FDA Requirements for Supplement Marketing

For consumer brands in the supplement space, understanding FDA requirements for supplement marketing is more than just ticking boxes, it's the foundation for trust, transparency, and long-term success. While the supplement industry offers exciting opportunities for innovation with vitamins, botanicals, superfoods, and nutraceuticals, it also demands a clear grasp of regulatory compliance.

Below, we break down what every supplement brand needs to know about FDA guidelines, including how to craft compliant claims, label products correctly, and stay on top of evolving regulations.

What Role Does the FDA Play in Supplement Marketing?

The Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA). While the FDA does not approve dietary supplements before they go to market, it does oversee labeling, marketing claims, packaging, and ingredient safety to protect public health and ensure consumers are not misled.

Here’s how supplement brands can navigate FDA requirements effectively.

1. Structure-Function Claims

Structure-function claims describe how a supplement “supports” or “maintains” normal body functions, for example, “supports immune health” or “helps maintain healthy joints.”

These claims:

• Do not require FDA pre-approval, but

• Must be truthful, not misleading, and

• Must be substantiated by scientific evidence.

Pro Tip: Always include the FDA-mandated 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."

2. Health Claims

Health claims link a substance to reduced risk of a disease or health-related condition (e.g., “calcium may reduce the risk of osteoporosis”). These require:

• FDA authorization, or

• Qualified health claim status, backed by credible scientific agreement.

Brands must submit these claims to the FDA for review and must include specific language and disclaimers outlined by the agency.

3. New Dietary Ingredient (NDI) Notifications

If your supplement includes a new dietary ingredient (one not marketed in the U.S. before 1994), you must submit an NDI notification at least 75 days before marketing the product.

The notification must provide:

• Safety data

• Evidence of historical use or research

• Justification for the ingredient’s use in supplements

4. Supplement Labeling Requirements

To meet FDA labeling guidelines, every supplement label must clearly display:

• The product name and identity

• Net quantity of contents

• Supplement Facts panel

• Ingredient list

• Manufacturer or distributor contact information

Claims on the label must be accurate, not misleading, and must reflect the supporting research behind them.

Avoiding FDA Regulatory Pitfalls

To avoid FDA warning letters or market setbacks, keep these best practices in mind:

Prioritize Scientific Evidence

Invest in clinical research to support your claims. Brands that back their marketing with data build trust and are better positioned to withstand regulatory scrutiny.

Partner with Legal and Clinical Experts

Consider working with a Contract Research Organization (CRO). CROs offer specialized support for supplement trials and regulatory compliance, saving you time and reducing risk.

Avoid Overstatements

Never promise outcomes like "cures" or "guaranteed results" unless your data indisputably supports it. The FDA prohibits misleading or exaggerated claims.

Keep Organized Documentation

Maintain records of all studies, clinical trials, and correspondence with regulatory bodies. These are essential for defending your claims if challenged.

Monitor FDA and FTC Updates

Regulations change. Stay informed about updates from both the FDA and the Federal Trade Commission (FTC), especially as both agencies increase scrutiny of influencer marketing, social media claims, and online labeling.

Building Trust Through Compliance

Following FDA requirements for supplement marketing isn’t just about avoiding penalties, it’s about building a brand that consumers trust. By aligning your product claims with scientific evidence and regulatory standards, your brand will not only stay compliant but also stand out in a competitive market.

If you're unsure where to start, a CRO can help you plan, execute, and document research-backed marketing claims, without breaking your budget.

Ready to Back Your Claims with Science?

At Citruslabs, we make clinical research simple, affordable, and accessible for supplement brands of all sizes. Our team designs customized clinical trials that help you generate real-world evidence and craft FDA-compliant product claims.

Want to stand out with transparent, research-driven marketing? Contact us today and let’s talk about your next step.