The first job of a food label is to catch the consumer’s eye. A good label makes us want to try what’s inside the package. A label accomplishes this by being attractive and by telling the product’s story. What is it? Why should we want to buy and eat it? The story may vary a great deal depending on the product. But there are some elements of the story that each and every food product label is required to tell. These elements are mandated by federal labeling regulations.
Food labeling regulations are designed to ensure a consumer has all the information about the product he or she needs to make an informed buying decision. More specifically, the regulations ensure a consumer can reliably find accurate information on a food product label regarding product identity, quality, nutrition, and relevant health and safety information.
What we see on a food label today is the result of many years of laws and regulations, including the Food, Drug, and Cosmetic Act of 1938, the Fair Packaging and Labeling Act of 1966, the Nutrition Labeling and Education Act of 1990, and the Food Allergen Labeling and Consumer Protection Act of 2006. All of these laws have led to a complicated and sometimes confusing set of standardized labeling requirements. Fortunately, breaking down the requirements into a basic set of guidelines makes it easier to design food product labels that are compliant with all the relevant regulations while still being eye-catching.
There are five pieces of information that are required on all food labels with few exceptions: a statement of identity; a net weight or contents statement; the Nutrition Facts panel; an ingredients statement; and a statement that gives the name and place of business of the product’s manufacturer, packer, or distributor. Label designers should note there are general requirements for how this information must be presented in terms of type style and size, as well as label location.
The statement of identity is preferably the common name of the food, although a unique name may be used if no common name exists as long as the name is descriptive enough to allow the average consumer to understand what the product is.
The net weight or contents statement describes the amount of edible product in the container by weight, volume, or numerical count as appropriate. Weights and volumes must be listed in both English and metric units.
The Nutrition Facts panel is familiar to most consumers. Label designers need to know the formatting requirements for the Nutrition Facts panel are rigorous in terms of layout, type style and size, and so on. It’s not enough to have the correct information; it must be properly formatted as well. Also of note, on May 20, 2016, the FDA announced a redesign of the panel to incorporate changes in formatting and in some of the nutrient content information required. Food manufacturers with $10 million or more in annual sales will need to use the new label design by July 26, 2018; smaller manufacturers will have an additional year to comply.
The ingredients statement must follow the Nutrition Facts Panel and must list all of the ingredients in the product in descending order of predominance by weight. The regulations lay down specific requirements for how various ingredients need to be identified. This is another area of label design that often trips up food manufacturers.
The name and place of business of the food product’s manufacturer, packer, or distributor statement must follow the ingredients statement and may consist of a business name, city, and zip code if the business’ street address may be found in a public directory under the business name. Otherwise, the complete address must be found on the label.
A food label is typically divided into two main areas for purposes of describing required label information. One area is termed the Principle Display Panel (PDP). The PDP is the main area of the label that is normally presented to the consumer. If there is additional space on the label, the PDP will normally contain the statement of identity and the net contents statement. The other label area that is identified for regulatory purposes is the Information Panel (IP). This is the area of the label immediately to the right of the PDP. If that area is unsuitable for labeling then the IP may be placed elsewhere, such as on the back of the container.
Labeling regulations state the Nutrition Facts panel, the ingredients statement, and the name and place of business of the food product’s manufacturer, packer, or distributor must be presented in sequential order on the label and without any intervening material. Optional but commonly supplied label information such as barcodes, graphics, website addresses, and the like are considered intervening material if they act to separate any of the required information. For example, if a manufacturer lists a website after the company name and before the city and zip code that would be considered intervening material and the label would be non-compliant. Similarly, inserting a picture after the Nutrition Facts panel or after the ingredients statement would also render the label non-compliant.
These five pieces of information are mandatory for all food labels, but label designers should be aware that other information may also be required on the PDP and/or IP if some types of nutrient content claims are made.
Undeclared allergens have become the most common cause of U.S. product recalls due to mislabeling. Most often this is the result of accidental allergen cross-contact during production or a formulation change that unwittingly replaces a formerly non-allergenic ingredient with an allergen-containing ingredient.
