FDA Food Label Regulations

Request a Quote

FDA nutrition label help

The FDA Food Labeling Guide is an exhaustive set of rules and regulations you need to become familiar with if you intend to manufacture food products for sale in the United States. The guidelines have become more cumbersome over the years and our clients often find the FDA website difficult to navigate.


The simplified reference or "Quick Start Guide" we are providing here should serve as a primer for the high-level requirements for most food, however you will need to read and follow the specific FDA guidelines for your products. The FDA guidelines include numerous exemptions, variations, and exceptions not covered here, and at the time of this writing there are proposed changes to Nutrition Facts labels.


Note: Foods that do not require nutrition labeling are: whole or ground coffee beans, tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables (e.g., dried garlic), flavor extracts and food colorings.

 

Table of Contents:


Important: Labeling Area

Label Panels

Principal Display Panel (PDP)

PDP - Statement of Identity

PDP - Net Quantity Statement

Information Panel

Font / Type Guidelines for Information Content

Name and address of the food manufacturer, packer, or distributor

Ingredients

Nutrition Facts

Small Business Labeling Exemption

Nutrition Content Claims Defined

Nutrition Facts - Type Specifications

Allergen Labeling

Examples of Graphic Enhancements used by the FDA

Label Exceptions

FDA Nutrition Facts Resources

Disclaimer

 


FDA food label panels

Important: Labeling Area

The following guidelines apply to each panel outlined below: When determining the label area on your package, you are allowed to exclude unusable areas such as flaps, closures, shoulders, and necks. Bottoms of boxes that are easily accessible and viewable by consumers are included in the total calculated area. The size of the labeling area is determined by the total available area for labeling on your container, not just the size of the label you are applying to it.

 

Cellophane windows on boxes and visible parts of cellophane bags are considered labeling area if any labeling is on it—including non-required information such as a price callout label. If there is no labeling on the cellophane, then it’s not considered part of the labeling area.

 

Back to top ⇧

Label Panels


Principal Display Panel (PDP):
Typically the front of the package, this is the main area of your label, the panel the consumer will see first when your products are displayed on a retail shelf. If you have multiple panels on your label that meet this definition, they are considered Alternate PDPs.

 

The PDP is required to include a Statement of Identity (what is the food?) and the Net Quantity Statement (how much of the food is in there?). If your package includes Alternate PDPs, the Statement of Identity and Net Quantity Statement must appear on each of them.

 

Back to top ⇧

1. PDP – Statement of Identity: The name of the food is required to be displayed prominently on the PDP, meaning it must be bold, and at least half the height of the largest text on the label (which would typically be your product name). For example, if the largest font on your package is 18pt type, the Statement of Identity would need to be both bold, and at least 9pt.

 

The food name has to be truthful. Acceptable food names are determined by FDA law or regulation. If a food name suitable for your product has not been defined, you must use the “common or usual” name of the food. If a “common or usual” name does not exist, a reasonable, descriptive name that is clear and not misleading must be used. However, if laws or regulations do not define an acceptable food name, and a “common or usual” name for the food does exist, it must be used or your labels will be considered misleading. In other words, you cannot come up with a completely new name for a food everyone recognizes by an existing, established name.

 

Note: Brand names or logos are not considered part of the Statement of Identity, and they should be appropriately less prominent than the food name.

 

“Fanciful names” are acceptable when the nature of the food is obvious, and the fanciful name is commonly used and understood by the public, for example “Breakfast Patties”. If a fanciful name is used, it must be accompanied by a descriptive phrase at least 1/2 the type size of the food name.  

 

The Statement of Identity must also describe the “form” of the food when different forms are available, for example sliced, shredded, or grated.

 

The product name can be different from the food name required in the Statement of Identity. If you have given your product the name “Snacklyums”, this would typically be the largest text on the PDP, and the actual food name, (Statement of Identity) we’ll say it is “crackers” in this example, would then need to be half the height of Snacklyums. 

 

FDA food label regsRegulations: Name of Food

 

Back to top ⇧

2. PDP – Net Quantity Statement: The Net Quantity is the amount of the product, by weight, measure, or numeric count, for example ’10 biscuits’. If you are using weight or measure, you must include both the US and metric designations. The order is up to you, the metric weight or measure may come before or after the US version, or be above or below it.

