FDA Food Product Labeling & Packaging Requirements | ESHA Research (2024)

March 15, 2022

FDA Food Product Labeling & Packaging Requirements | ESHA Research (1)

The FDA regulates most packaged foods sold in the United States and has specific requirements for what elements a package must contain (e.g. a Nutrition Facts panel, ingredient statement, etc.). In order to sell your food products, you must comply with the FDA’s packaging laws unless your operation is exempt.

The regulations are a little complicated, but this blog should help offer clarity. We will cover the basics of packaging regulations, including:

  • Packaging Areas
    • Principal Display Area
    • Information Panel
  • Required Packaging Elements and Placement
    • Statement of identity, or name of the food
    • Net quantity of contents, or amount of product
    • Nutrition Facts Label
    • Ingredient Statement
    • Allergen Declaration
    • Name and address of the manufacturer, packer, or distributor
  • Additional Information
    • Nutrient Content Claims
    • Barcode
    • Best before, expiration, or sell-by date

Packaging Areas Defined

FDA Food Product Labeling & Packaging Requirements | ESHA Research (2)

Before we discuss placement, it’s important to understand what each area is called and where it is on the package.

PDP (Principal Display Panel)

This is the area most likely to be seen by a buyer at the time of purchase. For a rectangular container like a cereal box, thePDP areais the product of the height times the width. For a cylindrical container like a can, thePDP areais 40 percent of the product of the height times the circumference.

Information Panel

The information panel is the panel (or space, if the package is cylindrical) immediately to the right of the PDP.

Required Packaging Elements and Placement

Statement of Identity

The Statement of Identity is the legal name of the food (example: Nilla Wafers), the common name of the food (example: peanut butter), or, when the other two are not appropriate, a description of the food (example: whole green peas). This is not the same as the brand name (example: Kellogg’s).

Placement:The Statement of Identitymust be placed on the PDP as one of the primary art elements. The font type height should be, at a minimum, half the size of the largest font on the package.

Net Quantity of Contents

Net quantity is simply the amount of food in the package, shown as a weight, fluid measure, or the number of items.

Placement: This is placed in the bottom 30 percent of the PDPin a type height determined by total PDP area, per this chart:

FDA Food Product Labeling & Packaging Requirements | ESHA Research (3)

Nutrition Facts Label

FDA Food Product Labeling & Packaging Requirements | ESHA Research (4)

The Nutrition Facts Label is used to communicate important information about the food consumers eat. The FDA also governs what label format to use on your productbased on package size and contents.

The Nutrition Facts Label must show:

  • Serving size (Consult the RACCto determine this)
  • Household measure/common household unit
  • Servings per container
  • Mandatory nutrients (total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, potassium)

Placement: In general, place the Nutrition Facts Label on the PDPor the Information Panel, near the ingredient statement.

Ingredient Statement

You must display the ingredient statement on thesame panel as the manufacturer’s information. The ingredients are listed in descending order of weight in a type at least 1/16” tall and easy to read.

Placement: In general, place the Ingredient Statementon the PDPorthe Information Panel, near the Nutrition Facts label.

Allergen Declaration

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandates that packaged food items must declare, in plain language, the presence of any major food allergens (Milk, Egg, Fish, Crustacean shellfish, Tree nuts, Wheat, Peanuts, Soybeans, Sesame) on the product packaging.

Placement: In general, place the Allergen Declaration on the PDP or the Information, near the Nutrition Facts Label.

Allergens may appear either:

  • In a parenthetical directly after the name of the ingredient within the ingredient statement.Example: Peanut butter (peanuts), casein (milk), spice (sesame)…

OR

  • In a separate “Contains” statement.Example: Contains peanuts, milk, and sesame.

Name and Address of the manufacturer, packer, or distributor

The food package must show the name of the manufacturer (or packer/distributor, accompanied by a qualifying phrase that states the firm’s relationship to the product, e.g., “manufactured for” or “distributed by”) and the full street address.

Placement: Most often, this goes on theInformation Panel,but, again can appear on the PDP.

Additional Packaging Elements

Nutrient Content Claims

A Nutrient Content Claim is any statement regarding a nutrient level in your food (examples: “low fat,” “high fiber,” “sugar-free”).

FDA Food Product Labeling & Packaging Requirements | ESHA Research (6)

Regulations determine what claims are valid.

Claims can bedisplayed on the PDP, Information Panel or anywhere else on the package, in a type size that can’t be larger than twice the size as the font used for the Statement of Identity.

Important: If you choose to use a Nutrient Content Claim on your package, you must have a Nutrition Facts Panel showing that nutrient and its value.

Barcode

No government regulatory agency requires that your food package have a barcode. Most retail establishments, however, will. The barcode must be placed in a manner where it doesn’t interfere with the required elements.

Best before, expiration, or sell-by date

Some states require dates on some foods. You will need to check into the specific regulations for your state and food.

