26% of Americans have used dietary supplements to treat a health problem, and misinformation on labels may lead to severe side effects.
That's why supplement labels have strict regulations, and failure to comply with them will lead to product recalls and warnings, emphasizing the importance of using effective label design software.
However, information surrounding these regulations is scattered, and decoding information on official websites is time consuming.
To save your time and help you stay compliant, we've created a comprehensive guide on FDA's labeling regulations for dietary supplements that combines all the essential information on labeling under a single roof.
1. Definitions of Terms
Here, we include definitions of the most common terms we use in this article to avoid confusion.
a. Dietary Supplements
Dietary supplements are foods that complement your diet and contain one or more of the following ingredients:
- Herb or other botanical
- Amino acid
- Substances that help improve our dietary intake
You can ingest them as liquids or in the form of capsules, tablets, powders, softgels ,or gelcaps.
The term dietary supplements also include new drugs, antibiotics, and drugs which were previously approved as dietary supplements.
Note: A product is not considered a dietary supplement if it can be used as a conventional food or an item of a meal or diet.
Any written, printed, or graphic matter on the immediate container of your product is considered a label.
All labels and other written, printed, or graphic matter appearing on:
Your product on any of its containers or wrappers.
Posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. that accompany your product.
Note: Advertising materials that accompany your product are also included under "labeling."
d. Principal Display Panel (PDP)
The PDP is the label’s part that the consumer is most likely to view. Usually, it's the label’s front panel, but some packages may have alternate PDPs because of their shape.
To calculate the type size of the net quantity of contents, we must determine the PDP’s area.
The table below helps you calculate the area according to the shape of the container.
Note: If your package has alternate PDPs, you must duplicate the required information on them.
e. Information Panel (IP)
The panel to the PDP’s right is called the Information Panel (IP). If this panel is unusable because of the construction or design of the package (e.g., folded flaps), then the most prominent panel to its right must be used as the IP.
Note: If your PDP is the top of the container, the panel adjacent to it must be used as IP if it doesn't have any alternate PDPs.
In case there are alternate PDPs, the IP is the panel to the PDP's right.
2. Required Label Statements
These are statements that you must include on the labels of your packages and containers. The following table lists the required label statements.
Placement of Information
You must place the required label statements on the label’s front panel, PDP, or IP in type sizes no less than 1/16" with a height to width ratio of 3:1.
There must be no obscuring vignette or graphic on your label, and the background color must sufficiently contrast the type color to ensure readability.
The following table tells you where each of the required label statements must go on the label.
Note: If your packaging isn't large enough to accommodate a type size of 1/16", you must file a petition to request an alternate labeling regulation.
You may not place intervening material, i.e., label information that isn't required (e.g., UPC code) between required label statements on the IP.
3. Statement of Identity
The statement of identity of food is the common or usual name of food as specified by the law. It’s placed on the PDP, parallel to its resting base.
As the term "dietary supplements" adequately describes the nature of the food, it's a valid statement of identity.
You may also lengthen the statement of identity with more descriptive terms (e.g., cod liver oil dietary supplement) or replace the word "dietary" with other appropriately descriptive terms (e.g., calcium supplement)
Note: Brand names aren't part of the statement of identity, so you must not make them more prominent than the statement of identity.
4. Net Quantity of Contents
The Net Quantity of Contents refers to the amount of dietary supplement your package or container has and must be expressed accurately in the metric system and the US Customary system.
The following table lists the acceptable units in which you can express your weights.
You may also include information like the size and measure of individual units if the net quantity can't adequately express the amount of your dietary supplement.
Note: The net quantity of contents doesn't include the weight of the wrappers and other packing materials included with the supplement.
The type must contrast with the background to be prominent and readable.
You must not include terms that exaggerate the weight, measure, or count (e.g., a "giant" quart) in the net quantity of contents.
The Net quantity must appear within the bottom 30% of the PDP in lines parallel to the resting base of the container unless the PDP area is less than 5 sq. in.