Type / Font size is determined by the physical area of the PDP using the following formula:

  • Width X Height for a rectangle or square, or 40% of Product Height X Circumference for cylindrical containers.

 


These guidelines must be followed for the Net Quantity Statement type, and the type must be at least 
the smallest type size permitted based on the PDP’s area:


If your PDP area measures
.................Your minimum allowable type size is:

≤ 5 in² (32.26cm²)..................................................................1/16 in (1.6mm)

> 5 in² (32.26cm²) but ≤ 25 in² (161.29cm²)...........................1/8 in (3.2mm)

> 25 in² (161.29cm²) but ≤ 100 in² (645.16cm²)..................... 3/16 in (4.8mm)

> 100 in² (645.16cm²) but ≤ 400 in² (2,580.6cm²)..................1/4 in (6.4mm)

> 400 in² (2,580.6cm²)...........................................................1/2 in (12.7mm)

Note: Refer back to the “Important: Labeling Area” section for guidance on determining your label area.

 


FDA food label regsRegulations:
Net Quantity of Contents Statements

 

Back to top ⇧

 


Information Panel:
The information panel is the label panel immediately to the right of the PDP, as displayed to the consumer. If this panel is not usable, due to package design and construction, (e.g., folded flaps), then the information panel is the next label panel immediately to the right.

 

Font / Type Guidelines for Information Content (Nutrition Facts have their own requirements, listed under item No. 3 below):

A. The size of Information Panel text must be 1/16 inch at a minimum, based on the lowercase ‘o’, or the uppercase ‘O’ if you are using all capital letters.

B. Letter height cannot exceed 3x the letter width.

C. Sufficient contrast and easy legibility must be used on all required information.

D. If you are including a foreign language translation anywhere on your packaging, you must include the foreign language and the English text for all required information.

E. Design and artwork elements cannot be misleading, or detract from the prominence of the required information.

 

Back to top ⇧


Content required on the Information Panel

Note: No other information or design elements are allowed between the required Information Panel content.

 

1. Name and address of the food manufacturer, packer, or distributor. If the actual manufacturer’s name and address are not included on the food, the name and address of the company whose name is used must also include that company’s relation to the product, for example “manufactured for” or “distributed by”. If the company’s name is readily available in a current city directory or phone book, you can omit the the physical street address and simply include the city or town, state, and ZIP code (For locations outside the US, use a mailing code). Country of Origin for the product is not required, however if you choose to include Country of Origin it must be placed near the company’s name and address information in a similar sized font.

Back to top ⇧


2. Ingredients.
Ingredients must be listed by weight, in order from greatest to least. The ingredients must be on the same panel as the name and address info from item No. 1 above, but they can be located before or after the any nutrition facts, and before or after the name and address. You may list “sub-ingredients” of a food in parenthesis after the ingredient name like this:

Semisweet Chocolate Chips (Sugar, Unsweetened Chocolate, Cocoa Butter, Soy Lecithin [Emulsifier], Vanilla)

Or you may factor in all sub-ingredients as main ingredients listed by weight in order from greatest to least without naming the original ingredient that is compromised of the sub-ingredients.


Back to top ⇧



3. Nutrition Facts:
Nutrition Facts are highly regulated, with prosed changes currently under review. As with all information provided here, read the current FDA regulations and consult with a professional when including Nutrition Facts on your labels. While the FDA has indicated that they will not pursue minor, unintentional mistakes, they must be corrected on future printing once discovered.

 

As mentioned above, foods that do not require nutrition labeling are: whole or ground coffee beans, tea leaves, plain instant unsweetened instant coffee and tea, condiment-type dehydrated vegetables (e.g., dried garlic), flavor extracts and food colorings. However, if spices have nutrient levels significant enough to warrant labeling, then nutrition labeling is required. If your product labeling does not include nutrition labeling, you cannot include any other health or nutrition claims.

 

Note: If you decide to include nutrition labeling even when it is not required, you will need to follow the same guidelines and requirements as food products that are required.

 

When Nutrition Facts are required, they must be placed together with the ingredients and name and address information, either on the PDP or more commonly, the Information Panel. If there is not sufficient space on the Information Panel, Nutrition Facts should go on the next panel to the right. If that panel is also too small, then you may include the Nutrition Facts on any panel visible to the consumer.

