Dietary Supplement Labeling Requirements

What Qualifies as a Dietary Supplement?

Before diving into labeling requirements, it's important to understand what qualifies as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

A dietary supplement must:

• Be intended for ingestion: Oral consumption in pill, capsule, tablet, liquid, powder, or similar form
• Supplement the diet: Contain one or more dietary ingredients
• Be labeled as a dietary supplement: Clearly identified on the label
• Not be represented as a conventional food:Cannot be marketed as a meal or as a conventional food item

Dietary Ingredients

Acceptable dietary ingredients in supplements include:

• Vitamins
• Minerals
• Herbs or other botanicals
• Amino acids
• Dietary substances to supplement the diet by increasing total dietary intake
• Concentrates, metabolites, constituents, extracts, or combinations of the above

What Must Appear on a Dietary Supplement Label?

FDA requires specific information on dietary supplement labels. Missing any required element can result in the product being deemed misbranded.

What Goes on a Supplement Facts Panel?

The Supplement Facts panel is the cornerstone of dietary supplement labeling. It must follow a specific format and include required information in a prescribed order.

Panel Format Requirements

• Title: "Supplement Facts" at the top, in bold type
• Serving size: Listed immediately below the title
• Servings per container: Number of servings in the package
• Hairline rules: Lines separating sections
• Consistent formatting: Specific font sizes, spacing, and alignment

Listing Dietary Ingredients

Dietary ingredients must be listed in a specific order:

1. Total calories (if applicable)
2. Calories from fat (if applicable)
3. Nutrients with Daily Values (DVs): Listed in a prescribed order (Vitamin A, C, D, E, K, B vitamins, minerals, etc.)
4. Other dietary ingredients: Ingredients without established DVs, listed below a heavy bar

Percent Daily Value

For nutrients with established Daily Values, you must declare:

• Amount per serving (in appropriate units)
• Percent Daily Value (%DV)
• A footnote: "*Percent Daily Values are based on a 2,000 calorie diet" (for certain nutrients)

For ingredients without Daily Values, use a dagger (†) and the footnote: "†Daily Value not established."

How Do I List Ingredients on a Supplement Label?

Beyond the Supplement Facts panel, dietary supplements require a complete ingredient statement listing all ingredients in the product.

Other Ingredients

Ingredients that are not dietary ingredients (binders, fillers, capsule materials, etc.) must be listed under "Other Ingredients" in descending order of predominance by weight:

• Gelatin (capsule)
• Cellulose (filler)
• Magnesium stearate (flow agent)
• Silicon dioxide (anti-caking agent)

Botanical Ingredients

For botanical ingredients, you must declare:

• Common or usual name
• Plant part used (root, leaf, seed, etc.)
• Standardization information (if standardized to a specific marker compound)

Proprietary Blends

If using a proprietary blend, you may list ingredients in the blend without individual amounts, but you must:

• Declare the total amount of the blend
• List ingredients in descending order by weight
• Use a proprietary name that is not misleading

What Claims Can You Make on Supplement Labels?

Structure/function claims describe the role of a nutrient or dietary ingredient in maintaining normal structure or function of the body. These claims are permitted on dietary supplements with certain requirements.

Permitted Claims

Structure/function claims may describe:

• The role of a nutrient in affecting structure or function ("Calcium builds strong bones")
• How the product maintains normal function ("Supports healthy immune function")
• General well-being from consumption ("Promotes relaxation")

Prohibited Claims

Structure/function claims cannot:

• Claim to diagnose, treat, cure, or prevent disease (drug claims)
• Mention specific diseases ("Prevents heart disease")
• Imply disease treatment ("Reduces tumor size")

FDA Notification

If you make structure/function claims, you must:

• Notify FDA within 30 days of marketing the product with the claim
• Have substantiation that the claim is truthful
• Include the required disclaimer on the label

What Health Claims Are Allowed on Supplements?

Health claims describe a relationship between a substance and a disease or health-related condition. These require FDA authorization (unlike structure/function claims).

Authorized Health Claims

FDA has authorized specific health claims for dietary supplements, including:

• Calcium and osteoporosis
• Folic acid and neural tube defects
• Fiber and heart disease or cancer

Qualified Health Claims

Qualified health claims are supported by some scientific evidence but don't meet the significant scientific agreement standard. They must include qualifying language reflecting the strength of evidence.

What Disclaimers Are Required on Supplement Labels?

Dietary supplements making structure/function claims must include the mandatory FDA disclaimer.

Structure/Function Claim Disclaimer

When making structure/function claims, your label must include:

Disclaimer Requirements

• Must appear on the label (not just marketing materials)
• Must be in boldface type
• Must be placed in proximity to the structure/function claim (preferably boxed)
• Must be in type size at least 1/16 inch

What Goes on the Principal Display Panel?

The Principal Display Panel (PDP) is the portion of the label most likely to be displayed to consumers. Required PDP elements include:

Statement of Identity

Must identify the product as a dietary supplement:

• "[Product Name] Dietary Supplement" or
• "[Specific ingredient] Supplement" (e.g., "Vitamin C Supplement") or
• "[Category] Supplement" (e.g., "Herbal Supplement")

Net Quantity of Contents

Must be declared in terms of:

• Count (for discrete units like tablets, capsules, softgels)
• Weight (for powders)
• Fluid volume (for liquids)

Declaration must be in the lower 30% of the PDP, in lines parallel to the base of the container.

What Are the Most Common Supplement Labeling Mistakes?

Avoid these frequently cited labeling violations that result in FDA warning letters:

How Do I Review My Supplement Label for Compliance?

Use this checklist to ensure your dietary supplement label is compliant: