Structure/Function Claims in Dietary Supplements

Supplement labels can carry several kinds of claims. Some describe how much of a nutrient a product contains; others describe how an ingredient affects the body's structure or function. Structure/function claims specifically describe the role of a nutrient or dietary ingredient intended to provide an effect on the normal structure or function of the human body. For a brand, getting these claims right is what keeps a label compliant. This guide covers what structure/function claims are, what is and isn't allowed, and how working with experienced dietary supplement manufacturers helps you stay compliant.

Key Takeaways

• Structure/Function Claims Must Not Mention Diseases: These claims are strictly limited to describing how a supplement supports normal body functions, like digestion or immunity, without suggesting treatment, prevention, or cure of any disease. Terms like “cure” or “therapy” and any disease-specific references are prohibited.
• Manufacturer Responsibility with FDA Notification: While FDA pre-approval isn't required, the firm marketing the product must notify the FDA within 30 days of first marketing it with a structure/function claim. That firm is responsible for ensuring the claim is truthful, non-misleading, and backed by adequate evidence.
• Compliance Requires Clarity in Labeling and Language: To remain compliant, brands must avoid symptom-related words, medical imagery, and drug comparisons. Working with an experienced supplement manufacturer like F.A.M.E. Health Labs helps you catch claim problems before the label is printed.

What Is a Structure/Function Claim?

What are Health Claims?

Authorized health claims link a food or supplement ingredient directly to reducing the risk of a specific disease. They require significant scientific agreement to ensure accuracy and are strictly regulated by authorities. Unlike structure/function claims, authorized health claims must have substantial evidence and are scrutinized before appearing on labels.

What are Nutrient Content Claims?

Nutrient content claims describe the level of a specific nutrient within a product, such as “high in fiber” or “low in fat.” These claims help consumers easily identify nutritional value, unlike structure/function claims, which explain how a nutrient supports body functions. They’re governed by strict guidelines to ensure clarity and truthfulness.

What are the Different Categories and How Do They Work?

Free

"Free" refers to products that contain an insignificant amount of a particular nutrient, such as sugar or sodium. For example, "sugar-free" means minimal sugar content per serving, typically less than 0.5 grams. Such claims help consumers with specific dietary needs make informed choices.

Low

"Low" means a product contains a small amount of a nutrient, like calories or sodium. For example, "low sodium" indicates the product has 140 mg or less per serving. This claim helps people manage dietary restrictions related to various health conditions.

Reduced/Less

"Reduced" or "less" signifies that a product has at least 25% less of a specific nutrient or calories compared to a reference product. This labeling helps consumers who want to cut back on a nutrient without giving up flavor entirely.

Learn About the Permissible vs. Impermissible Structure/Function Claims for Dietary Supplements

Are you able to suggest that your product has an impact on a disease?

No, structure/function claims must not suggest your product can diagnose, treat, cure, or prevent any disease. They should focus on how a nutrient supports normal body functions, following FDA rules for dietary supplement labeling.

Absence of any reference to the specific signs or symptoms associated with a disease or disease group

Structure/function claims should avoid mentioning specific signs or symptoms associated with any diseases. These claims must focus on supporting normal body functions rather than implying direct health improvements related to specific health issues or conditions.

Mentions of Symptoms

When you write structure/function claims, don't mention specific symptoms of diseases. Instead, the focus should remain on the overall support of normal body functions and general well-being, without implying treatment or relief of any medical condition.

Name your product

When naming your product, avoid including terms that insinuate treatment or prevention of diseases. The name should emphasize the dietary supplement's intended support function without suggesting it as a substitute for medical drugs or therapies.

Composition of Supplement Formulation

The composition of your supplement formulation should be clearly stated without implying therapeutic benefits. You should focus on how each ingredient supports normal body functions and contributes to health, avoiding claims that suggest medical advantages.

Can you include a reference to an article in your claim?

Be careful. Citing an article or study whose title mentions a disease can turn your claim into an implied disease claim. Keep claims focused on how an ingredient supports normal body functions, and keep your supporting research in your substantiation file.

What words are not recommended to use?

Avoid words like "cure," "treat," "prevent," "disease," or "therapy" in dietary supplement labeling claims. These terms suggest drug benefits, which dietary supplements cannot claim, and may violate labeling regulations. Focus instead on support and maintenance functions.

Refrain from using visuals or symbols that indicate disease treatment

Avoid visuals or symbols that imply disease treatment on your supplement labels. Images of medical equipment or symbols like a hospital cross suggest therapeutic benefits, which structure/function claims are not intended for. Stick to imagery that reflects general wellness.

Do not suggest that your supplement is an alternative to a drug.

Ensure your structure/function claims do not imply your supplement can replace medications. Claims should emphasize how the supplement supports the body's normal functions without implying that it serves as a substitute for prescribed drugs.

Avoid suggesting that your dietary supplement is safe or beneficial alongside regular prescription drug usage

Refrain from claiming that your dietary supplement is safe or effective for use with prescription drugs. Structure/function claims should solely describe how the supplement supports regular body functions without suggesting compatibility with prescription medications.

Who decides if a structure/function claim meets the required standards?

The responsibility falls primarily on the manufacturer to ensure that a structure/function claim complies with regulatory standards. However, the Food and Drug Administration (FDA) monitors these claims, assessing whether they truthfully reflect the role of the dietary ingredients without misleading consumers. Any misleading information can attract scrutiny and repercussions from the FDA. An experienced custom supplement manufacturer can help you review claims before launch.

How and where to submit your structure/function claim?

Notify the FDA no later than 30 days after you first market the product with the claim. The notification includes the text of the claim; you do not send your evidence, but you must already have substantiation on file showing the claim is truthful and not misleading. The label must also carry the FDA disclaimer: the statement has not been evaluated by the FDA, and the product is not intended to diagnose, treat, cure or prevent any disease. Utilizing packaging solutions that clearly and accurately represent these claims can further enhance product credibility.

Partner with F.A.M.E. Health Labs for Your Supplement Manufacturing

At F.A.M.E. Health Labs we manufacture supplements in our FDA-registered, cGMP facility in Cedartown, Georgia. We offer custom supplement formulation, 450+ stock formulas, label and packaging design support, and guidance on claim wording. Our team flags disease language before your label goes to print, so you launch a new line or extend an existing one with fewer compliance surprises.

Final Thoughts

Understanding and utilizing structure/function claims correctly can be a powerful tool in marketing dietary supplements. Such claims help communicate a product's benefits in supporting normal body functions without implying any medical treatment attributes. Your brand is responsible for claim accuracy, and an experienced manufacturer like F.A.M.E. Health Labs can help you get it right. Keep claims honest and within the rules, and consumers will trust your label. Ultimately, this approach benefits not only your brand but also the consumers you aim to serve.

FAQs

What's the difference between a health claim and a structure function claim?

Health claims link a product to disease risk reduction and require scientific backing, while structure/function claims describe how ingredients support normal body functions without implying disease prevention. Each serves different marketing and regulatory purposes.

Do structure/function claims need FDA approval?

No, structure/function claims do not require FDA pre-approval. However, the manufacturer must notify the FDA within 30 days of marketing the product and ensure that claims are truthful and not misleading.

Are there specific examples of permissible structure/function claims?

Yes, permissible structure/function claims include statements like "supports a healthy immune system" or "promotes joint health." These claims focus on how a product aids body functions without referring to disease treatment.

What is the one criterion for a structure function claim?

The key criterion for a structure/function claim is that it must reflect how an ingredient supports or maintains normal body functions without suggesting disease prevention, treatment, or cure.