(i). The Net quantity must appear as a standalone statement. It must be separated from printed information above and below with a spacing equal to the height of the letters used in the declaration.
(ii). There should also be sufficient spacing to the left and right of the declaration, and it must be at least twice the width of your typeface’s letter "N."
(iii). The type size of the net quantity of contents is calculated based on the PDP area, but the height to width ratio of the letters must be no more than 3:1.
(Refer to the Principal Display Panel section above to see how the area of the PDP is calculated.)
The table below lists the acceptable type sizes.
Note: Type size of fractions must be one-half the minimum height requirements set for the remaining text.
1. Declaration for packages less than 4 pounds or 1 gallon
For weight-based declarations, you must express the net quantity in ounces.
Then, you must make another declaration in parentheses with weight in pounds followed by the remaining weight in ounces, or common fractions or decimals of pounds.
Here are examples of a correct net quantity declaration for 1 1/2 pounds
Net Wt. 24 oz (1 lb 8 oz)
Net Wt. 24 oz (1 1/2 lb)
Net Wt. 24 oz (1.5 lb)
For liquid-based declarations, you must use the largest whole unit followed by the remaining volume in fluid ounces or common decimals of the pint or quart.
Here are examples of a correct net quantity declaration for 1 3/4 quarts
Net contents 56 fluid ounces (1 quart 1 1/2 pints)
Net 56 fluid oz (1 qt 1 pt 8 oz)
2. Declaration for packages greater than 4 pounds and 1 gallon
Weights must be expressed in pounds, and the remainder must be expressed in ounces or common or decimal fractions of pounds.
Here are examples for a correct net quantity declaration for 5 ½ pounds:
Net wt. 5 lb 8 oz
Liquid measures must be expressed in the largest whole unit (gallon), and the remaining volume must be expressed in the next largest whole unit (pints and quarts).
Here are examples for a correct net quantity declaration for 2 1/2 gallons:
Net contents 2 1/2 gallons
Net contents 2.5 gallons
Net contents 2 gallons 2 quarts
Note: Only common fractions, i.e., ¾, ½, ¼, ⅛, 1/16, and 1/32, must be used in a declaration.
5. Nutrition Labeling
A Supplement facts panel or a nutritional label displays the names and quantities of *dietary ingredients in your dietary supplement in terms of "servings" and "servings per container."
*Ingredients that add to the total dietary intake of humans are called dietary ingredients.
a. Serving Size
The maximum amount of dietary supplement that one can eat on a single occasion is called serving size. If there's no recommended amount, the serving size is 1 unit (pill, teaspoon, etc.)
Note: Don't use an alternate term for "Serving Size."
Servings per Container
The number of servings that a container of your dietary supplement holds is called the servings per container.
E.g., If the net quantity statement is 50 capsules, then the servings per container will also be 50 capsules.
Note: For capsules, tablets, and other types of dietary supplements that use the numerical count-based net quantity statement, the "Servings per Container" statement may be omitted as it's the same as the net quantity of content.
b. Nutrient Declaration
All nutrients present in measurable amounts must be listed on the Supplementary Facts panel, and this includes:
Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron.
You must also declare calories from unsaturated fats, fibers, and carbohydrates if your product makes claims about these nutrients.
(i). A box with hairlines must enclose the supplement panel, and its title, "Supplement Facts," should be made full-width and have the most prominent type size in the box.
(ii). The type size of the content within the box must be no less than 8 points, and footnotes must be in type sizes no less than 6 points.
(iii). All titles and headings must be bolded to ensure readability.
d. Order of Ingredient Declaration
You must declare ingredients with DVs in descending order of predominance, i.e., ingredients present in the highest concentrations must be listed first.
However, vitamins, minerals, and electrolytes must be listed together in the following order:
Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, and potassium.
