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Comprehensive Guide to Dietary Supplement Labeling Compliance:

Navigating the complex landscape of dietary supplement labeling can be daunting. As an FDA label consultant specializing in dietary supplement compliance, it's essential to understand and adhere to the regulations set forth in § 101.36 of the Code of Federal Regulations (CFR). This guide provides a detailed overview of the requirements for labeling dietary supplements, ensuring your products meet necessary standards.

Introduction to § 101.36 Labeling

The Food and Drug Administration (FDA) mandates specific labeling requirements for dietary supplements to ensure transparency and protect consumer health. Dietary supplement consulting involves guiding businesses through these regulations to achieve compliance and maintain market integrity.

When is Labeling Required?

Under § 101.36(a), any dietary supplement offered for sale must bear nutrition labeling unless an exemption applies. Exemptions are outlined in § 101.36(h) and include scenarios such as small-volume products or bulk shipments not intended for direct consumer distribution.

Key Components of Dietary Supplement Labels

  1. Serving Size (§ 101.36(b)(1))

    • Placement: The subheading “Serving Size” should appear under the heading “Supplement Facts” aligned to the left.

    • Expression: Use appropriate terms based on the supplement form, such as “tablets,” “capsules,” “packets,” or “teaspoonfuls.”

    • Servings Per Container: Positioned below “Serving Size” unless included in the net quantity of contents.

  2. Dietary Ingredients with Reference Daily Intake (RDI) or Daily Reference Value (DRV) (§ 101.36(b)(2))

    • Declaration: Ingredients like total calories, fat, cholesterol, sodium, carbohydrates, fiber, sugars, protein, and specific vitamins and minerals must be listed if they exceed thresholds for zero declaration.

    • Presentation:

      • Amount Per Serving: Quantitative amounts by weight are listed under this heading.

      • % Daily Value: Percentage of daily intake based on established RDIs or DRVs.

  3. Other Dietary Ingredients (§ 101.36(b)(3))

    • Ingredients without established RDIs or DRVs must be listed by their common or usual names.

    • Quantitative Amount: Presented in the same manner as § 101.36(b)(2), focusing on the weight of the dietary ingredient itself.

  4. Proprietary Blends (§ 101.36(c))

    • Identified by terms like “Proprietary Blend” and may include a total weight of all ingredients in the blend.

    • Order and Indentation: Ingredients within the blend are listed in descending order by weight and indented appropriately.

  5. Source Ingredients (§ 101.36(d))

    • Must be identified in parentheses following the dietary ingredient (e.g., “Calcium (as calcium carbonate)”).

    • Ensures clarity on the source of each dietary ingredient.
       

Formatting and Presentation Requirements (§ 101.36(e))

  1. Type Size and Style

    • Minimum Size: Information should be no smaller than 8-point type, with certain allowances for smaller packages.

    • Uniformity: Use a single, easy-to-read type style with sufficient spacing between lines and letters.

  2. Layout of the Supplement Facts Panel

    • Title: “Supplement Facts” should be prominently displayed in a larger, bold typeface.

    • Boxes and Lines: Information should be enclosed in a box using hairlines, with light and heavy bars separating different sections.

    • Columns: Nutrient names and their amounts should be aligned in columns, with % Daily Value (% DV) to the right.

  3. Symbols and Footnotes

    • Use symbols (e.g., asterisks) to denote nutrients without established Daily Values, accompanied by appropriate footnotes.

  4. FDA Labeling Examples: These can be found here and are excellent resources to confirm formatting and layout.

​​​Exemptions and Special Cases (§ 101.36(h) & (i))

  1. Small and Intermediate-Sized Packages (§ 101.36(i)(2))

    • Type Size Adjustments: Smaller packages may use smaller type sizes under specific conditions.

    • Alternate Display Methods: When space is limited, innovative formatting such as dot lines can be used to separate columns.

  2. Bulk Shipments (§ 101.36(h)(3))

    • Products not intended for direct consumer sale may be exempt from certain labeling requirements.
       

Compliance and Enforcement

Adherence to § 101.36 is critical to avoid FDA warning letters, litigation, and potential product recalls. Dietary supplement regulation training can equip your team with the knowledge to ensure labels meet all regulatory standards. Regular audits and consultations with an FDA label consultant can preemptively identify and rectify compliance issues.

Best Practices for Dietary Supplement Labeling

  1. Accuracy and Clarity

    • Ensure all listed ingredients and their quantities are accurate and verifiable.

    • Use common or usual names for all dietary ingredients to avoid confusion.

  2. Consistent Formatting

    • Maintain uniform type sizes and styles across the label to enhance readability.

    • Follow the specified order for listing vitamins and minerals.

  3. Avoid Misleading Claims

    • Refrain from making disease claims and unsubstantiated health claims that could classify the product as a drug under FDA regulations.

  4. Stay Updated

    • Regulatory guidelines can evolve; continuous dietary supplement consulting ensures your labels remain compliant with the latest standards.
       

Leveraging Professional Consulting Services

Partnering with a seasoned dietary supplement marketing consultant or FDA label consultant can streamline the compliance process. These professionals offer:

  • Dietary Supplement Labeling Guides: Comprehensive resources outlining labeling requirements.

  • Regulation Training: Educative sessions for your team on navigating FDA regulations.

  • Label Audits and Reviews: Detailed assessments to ensure your labels meet all necessary criteria.
     

Investing in expert consulting not only safeguards your business against regulatory risks but also enhances your brand’s credibility and consumer trust.

Conclusion

Understanding and implementing the requirements of § 101.36 is fundamental for any dietary supplement brand. This dietary supplement labeling guide serves as a foundational tool to help you navigate the complexities of FDA regulations. For tailored advice and comprehensive support, engaging with an FDA label consultant ensures your products are both compliant and market-ready.

For more information or personalized consulting services, feel free to reach out. Ensuring your dietary supplements meet all labeling standards is a crucial step towards fostering consumer trust and achieving long-term success in the market.

Additional Resources

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.

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