Supplement Facts Panel Requirements - The Complete 21 CFR §101.36 Guide

Legal definitions and applicability

• Dietary supplements: Under 21 CFR §101.36, any product classified as a dietary supplement as defined in Section 201(ff) of the Act must display a "Supplement Facts" panel.
• Conventional foods: Conventional foods must display a "Nutrition Facts" panel in accordance with 21 CFR §101.9.

The line of demarcation

To determine which panel applies, evaluate the following three criteria:

• Statement of identity: If the product's principal display panel (PDP) identifies the product as a "Dietary Supplement" (or a specific type of supplement, such as "Herbal Supplement" or "Vitamin C Supplement"), it must feature a Supplement Facts panel.
• Product form: Dietary supplements are typically represented in liquid, powder, tablet, capsule, softgel, or gelcap forms. However, if a liquid product is represented as a conventional beverage (e.g., packaged in a typical beverage can and promoted for thirst-quenching), it must be labeled as a conventional food with a Nutrition Facts panel.
• Directions for use: Dietary supplement labels must contain directions for use (e.g., "Take one capsule daily"). If the product's labeling suggests it should be used as a conventional meal replacement or as part of a standard diet, it falls under conventional food labeling regulations (21 CFR §101.9).

Formatting specifications

• The title: The panel must be titled "Supplement Facts." This title must be set in a bold, prominent typeface. It must be the largest type size within the panel, typically set in a sans-serif font (such as Helvetica or Arial) to ensure maximum legibility.
• Bordering and box enclosure: The entire Supplement Facts panel must be enclosed within a box (or border) formed by thin black rules.
• Heading formatting: All headers, including "Serving Size," "Servings Per Container," "Amount Per Serving," and "% Daily Value," must be bolded to distinguish them clearly from the underlying ingredient declarations.
• Alignment: The title "Supplement Facts" must be aligned to the left or centered at the very top of the panel, separated from the rest of the text by a heavy horizontal bar.

Determination rules

In accordance with 21 CFR §101.36(b)(1) and 21 CFR §101.9(b), the serving size must be the maximum quantity of the dietary supplement recommended for consumption at one time on the label's directions for use. If the directions state "Take 1 to 2 capsules with meals," the serving size must be calculated and declared based on 2 capsules (the maximum recommended dose).

Expression rules

The serving size must be expressed using common household measures followed immediately by the equivalent metric quantity in parentheses (fluids in milliliters, and all other forms in grams).

• Tablets/capsules: Serving Size: 2 Tablets (1.5 g)
• Powders: Serving Size: 1 Scoop (5 g)
• Liquids: Serving Size: 2 Tablespoons (30 mL)

Rounding rules

• Metric weights for serving sizes must be rounded to the nearest tenth of a gram (e.g., 1.45 g rounds to 1.5 g).
• For dosages less than 0.5 grams, the metric weight can be expressed in milligrams without decimal points (e.g., Serving Size: 1 Capsule (450 mg)).

Declaration rules (21 CFR §101.36(b)(1)(ii))

• Standard declaration: The total number of servings must be declared directly below the "Serving Size" line.
• Whole numbers: If the servings per container is a whole number, declare it as such (e.g., Servings Per Container: 30).
• Fractional values: If it is a fractional number, it may be rounded to the nearest whole number (e.g., 30.4 or 29.6 can be declared as 30).
• Variable fill: If the container contains a highly variable amount, or if it is a multi-serving liquid or powder where density may settle, you may use the term "About" (e.g., Servings Per Container: About 60).
• Visual separation: Under 21 CFR §101.36(e)(6), a heavy black horizontal bar must run directly underneath the "Servings Per Container" line, visually separating the panel's serving information from the nutrient/ingredient declarations.

When required (21 CFR §101.36(b)(2))

Calories must be declared if they are present at 5 calories or more per serving. If the caloric value is less than 5 calories, it is considered "insignificant" and must not be declared, unless a claim is made about calories on the label (such as "Low Calorie").