Note: If your product has naturally occurring nutrients that aren't a part of the 14 mandatory dietary ingredients, you needn't list them in the "Supplementary Panel."
e. Synonyms for Dietary Ingredients
You may use synonyms in parentheses for the following dietary ingredients.
Note: You may use "folate" in place of "folic acid" or "folacin" without using parentheses.
f. Declaration of Amounts
You may place the amount next to the dietary ingredients or in a separate column in the Supplementary Facts panel.
The FDA also allows you to declare the amount per serving, amount per unit, and the amounts for more than one serving if your supplement has different serving sizes.
Instead of using "amount per serving" in your headings, you may also use terms like "Each tablet contains," "Amount per 2 Tablets," capsule, packet, and teaspoonful.
E.g., If your tablet must be taken once in the morning and twice at night, you may present two separate columns titled "Amount per 1 Tablet" and "Amount per 2 Tablets."
Note: You must list the weight of the dietary ingredient instead of listing the weight of the source it was obtained from.
If your supplement contains calcium obtained from calcium carbonate, you must list the amount of calcium instead of listing the weight of calcium carbonate.
g. Units of Measurement
Dietary ingredients that are present in amounts greater than 5 milligrams must be declared on the "Supplementary Facts" Panel using the appropriate units of measurement.
(The only exception to the above rule is cholesterol, for which the minimum declaration is 2 mg).
The table below lists the units of measurement for all the dietary ingredients.
1. Retinol Activity Equivalent (RAE) is the amount of active Vitamin A that our bodies can actively absorb.
1 mg RAE = 1 microgram retinol, 2 microgram supplemental [beta]-carotene, 12 micrograms dietary [beta]-carotene, or 24 micrograms dietary [alpha]-carotene, or dietary 24 micrograms dietary [beta]-cryptoxanthin.
2. Vitamin E
1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all rac-[alpha]-tocopherol.
3. NE refers to Niacin Equivalents and is the amount of preformed niacin and the niacin made from tryptophan.
1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
4. You must declare the amounts of folate and folic acid on the label of your dietary supplement.
Dietary Folate Equivalents (DFE) is used to declare folic acid, while folate is expressed as % DV.
DFE accounts for the differences in the absorption of naturally occurring folate and synthesized folic acid.
1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.
h. Percentage of Daily Values (% DV)
Daily Values or DV is the amount of nutrients you must consume in a single day. The percentage of Daily Values (% DV) is the percent of the recommended nutrient amount your supplement provides daily.
You must list the % DV for all dietary ingredients that have DVs except protein.
If your product is intended to be used by pregnant or lactating women, infants, and children under 4 years of age, you must not declare the % DVs for the following dietary ingredients:
Total fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, manganese, chromium, molybdenum, chloride, sodium, or potassium.
Note: When expressing % DV, you must round off the values to the nearest whole number and use "less than 1%" instead of 0 when the dietary ingredient is large enough to be expressed.
The FDA has established four sets of % DV values to be used for pregnant or lactating women, infants, children above 4 years, and adults. Therefore, you may make four separate columns to list % DVs for each.
i. Other Dietary Ingredients
Ingredients that don't have a recommended daily value are termed as "other dietary ingredients." E.g., phosphatidylserine.
You must place an asterisk before the "% DV" column that refers to a footnote that says "Daily Value Not Established."
If you don't follow the table format, the asterisk must follow the weight of the ingredient.
(i). Liquid Extracts
You must list the liquid extracts in terms of volume or weight of the material it was extracted from and mention the condition of the material before the extraction.
Here's an example of a correct listing:
fresh dandelion root extract, x (y:z) in 70% ethanol
x: Amount of extract in mL or mg.
y: Weight of the starting material
z: Volume (mL) of the solvent
(ii). Dried Extracts
List the weight of dried extracts from which the solvent has been removed.
(iii). Proprietary Blends
Use the term "Proprietary Blends" to identify your blend and list its weight in the same line.
In the following line, list the dietary ingredients it contains in decreasing order of predominance. If your ingredients don't have an established Daily Value, they must be listed separately in the above format.
