Ultimate Dietary Supplement Labeling Guide (FDA Guidelines Simplified)

Creating a dietary supplement label that adheres to FDA regulations can appear overwhelming. However, this guide simplifies the process into manageable steps, ensuring your product’s label is compliant and consumer-friendly. Whether you’re new to the supplement industry or looking to ensure your existing products meet current standards, this guide has you covered.

Key Takeaways For Your Supplement Label

Statement of Identity: This is essentially the product name, which should include the term “dietary supplement” or a description of its contents (e.g., “Vitamin C Supplement”).
Net Quantity of Contents: This tells the consumer how much of the product is in the container. It could be in units (like “60 capsules”), weight (“100g”), or volume (“500 ml”).
Nutrition Labeling: The “Supplement Facts” panel. It lists serving size, nutrients included, and other dietary ingredients.
Ingredient List: Besides the main dietary ingredients, you also need to list all other ingredients, like fillers or binders.
Manufacturer Information: Include the name and address of your business as the maker, packer, or distributor.

Where to Place These Elements

Principal Display Panel (PDP): This is the front of the package and must show the statement of identity and net quantity of contents. If your package has multiple PDPs (like on different sides of a box), this information must be on all of them.
Information Panel: Typically found to the right of the PDP, this section includes the “Supplement Facts,” ingredient list, and manufacturer information. If there’s not enough room, you might be able to place these details elsewhere on the package, following specific FDA guidelines.

Designing Your Label for Clarity and Compliance

Visibility: Make sure all text is easy to read. This means using a font size at least one-sixteenth of an inch tall and ensuring the text contrasts nicely with the background.
Country of Origin: If your product or its ingredients come from outside the U.S., you must clearly state this on the label.
UPC Bar Code: If you’re selling your product in stores or online, you’ll need a UPC bar code. You can get this from the Uniform Code Council.
Expiration Dating (Optional): While not required, if you choose to include an expiration date, ensure it’s supported by data proving the product remains effective until that date.

Practical Example to Guide You

Let’s apply these rules to a hypothetical product: “John’s Omega-3 Fish Oil Dietary Supplement.”

Front of the Package (PDP): Display “John’s Omega-3 Fish Oil Dietary Supplement” prominently. Below, in a clear font, state “Net Wt. 60 capsules (100g).”
Side or Back of the Package (Information Panel): Here, you’ll include the “Supplement Facts” showing serving size (e.g., “2 capsules”) and other nutritional information. List all other ingredients below the Supplement Facts. Finally, add your business’s name and address.
Design Tips: Use bold and contrasting colors to make the text stand out. Ensure the font size for the net quantity is at least 1/16 inch tall.

Understanding Statement of Identity

The “Statement of Identity” is your dietary supplement’s name. It informs consumers about the nature of the product they are considering. The term or name mandated by federal law or commonly understood identifies the product as a dietary supplement. For example, it could be “Vitamin C Dietary Supplement” or “Herbal Sleep Aid.”

Requirements: The name must include the phrase “dietary supplement,” unless you specify the type of dietary ingredient(s) it contains, like “herbal supplement,” or mention specific ingredients like “bee pollen supplement.”

Flexibility: The term “dietary supplement” can be your statement of identity if it aptly describes your product. Alternatively, you can use a more descriptive term that fits the contents, such as “calcium supplement.”

Placing the Statement of Identity

Where to Place: This statement should be prominently displayed on the principal display panel (PDP) of your packaging. If your product has alternate PDPs (like on different sides of a box), the statement must appear on each.
Visibility: Ensure the statement stands out by using bold typeface and sizing it about the most prominent printed matter on the front panel. This makes it one of the first things a consumer notices.
Orientation: The statement should run parallel to the package’s base, aligning with the general direction in which the consumer will read the package.

