Labeling Requirements

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Wholesale/Manufactured Food Program Labeling Requirements

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Labeling Requirements

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Imported foods and foods produced in the United States are required to be labeled. All required information must be legible and in English. Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts and drinks. The following is a brief overview of the basic requirements of a food label.

Basic Food Label Requirements

The food label has three primary panels:

Principal Display Panel

The Principal Display Panel must contain the following information:

Information Panel

The Information Panel must contain the following information:

Note: A website, social media address or internet address is not a substitute for any of the requirements listed.

Allergens

Manufacturers are responsible for ensuring that food is not adulterated or misbranded because of the presence of undeclared allergens. The U.S. Food and Drug Administration (FDA) has identified the following foods that can cause serious allergic reactions in some individuals and account for 90% of all food allergies reactions: peanuts, tree nuts, eggs, fish, crustacean shellfish, wheat, milk and soybeans. These eight foods are “major food allergens” and must meet additional labeling requirements.

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If the “major food allergen” is a tree nut, fish, or crustacean shellfish, the regulation requires additional labeling. For any tree nut the specific type of nut must be declared (e.g., walnut, pecan, almond etc.). The species must be declared for any fish (e.g., flounder, anchovy, cod, etc.) or crustacean shellfish (e.g., lobster, crab, shrimp, etc.).

Sesame

Under the FASTER Act of 2021, sesame is being added as the ninth major food allergen effective January 1, 2023.  Until that time, manufacturers do not have to list it as an allergen, although in most cases it must appear in the ingredient statement. An exception is when sesame is part of a natural flavoring or spice. Another exception is when sesame is not in the common or usual name of a food (e.g., tahini, which is made from sesame seeds). In November 2020, to help consumers who are allergic or sensitive to sesame to avoid these products, the FDA issued a draft guidance to encourage manufacturers to voluntarily declare sesame in the ingredient list when it is used as a “flavoring” or “spice” or when the common or usual name (such as tahini) does not specify sesame. The guidance is intended to help protect consumers who are allergic to sesame by encouraging manufacturers to identify all ingredients that contain sesame right now.

Nutrition Facts Panel

The Nutrition Facts Panel must contain the following information:

Exemptions from Nutrition Facts Panel

The regulations require packaged foods and dietary supplements to bear nutrition labeling unless they qualify for an exemption. One exemption, for low-volume products, applies if the person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and sells fewer than 100,000 units of that product in the United States in a 12-month period. To qualify for this exemption, the person must file a notice annually with FDA. Refer to FDA's Small Business Nutrition Labeling Exemption webpage and Small Business Nutrition Labeling Exemption Guide for more information.

Reference 21 CFR 101.9(J) for other possible exemptions.

Additional Information

The FDA has created its Guidance for Industry: Food Labeling Guide to assist in answering the many questions from manufacturers, distributors and importers about the proper labeling of their food products. This guidance is a summary of the required statements that must appear on food labels under current laws and their regulations. To help minimize legal action and delays, it is recommended that manufacturers and importers become fully informed about the applicable laws and regulations before offering foods for distribution in the United States. 

The Nutrition Labeling and Education Act (NLEA), requires most foods to bear nutrition labeling and requires food labels that bear nutrient content claims and certain health messages to comply with specific requirements.

Note: Chapter 7 (Nutrition Labeling) of the Food Labeling Guide is currently under revision and does not reflect all the most up-to-date labeling requirements.

Until the guide is updated, refer to the Nutrition Facts Label Final Rule for information about updating nutrition labels.

Dietary Supplements

For detailed information on dietary supplements, a special category of products that comes under the general umbrella of foods, but which has separate labeling requirements, see Dietary Supplements.

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