6. Ingredient Labeling
An ingredient is any substance used to manufacture your dietary supplement and is declared in descending order of predominance. This term also includes binders, colors, filler, flavors, and excipients.
If your ingredients are listed with their source, you don't have to declare them separately in the ingredient statement (ingredient list). E.g., Calcium (calcium carbonate.)
You must precede the ingredient list with the term "Ingredients" before listing them.
If your supplement has source ingredients (e.g., calcium carbonate is the source ingredient of calcium), you must precede the listing with "Other Ingredients."
a. Placement of Information
You must place the Ingredient labeling list immediately below the Supplementary Facts panel. If this placement isn't possible, the label must appear to the right of the supplementary facts.
b. Type Size
The type size is the equivalent of lowercase "o" and mustn't be less than 1/16"
c. Declaration of ingredients
The following section explains the format for declaring flavors, spices, coloring, etc.
(i). Spices & Flavors
You can use the terms "spices," "artificial flavor," or "natural flavor" or use specific, common, or usual names to declare spices, natural flavors, or artificial flavors.
If a spice is also a coloring, use "spice & coloring" to list the ingredient. E.g., turmeric may be listed as "turmeric" or as "spice and coloring."
(ii). Artificial Colors
You can list certified colors with their specific or abbreviated name. E.g., "FD&C Red No. 40" or "Red 40."
If the color is not certified, you may list the color using terms like "Artificial Color," "Artificial Color Added," or "Color Added."
(iii). Chemical Preservatives
List the common or usual name of a preservative followed by the purpose. E.g., Sodium benzoate to help protect flavor.
A nutrient content claim characterizes the level of a nutrient in your supplement explicitly or implicitly.
This section discusses the regulations for various types of nutrient claims your dietary supplement makes.
Note: The type size of nutrient claims may not be more than 2x larger than the statement of identity.
a. High Source/Good Source Claim
If your product contains 10-19% DV of the ingredient, you may make a good source claim. However, if the % DV exceeds 20%, you may make a high source claim.
b. Low/Free claims
You may make low/free claims only when your product is specially processed to lower or remove the nutrient.
c. Antioxidant claims
To make an antioxidant claim, your supplement must contain antioxidants with * recognized activity in quantities sufficient to make a high source claim. The nutrient may or may not have a Recommended Dietary Intake (RDI) value.
E.g., a supplement that claims to be "high in antioxidant vitamin C" must have 20% DV of vitamin C in it.
*scientific evidence that the nutrient reduces free radicals after the gut absorbs it.
d. High Potency Claims
You may make a high potency claim if your supplement provides 100% DV or more of at least two-thirds of vitamins and minerals listed as dietary ingredients.
When you use the term "high potency" to describe individual vitamins and minerals, you must clearly state the name of the vitamin or mineral to identify it. E.g., Botanic X with high potency Vitamin E.
e. Percentage Claims
The amounts of dietary ingredients with no RDI and DV can be characterized by percentage claims followed by a disclosure statement.
This is called a simple percentage claim, and it lists the amount of dietary ingredient per serving present in the supplement next to the percentage values.
E.g., 40 percent omega-3 fatty acids, 10 mg per capsule.
You may also use a reference ingredient to characterize the amount of dietary ingredients present in your product.
This is called a comparative percentage claim, and you must declare the reference food, the amount of that food, and the amount of dietary ingredients present in your supplement and the food.
E.g., Twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)
f. Health Claims
A health claim is a written statement, vignette, or symbol that implies a relation between the supplement and a disease or health-related condition.
All health claims are based on scientific agreements and cannot be displayed on the label without the FDA's authorization.
For more information related to health claims for dietary supplements, browse this FDA's resource.
As dietary supplements are becoming commonplace, you must adhere to labeling guidelines to prevent misinformation and severe side effects. Our guide contains essential information on labeling regulations that help you stay on track with the latest requirements.