 

Back to top ⇧


Small Business Nutrition Labeling Exemption

For low-volume products, an exemption from nutrition labeling is available if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. To qualify for this exemption the person must file a notice annually with FDA.

 

Note: Low volume products that bear nutrition claims do not qualify for an exemption of this type. 

 

Back to top ⇧

 

Nutrition Content Claims Defined

Any statement regarding a nutrient level in the food is a Nutrition Content Claim. Some examples include low fat, high fiber, or fat free.

The FDA has approved specific nutrition content claims, and only their approved claims may be used.

 

Nutrition Content Claims cannot be more than 2x the size or prominence as the Statement of Identity.

 

Nutrition labeling, typically a Nutrition Facts panel, is required if you are including any nutrition claims on your labels. You cannot make nutrition claims if you do not include required nutrition labeling.

 

Note: Regulations now require that your food product have less than 20 parts per million of gluten if you will include “gluten-free’ on your labels.

 

Back to top ⇧

 

Nutrition Facts – Type Specifications

The Nutrition Facts box is required to have high contrast, with dark type on a light, graphic free background, or light type on a dark graphic free background. The information must be enclosed in a box with at least a 1/2-point rule.

 

The example labels from the FDA use Franklin Gothic and Helvetica, but that is not a requirement and any legible font may be used. As long as all type requirements are met, condensed fonts may also be used.

 

The minimum type size for any text in the Nutrition Facts box is 6-point, or you may use all uppercase type that is at least 1/16 inch tall (1.6mm).

 

Label headings such as Amount Per Serving and % Daily Value must be at least 6-point type, while key nutrients must be at a minimum 8-point type.

 

“Nutrition Facts” must be the largest text in the panel, extending the full width of its enclosing box. Examples of other permitted formats (such as horizontal boxes) are outlined on the FDA website in the links below.

 

The FDA recommends 7-point rules for separating the main sections of the box, and a 3-point rule for separating sub-sections.

 

Back to top ⇧


4. Allergen Labeling (when applicable): The eight major allergens that you are required to list if they are included in your product’s ingredients are: milk, egg, fish (species must be listed), crustacean shellfish (species must be listed), tree nuts (specific nuts must be listed), wheat, peanuts, and soybeans. You have the option to list either the name of the food source within the ingredients parenthetically following the name of the food allergen, for example “whey (milk)” or you can say “Contains:” followed by the allergen source(s), for example “Contains: milk, egg, and pistachios.” When using the Contains: option, it must be placed adjacent to or immediately after the ingredients list. Allergen text is required to be the same size (or larger) than the ingredients text.

 

You are not required to include advisory allergen labeling such as “May contain…” or “Processed in a facility that also processes…”, but if you choose to do so it must be factual and not misleading. Since this information is not required, it cannot intervene with required content of information in any way.

 

Back to top ⇧


Examples of Graphic Enhancements used by the FDA

FDA-nutrition-facts-sample-label

Back to top ⇧

 

Label Exceptions: 

1. All required label information can be placed on the PDP.

2. Content required on the Information Panel may be split up onto two Information Panels if there is not enough space on a single panel. When calculating your sufficient space, the entire label area of the package must be considered, regardless of your logo and design elements, or any other non-required information used. If you are using multiple Information Panels, information needs to be grouped together and not split apart. For example, the ingredients should all be on one panel and not split apart.

3. For limited label space, as defined as a label area smaller than 12 in² (77.42cm²), and unusual or odd shaped containers without sufficient label space, it is permissible to include contact info for consumers to access nutrition information, in the form of a phone number or mailing address.

 

FDA food label regsRegulations: General Requirements, Ingredient Lists

Back to top ⇧

 

FDA Nutrition Facts Resources:

 

Nutrition Facts rounding amounts rules

Percent Daily Values calculations

Nutrition Labeling Regulations

Nutrition Content Claims 1

Nutrition Content Claims 2

Gluten-Free Claims

Proposed Changes to the Nutrition Facts Label

Small Business Nutrition Labeling Exemption

 

Back to top ⇧

 

 

Disclaimer: The labeling information provided here is not intended to supplant FDA regulations. You must read the FDA regulations and comply with applicable guidelines, and the materials we are providing here will not release you from that obligation. This reference is not intended as legal advice on how to comply with FDA regulations. You are encouraged to read the FDA guidelines and consult a professional for assistance with your specific packaging.

Back to top ⇧