Structure/Function Claims: What You Can and Can’t Say

Structure/function claims provide a clear understanding of what a supplement can do for your body. These claims explain how vitamins, minerals, probiotics, or herbal supplements support normal health without claiming to treat or cure diseases. 

Every claim must follow FDA food-safety rules, include a disclaimer, and be backed with scientific proof from reliable sources such as the National Institutes of Health.

Understanding the difference between structure/function claims and disease claims helps you read labels with confidence. 

A structure/function claim may say “supports memory,” while a disease claim may say “treats Alzheimer’s.” 

That small difference in food labeling changes everything.

What Are Structure/Function Claims?

Structure/function claims explain how a supplement supports the normal health of your body. These statements focus on maintenance instead of treatment, keeping the language within FDA rules. 

They help you understand what a product is meant to support without making medical promises often associated with medicines.

A nutrient often becomes the focus of these statements because of its role in your body. Calcium supports strong bones, while fiber helps maintain regular digestion. 

Fish oil and omega-3 fatty acids, for example, may support cardiovascular health, while antioxidants help protect cells from damage.

The wording of these statements makes the real difference between legal and illegal claims. A label may say “supports memory,” but cannot say “treats Alzheimer’s.” 

That small change in phrasing keeps the claim compliant and honest for the supplement industry.

How Structure/Function Claims Are Worded

The wording of a claim usually centers on terms like “supports,” “helps,” or “maintains.” According to The Dietary Supplement Health and Education Act of 1994 (DSHEA), claims may also describe a benefit such as improving a nutrient deficiency, but they must state how common that deficiency is in the U.S. This rule keeps claims clear and grounded in facts recognized by the National Institutes.

A product label often highlights natural processes instead of conditions. Structure/function claims must also follow Food and Drug Administration guidelines, which require the proper disclaimer and notification. 

Working with manufacturers who know FDA rules helps you bring vitamins and minerals, herbal supplements, or multivitamin products to the market quickly and correctly.

The language used matters because one word can shift meaning. “Helps maintain digestion” passes FDA rules, but “relieves ulcers” does not. 

Choosing the right words protects both the consumer and the food supplements company.

Contact Bustos Law Group for guidance.

FDA Criteria and Requirements

FDA criteria set the framework for how structure/function claims appear on dietary supplements. Every claim must have solid scientific backing before it goes on a label. 

This process keeps information reliable and consistent for consumers who rely on supplementation.

Substantiation is the first requirement. A company must have credible evidence, such as scientific studies or peer-reviewed research, to support the claim. Without claim substantiation, the claim does not meet FDA standards.

Notification is the second step in FDA compliance. Manufacturers must notify the FDA within 30 days of first marketing a product with a structure/function claim. 

This ensures transparency and allows the FDA to monitor the types of claims being marketed.

The final piece is the disclaimer. Every structure/function claim must include a clear statement that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent disease. 

This FDA disclaimer statement protects consumers while setting realistic expectations for vitamins, amino acids, or omega products.

Labeling and Notification: Step-by-step FDA Processes

You need to follow FDA processes carefully when labeling supplements. Each step plays a role in making sure your product reaches the market safely.

Step 1: Prepare Label Content

You must prepare label content that clearly shows your structure/function claims. The label should also include the Supplement Facts panel, ingredient list, and net quantity. 

Your company’s name and contact information must appear on the label to meet food labeling requirements.

Step 2: Include the FDA Disclaimer

You must include the FDA disclaimer statement with every structure/function claim. The disclaimer informs consumers that the FDA has not evaluated the claim. You should place it where people can easily read it without confusion.

Step 3: Gather Claim Substantiation

You need to gather claim substantiation before using a structure/function claim. Strong substantiation may come from clinical trials, peer-reviewed studies, or reliable research sources. Research from the National Institutes of Health is often cited to support antioxidants, omega fatty acids, or herbal claims.

Step 4: Submit Notification to FDA

You must submit a notification to the FDA within thirty days of first marketing. The notification should contain the exact claim text along with supporting documentation. You can complete this process electronically through the FDA’s submission portal.

Step 5: Keep Records and Be Ready to Respond

You should maintain detailed records of your labels, claims, and substantiation. Both the FDA and FTC may request these records at any point. Quick and accurate responses help protect your company from penalties and delays in the supplement industry.

Step 6: Review and Update Labels as Needed

You must review your product labels regularly to make sure they remain accurate. Any new FDA guidance or updated regulations may require you to adjust claims. 

This is especially important as new research on omega-3 fatty acids, herbal supplements, or multivitamin products continues to grow.

Permissible vs. Impermissible Claims

Structure/function claims must focus on supporting the body’s normal functions.

Permissible Claims

Permissible claims describe how a nutrient or supplement supports normal body functions. For example, you can say a product “helps maintain healthy cholesterol levels” or “supports bone strength.” These claims are often made for vitamins and minerals, probiotics, or fish-oil supplements.

Impermissible Claims

Impermissible claims directly state or imply that a supplement treats or cures a disease. An example would be “lowers cholesterol” or “prevents heart disease,” which suggest medical outcomes. Claims like these turn supplements into medicines and are not allowed.

Why the Difference Matters

The difference between permissible and impermissible claims matters because it protects consumers. Permissible claims set realistic expectations about what a supplement can do. Impermissible claims mislead consumers and expose your business to legal action.

Who Decides if a Structure/Function Claim is Substantial?

The FDA sets the rules, but the company making the supplement must prove the claim. The responsibility for substantiation starts with you as the manufacturer or marketer.

Role of the Company

The company must collect scientific evidence before using a claim. Substantiation should include well-designed clinical trials, peer-reviewed studies, or published data. You must keep this evidence on file in case the FDA or FTC requests it.

Role of the FDA

The FDA reviews claims when products enter the market or during inspections. The agency checks if the company followed labeling rules and added the disclaimer. The FDA does not pre-approve claims, but can take action if a claim is misleading.

Role of the FTC

The Federal Trade Commission oversees advertising claims related to supplements. The FTC makes sure marketing messages are truthful and not deceptive. Both the FDA and FTC work together to monitor marketed claims in the supplement industry.

Why Substantiation Matters

Substantiation matters because it keeps consumers safe and builds trust. A claim backed by science helps your product stand out in the growing supplementation market. Weak or false claims can lead to warnings, penalties, or removal from store shelves.

So, what you need

You need to make structure/function claims that are clear, legal, and supported by evidence. Following FDA and FTC rules keeps your supplements compliant and builds trust with consumers. 

Start reviewing your labels today, gather strong substantiation, and work with experts to make sure your vitamins, herbal supplements, and multivitamin claims stand strong.

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