Supplement Facts Panel: Proper Formatting and Compliance

For contract manufacturers and brand owners, ensuring FDA-compliant supplement labeling is essential for product integrity and regulatory approval. One of the most scrutinized elements of supplement labeling is the Supplement Facts Panel—the key section that provides consumers with essential product information. As an attorney practicing FDA regulatory compliance, I understand how formatting errors, omissions, or misinterpretations can lead to warning letters, enforcement actions, and brand reputation damage. This guide outlines best practices for supplement facts panel formatting and compliance, helping businesses avoid regulatory pitfalls while maintaining market trust.

Why Proper Formatting Is Essential

The Supplement Facts Panel serves multiple functions:

• Regulatory Compliance: Adhering to FDA regulations ensures legal marketability.

• Consumer Transparency: Proper labeling builds consumer trust and brand credibility.

• Quality Assurance: Accuracy prevents misbranding violations, which could lead to recalls.

Mistakes in panel formatting can lead to significant setbacks, including FDA warning letters, product misbranding allegations, and financial losses due to required corrective actions.

Key Requirements for an FDA-Compliant Supplement Facts Panel

1. Serving Size and Servings Per Container

• Clearly state the serving size in both common household measurements (teaspoons, capsules, etc.) and metric equivalents.

• Indicate the total servings per container to prevent misinterpretation of dosage recommendations.

2. Ingredient Listing and Quantities

• Active Ingredients: List each ingredient along with its quantitative amount per serving (e.g., 500 mg of Vitamin C).

• Percent Daily Value (%DV): If applicable, include the %DV next to each ingredient based on FDA-established nutrient reference values.

• Other Ingredients: Non-active ingredients (e.g., fillers, flavors, preservatives) should be listed separately below the active ingredients.

3. Proper Formatting Standards

The FDA mandates specific formatting requirements:

• Font Size & Style: Legibility is crucial—text must be readable with FDA-approved font sizes.

• Column Arrangement: Nutrients and ingredient information must be neatly structured in a column format.

• Consistency in Units: Use appropriate measurement units such as milligrams (mg), micrograms (µg), or International Units (IU) to maintain accuracy.

4. Mandatory Disclaimers

If making structure/function claims, the following disclaimer must be included:
"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."

Common Labeling Mistakes That Lead to FDA Warning Letters

Even experienced manufacturers can make errors that lead to FDA action. Here are common mistakes to avoid:

• Incorrect Serving Size Representation: Misstating dosage information can mislead consumers and result in regulatory penalties.

• Failure to Include %DV When Required: Nutritional and supplement labeling must include established %DV values for applicable ingredients.

• Mislabeling Proprietary Blends: If using proprietary blends, they must be labeled correctly, listing each component while providing a total weight of the blend.

• Non-Compliance with Formatting Rules: Panel structure, column alignment, and required font sizes must be meticulously followed.

Best Practices for Ensuring Compliance

To maintain compliance, contract manufacturers and brand owners should implement the following measures:

1. Conduct Regular Label Audits

Internal and third-party reviews can help catch errors before product launch. Routine label audits ensure alignment with FDA guidelines.

2. Stay Updated on Regulatory Changes

The FDA periodically updates labeling standards. Subscribe to industry bulletins, participate in regulatory workshops, and consult with legal experts to stay informed.

3. Leverage FDA Compliance Software

Many compliance-focused labeling software solutions can automate formatting checks, helping brands streamline adherence to regulatory standards.

4. Work with FDA Regulatory Attorneys

Legal oversight ensures proper claim substantiation, label accuracy, and proactive compliance strategies. Having an FDA regulatory attorney review your labels before product launch can mitigate risks and strengthen your brand’s credibility.

Final Thoughts

FDA-compliant supplement labeling is a critical aspect of brand integrity. Proper formatting of the Supplement Facts Panel is not just a regulatory requirement—it’s a strategic advantage that ensures market trust, prevents enforcement actions, and sets a high standard for product quality.

For contract manufacturers and brand owners looking to streamline compliance, proactive legal and regulatory support can be a key differentiator. If you need expert guidance on FDA labeling requirements, reach out to discuss how legal oversight can help your business stay compliant and competitive.