Food Labeling and Misbranding

Definition of Label and Labeling

It is important to note the distinction between the words ‘label’ and ‘labeling’. Label refers to legible material that is affixed to the packaging which provides information on the product. However, labeling is a broader term that includes the label along with other materials associated with the product but is not affixed to the packaging. These materials include any material designed to promote, sell, and distribute the product such as brochures, videos, audio recordings, and website information. The informational material does not have to accompany the product, as long as it can be found that there is a direct link between the promotional material and the product transaction. Labeling is therefore a form of advertising, so in this case, the FDA has some jurisdiction over advertising. However, regulation of advertising is largely the responsibility of the Federal Trade Commission (FTC).

What is Misbranding?

Labeling is deemed as misbranded if it is “false or misleading in any particular”. This is a very broad definition that provides the FDA with the leverage to take action whenever they find any indication of falsehood or deception in the labeling. Besides this general rule, a product is misbranded when:

1. The product is offered falsely under another name
2. It imitates a traditional food without declaring that it is “imitation”
3. The container is made, formed, or filled to be misleading
4. Label does not contain all the basic required elements such as product name, net weight, ingredient listing, address, or responsible party (e.g. manufacturer or distributor)
5. Information is not prominently placed on the product and cannot be easily read
6. It does not conform to the standards of identity
7. It does not conform to the standards of fill
8. It does not contain the common name or usual name of the food except in the case where the ingredient is a spice, flavoring, or coloring
9. It claims to have dietary benefits without declaring its dietary properties e.g. vitamin and mineral content
10. Artificial additives and preservatives are added without declaring them

Regulatory Components of the Food Label

Labels comprise two main panels or sections, the principal display panel (PDP) and the information panel (IP). The PDP is the part of the label that the consumer is most likely to see on display. It contains the name of the product (statement of identity) and the net weight of the product in both metric and imperial (inch-pound) units. Net weight allows consumers to make fair price comparisons. To the immediate right of the PDP is the IP containing the name and address of the manufacturer, packer, or distributor, the ingredient list, and nutrition label information. Any required allergy labeling is included beginning with the word “Contains”. The label information must be in English or if a foreign language is present, the English translation must also be stated. For readability, the lettering must be legible and conspicuous.

Naming your Product

The statement of identity is the product name shown on the PDP. The statement of identity should not be confusing but should represent what is in the container. In naming a product, the manufacturer should first determine if it is a standardized food. Standardized foods are foods with a standard of identity (21 CFR Parts 131 through 169). A standard of identity is a federally set requirement describing the name of the food product and its characteristics, including what it should contain. These standards were developed to ensure uniformity so consumers will know what to expect wherever they may purchase the product. If there is a standard of identity, a manufacturer must adhere to all its requirements including the given product name. If there is no standard of identity (undefined food) then in naming his product, a manufacturer must aim for simplicity. The name should describe the basic nature of the food. For example, use the name “chocolate covered caramel corn” instead of “superlicious snackable” or other fanciful names.

Fanciful names can only be used when they are generally known and understood by the public e.g. “submarine sandwich”. In some cases, a brand name can be used as a statement of identity if it is commonly used and understood by the public e.g. Pepsi and Coca-Cola. In cases where ingredients are mentioned in a statement of identity, the product should be named based on descending predominance of ingredients. For example, if the product is a cake with a blend of strawberries and apples; where apple content is greater than strawberry, you should name the cake “apple-strawberry cake” and not “strawberry-apple cake” even though strawberries may be the more valuable ingredient.

Products containing artificial flavors should be identified as “artificially flavored”. For example, an apple muffin mix that do not have apples but is instead apple-flavored should be named “Apple Muffin Mix” followed by the words “Artificially Flavored”. The words “Artificially Flavored” should not be less than ½ the size of the product name.

A food that is an imitation of another should be labeled accordingly. Imitation means that the product resembles the traditional, but is inferior in nutritional value. The word “imitation” should be the same size as the product name it is imitating.

Listing Ingredients on Label

An ingredient listing is required when there is more than one ingredient in the product. Listing ingredients allow consumers to avoid allergens and to select ingredients based on their likes or dietary needs. Ingredients should be listed in their common names and must be in decreasing order of their predominance by weight. Some products may have two components. For example, a prepackaged pie may consist of the crust and the filling. In this case ingredients of both components should be listed.

