What Needs to Be on a Dietary Supplement Label?

According to the FDA, certain information is legally required on a dietary supplement label to ensure consumer safety and informed choice. Understanding what needs to be on a dietary supplement label is crucial for verifying product quality and making healthy decisions for yourself and your family.

Quick Summary

A comprehensive guide to dietary supplement labels, detailing the mandatory elements required by the FDA. This includes the Supplement Facts panel, ingredient list, proper handling of label claims, and manufacturer information for consumer protection.

Key Points

• Check the Supplement Facts Panel: This panel breaks down all active ingredients, serving size, and Daily Values (%DV), which is crucial for dosage awareness.

• Read the Other Ingredients List: A separate list reveals inactive components like fillers and binders, which can be important for allergy or sensitivity avoidance.

• Understand Label Claims: Distinguish between FDA-approved Health Claims and Structure/Function Claims, which must carry a specific disclaimer and are not pre-approved by the FDA.

• Identify the Manufacturer: The label must include the name and address of the manufacturer, packer, or distributor, along with a domestic contact for adverse event reporting.

• Look for Warnings and Allergens: Always scan for specific warnings, usage instructions, and allergen declarations to ensure the product is safe for you.

• No FDA Approval Needed: The FDA does not pre-approve dietary supplements for safety and effectiveness before they are marketed, though they do monitor the market.

The Core Components of a Dietary Supplement Label

Understanding the information presented on a dietary supplement label is essential for any consumer. The label serves as a legal document governed by the U.S. Food and Drug Administration (FDA) and the Dietary Supplement Health and Education Act (DSHEA) of 1994. Knowing how to read these details empowers you to verify product quality, dosage, and potential allergens before purchasing.

The "Supplement Facts" Panel

The "Supplement Facts" panel is a crucial element that provides a detailed breakdown of the product's ingredients, formatted specifically for supplements.

This panel must include:

1. Serving Size: The amount considered a single serving.
2. Servings Per Container: The total number of servings in the package.
3. List of Dietary Ingredients: All vitamins, minerals, herbs, amino acids, and other dietary ingredients.
4. Amount Per Serving: The quantity of each ingredient per serving, typically by weight.
5. Percent of Daily Value (%DV): The percentage of recommended daily intake for ingredients with established Daily Values. For others, it will state "Daily Value Not Established".

The Ingredient List and Other Information

Following the Supplement Facts panel is a list of "other ingredients," which are non-dietary components like fillers, binders, or flavorings. These must be listed in descending order of predominance by weight. Common examples include gelatin, flavors, colors, stabilizers, and magnesium salts.

Understanding Label Claims

Label claims highlight potential benefits, but there are specific rules for their use.

Feature	Structure/Function Claims	Health Claims
Describe	The role of a nutrient or ingredient on the body's structure or function (e.g., "Supports immune health").	A relationship between a substance and reduced risk of disease (e.g., "Folate may reduce the risk of neural tube defects").
FDA Review	Do NOT require premarket approval; manufacturers must notify FDA within 30 days.	MUST be authorized by the FDA based on significant scientific agreement.
Disease Claims	CANNOT mention or imply treating, curing, or preventing disease.	CAN link to reduced risk of disease with approved language.
Disclaimer	Required: "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.".	Not Required.

Manufacturer Information and Reporting

Labels must include the name and place of business of the manufacturer, packer, or distributor. A U.S. phone number or mailing address is also required for reporting serious adverse events.

Other Critical Label Details

Additional mandatory information includes:

• Statement of Identity: Clearly identifies the product as a "dietary supplement" or similar.
• Net Quantity of Contents: The weight, volume, or count in the package.
• Directions for Use: Instructions on how to take the supplement.
• Allergen Warnings: Declaration of major food allergens under FALCPA.
• Warning and Precautionary Statements: Specific warnings, such as for pregnant women or those with certain conditions.

For more detailed regulatory guidance, consult the FDA's official Dietary Supplement Labeling Guide.

Conclusion

Carefully reading dietary supplement labels is essential for consumers. By understanding the mandated information—including the Supplement Facts panel, other ingredients, and the distinctions between label claims—you can make informed decisions. These requirements promote transparency and ensure you are aware of what you are consuming. Always review the full label to make safe and effective choices for your health.

Frequently Asked Questions

Does the FDA approve dietary supplements before they are marketed?

No, the FDA does not approve dietary supplements for safety and effectiveness before they are marketed. The manufacturer is responsible for ensuring the product is safe and that any label claims are truthful and not misleading.

What is the difference between a 'Supplement Facts' panel and a 'Nutrition Facts' panel?

The 'Supplement Facts' panel is a specific format for dietary supplements, with different rules than the 'Nutrition Facts' panel used for conventional foods. Key differences include how dietary ingredients are listed and the declaration of ingredients without a Daily Value.

What is a 'proprietary blend' and what information must be included?

A 'proprietary blend' is a mix of dietary ingredients listed on the label by total weight, but not by the individual quantities of each ingredient within the blend. The individual ingredients in the blend must still be listed in descending order by weight.

What are structure/function claims and why do they require a disclaimer?

Structure/function claims describe how a nutrient or dietary ingredient affects the body's structure or function (e.g., 'Calcium builds strong bones'). They require a disclaimer because they are not pre-approved by the FDA and cannot claim to diagnose, treat, cure, or prevent a disease.

Why is the manufacturer's contact information on the label?

A manufacturer's domestic phone number or mailing address is required on the label to provide a way for consumers to report serious adverse events associated with the product.

Are allergens always listed on dietary supplement labels?

Yes, under the Food Allergen and Labeling Consumer Protection Act (FALCPA), major food allergens must be clearly declared on the label.

What does 'Daily Value Not Established' mean on a label?

This statement appears for dietary ingredients that the FDA has not established a daily recommended intake for, meaning there is no official percentage of daily needs to measure against.