Can the FTC take action against supplement brands for advertising claims?

Yes. The FTC enforces truth-in-advertising standards for dietary supplements independently of the FDA. The FTC requires 'competent and reliable scientific evidence' to support advertising claims. This applies to all advertising channels including social media, influencer content, and paid endorsements. The FTC has increased enforcement in recent years, including actions against celebrity endorsers and influencer marketing campaigns.

Structure/Function Claims: What Supplement Brands Can and Cannot Say

What you say about your supplement on the label, on your website, and in advertising determines whether your product is a legal dietary supplement or an unapproved drug. That distinction is not hypothetical. FDA warning letters for illegal disease claims are the single most common enforcement action against supplement brands.

This guide explains what structure/function claims are, how they differ from disease claims, the FDA notification requirement, FTC advertising standards, and the common mistakes that trigger enforcement actions. A regulatory attorney should review your claims before you go to market.

Dietary supplement manufacturers must comply with 21 CFR Part 111 (Current Good Manufacturing Practice for dietary supplements). This includes requirements for personnel, facilities, equipment, production, laboratory operations, and record-keeping.

What Structure/Function Claims Are

The Dietary Supplement Health and Education Act (DSHEA) of 1994 allows supplement manufacturers to make claims about how a nutrient or ingredient affects the normal structure or function of the human body. These are called structure/function claims.

Structure/function claims describe an effect on normal body processes. They cannot claim to diagnose, treat, cure, mitigate, or prevent any disease. The moment a claim crosses that line, the product is legally classified as an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(6)).

Three types of structure/function claims exist under DSHEA:

Claims about the role of a nutrient in affecting the body's structure or function. Example: "Calcium builds strong bones."
Claims that describe the mechanism by which a nutrient acts. Example: "Fiber helps maintain digestive regularity."
Claims about general well-being from consuming a nutrient. Example: "Supports overall immune health."

Claims That Pass vs Claims That Fail

The difference between a legal structure/function claim and an illegal disease claim is often just a few words. These examples show where the line falls across common supplement categories.

Category	Permitted (Structure/Function)	Prohibited (Disease Claim)
Joint health	Supports joint flexibility and comfort	Treats arthritis pain
Heart health	Supports healthy cholesterol levels already within normal range	Lowers cholesterol / Prevents heart disease
Immune support	Supports immune system function	Prevents colds and flu
Cognitive	Supports memory and focus	Prevents Alzheimer's / Treats ADHD
Digestive	Promotes digestive regularity	Treats IBS / Cures constipation
Bone health	Calcium builds strong bones	Prevents osteoporosis
Weight	Supports healthy metabolism	Burns fat / Guaranteed weight loss
Sleep	Promotes relaxation and restful sleep	Treats insomnia

Watch for implied disease claims. The FDA evaluates the "net impression" of your labeling, not just the literal words. Product names like "CardioGuard" or "DiabeFree" can constitute implied disease claims. Images of medical equipment, stethoscopes, or prescription bottles on labels also create disease claim implications.

The 30-Day FDA Notification Rule

DSHEA requires that you notify the FDA within 30 days of first marketing a dietary supplement with a structure/function claim. This applies to every product with any structure/function claim on the label.

What the Notification Includes

The text of the structure/function claim
The name of the dietary ingredient that is the subject of the claim
The name of the dietary supplement product
The name and address of the manufacturer, packer, or distributor

The Required Disclaimer

Every product with a structure/function claim must display this disclaimer on the label:

"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 disclaimer must appear in boldface type in a size no smaller than one-sixteenth of an inch. It must be placed on the part of the label immediately adjacent to the structure/function claim. For more on label requirements, see our packaging and label compliance guide.

The notification is not an approval. FDA does not review or approve structure/function claims. The notification requirement is a registration process. The FDA may later object if it determines a claim is actually a disease claim, but not responding to your notification does not mean the FDA has endorsed or accepted your claim.

FTC Advertising Standards

The FDA regulates what appears on your product label. The Federal Trade Commission (FTC) regulates what you say everywhere else: your website, social media, advertising, email marketing, and any endorsements or testimonials.

The FTC standard for supplement advertising is "competent and reliable scientific evidence." This means claims must be supported by published, peer-reviewed studies before you make them. "We believe it works" or "our customers say it works" does not meet this standard.

What the FTC Watches For

Unsubstantiated efficacy claims. Any claim about what your product does must be supported by evidence. "Clinically proven" requires actual clinical trials.
Misleading testimonials. Customer testimonials must reflect typical results. If results are atypical, you must clearly disclose that.
Influencer and endorser liability. Both the brand and the influencer can be liable for false or misleading claims. The FTC has issued warning letters to individual influencers.
"Made in USA" claims. Products must be "all or virtually all" made in the United States to use this claim. Imported ingredients can disqualify the claim.
Before/after representations. Before and after photos or stories must be truthful and represent typical results. Staged or misleading comparisons violate FTC rules.

Recent FTC enforcement has been aggressive. In 2025, the FTC issued a warning letter to a celebrity for supplement advertising that lacked adequate substantiation. The agency has also increased scrutiny of social media marketing and affiliate programs.

Common Claims Mistakes

Most claims violations are not intentional. Brand owners write marketing copy that sounds reasonable but crosses a legal line they did not know existed.

Using disease names anywhere on the label or website. Mentioning diabetes, cancer, Alzheimer's, arthritis, or any named disease in connection with your product creates a disease claim. Even phrases like "helps with blood sugar issues" can trigger enforcement if they imply a disease connection.
Copying competitor claims without verification. Your competitor may be making illegal claims that haven't been enforced yet. Copying their language does not make it legal. It makes two brands out of compliance instead of one.
Relying on the DSHEA disclaimer as a defense. The disclaimer ("not intended to diagnose, treat, cure, or prevent any disease") does not make a disease claim legal. If the claim itself is a disease claim, the disclaimer does not fix it.
Ignoring social media content. Everything your brand posts, every influencer endorsement, and every customer testimonial you share is subject to FTC scrutiny. Social media is advertising, not casual conversation.
Using clinical study language without clinical studies. "Clinically proven," "scientifically tested," and "doctor recommended" all create specific evidentiary obligations. If you don't have the evidence, don't use the language.
Not filing the 30-day FDA notification. This is a straightforward administrative requirement. Missing it is an unnecessary compliance gap that draws attention during inspections.

Building a Claims Review Process

Experienced brand owners don't leave claims compliance to chance. They build a review process that catches problems before they reach consumers or regulators.

Have a regulatory attorney review all label claims before production. This typically costs $1,500 to $5,000 per product and is significantly cheaper than responding to a warning letter.
Create a claims library: a document listing every approved claim, the evidence supporting it, and the exact language approved by your regulatory attorney.
Train everyone who writes marketing copy (including social media managers and freelancers) on the difference between structure/function claims and disease claims.
Review all customer testimonials before sharing them. Testimonials that describe disease-related outcomes ("cured my arthritis") cannot be used.
Monitor influencer content if you have endorsement relationships. You are liable for claims your endorsers make about your product.
Keep a file of the scientific evidence supporting each claim. If the FTC asks, you need to produce this evidence. Having it organized beforehand matters.

For a broader view of compliance risks beyond claims, see our supplement compliance risks guide. For the current regulatory environment, see our 2026 regulatory landscape overview.

Disclaimer: This guide is educational content, not legal or regulatory advice. Claims compliance is a legal matter. Consult a regulatory attorney experienced in dietary supplement law before finalizing product claims. See our Terms of Service for details.