Calculation methods

Calories must be calculated in accordance with 21 CFR §101.9(c)(1) using one of the following accepted methods:

• Atwater factors: Using the specific Atwater factors given in USDA Handbook No. 74, or the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate, and total fat, respectively.
• Bomb calorimetry: Direct measurement of the dry supplement material, subtracting 1.25 calories per gram of protein to correct for incomplete digestibility.
• Modified Atwater factors: Subtracting non-digestible carbohydrates or applying the specific factors established for sugar alcohols (e.g., erythritol calculates at 0 calories per gram, xylitol at 2.4).

Rounding rules

• 50 calories or less: Express to the nearest 5-calorie increment (e.g., 32 calories must be rounded and declared as 30 Calories).
• Above 50 calories: Express to the nearest 10-calorie increment (e.g., 104 calories must be rounded and declared as 100 Calories).

The (b)(2)-dietary ingredients (21 CFR §101.36(b)(2)(i))

The full (b)(2) list runs considerably longer than most label teams expect, and it is worth checking your panel against the complete set - not just the handful of nutrients that appear on a typical protein or multivitamin label:

• Core declaration: Calories, Total Fat, Saturated Fat, Trans Fat, Cholesterol, Sodium, Total Carbohydrate, Dietary Fiber, Total Sugars, Added Sugars, Protein
• Vitamins: Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin K, Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Choline
• Minerals: Calcium, Iron, Phosphorus, Iodine, Magnesium, Zinc, Selenium, Copper, Manganese, Chromium, Molybdenum, Chloride, Potassium
• Optional but conditional: Calories from Saturated Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble Fiber, Insoluble Fiber, and Sugar Alcohol may be declared voluntarily - but become mandatory the moment a claim is made about them on the label.

The threshold rule

A (b)(2)-dietary ingredient must only be listed if it is present in a significant amount.

Zero declarations prohibited: Unlike conventional foods, which must declare zero-values for many core nutrients, a dietary supplement must not declare a (b)(2)-dietary ingredient if it is present at an insignificant level (e.g., less than 2% of the RDI for vitamins/minerals, or less than 0.5 g of fat or carbohydrates). Declaring 0% or 0 g for Vitamin A, Vitamin D, Vitamin B12, or cholesterol on a supplement label is a direct violation of 21 CFR §101.36(b)(2)(i).

Nutrients requiring %DV

All (b)(2)-dietary ingredients (macronutrients, vitamins, and minerals) that have an established Daily Reference Value (DRV) or Reference Daily Intake (RDI) must declare their %DV within the panel, aligned to the right-hand column.

Nutrients that do not have a %DV

(b)(3)-dietary ingredients (e.g., botanical extracts, proprietary blends, specific amino acids) do not have established RDIs or DRVs. Therefore, no numerical percentage can be assigned to them.

The footnote requirement

For any (b)(3)-dietary ingredient listed, you must place a reference symbol (typically an asterisk * or a dagger †) in the "% Daily Value" column next to the ingredient.

This symbol must point to a footnote at the very bottom of the Supplement Facts panel that reads exactly:

† Daily Value not established.

Do not combine this footnote with other standard food statements. Statements like "Your daily value may be higher or lower depending on your calorie needs" are not permitted in a Supplement Facts label.

Mandatory disclosures (21 CFR §101.36(b)(3)(iii))

If your product contains a proprietary blend, you must:

• Identify the blend: Use the term "Proprietary Blend" or a descriptive name (e.g., "Phyto-Nutrient Proprietary Blend") as the heading.
• Declare total quantitative weight: State the total weight of the entire blend per serving (e.g., Proprietary Blend ... 500 mg).
• List all ingredients: List every single ingredient contained within the blend in descending order of predominance by weight.
• Indicate no individual weights: Place the "†" symbol in the %DV column for the entire blend, and do not disclose the individual weights of the constituents.