Practical Tips for Effective Statement of Identity

Highlight Your Identity: Make the statement of identity the focal point on your label. For example, “John’s Omega-3 Fish Oil Dietary Supplement” should be bold and positioned where it catches the eye immediately.
Use Descriptive Terms: If your supplement focuses on a specific benefit or contains a key ingredient, highlight this in the statement. For instance, “John’s Bone Strength Calcium Supplement” can be more appealing and informative than “Calcium Supplement.”
Ensure Readability: The text must be noticeable and easily readable. Consider the font size, style, and contrast against the label background to ensure clarity at a glance.
Consistent Placement: For products with multiple viewing angles, like cylindrical containers, repeat the statement of identity on all principal display panels to catch the consumer’s attention from any direction.

Statement of Identity Example

For a product like “John’s Probiotic Dietary Supplement”:

Front of the Package (PDP): Boldly state “John’s Probiotic Dietary Supplement.” The font size should be balanced with the package design but clearly legible and larger than most other text on the panel.
Design Consideration: If using imagery or colors, ensure they do not overshadow or interfere with the visibility of the statement of identity. The name should be in a contrasting color to stand out effectively.

Understanding Net Quantity of Contents

This statement tells your customers exactly how much of the supplement they’re getting, whether in capsules, grams, or milliliters.

Requirement: It’s a must-have on every dietary supplement label, ensuring consumers are well-informed about the quantity of the product inside the packaging.

Placing the Net Quantity Statement

Location: The net quantity must be placed in the bottom 30% of the principal display panel (PDP) and run parallel to the base of the container. This makes it easy for customers to find and read.
Exception for Small Packages: If your PDP is 5 square inches or smaller, you have more flexibility with placement as long as the statement is still clear and meets other specified requirements.

Expressing the Net Quantity Statement

How to Express: You can list the quantity in weight, volume, count, or a combination, depending on what makes the most sense for your product.
Unit Requirements: Include both metric (e.g., grams, milliliters) and U.S. customary units (e.g., ounces, fluid ounces) to cater to all consumers.

Calculating the PDP Area

Why It’s Necessary: The area of your PDP determines the minimum font size you can use for the net quantity statement, ensuring readability for your customers.
How to Calculate:
- Rectangular/Square Packages: Multiply the height by the width.
- Cylindrical Packages: Use 40% of the circumference multiplied by the height.

Ensuring Visibility Of Net Quantity Statement

Font Style: The net quantity statement must be easy to read, with letters not more than three times as high as they are wide and a stark contrast against the package background.
Minimum Type Size: The smallest permissible font size depends on the PDP area, with specific measurements ranging from 1/16 inch for small panels to 1/2 inch for large ones.

Content Specifics Net Quantity Statement

Weight-Based Statements: Include only the product weight, not the packaging. The propellant weight is part of the net quantity for aerosol or pressurized packages.
Count-Based Statements: Clearly state the number of units, like “100 tablets.”
Avoiding Exaggeration: Don’t use phrases that might inflate the perceived quantity of the product (e.g., “giant bottle”).

Practical Of Net Quantity Statement

Imagine you’re labeling “Sunshine Vitamin D Capsules”:

Front Panel (PDP): Place “Net Qty: 120 Capsules (150g)” towards the bottom. Ensure it’s parallel to the container’s base for a clean, uniform look.
Visibility & Compliance: If your PDP is 30 square inches, your net quantity statement font size should be at least 1/8 inch, according to the guidelines, ensuring it’s prominent and legible.

Navigating the nuances of nutrition labeling for dietary supplements is crucial for compliance and consumer transparency. The label in question, known as the “Supplement Facts” panel, differs significantly from the “Nutrition Facts” found on food products. Here’s a breakdown to help you understand and implement these labels accurately.

Understanding Supplement Facts Label

This nutrition label designated for dietary supplements provides essential information about the product’s ingredients.

Dietary Ingredients: Unlike food items, you can list ingredients without Reference to Daily Intakes (RDIs) or Daily Reference Values (DRVs) on the “Supplement Facts” panel. However, these are not allowed on the “Nutrition Facts” panel for foods.
Ingredient Sources: The source of a dietary ingredient can be included on dietary supplement labels but not on food labels.
Plant Parts: If a dietary ingredient comes from a specific part of a plant, this detail must be included on supplement labels but is not permitted on food labels.
Zero Amounts: Listing “zero” amounts of nutrients is required on food labels but not allowed on supplement labels.
Required Information: The “Supplement Facts” must detail the names and quantities of dietary ingredients, “Serving Size,” and “Servings Per Container.” The “Servings Per Container” can be omitted if it matches the net quantity statement (e.g., 100 tablets with a serving size of one tablet means 100 servings).

