Understanding FDA Structure/Function Claims Notification (SFCN): Why and When It Is Necessary

The U.S. Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This legislation grants manufacturers the right to make certain types of claims about their products, provided these claims are truthful and not misleading. Among these are structure/function claims, which describe the role of a dietary supplement in maintaining normal structure or function in the human body. However, such claims require adherence to strict notification procedures. This article explores the FDA’s Structure/Function Claims Notification (SFCN), why it is essential, and when it becomes necessary.

What Are Structure/Function Claims?

Structure/function claims are statements that describe how a dietary supplement affects the body or supports its normal functions. These claims do not assert that the supplement can treat, diagnose, cure, or prevent any disease. Examples of acceptable structure/function claims include:

“Supports immune system health.”
“Promotes healthy digestion.”
“Helps maintain strong bones.”

Such claims focus on maintaining health and emphasize normal physiological functions rather than disease treatment.

Why Are Structure/Function Claims Important?

Structure/function claims are vital marketing tools for dietary supplement manufacturers. They help communicate a product’s intended benefits to consumers without crossing into medical claims, which are regulated differently. However, these claims can lead to legal and regulatory consequences if they are not substantiated or if they mislead consumers.

The FDA monitors structure/function claims to ensure:

Consumer Protection: Claims must not be deceptive or imply that the product can treat or prevent diseases.
Compliance with DSHEA: Manufacturers must submit a notification and include the required disclaimer on the product label.
Market Integrity: Regulating claims maintains trust in the dietary supplement industry by preventing false or exaggerated marketing.

What Is the Structure/Function Claims Notification (SFCN)?

The SFCN is a requirement for manufacturers or distributors who make structure/function claims on dietary supplements. It is a formal notification submitted to the FDA, affirming that the claims made for a dietary supplement are truthful, not misleading, and supported by scientific evidence.

Key aspects of the notification process include:

Timing: Manufacturers must submit the notification no later than 30 days after marketing the product with the claim.
Content: The notification must include:
- The exact wording of the structure/function claim.
- The dietary supplement’s brand name.
- The manufacturer’s name and address.
- A statement that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.
Scientific Basis: The manufacturer must have substantiation supporting the claim’s validity.

Why Is SFCN Necessary?

The SFCN process is necessary for several reasons:

1. Regulatory Compliance

Submitting the SFCN ensures compliance with FDA regulations under DSHEA. Failure to submit the notification can lead to enforcement actions, such as warning letters, fines, or product recalls.

2. Legal Protection

By filing the notification, manufacturers demonstrate that they are making an effort to comply with the law. This can provide some protection against potential legal challenges from regulators or competitors.

3. Consumer Confidence

Properly substantiated and notified claims help maintain consumer trust. Transparency in marketing builds confidence in the safety and efficacy of dietary supplements.

4. Avoiding Misbranding

The FDA requires dietary supplement labels to include specific disclaimers when making structure/function claims. Without the proper notification and disclaimers, products can be deemed “misbranded,” leading to regulatory penalties.

When Is SFCN Necessary?

The SFCN is required in the following scenarios:

1. New Products with Structure/Function Claims

If a dietary supplement is introduced to the market with structure/function claims, the manufacturer must submit the SFCN within 30 days of the product’s marketing.

2. Existing Products with New Claims

If an existing product’s labeling or marketing materials are updated to include new structure/function claims, the notification must be submitted within 30 days of implementing the change.

3. Change in Product Distributor

If the distributor of a dietary supplement changes and the new distributor adds or modifies structure/function claims, they must also submit an SFCN.

4. Introduction of Structure/Function Claims in Advertising

Even if a claim appears primarily in advertising rather than on product labeling, it may still require notification, depending on its presentation and context.

What Happens If SFCN Is Not Filed?

Failing to submit the required notification can result in significant consequences, including:

Warning Letters: The FDA frequently issues warning letters to companies that fail to notify the agency about structure/function claims or make unsubstantiated claims.
Product Recalls: Non-compliant products may be removed from the market.
Legal Action: Repeated or egregious violations can lead to lawsuits or fines.
Loss of Consumer Trust: Negative publicity from regulatory actions can damage a company’s reputation and brand image.

How to File an SFCN

The SFCN process involves the following steps:

Draft the Claim Write the structure/function claim, ensuring it does not make disease-related assertions. For example, use “supports heart health” instead of “reduces heart disease.”
Substantiate the Claim Gather scientific evidence supporting the claim, such as clinical studies, published research, or expert opinions.
Prepare the Notification Include all required elements:
- Exact wording of the claim.
- Product and manufacturer details.
- A disclaimer stating that the claim has not been evaluated by the FDA.
Submit the Notification Send the completed notification to the FDA within 30 days of marketing the product. Notifications can be sent electronically or via mail.

Best Practices for Structure/Function Claims

1. Focus on General Health

Structure/function claims should emphasize general health benefits rather than specific disease outcomes.

2. Use Clear, Non-Misleading Language

Ensure claims are easy for consumers to understand and avoid implying medical benefits.

3. Back Claims with Evidence

Maintain thorough documentation of the scientific basis for each claim.

4. Include Required Disclaimers

Every label or advertisement with a structure/function claim must state:

“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.”

Conclusion

The FDA’s Structure/Function Claims Notification (SFCN) process is a critical step for dietary supplement manufacturers to ensure regulatory compliance, maintain consumer trust, and avoid legal risks. By understanding when and why the SFCN is necessary, companies can effectively market their products while adhering to FDA guidelines. Filing the SFCN not only fulfills a legal obligation but also demonstrates a commitment to transparency and consumer safety—cornerstones of a reputable dietary supplement brand.

By carefully crafting, substantiating, and notifying structure/function claims, dietary supplement companies can thrive in a competitive market while ensuring their products meet regulatory and consumer expectations. Cosmereg can assist you with Dietary Supplement label compliance and Structure/Function Claims Notification just contact us.