What you can legitimately protect

You are legally permitted to keep the exact milligram weight of individual ingredients within the blend a trade secret. Only the total weight of the combined blend must be declared.

Nomenclature rules

• Standardized common name: The common or usual name of a botanical must be the standardized common name listed in the reference book Herbs of Commerce. For example, you must use "soursop" instead of "guanabana," and "canary grass" instead of "canary seed" if that is what the reference mandates.
• Latin binomial: The Latin binomial (genus and species) must be declared in parentheses immediately following the common name if it is not already established in Herbs of Commerce (e.g., Eleutherococcus senticosus).

The "ginseng" restriction (Section 403(u) of the Act)

Under Section 403(u) of the Act (originating from the Farm Bill of 2002), the term "ginseng" may only be used for plants classified within the genus Panax.

Siberian ginseng violation: You cannot use the term "Siberian ginseng" to describe the botanical Eleutherococcus senticosus. This botanical must be declared as "eleuthero" or "Eleutherococcus senticosus." Representing a non-Panax herbal ingredient as "ginseng" will result in immediate DWPE (Detention Without Physical Examination) under FDA Import Alert 54-12.

Plant part and preparation

Under 21 CFR §101.4(h)(1), you must clearly identify the specific part of the plant from which the ingredient is derived - for example, roots, leaves, seeds, stems, or aerial parts.

• Incorrect: Ginkgo biloba
• Correct: Ginkgo biloba (leaf) or Ginkgo extract (leaf)
• You must also identify the preparation type if it is an extract (e.g., powder, 4:1 extract, standardized to 24% ginkgoflavonglycosides).

The nine major allergens

Under US law, there are nine major food allergens that must be clearly declared on the label:

• Milk
• Eggs
• Peanuts
• Tree nuts (the specific type of nut must be declared, e.g., Almonds, Walnuts, Coconuts)
• Wheat
• Fish (the specific species must be declared, e.g., Salmon, Cod)
• Crustacean shellfish (the specific species must be declared, e.g., Crab, Lobster, Shrimp)
• Soybeans
• Sesame (mandatory since January 1, 2023, under the FASTER Act, which was signed into law on April 23, 2021 and gave manufacturers a roughly 20-month transition window before enforcement began)

The "Contains:" statement formatting

If any ingredient in your dietary supplement is derived from one of these nine major allergens, it must be declared using one of two methods:

• Method A (ingredient list): The common or usual name of the allergen must appear in parentheses within the ingredient list (e.g., Lecithin (soy)).
• Method B (contains statement): A separate, highly visible statement placed immediately below or adjacent to the ingredient list/Supplement Facts panel. It must read exactly as follows: Contains: Soy, Wheat. (set in bold type, with capitalization as shown).
• For a deeper walkthrough of the sesame transition specifically - including what to do with existing packaging inventory - see our companion article on FASTER Act compliance for supplement labels.

The three situations requiring dual-columns

• Products requiring reconstitution or preparation: If a supplement is a powder or liquid concentrate that must be mixed with another food (e.g., a protein powder mixed with 8 oz of skim milk), the first column must show the values for the supplement alone, and the second column must show the values for the supplement as prepared.
• Multiple dosage levels (e.g., adult vs. child directions): If the directions for use specify different dosages for different populations (e.g., "Adults: Take 2 capsules daily. Children 4–12: Take 1 capsule daily"), you must use a dual-column format to show the quantitative values and %DVs for each dosage level.
• Containers offering a "per serving" and "per container" declaration: For single-serving or dual-serving containers, or containers where it is beneficial to show the daily cumulative nutritional intake alongside the individual serving, a dual-column format displaying both values side-by-side is required.

