Structure/Function Claims: What You Can and Cannot Say on Your Label

When marketing dietary supplements, the line between permissible claims and regulatory violations can seem razor-thin.

Structure/function claims represent one of the most powerful tools in your marketing arsenal, when used correctly.

However, missteps in this area can trigger costly FDA enforcement actions and FTC compliance issues that derail your product launch or market expansion.

Understanding the nuances of what you can and cannot say on your supplement labeling isn’t just about avoiding regulatory trouble—it’s about maximizing your marketing impact while building consumer trust.

Companies that master structure/function claims gain a significant competitive advantage in the marketplace – both in sales and in market access.

What Are Structure/Function Claims?

Structure/function claims describe the role of a nutrient or dietary ingredient in affecting normal structure or function of the human body. Unlike disease claims, these statements focus on maintaining normal, healthy bodily processes rather than treating, preventing, or curing specific conditions.

The FDA defines structure/function claims as statements that:

• Describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans
• Characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function
• Describe general well-being from consumption of a nutrient or dietary ingredient
• May discuss non-clinical study results that show that the nutrient “may support” certain structures and functions.

We consistently see companies struggle with the distinction between permissible claims and prohibited disease claims. The key lies in understanding that structure/function claims must focus on normal physiological processes, not pathological conditions.

Permissible Structure/Function Claims

Supporting Normal Body Functions

You can make claims about supporting normal, healthy bodily functions. These statements typically use language like “supports,” “maintains,” or “promotes” when describing physiological processes.

Examples of acceptable structure/function claims include:

• “Supports healthy immune function”
• “Promotes cardiovascular health with diet and exercise”
• “Provides nutritional support for bone density”
• “Nutritional support for cognitive function”
• “Helps maintain healthy cholesterol levels already within normal range”

Describing Mechanisms of Action

You can describe how your ingredient works at a cellular or molecular level, provided you’re referencing normal physiological processes. For instance, “Provides antioxidants that help neutralize free radicals” or “Contains fiber that supports digestive health.”

General Wellness Statements

Broad statements about general well-being are generally permissible. These might include claims like “promotes energy and vitality” or “supports overall wellness.”

What You Cannot Say: Prohibited Disease Claims

The FDA draws a clear line at disease claims—statements that suggest your product can diagnose, treat, prevent, or cure a specific disease or condition. In our experience, this is where most FTC compliance issues arise for supplement companies.

Explicit Disease Claims

Never make direct statements about diseases or pathological conditions. Avoid phrases like:

• “Treats arthritis”
• “Prevents heart disease”
• “Cures depression”
• “Reduces risk of cancer”

Implicit Disease Claims

More subtle disease claims can be equally problematic. These include:

• Using disease-related terminology (even without naming the disease directly)
• Referencing abnormal conditions or symptoms
• Suggesting your product addresses specific medical conditions
• Making before-and-after claims that imply treatment of disease states

For example, “relieves joint pain” implies treatment of a symptom, while “supports joint comfort” focuses on normal function.

Key Compliance Requirements

FDA Notification and Disclaimers

All structure/function claims must be accompanied by the FDA 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.”

Additionally, you must notify the FDA within 30 days of first marketing any product bearing structure/function claims. This notification must include the text of your claims and supporting substantiation.

Substantiation Requirements

Every structure/function claim must be backed by competent and reliable scientific evidence. The FTC requires that you possess substantiation before making any claim, not after. We consistently see companies underestimate the level of evidence needed to support their claims.

Acceptable substantiation may include:

• Peer-reviewed clinical studies
• Systematic reviews and meta-analyses
• Established nutritional science
• Traditional use evidence (in limited circumstances)

Best Practices for Compliant Claims

Use Qualifying Language

Incorporate softening language that emphasizes support rather than treatment. Words like “may,” “helps support,” and “contributes to” can help maintain compliance while preserving marketing impact.

Focus on Ingredients, Not Outcomes

Rather than promising specific results, focus on what your product contains and the established functions of those ingredients. “Contains omega-3 fatty acids that support heart health” is preferable to “improves cardiovascular function.”

Target Healthy Populations

Structure/function claims should clearly target healthy individuals maintaining normal function, not people seeking to address health problems.

This distinction is crucial for both FDA claims compliance and consumer understanding.

Common Pitfalls to Avoid

In our experience, certain mistakes appear repeatedly across the industry. Avoid these common compliance traps:

• Making claims that reference specific diseases, even indirectly
• Using customer testimonials that contain disease claims
• Failing to maintain adequate substantiation files
• Overlooking claims made in marketing materials beyond the label
• Assuming that “natural” products have more lenient claim requirements

Final Thoughts

Structure/function claims offer tremendous opportunities for supplement companies to communicate product benefits while maintaining regulatory compliance.

The key lies in understanding the clear boundaries between permissible structure/function claims and prohibited disease claims.

Success in this area requires more than just knowing the rules, it demands strategic thinking about how to maximize marketing impact within regulatory constraints.

Companies that invest in proper claim development and substantiation create sustainable competitive advantages while building consumer trust.

Remember that regulatory compliance isn’t just about avoiding enforcement, it’s about building a foundation for long-term growth in an increasingly competitive marketplace.