A rigorous allergen control program in combination with good allergen labeling practices should help minimize the incidence of allergen-related recalls. In an effort to raise awareness and strengthen allergen control measures industry-wide, the new preventive controls rule of the Food Safety Modernization Act (FSMA) requires most food processors to create and implement a robust allergen control program if they do not already have one.
Regulations mandate allergen labeling if a food product contains one of the so-called big eight allergens: eggs, milk, soy, peanuts, tree nuts, fish, crustacean shellfish, and wheat. It is important to note that regulations also require the type of tree nut, the type of fish, and the type of crustacean shellfish to be specifically declared because these types of allergies can be species specific and a person who is allergic to pecans, for example, may not be allergic to almonds.
Manufacturers sometimes ask what constitutes a “tree nut.” The FDA considers the following list to be tree nuts for allergen labeling purposes: almond, beech nut, brazil nut, butternut, cashew, chestnut (Chinese, American European, Seguin), chinquapin, coconut, filbert/hazelnut, ginko nut, hickory nut, lichee nut, macadamia nut/bush nut, pecan, pine nut/pinon nut, pili nut, pistachio, sheanut, and walnut (English, Persian, Black, Japanese, California)/heartnut/butternut. Also, crustacean shellfish such as lobster, crab, shrimp, and so on are considered allergens, but molluscan shellfish, such as oysters, clams, mussels, or scallops, are not.
There are two basic options for declaring an allergen on a food label. First, the declaration may be made in the ingredients statement. If the allergen is clearly identified by its common name, such as milk, then no further label declaration is required. If the ingredient is derived from an allergen, but not clearly identified by name, then a parenthetical statement may follow the ingredient in the list to identify the allergen. For example, whey protein is derived from milk but does not contain the word “milk” in its name. In this instance, allergen-labeling requirements is satisfied by listing “whey protein (milk)” in the ingredients statement.
The other option for allergen labeling is through the use of a “Contains” statement. This type of statement lists allergens in the product immediately after the ingredients statement. In the example listed above, the manufacturer could list whey protein in the ingredients statement and follow that with “Contains milk.” Note that the “Contains” statement must immediately follow the ingredients statement as a separate line and must use the same font size and style as the ingredients statement. The “C” in “Contains” also must be capitalized. If a manufacturer chooses to use a “Contains” statement, it must list all allergens present in the product, even if they also are identified in the ingredients statement.
The FDA prefers manufacturers to either identify all allergens in the ingredients statement, using parenthetical identifications as necessary, or to use a “Contains” statement. Some manufacturers use both, and while this is not a violation, it is discouraged.
Finally, many manufacturers choose to use additional allergen warning statements such as, “This product was manufactured in a facility that also manufactures products containing peanuts.” The FDA does not recognize these statements, but does not prohibit them. The agency has indicated such statements cannot take the place of a proper allergen control program. In addition, such statements may be considered disallowed intervening material depending on where they are placed on the label.
Additional Labeling Requirements
Food manufacturers should also be aware that there is a long list of labeling regulations related to permitted health and nutrient content claims. The regulations are very specific in terms of what kind of claims can be made and how they can be made. Food manufacturers wishing to make such label claims should carefully review the applicable regulations before finalizing their label design.
Imported foods must comply with all U.S. labeling requirements. In addition, processed foods not originally manufactured or processed in the U.S. must declare that product’s country of origin on the label. The only exception to this requirement is if the product is “substantially transformed” by further processing in the U.S.
Finally, there are some label elements that are commonly seen on food products that are surprisingly not required by regulation. One example is UPC coding. This may be required by various wholesalers and/or retailers to facilitate inventory control, pricing, and collection of sales data, but they are completely optional as far as the government is concerned.
For more information on labeling:
- Electronic Code of Federal Regulations, Title 21, part 101 – Food Labeling
- FDA Guidance for Industry: A Food Labeling Guide
- FDA Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance
McGlynn is a horticultural food scientist at Oklahoma State University’s Robert M. Kerr Food & Agricultural Products Center, which strives to discover, develop, and deliver information that will stimulate and support the growth of value-added food and agricultural products and processing in Oklahoma. Reach him at firstname.lastname@example.org.