As far as placement on the package, the date cannot interfere with required labeling elements and must show the month, day, and year immediately adjacent to an explanatory phrase (“best before,” “sell by,” etc.)

Learn More

eBook: Food Labeling 101

For a more extensive and printable version of this blog, download our ebook:Food Labeling 101.

FDA eCFR Resources

For more information on the regulations, please refer to theCode of Federal Regulations. Use the drop-down menu to select Title 21 and click on 100-169 under Browse Parts.

Tag(s): Food Labeling

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FDA Food Product Labeling & Packaging Requirements | ESHA Research (2024)

FAQs

FDA Food Product Labeling & Packaging Requirements | ESHA Research? ›

FDA-regulated food packages must contain these 5-6 components: Statement of identity, or name of the food. Net quantity of contents, or amount of product. Nutrition Facts.

What are the FDA requirements for product labeling? ›

All labels must be designed and applied to devices and containers so that the labels will remain in place and legible during the customary conditions of distribution, storage, and use. Likewise, other labeling, such as user instructions, should remain legible during customary storage and use.

What are the 5 mandatory requirements in labeling packaged food? ›

Food Product Labeling and Packaging 101
  • Statement of identity, or name of the food.
  • Net quantity of contents, or amount of product.
  • Nutrition Facts Label.
  • Ingredient Statement.
  • Allergen Declaration.
  • Name and address of the manufacturer, packer, or distributor.

What is the FDA required component of a food packaging label? ›

The FDA requires the food name to be displayed on the front of the food package. The FDA requires the weight of the food, excluding the weight of the package or packing material.

What are the general requirements for Labelling of food? ›

Key content of the labeling requirements are summarized below.
  • Language. ...
  • Designation/description of the food. ...
  • Ingredient labeling. ...
  • Minimum net weight/volume/number of package content. ...
  • Name and address of manufacturer/importer/country of origin. ...
  • Best Before / Expiration Date Requirements. ...
  • Prohibited statement/claims.

What are 3 requirements for labeling under the Fair Packaging and Labeling Act? ›

This Act directs the Commission to issue regulations requiring that all consumer commodities other than food, drugs, therapeutic devices, and cosmetics be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor.

What are the rules for product labeling? ›

Labels must not be misleading about things like:
  • quantity or size.
  • the price.
  • what it's made of.
  • how, where and when it was made.
  • what you say it can do.
  • the people or organisations that endorse it.

Does food packaging need FDA approval? ›

The FDA regulates the safety of ingredients added directly to food and substances that come into contact with food, such as those added to packaging materials, cookware or containers that store food. Food manufacturers are responsible for marketing safe foods.

Does the FDA require all ingredients to be listed? ›

Food manufacturers are required to list all ingredients in the food, unless ingredients are subject to an exemption from this requirement such as incidental additives.

What does federal law require on a food label? ›

Under section 403 of the FD&C Act (21 USC § 343), every food label must contain the name of the food, a statement of the net quantity of contents (typically net weight), and the name and address of the manufacturer or distributor.

What are the mandatory parts of a food label? ›

Most food labels must include:
  • a nutrition facts table, which shows: serving size. calories and nutrients. % daily value (% DV)
  • a list of ingredients, including: added sulphites. common allergens. gluten sources (when present as ingredients or components of ingredients)
Jan 8, 2024

What information is not required on food labels? ›

5. Trans Fat
Table 1: Nutrition Labels 101: What's Optional?
Calories from FatOther CarbohydratesRiboflavin (Vitamin B2)
Polyunsaturated FatVitamin ANiacin (Vitamin B3)
Monounsaturated FatVitamin CFolate
Soluble FiberVitamin EVitamin B12
3 more rows
Oct 17, 2017

What needs to be on a product label? ›

Name and address of the manufacturer, packer, or distributor; Product description, including contents, materials, and the amount of the product included. You may also include a serial number or a batch number for tracking purposes; Compliance marks for specific regulatory standards.

What are the product requirements for the FDA? ›

The FDA requires that you show that the new device is safe and effective for its intended use. The purpose of the product requirements document (PRD) or product spec is to clearly and unambiguously articulate the product's purpose, features, functionality, and behavior.

What are the Labelling requirements? ›

Name of the food product or where no name is known, a name or description of the food that clearly states the true nature of the food. Labels must tell the truth. Labels must be clear, in full view and in English.

What are the 7 sections that a product label needs to have to be in compliance with the Hazard Communication Standard? ›

Labels for a hazardous chemical must contain:

Name, Address and Telephone Number • Product Identifier • Signal Word • Hazard Statement(s) • Precautionary Statement(s) • Pictogram(s) Page 3 3 above, the label could state, “Do not breathe vapors or spray. Get medical attention if you feel unwell.

What are the three categories of labeling requirements? ›

Among the claims that can be used on food and dietary supplement labels are three categories of claims that are defined by statute and/or FDA regulations: health claims, nutrient content claims, and structure/function claims.

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