Panel structural and typography compliance

• Panel is enclosed in a box or defined border with thin black rules.
• Title is exactly "Supplement Facts" and is bolded.
• "Supplement Facts" title is the largest text size inside the panel.
• All subheadings ("Amount Per Serving," "Active Ingredients," "% Daily Value") are bolded.
• Font used is clean, sans-serif (e.g., Arial, Helvetica) and highly legible.
• Font size for dietary ingredient names is at least 8 point (or 4.5 point on very small packages).
• A heavy black bar runs horizontally below "Servings Per Container."
• A second heavy black bar runs horizontally below the (b)(2)-dietary ingredients (if any are present).
• Light horizontal rules separate individual dietary ingredients.
• Alignment of the quantitative weights is set in a column aligned to the right.
• % Daily Value column is aligned to the far right, matching the vertical line of the heading.

Serving size and container verification

• Serving size represents the maximum dose recommended in the directions for use.
• Serving size is expressed first in household measures (e.g., "1 Tablet," "2 Capsules").
• Household measure is followed by the metric equivalent in parentheses.
• Metric weight or volume is rounded to the nearest tenth of a gram or milliliter.
• "Servings Per Container" is declared directly below Serving Size.
• Servings per container value is accurate based on the total physical package weight/count.
• Multi-serving containers with variable settling use the qualifier "About" (e.g., "About 30 servings").

Caloric and macronutrient calculations

• Calories are declared if they equal or exceed 5 calories per serving.
• Calories are calculated using the general 4-4-9 factors or another approved scientific method.
• Calorie count is rounded to the nearest 5-calorie increment (if under 50 calories).
• Calorie count is rounded to the nearest 10-calorie increment (if over 50 calories).
• Macronutrients (Fat, Carbohydrates, Protein) are rounded using correct significance rules.

Ingredient classifications and ordering

• (b)(2)-dietary ingredients are listed first, above any (b)(3)-dietary ingredients.
• (b)(2)-dietary ingredients are listed in the exact order required by 21 CFR §101.36(b)(2)(i).
• No (b)(2)-dietary ingredients with zero or insignificant values are declared in the panel.
• (b)(3)-dietary ingredients are listed below the (b)(2) ingredients and separated by a horizontal line.
• (b)(3)-dietary ingredients are listed in descending order of predominance by weight.
• Quantitative weights of all dietary ingredients are written with their respective units (g, mg, mcg).

Proprietary blend compliance

• Blend is explicitly identified as a "Proprietary Blend" or another approved descriptive name.
• Total quantitative weight of the entire blend is declared.
• Individual ingredients inside the blend are listed in descending order of predominance by weight.
• No individual weights of ingredients within the blend are disclosed.

Botanical and herb nomenclature

• Common names of botanicals match the standardized common names in Herbs of Commerce.
• Latin binomials (Genus species) are included in parentheses where required.
• No botanical derived from Eleutherococcus senticosus uses the term "Siberian ginseng."
• The word "ginseng" is reserved exclusively for plants within the genus Panax.
• The specific part of the plant used (e.g., leaf, root) is declared in parentheses.
• Extract ratios or standardization details are accurately specified.

Footnotes and percent daily value symbols

• % Daily Values are calculated using the current FDA RDI and DRV tables.
• (b)(3)-dietary ingredients have a reference symbol (e.g., †) in the %DV column.
• Footnote reading "† Daily Value not established." is placed at the bottom of the panel.
• No unapproved conventional food footnotes are present in the panel.

Allergen and language regulations

• All nine major allergens (Milk, Eggs, Peanuts, Tree Nuts, Wheat, Fish, Crustacean Shellfish, Soy, Sesame) are declared.
• If a separate "Contains" statement is used, it is located immediately below or adjacent to the Supplement Facts panel.
• "Contains" statement is set in bold and lists the common allergen sources (e.g., Contains: Milk, Soy.).
• Specific tree nuts, fish, or crustacean species are declared by their common names (e.g., "Contains: Coconut," "Contains: Cod").
• If any part of the label is written in a foreign language, the entire Supplement Facts panel is repeated in that language.
• Statement of Identity ("Dietary Supplement") is printed in bold type on the PDP.
• Label artwork is based entirely on the current, revised nutrition labeling regulations.