Serving Size Clarifications in Supplement Facts Label

Definition: The serving size is based on the maximum amount recommended on the label per eating occasion, or if no recommendation is provided, one unit (tablet, capsule, etc.).
Flexibility in Wording: The term “Serving Size” must be used without variations.

Declaring Nutrients and Ingredients In Supplement Facts Label

Nutrients to List: Certain nutrients, like total calories, fats, cholesterol, sodium, carbohydrates, dietary fiber, sugars, protein, vitamins A and C, calcium, and iron, must be listed if they are present in measurable amounts.
Vitamins and Minerals: Only need to be declared if added for supplementation or if a claim is made about them.
Other Dietary Ingredients: Those without Daily Values must be listed by name and identified as not having a Daily Value.

Format and Compliance Supplement Facts Label

Display Requirements: The panel must be enclosed in a box with hairlines, have a bold “Supplement Facts” title, and follow specific type size and style guidelines to ensure readability.
Special Provisions for Small and Intermediate Packages: There are allowances for smaller type sizes and alternative formats (tabular or linear) for packages with limited space.

Exemptions and Special Labeling Provisions

Small Business Exemptions: Businesses with annual gross sales below certain thresholds may be exempt from the “Supplement Facts” panel requirement, provided no nutrition claims are made on the label.
Bulk Products: For dietary supplements sold in bulk, nutrition information must be displayed clearly at the point of purchase rather than on individual units.

Understanding Ingredient Labels in Dietary Supplements

An “ingredient” encompasses the active dietary components like vitamins or minerals and other substances used in the product’s formulation, such as binders, flavors, or colors.

Unique Aspects of Ingredient Labeling

Listing Sources in the Supplement Facts: Ingredients that are sources of dietary ingredients (e.g., “Calcium (as calcium carbonate)”) can be listed within the “Supplement Facts” panel. When listed this way, there’s no need to repeat them in a separate ingredient list, provided there are no other ingredients in the product.

Requirements for an Ingredient Label

Necessity of an Ingredient Statement: If all your product’s ingredients are detailed in the “Supplement Facts” panel, and there are no other components like excipients or fillers, you don’t need a separate ingredient statement.
Identification and Placement: If present, the ingredient list must be introduced by the word “Ingredients” or “Other Ingredients” (if some are already listed on the nutrition label) and placed immediately below or beside the nutrition label for visibility.
Type Size for Visibility: The information must be easy to read, with a type size no smaller than 1/16 inch, ensuring prominence and clarity.

Ordering and Declaring Ingredients In an Ingredient Label

Order of Ingredients: Ingredients should be listed in descending order of weight, meaning the most predominant ingredient is listed first.
Declaring Specific Types of Ingredients:
- Spices and Flavors: Can be listed by common names or simply as “spice,” “natural flavor,” or “artificial flavor.”
- Colors: Artificial colors must be listed by their specific names (e.g., “FD&C Red No. 40”), while non-certified colors can be labeled more generally (e.g., “Artificial Color”).
- Fats and Oils: The “and/or” designation allows for varying blends of fats and oils that are not predominant in the product.
- Water and Preservatives: Added water and preservatives must be listed, with preservatives identified by their function (e.g., “preservative” or “to promote color retention”).

Practical Tips for Ingredient Label

Clarity Is Key: Ensure the ingredient list is clear and understandable to the consumer, avoiding technical jargon.
Transparency Builds Trust: Accurately listing every ingredient, including those not required to be listed in the “Supplement Facts” (like binders or fillers), enhances consumer trust.
Compliance Avoids Complications: Adhering to FDA guidelines ensures legal compliance and minimizes the risk of consumer confusion or potential health issues.

