74% of American adults used dietary supplements in 2023 to treat a health problem. Imagine how a single piece of misinformation on labels could lead to severe side effects for three-quarters of the country.

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 management software.

However, information surrounding these regulations is scattered, and decoding information on official websites is time-consuming.  

To save 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. 

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Disclaimer: This blog post derives information from the U.S. Food and Drug Administration (FDA) website and is updated as of March 1st, 2024. Do refer to the FDA website for final and updated information regarding regulations. Artwork Flow is a software designed to streamline compliance for brands, not a service providing legal or regulatory advice.

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Also read: 11 Best Label Management Software For Fast-Growing Industries

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:

• Vitamin
• Mineral
• Herb or other botanical
• Amino acid
• Concentrate 
• Metabolite
• Constituent
• Extracts or a combination of any above-mentioned ingredient.

You can ingest them as liquids or in the form of capsules, tablets, powders, softgels, or gel caps. 

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The term dietary supplements also includes new drugs, antibiotics, and drugs that were previously approved as dietary supplements.  

b. Label

Any written, printed, or graphic matter on the immediate container of your product is considered a label. 

c. Labeling

All labels and other written, printed, or graphic matter appearing on the containers or wrappers of your product is called labeling.

It also includes posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, and more that accompanies the product.

Also read: Pharmaceutical Labeling 101: FDA Regulations Guide - Artwork Flow

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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. 

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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. 

In case there are alternate PDPs, the IP is the panel to the PDP's right. 

Download now: The Essential Guide to AI-powered Label Compliance

2. Required label statements

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These are statements that you must include on the labels of your packages and containers. The following table lists the required label statements.

Also read: 3 Ways to Ensure Product Labeling Compliance

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. 

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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) 

4. Net Quantity of Contents 

The Net Quantity of Contents refers to the amount of dietary supplement your package or container has. It 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.

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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. 

a. Regulations

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. 

b. Location 

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. 

c. Format 

(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.

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1. Weight-based declarations for packages less than 4 pounds or 1 gallon will be expressed in ounces.

Further, 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

(i) Net Wt. 24 oz (1 lb 8 oz)

(ii) Net Wt. 24 oz (1 1/2 lb)

(iii) 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:

(i) Net contents 56 fluid ounces (1 quart 1 1/2 pints)

(ii) Net 56 fluid oz (1 qt 1 pt 8 oz)

2. Declaration for packages greater than 4 pounds and 1 gallon in weight must be expressed in pounds, and the remainder must be expressed in ounces or common or decimal fractions of pounds. 

An example of a correct net quantity declaration for 2 ½ pounds is 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 of a correct net quantity declaration for 2 1/2 gallons:

(i) Net contents 2 1/2 gallons

(ii) Net contents 2.5 gallons

(iii) Net contents 2 gallons 2 quarts

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

(i) The maximum amount of dietary supplement 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.)

(ii) 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. 

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, and iron. 

You must also display calories from unsaturated fats, fibers, and carbohydrates if your product makes claims about these nutrients. 

c. Format

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(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. 

*Hairlines are strokes, lines, frames, or paragraphs with a line width less than 0.25 points.

(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 and they are distinguished from other information. 

d. Order of ingredient declaration

You must declare ingredients with Daily Values (DVs) in descending order of predominance, i.e., ingredients 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 and folic acid, vitamin B12, biotin, pantothenic acid, choline, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, potassium, and fluoride. 

e. Synonyms for dietary ingredients

You may use synonyms in parentheses for the following dietary ingredients.

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, the 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."

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.

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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. 

The FDA labeling requirements for dietary supplements have established four sets of % DV values for pregnant or lactating women, infants, children above 4 years, and adults. Therefore, you may make four separate columns to list % DVs for each. (For eg., one column would be % Daily Value for Children Under 4 Years of Age)

i. Other dietary ingredients

Ingredients that don't have a recommended daily value are termed "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 the 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. 

Submitting your supplement label for FDA review

To submit a supplement fact for FDA review, you should send it to the Office of Dietary Supplement Programs (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740-3835.

Also, manufacturers should notify the FDA 75 days before delivering the supplement for interstate commerce. Also, before a new ingredient is introduced into a supplement for consumer use, the manufacturer must notify the FDA.

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, fillers, flavors, and sweeteners. 

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 ingredients. 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.

