What are the rules for supplement labeling?

December 8, 2025 •

3 min read

According to the FDA, dietary supplements are a category of food, not drugs, a distinction that fundamentally dictates what are the rules for supplement labeling. This regulatory framework, primarily defined by the Dietary Supplement Health and Education Act (DSHEA), ensures consumers receive essential information on product identity, contents, and ingredients. Understanding these rules is crucial for both manufacturers aiming for compliance and consumers looking for trustworthy products.

Quick Summary

This article outlines the complex regulations governing dietary supplement labeling in the U.S. It details the mandatory components of an FDA-compliant label, clarifies the distinctions between different types of product claims, and emphasizes the importance of adherence to Good Manufacturing Practices (GMP) for ensuring quality and safety. The information is vital for anyone involved in the supplement industry or for informed consumers.

Key Points

Mandatory Label Elements: All dietary supplements must clearly display a statement of identity, net quantity of contents, a Supplement Facts panel, and the manufacturer's information on their labels.
Claims Regulation: Supplement claims are categorized as structure/function, nutrient content, or health claims, with specific rules governing each type. Disease claims are strictly prohibited.
Structure/Function Disclaimer: Manufacturers must include a mandatory disclaimer stating the FDA has not evaluated structure/function claims and the product is not intended to treat, cure, or prevent any disease.
Supplement Facts Panel Details: This panel details serving size, dietary ingredients with quantities and % Daily Value, and must be formatted according to strict FDA specifications.
Good Manufacturing Practices (GMP): Manufacturers are required to follow GMP to ensure the quality, purity, and safety of their products, from sourcing ingredients to final testing.
Ingredient Transparency: All ingredients, including dietary ones in the Supplement Facts panel and other ingredients listed below it, must be disclosed in descending order of predominance by weight.
Warning Statements: Specific products, particularly those containing iron, require prominent warning statements on the label.

Mandatory Elements of a Dietary Supplement Label

For a dietary supplement to be sold legally in the United States, its label must include several key components, often located on the Principal Display Panel (PDP) and the Information Panel. These elements are designed to provide transparency and necessary information to the consumer.

Principal Display Panel (PDP)

Statement of Identity: This clearly identifies the product, such as "Vitamin C Supplement" or "Multivitamin".
Net Quantity of Contents: This states the amount of the supplement in the package by weight, measure, or numerical count.

Information Panel

Supplement Facts Panel: This is the most detailed section and must be formatted strictly according to FDA rules. It must contain:
- Serving size and servings per container.
- A list of all dietary ingredients, including quantities and the percent of Daily Value (%DV) if established by the FDA.
- The source of a dietary ingredient (e.g., "Vitamin C (as ascorbic acid)").
Other Ingredients: A list of all non-dietary ingredients, such as fillers, binders, and flavors, listed in descending order of weight.
Name and Address: The name and place of business of the manufacturer, packer, or distributor.
Warning Statements: Specific warnings are required for products containing iron.

Understanding Different Types of Claims

Claims made on supplement labels are heavily regulated to prevent consumers from being misled. The FDA differentiates between several types of claims, and each comes with its own set of requirements.

Structure/Function Claims

These claims describe the role of a nutrient or dietary ingredient in affecting the normal structure or function of the human body. They do not require FDA approval before being used, but manufacturers must notify the FDA within 30 days of marketing the product.

Requirements for Structure/Function Claims:

Substantiation: The manufacturer must have competent and reliable scientific evidence to back up the claim.
Disclaimer: The label must include the mandatory 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".

Disease Claims (Prohibited)

Supplement manufacturers are strictly prohibited from making claims that their product can diagnose, mitigate, treat, cure, or prevent a specific disease. Making such a claim would cause the product to be regulated as a drug, triggering more rigorous approval processes.

Nutrient Content Claims

These claims characterize the level of a nutrient in a supplement, such as "high source of calcium". These claims must meet specific FDA criteria. For example, a "high source" claim requires the product to contain at least 20 percent of the Daily Value for that nutrient.

Health Claims

Health claims, which state or imply a relationship between a food substance and a reduced risk of a disease, require prior FDA approval. They are less common for dietary supplements due to the high burden of proof required.

Quality and Manufacturing Standards

Beyond the label, manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure the identity, purity, strength, and composition of their products. While the FDA does not approve supplements, it can take action against non-compliant manufacturers.

Comparison of Supplement Facts vs. Nutrition Facts Panels


Feature	Supplement Facts Panel (Supplements)	Nutrition Facts Panel (Conventional Foods)
Title	"Supplement Facts"	"Nutrition Facts"
Ingredients without Daily Values	Must be listed	Not permitted
Source of Dietary Ingredient	Can be listed within the panel	Cannot be listed in the panel
Plant Part	Must be included if applicable	Not permitted
Zero Amounts	Cannot list "zero" amounts of nutrients	Required to list "zero" amounts
Proprietary Blends	Listed by total weight and ingredients	Not applicable

Conclusion: Ensuring Compliance and Consumer Trust

Following the specific rules for supplement labeling is a critical and complex undertaking for manufacturers. It involves not only accurate and transparent disclosure of ingredients but also careful wording of any claims to avoid misbranding. Adherence to these regulations, overseen by the FDA and backed by GMPs, is essential for maintaining product safety and building consumer trust. For consumers, understanding these labels empowers them to make informed choices about the supplements they purchase. Staying current with FDA guidelines, such as those detailed in the FDA's Dietary Supplement Labeling Guide, is the best way to navigate this important aspect of health and nutrition.

Frequently Asked Questions

DSHEA is the 1994 law that defines dietary supplements and establishes the regulatory framework for their labeling and claims in the United States, placing them under the 'food' category and not as drugs.

The FDA does not approve dietary supplements for safety or effectiveness before they are marketed. However, manufacturers are responsible for ensuring their products and label claims are safe and not misleading.

A 'Supplement Facts' panel is the required nutrition label for dietary supplements, detailing the serving size, servings per container, and a list of all dietary ingredients with their quantities per serving.

Structure/function claims describe how a dietary ingredient affects the structure or function of the body, such as 'calcium builds strong bones.' They must be substantiated by evidence and carry a specific FDA disclaimer.

No, supplement labels are explicitly prohibited from making disease claims, such as diagnosing, treating, or preventing a specific illness. Only FDA-approved drugs can make such claims.

GMPs are regulations enforced by the FDA to ensure that dietary supplements are consistently produced and controlled according to quality standards. This covers everything from ingredient sourcing to final product testing.

Proprietary blends must be listed with their total weight and the names of the ingredients they contain, in descending order of predominance by weight. The individual quantities of each ingredient within the blend do not have to be disclosed.

Yes, certain small businesses with low annual sales may be exempt from the nutrition labeling requirements, provided their labels do not carry any claims.