Nutrient Content Claims

Nutrient content claims describe a specific nutrient level within a product, like “high in vitamin C” or “good source of fiber.” These claims are regulated to ensure they meet specific FDA-defined levels.

Examples:
- High in Omega-3: This claim means the product contains a significant amount of Omega-3, following FDA guidelines for what constitutes “high.”
- Calcium: Good Source: Indicates that the supplement provides a substantial but not excessive amount of calcium, as per the FDA’s definition of “good source.”

Disclosure Statements

When a product has a nutrient content claim but also contains high levels of certain other nutrients, such as fat or sodium, a disclosure statement is needed to inform consumers.

Example: If a supplement claims to be a “good source of fiber” but has high levels of saturated fat, the label must include a disclosure like, “See nutrition information for saturated fat content.”

Health Claims

Health claims explicitly or implicitly link a nutrient or food substance to a disease or health-related condition, requiring pre-approval from the FDA.

Examples:
- Authorized Health Claim: “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.” The FDA authorized this claim based on significant scientific agreement.
- Qualified Health Claim: “Supportive but inconclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease.” This claim is qualified and must be accompanied by a disclaimer about the level of scientific evidence.

Structure/Function Claims

These claims describe how a nutrient affects the structure or function of the human body, not linking to disease risk reduction. They don’t need FDA pre-approval but must be accompanied by a disclaimer and notification to the FDA.

Examples:
- “Calcium builds strong bones.” This is a straightforward structure/function claim indicating calcium’s role in bone health.
- Disclaimer Required: For any structure/function claim, such as the calcium example, the product must carry a disclaimer stating, “The Food and Drug Administration has not evaluated this statement. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Practical Tips for Labeling

Be Specific: Clearly state the nutrient content, such as “Contains 300mg of Omega-3 per serving,” providing consumers with precise information.

Use Approved Claims: Stick to health claims that the FDA has authorized or for which you can provide a disclaimer for qualified claims.

Highlight Function: When using structure/function claims, focus on the general benefits, like “Supports heart health,” followed by the required disclaimer.

Educate Through Labeling: Use your label as an educational tool. If claiming antioxidants, specify which antioxidants and how they are beneficial, e.g., “Rich in antioxidant Vitamin C to support immune health.”

Other Supplement labeling information

Iron-Containing Dietary Supplements

Suppose your dietary supplement is in a solid oral dosage form, such as tablets or capsules, and contains iron or iron salts intended for use as an iron source. In that case, you must include a specific warning statement on the label. For products containing iron, the specific warning is non-negotiable and must be displayed according to FDA requirements.

Mandatory Warning Statement:
- Text: “WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.”
- Placement: This warning must be prominently and conspicuously placed on the information panel of the product’s immediate container and set off in a box using hairlines. The warning must also appear on the outer package if there’s an outer package.
Example of Compliance:
- Imagine you’re selling “Iron Boost Tablets” for adults. On the side panel of the bottle (immediate container) and the box (outer package), you would include the mandatory warning statement in a clear, boxed format to alert consumers to the potential risks for children.

Packaging Requirements for Iron-Containing Supplements

As of October 17, 2003, the FDA does not enforce unit-dose packaging for iron dietary supplements. This change came after a federal appeals court decision indicating that the FDA lacked the authority to require such packaging solely for poison prevention.

Practical Implication: You’re not required to package each dose of your “Iron Boost Tablets” separately. However, maintaining clear labeling and the specified warning statement is non-negotiable for consumer safety.

Organic Claims on Dietary Supplements

If you wish to label your dietary supplement as “organic,” this falls under the jurisdiction of the U.S. Department of Agriculture (USDA) and its National Organic Program (NOP). To claim your product is organic, ensure compliance with USDA’s NOP standards and regulations.

Regulatory Body: U.S. Department of Agriculture (USDA)
Program: National Organic Program (NOP)
Website: USDA’s NOP Website
Example of Compliance: If your supplement, say “Organic Spirulina Capsules,” meets the USDA’s NOP standards for organic certification, you can label it “organic.” This involves ensuring that your product is produced per NOP regulations, including sourcing certified organic ingredients and adhering to approved manufacturing processes.