Flavors, spices, and colors used as ingredients may be listed generically as “artificial flavors”, “spices” and “artificial colors” without naming each. If the colors are FDA-Certified, however, the name of the color should be stated e.g. FD&C Yellow No. 5 and FD&C Blue No. 1. Note that butter, cheese, and ice cream are exempted from having to show color except for FD&C Yellow No. 5 which is known to produce allergic reactions and is required to be declared in all foods having this additive.

Flavors should not be confused with flavor enhancers i.e. ingredients added to foods to balance and blend the total perception of other tastes. Examples of a flavor enhancer include monosodium glutamate (MSG) and protein hydrosylates. Protein hydrosylates should be declared by identifying the specific protein from which it is derived e.g. “hydrolyzed corn protein”.

Product Expiration Date

The FDA does not require food establishments to place “expired by”, “use by” or “best before” dates on food products. This information is entirely at the discretion of the manufacturer. Therefore foods may be sold past their expiration date as long as they are wholesome and fit for consumption.

Allergen Labeling

The Food Allergen Labeling and Consumer Protection Act (FALCPA) (2004) amended the FD&C Act to require foods that contain any of the following eight major allergens to declare them i.e. milk, egg, fish, shellfish, tree nuts, wheat, peanuts, and soybeans. Allergens can be declared in one of two ways:

1. Listing the allergen in the ingredient list and putting in parentheses the common name of the allergen (if the common name was not stated in the first place). For example, if the ingredient is “milk” then this is the common name and needs no explanation. However, if the allergen is caseinate, then in parentheses you should put “a milk derivative” or “milk protein”
2. Stating “Contains” followed by a list of the food source from which the allergen is obtained. This statement usually comes after the ingredient list but can also be adjacent to it

Under FALCPA foods must contain less than 20 ppm of gluten to be declared as “gluten-free”. Further, FALCPA requires that “incidental additives” that may cause an allergic reaction, must be declared on the label. Incidental additives are processing aids. They are used at very small concentrations and are present in very negligible amounts in the end product. They, therefore, have no functional effect on the finished product. Since they have no functional effects, the FDA generally exempts the declaration of processing aids from the ingredient listing (21 CFR 101.100(a)(3). However, if the processing aid is an allergen, even at negligible amounts it can cause a functional effect on the finished product and is therefore not exempt from ingredient listing.

“Natural” Labeling

Presently, FDA does not have a definition for “natural”. Therefore, the word natural is not regulated by the FDA. However, the USDA provides guidelines for use of the word on products they regulate. The be accepted as natural by the USDA, the product should not contain any artificial coloring, flavors, sweeteners, or ingredients.

Organic Labeling

The term organic is regulated by the USDA-AMS. Food establishments that meet the USDA National Organic Program standards are able to put a USDA Organic Seal on their product. This mark means that the product has been grown, produced, inspected, and certified to meet national standards. To be certified the operation cannot use, conventional pesticides and fertilizers, sewage sludge, antibiotics, or growth hormones. The products cannot be genetically modified, and the farm must observe sustainable agricultural practices.

New Food Labeling Requirements

Food labels are regulated by the FDA under the Nutrition Labeling and Education Act (1990). In May 2016, the FDA issued final rulings to bring about changes to the nutritional labeling regulations. By 2018, companies earning more than $10M per year will have to comply with the updates while companies earning less will get a year’s extension. Imported goods will be required to meet the new standard as well. See the changes to the label here. Changes include:

1. Number of calories made more prominent
2. Calories from fat removed
3. Percentage daily value (DV) shifted to the right
4. The total percentage of DV for fiber needed to support good health was increased. Therefore new label will show a lower percentage of DV for fiber
5. Added sugars included
6. Vitamins A and C are no longer mandatory
7. Vitamin D and potassium are now mandatory

References:

1. FDA. (2017). Changes to the nutrition facts label. 
2. Fortin N. D. (2009). Food regulation – Law, science, policy, and practice. Hoboken, NJ: John Wiley and Sons Inc.
3. Sanchez, M. C. (2015). Food law and regulation for non-lawyers – A US perspective. New York, NY: Springer International.