7. Claims 

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. 

a. Structure/function claims:

These claims describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the body. Examples include "supports healthy joints" or "promotes a healthy immune system" and not “reduces depressions” or “prevents cholestrols”. Manufacturers must include a disclaimer stating that the FDA has not evaluated the claim, and the product is not intended to diagnose, treat, cure, or prevent any disease.

b. Nutrient content claims 

These claims highlight the presence and amount of specific nutrients in a product. 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. Examples include "good source of calcium" or "high in vitamin C." 

C. 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. 

8. Optional labeling requirements for dietary supplements

While the label of a dietary supplement must clearly state its intended use and include a list of ingredients, there are additional labeling requirements that ensure consumer safety and understanding. The following are the optional requirements:

1. Recommended use: The label should suggest how the product should be used.
2. Notice: This space is used to add additional information including storage of the product.  
3. Expiration date and lot numbers: The label must have a clear expiration date and lot number for tracking.

Common labeling errors to avoid in your dietary supplements

Labeling errors can lead to legal consequences, financial losses, damage to your brand, and worried customers. Here are some common labeling mistakes that you should avoid:

1. Misleading claims: Avoid making unsubstantiated claims about the benefits of the supplement. Claims must be supported by scientific evidence.
2. Incorrect ingredient lists: Ensure that the ingredient list accurately mirrors the contents of the supplement. Avoid skipping ingredients or listing them incorrectly. Forgetting to add an allergen could land you in a major legal issue.
3. Missing or incorrect serving sizes: The serving size should be clearly stated and accurate. Incorrect serving sizes can mislead consumers about the amount of nutrients or ingredients they should intake.
4. Inaccurate nutrition facts: The nutrition facts label must accurately reflect the nutritional content of the supplement. Avoid errors in the calculation of calories, macronutrients, or micronutrients.
5. Lack of warnings: If the supplement contains ingredients that may interact with medications or pose risks to certain individuals, appropriate warnings must be included on the label.
6. Incorrect expiration dates: Ensure that the expiration date is accurate and clearly visible. Outdated supplements may no longer be effective or safe for consumption.

Wrapping up

Keeping up with regulatory updates is crucial to preventing the spread of misinformation and ultimately contributing to the well-being of consumers. Our guide contains essential information on labeling regulations for dietary supplements that help you stay on track with the latest requirements. 

Artwork Flow offers a robust label management solution that streamlines the label review and compliance process, providing smart proofing of content to be printed and ensuring FDA compliance. This is crucial for industries such as food and beverages, cosmetics, pharmaceuticals, agrochemicals, and nutraceuticals.

We know the compliance process is a vital part of printing and distributing your dietary supplement packages and it is important to address your needs as a leading label management software in the business. Hence, we would like to introduce you to our ComplyAI feature.

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What does ComplyAI do?

1. Flexible label compliance: Got 20 creatives and a rulebook of 100 pages? With ComplyAI, create your own rulebook for unique labels, and run each of them easily with the advanced and latest FDA guidelines in a shorter time. Now make sure the right allergen goes on the right packaging!
   

2. Cuts costs and improves brand reputation: It prevents printing mishaps and recalls by helping you check typos, fonts, grammar, and preferred or restricted terms (which you can set) in your labels using AI. The circulation of error-free packages builds trust among the consumers as well.
   

3. Barcode scanner: With the barcode verification feature, scan every barcode in every package to see if the right details are provided to avoid potential lawsuits. 

This is just a quick peek into what ComplyAI can offer. To learn how we can cover your A-Z labeling work smoothly, book a demo with Artwork Flow.

Frequently asked questions

1. What is the difference between dietary supplements and food supplements?

Dietary supplements are also called food supplements or nutritional supplements. The subtle differences between them are:

• Dietary supplements: These are products intended to supplement the diet by providing nutrients that may not be consumed in sufficient amounts through food alone. They can come in various forms, such as pills, capsules, tablets, liquids, and powders.
• Food supplements: This term is less commonly used but can be considered synonymous with dietary supplements. It emphasizes the idea that these products are intended to supplement, rather than replace, a balanced diet.

2. What is required on a dietary supplement label?

All dietary supplement labels should have the following information:

• The product’s name/identity and the term “dietary supplement” or equivalent on the principal display panel
• A list of all ingredients
• Contact information for the manufacturer or distributor
• Net quantity of contents
• Nutrition labeling/Supplement Facts Panel
• The recommended dosage
• Warnings and health claims
• The expiration date or “best before” date

3. How do you find FDA-approved supplements?

Most FDA-approved human drugs are listed in a searchable database - Drugs @ FDA. This database lets you search by drug name, active ingredient, or application number and provide the necessary information.