The 5 Types of Ingredients in FDA Dietary Supplement Labeling

Dietary supplement labeling in the United States is governed by 21 CFR 101.36 under the U.S. Food and Drug Administration (FDA). This regulation defines how ingredients must be categorized and displayed within the Supplement Facts panel and on the label packaging.

This article outlines the 5 types of ingredients recognized in dietary supplement labeling, per the definitions of the FDA regulations.

(1) Dietary Ingredients (Mandatory and Voluntary)

What are Dietary Ingredients? 

Dietary ingredients or “(b)(2)-dietary ingredients” are defined in the FDA regulations by 21 CFR 101.9(c). Most dietary ingredients have established RDI and DRVs, some are considered mandatory and some are considered voluntary. 

The 15 listed below are considered the Mandatory Dietary Ingredients:

Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium

These nutrients are required to be listed on the supplement label if they are present in a serving of the product in an amount greater than zero (as defined by the regulations). 

Voluntary Dietary Ingredients, like polyunsaturated fat, Vitamin A, Vitamin C, copper, and fluoride, can optionally be listed if they are present in a serving of the product in an amount greater than zero, and are required to be listed if a claim is made about them. 

These nutrients must be listed in the correct order using specific names and formatting that the regulations define. 

The complete list of “(b)(2)-dietary ingredients” can be found at 21 CFR 101.9(c).

(2) Other Dietary Ingredients

What are Other Dietary Ingredients? 

Dietary ingredients that do not have established RDI and DRVs and are not included in the list of “(b)(2)-dietary ingredients” are considered “other dietary ingredients”. In the supplement industry, these are sometimes referred to as “Actives” or “Active ingredients”. 

These include ingredients like: 

• Amino acids
• Botanicals (ex: herbs, extracts)
• Enzymes
• Probiotics

This category of ingredients has different rules for how these ingredients should be displayed on the supplement label. They must be listed with their quantitative amount per serving in a separate section from any declared “(b)(2)-dietary ingredients”. 

(3) Proprietary Blends

What is a Proprietary Blend? 

Per 21 CFR 101.36(c), dietary and other dietary ingredients may be grouped together into a “proprietary blend”.

To declare a proprietary blend on a supplement fact panel:

• The total weight of the blend must be declared to the right and on the same line as the title of the blend
• Individual ingredients in the blend must be listed in descending order of predominance by weight under the title “Proprietary Blend” or another appropriate title
• The individual ingredient amounts are not required to be disclosed
• The “(b)(2)-dietary ingredients” in the blend must be listed according to the regulations

(4) Source Ingredients

What is a Source Ingredient? 

Per 21 CFR 101.36(d), the ingredient that supplies a “(b)(2)-dietary ingredient” can be declared on the supplement fact panel as a source ingredient. 

Source ingredients should be in parentheses next to or below the dietary ingredient declared within the supplement fact panel, and should include the words “as” or “from” when applicable. 

Examples:

• Calcium (as calcium carbonate)
• Vitamin E (as d-alpha tocopheryl acetate)

When a source ingredient is included in the supplement fact panel, it is no longer required to be listed in the ingredient statement. However, if it is not listed in the panel, it should be included in the ingredient statement.

Source ingredients should be declared using the names as defined in 21 CFR 101.4(h).

(5) Non-Dietary Ingredients

What are Non-Dietary Ingredients? 

Non-dietary ingredients are ingredients that are present in a supplement product, but are not defined by the other ingredient categories. In the supplement industry these are sometimes called “Inactive” ingredients.

These ingredients may include:

• Fillers
• Binders
• Colors
• Flavors
• Preservatives

These ingredients must be listed outside the supplement facts panel in an ingredient statement per 21 CFR 101.4(g). They must be declared in descending order of predominance by weight and be preceded by the word “Ingredients” or words “Other Ingredients”.

Summary

FDA regulations define clear categories for ingredient types in dietary supplement labeling:

• Dietary ingredients (mandatory and voluntary)
• Other dietary ingredients
• Proprietary blends
• Source ingredients
• Non-Dietary ingredients

Each ingredient category has specific placement and declaration requirements within the label, primarily governed by 21 CFR 101.36 and supported by 21 CFR 101.4.

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