What Must Be Included on a Dietary Supplement Label?

December 1, 2025 •

3 min read

According to the FDA, dietary supplements are regulated as a subcategory of food, not medication, which dictates specific and crucial labeling requirements. This guide details what must be included on a dietary supplement label to ensure transparency and consumer safety.

Quick Summary

The required information on a dietary supplement label includes a statement of identity, net quantity, Supplement Facts panel, ingredient list, and manufacturer details, plus specific claims and warnings. Adherence to FDA rules ensures consumer protection and accurate product representation.

Key Points

Mandatory Elements: Every supplement label must feature a statement of identity, net quantity of contents, a "Supplement Facts" panel, an ingredient list, and manufacturer contact details.
"Supplement Facts" Panel: This area details serving size, servings per container, dietary ingredients by weight, and the percent of Daily Value (%DV).
Warning Statements: Specific warnings, such as for iron overdose or usage restrictions for certain populations (e.g., pregnant women, children), must be included where applicable.
Label Claims: Claims like "supports immune health" are permitted but require a mandatory FDA disclaimer stating the product is not intended to treat or cure any disease.
Proprietary Blends: While legal, these opaque blends only list total weight, not individual ingredient amounts, making it difficult to assess potency.
Regulatory Oversight: The FDA, which regulates supplements as food, mandates specific formatting rules for labels to ensure readability and clarity.

Essential Components of a Dietary Supplement Label

To ensure consumer safety and comply with the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplement labels must contain five key pieces of information. These elements help consumers make informed choices. The label is divided into the Principal Display Panel (PDP) and the Information Panel (IP). Proper placement and formatting are required for regulatory compliance.

Statement of Identity

The label needs to clearly state what the product is and identify it as a "dietary supplement". This should be prominently placed on the PDP.

Net Quantity of Contents

This statement indicates the amount of supplement in the package by weight, measure, or count (e.g., "100 capsules"). It must be located on the lower portion of the PDP.

The "Supplement Facts" Panel

This panel provides crucial nutritional details, similar to the "Nutrition Facts" found on food labels. It must be titled "Supplement Facts" in a large, bold font and enclosed within a box. Key information includes:

Serving Size
Servings Per Container
List of Dietary Ingredients
Amount Per Serving for each ingredient
Percent of Daily Value (%DV) if established, or an asterisk referencing a footnote for those without one.

Ingredients List

Any ingredients not in the "Supplement Facts" panel, like fillers or flavors, must be listed separately under "Other Ingredients" in descending order by weight. For botanicals, the specific plant part used is required.

Manufacturer, Packer, or Distributor Information

The label must include the name and full address of the responsible company. Contact information for reporting adverse events is also required.

Label Claims and Mandatory Disclaimer

Manufacturers can make certain claims, but these are regulated. The table below outlines different claim types:


Claim Type	Description	FDA Approval Required?	Mandatory Disclaimer?	Example
Structure/Function Claim	Describes how a nutrient affects the body's structure or function.	No (with FDA notification).	Yes	"Supports bone health".
Health Claim	Links an ingredient to reduced disease risk.	Yes.	No (if approved).	"May reduce heart disease risk".
Nutrient Content Claim	Characterizes the level of a nutrient.	No (if following rules).	No.	"High in Vitamin C".

Structure/function claims require a disclaimer: "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".

Important Warning and Caution Statements

Labels must include warnings for certain ingredients or potential risks. For example, products with iron need a warning about accidental overdose. Other warnings may cover use by pregnant women, children, and potential side effects or interactions. Allergen warnings are also mandatory.

Proprietary Blends: What to Know

Proprietary blends list multiple ingredients under a single name with only the total weight disclosed. This is legal but can obscure the exact amount of each ingredient. Ingredients in a blend must be listed in descending order by weight with a descriptive name for the blend. Consumers should be aware that these blends can make it difficult to assess product potency and quality.

Conclusion

Understanding what must be included on a dietary supplement label is vital for both manufacturers and consumers. Manufacturers must adhere to the FDA's detailed guidelines for legal compliance and transparency. For consumers, the label is essential for comprehending product contents, evaluating claims, and ensuring personal safety, including dosage and potential allergens. Elements like the "Supplement Facts" panel and the structure/function claim disclaimer are critical for making informed purchasing decisions. Clear and accurate labeling is fundamental to responsible dietary supplement use.

Frequently Asked Questions

A "Supplement Facts" panel is for dietary supplements, while a "Nutrition Facts" panel is for conventional foods. The content and format differ based on FDA regulations specific to each product category, with supplements often detailing ingredients like herbs or amino acids that are not typically found on food labels.

Yes. All ingredients must be declared. Those not listed in the main "Supplement Facts" panel (e.g., fillers, flavors) must appear in a separate list under the heading "Other Ingredients," in descending order by weight.

No. The FDA prohibits dietary supplement labels from making drug claims, which suggest that a supplement can diagnose, mitigate, treat, cure, or prevent any disease. Such statements would require the product to be regulated as a drug.

Yes, but with specific rules. Manufacturers can list a group of ingredients under a proprietary blend name and only disclose the total weight of the blend. However, the individual ingredients within the blend must still be listed in descending order by weight.

For any structure/function claim, the label must display the disclaimer: "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".

The serving size defines the dosage for a single serving and is crucial for consumers to understand how to use the product safely and effectively. It must reflect the maximum amount recommended per serving occasion.

Common warnings include statements about potential overdose (especially for iron), restrictions for children or pregnant women, and advice to consult a doctor if experiencing side effects or having specific health conditions.