Structure/Function vs. Drug Claims: How to Stay FDA-Compliant

In the competitive realm of product manufacturing and branding, clear and compliant labeling is crucial. One common area of confusion involves differentiating between structure/function claims and drug claims. As an attorney practicing FDA regulatory compliance, I often encounter brands that inadvertently cross the regulatory line, inviting scrutiny, warning letters, or even costly litigation. This guide will explain the differences and provide actionable strategies to ensure your claims remain within FDA guidelines.

Understanding the Terminology

Structure/Function Claims

Structure/function claims describe how a dietary supplement or food supports the normal structure or function of the human body. For example, a label might state that a supplement "supports a healthy immune system" or "helps maintain normal joint function." These claims do not imply that the product can treat, cure, or prevent any disease. Under FDA guidelines, structure/function claims must be substantiated with evidence demonstrating that the supplement performs the claimed function, and they must include the mandatory 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.”

Drug Claims

Drug claims, on the other hand, suggest that a product can treat, mitigate, or prevent a disease or condition. Such claims invoke the FDA's drug approval process, which requires rigorous clinical testing and approval before the product can be marketed. If a claim verges on being a drug claim without FDA approval, your product is at risk of being classified as an unapproved drug—resulting in enforcement actions, including warning letters or product seizures.

Regulatory Requirements and Potential Pitfalls

Key Regulatory Considerations

• Clear Distinction: It's essential to maintain a clear distinction in your product labeling. Ensure that the language used for structure/function claims does not imply therapeutic benefits or promise to cure or prevent specific diseases.

• Substantiation: Back up any structure/function claims with scientific evidence. Even though these claims do not require pre-market approval, they must be truthful and not misleading.

• Mandatory Disclaimers: Always include the FDA-required disclaimer for dietary supplements making structure/function claims. This can significantly reduce regulatory risk.

• Review Marketing Materials: Inconsistencies appear not only on the product labels but across all marketing platforms. Ensure that your website, brochures, and advertisements are aligned with the FDA’s definitions.

Common Pitfalls

• Ambiguous Language: Using terms like “treats” or “cures” may inadvertently trigger the classification of the product as a drug.

• Overstated Benefits: Exaggerating the benefits of a supplement can lead to regulatory sanctions. All claims must be supportable by evidence.

• Inconsistent Messaging: A lack of consistency between packaging and digital content can confuse consumers and attract unwanted FDA attention.

Best Practices for Maintaining Compliance

1. Develop a Robust Label Review Process

Establish internal audits of all labeling and marketing materials. Implement a multi-disciplinary review that involves legal, regulatory, and product development teams to catch potential misstatements before they go to market.

2. Stay Informed on Regulatory Updates

FDA guidelines can change. Subscribe to regulatory updates and participate in industry conferences and webinars. Staying current ensures that your policies evolve in tandem with regulatory standards.

3. Engage Expert Legal Counsel

Integrate legal review early in your product development process. As an attorney specializing in FDA compliance, I can offer tailored advice to help you navigate the complexities of claim substantiation and labeling.

4. Consistency Across Channels

Ensure that all forms of communication—packaging, digital content, and marketing materials—use uniform language to describe your product’s benefits. This consistency not only reinforces consumer trust but also fortifies your compliance position during an FDA inspection.

The Legal Perspective: Turning Compliance into a Competitive Advantage

Integrating a proactive legal review into your labeling strategy does more than avoid FDA warning letters—it’s a strategic investment in your brand’s reputation. Clear, compliant, and consistent labeling builds trust among consumers and sets your products apart in a crowded market. Leveraging expert legal guidance can help you refine your messaging and secure long-term success while minimizing regulatory risk.

Conclusion

The line between structure/function and drug claims is distinct but often blurred by ambiguous language and marketing overstatements. For contract manufacturers and brand owners, understanding and adhering to FDA guidelines is not just a regulatory necessity—it’s a competitive advantage. By developing robust label approval processes, staying current with regulatory updates, and engaging expert legal counsel, you can confidently market your products while safeguarding your brand against compliance issues.

If you’re ready to refine your labeling practices or need tailored legal guidance related to FDA regulatory compliance, feel free to reach out. Together, we can ensure that your brand communicates its benefits effectively while fully adhering to regulatory standards.