FDA Structure/Function Notifications for Dietary Supplements

If your dietary supplement makes structure/function claims such as “supports healthy sleep,” “helps maintain joint flexibility,” or “promotes immune health,” you are required by law to notify the FDA within 30 days of first marketing the product.

This step is called a Structure/Function Notification (SFN). While simple in concept, many brands misunderstand what needs to be filed, how to word claims correctly, and what documentation should be maintained. Filing incorrectly — or failing to file at all — can expose your brand to FDA scrutiny, legal due diligence issues, and retailer questions.

At Blue Ocean Regulatory, we prepare and file FDA-compliant structure/function notifications for dietary supplement brands. We ensure your claims are phrased properly, supported by evidence (when required, as a separate service), and submitted to the FDA in the correct format so you can focus on marketing your product with confidence.

What Is a Structure/Function Claim?

A structure/function claim describes how a supplement affects the body’s structure or function — without crossing into disease claim territory. Examples include:

• “Supports healthy digestion”

• “Promotes restful sleep”

• “Helps maintain strong bones”

By contrast, claims like “treats insomnia” or “prevents osteoporosis” are disease claims and are prohibited for dietary supplements.

The challenge is that the line between the two can be blurry. That’s why proper phrasing and substantiation are critical.

FDA Requirements for Notifications

Under the Dietary Supplement Health and Education Act (DSHEA):

• A notification must be submitted to FDA no later than 30 days after first marketing the product with the claim.

• The notification must include:

  • The exact text of each claim being made.

  • The name and address of the brand owner/distributor.

  • The product name.

  • A statement that the claim is truthful and not misleading.

  • Copy of the label.

• The label must also include the standard FDA disclaimer:
  “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Failure to follow these requirements can put your brand at risk.

How We Help Brands File Correctly

Our structure/function notification service ensures your claims are not only FDA-compliant but also strong from a marketing perspective.

1. Claim Review & Editing

   • Review proposed claims for compliance.

   • Rephrase borderline claims to avoid implied disease language.

   • Align claims with existing scientific support (clinical studies, ingredient monographs, authoritative texts).

2. Notification Preparation

   • Draft the notification in FDA’s required format.

   • Ensure all mandatory elements are included.

   • Prepare supporting documentation for internal recordkeeping.

3. Submission & Tracking

   • File with FDA within the required 30-day timeline.

   • Track submission status and provide confirmation for your compliance records.

4. Integration with Label & Marketing Review

   • Align your label, website, and marketing language with the filed claims.

   • Prevent inconsistencies that could raise regulatory red flags.

Common Mistakes We Prevent

• Submitting claims that FDA would view as disease claims.

• Forgetting to include the FDA disclaimer on labels.

• Missing the 30-day filing window after first marketing.

• Assuming retailer approval equals FDA compliance.

• Making different claims online vs. what was filed with FDA.

Why Brands Trust Blue Ocean Regulatory

We’ve worked with brands at every stage — from startups preparing their first notification to established companies filing dozens of claims across multiple SKUs.

Our expertise is recognized by NutraIngredients USA, through invitations to guest speak at Council for Responsible Nutrition events, and appearances on The Nutracast Podcast. Brands work with us because we provide practical, plain-language guidance that prevents costly mistakes while keeping marketing compelling.

Next Steps

If you’re planning to make structure/function claims on your supplement — or if you’re unsure whether your claims need to be filed — now is the time to act.

Schedule a consultation with Blue Ocean Regulatory, and let us prepare and file your FDA structure/function notification correctly. With our support, you can market your product confidently, knowing your claims are backed by compliance.