The first thing a consumer sees when purchasing food at the supermarket is the product label. Many decisions are made based on the information provided on the label, and it is the responsibility of the manufacturer to ensure all information is available and accurate. While the components of the label seem fairly simple, it is important to understand the requirements that have to be met to comply with regulations.
The goal of a labeling program is to ensure all food labels comply with government regulatory standards. This is to ensure that the correct and most current information for food products is provided to inform the consumer, avoid possible regulation violations, and prevent products from being subject to recall or disciplinary action.
Although FDA regulates most food products, USDA is in charge of beef, poultry, and pork regulations. USDA regulations are very similar to FDA’s, but there are some differences. Be sure you reference the proper set of regulations for your products.
PRINCIPAL DISPLAY & INFORMATION PANELS. The Principal Display Panel (PDP) is the section of the label the consumer most likely sees when the package is on display on retail shelves. The area of the PDP is determined by the size and shape of the package.
Information that is required on the PDP and any alternate PDPs are the identity and net quantity of the contents. Other information that is required on the PDP or the IP are the ingredient list, including allergens; statement of the responsible company; and nutrition (if for retail sale). Other information may be required depending on the nature of the food and other information on the label. For example, a claim may need additional supporting information.
STATEMENT OF IDENTITY. The statement of identity is the name of the type of food in the package. For example, if the product is bread, it must be named as such. This name may not be false or misleading to the consumer in any way. If this food is an imitation of another food, it must be labeled that way. If there is a standard of identity for the product, it must meet the requirements of that standard.
A standard of identity is a set of criteria that is created to establish the ingredients that are required or allowed in a certain type of food product for it to be named as such. Examples of some products that have standards of identities are enriched bread, flour, sour cream, and mozzarella cheese.
Most food products do not have a standard of identity. If there is no standard of identity for a product, the common name must be used. This is the name commonly known and recognized by consumers. Examples of common or usual names are crackers, cookies, and cereal.
Flavored products also have requirements that must be met. Naturally flavored products do not always have to be designated as “naturally flavored.” However, the natural flavor of a product must be identifiable for that product to be named with that flavor. If a product obtains any of its characterizing flavors from an artificial flavor, it must be labeled as “artificially flavored.”
INGREDIENT STATEMENT. The ingredient statement is the list of all the ingredients used in a product. This statement is required if a food is comprised of two or more ingredients. The ingredients are to be listed in order of predominance by weight of the ingredients used. This means the ingredients must be listed in order of the most used to the least used in that product. Ingredients used at 2% or less do not have to be listed in order of predominance if they are preceded with the statement “contains 2% or less of _______.”
The declaration of artificial colors, artificial flavors, and chemical preservatives must be included in the statement. The function of all chemical preservatives must be declared unless they are natural preservatives such as vinegar, cultured whey, or raisin-juice concentrate.
Groups of ingredients that may be parenthetically listed within the statement are leavening agents, yeast nutrients, dough conditioners, firming agents, and fats or oils.
Incidental additives do not have to be listed in the statement. Incidental additives are defined as substances that are present at insignificant levels and have no function in the finished product. The term “insignificant level” is not defined and is up for individual interpretation. An example of an incidental additive is a processing aid, such as mineral oil. Keep in mind, if an ingredient contains an allergenic substance, the ingredient cannot be categorized as incidental, and must be listed in the statement.
Allergens are a very important part of food labeling and their presence must be listed. The major food allergens in the U.S. include:
- Tree nuts
CRUSTACEAN SHELLFISH. In the case of tree nuts, fish, and crustacean shellfish, the type or species must be declared. There are two ways an allergen can be declared: If the allergen is listed in “plain English” by its food allergen name in the ingredient statement, a supplemental statement is not necessary. If the common or usual name of the ingredient does not disclose the allergen by the food allergen name, you may list the food allergen name in parentheses following the common or usual name of the ingredient. For example, whey is a milk product, so it would be listed as “whey (milk).”
Secondly, a company may choose to use a “Contains…” statement immediately following the ingredient statement. If a “Contains…” statement is used on a food label, the names of all the food sources of the major food allergens used must be declared. For example, if whey and natural flavor containing almonds are declared in a product’s ingredient statement, the “Contains…” statement on the label must identify the sources of the allergens. It would be listed as follows: “Contains milk, almonds.” The “Contains…” statement must be immediately after or adjacent to the ingredient statement in the same font size as the ingredient statement.
NET QUANTITY OF CONTENTS. The Net Quantity of Contents is the amount of food in the package. That is, the amount of the food itself excluding the package. For retail products, the net quantity must be declared in avoirdupois (inch-pounds) and metric units. Typically, the inch-pound declaration is listed first, with the metric following in parentheses. For example, if a packaged food is 12 ounces, its net quantity would be listed as 12 oz. (340 g). For inch-pound units the remainder of a unit can be declared as a common fraction, decimal fraction, or as the smaller unit (e.g., one and one-half pounds would be declared as 1-1/2 lbs., 1.5 lbs. or 1 lb. 8 oz.). Metric declarations may only use decimal fractions, if needed. For products declared by weight, you must include the phrase “net weight” but no phrase is needed for volume measurements.
RESPONSIBLE PARTY. A statement of responsible party must be located on the PDP or IP. The statement must contain the name of the party responsible for the labeling, be it the manufacturer or distributor, and a current address. If the company listed is not the manufacturer, the statement should be qualified with “distributed by,” “manufactured for,” or some other equally informative statement. The address must contain the street address, city, state, and zip code. The street address may be omitted if the responsible party can be found in a local phone book or city directory.
NUTRITION FACTS. The Nutrition Facts Panel can take on many formats. The standard format, which applies to most packages, must be used unless the package meets the definition of an exception. Nutrition facts must be printed in black or in one color that can be easily read, and must be printed on a white or neutral background so as not to distract from the required information. The type style must be easy to read, and contain both upper and lowercase letters. The following statements must be bolded:
- Nutrition Facts
- Amount Per Serving
- % Daily Value*
- Total Fat
- Total Carbohydrates
There are several exceptions to the standard format. However, there are strict guidelines on how and when they are to be used. These alternate formats include simplified, tabular, linear, dual listing, dual language, aggregate, and food for children formats.
THE RACC. FDA has created a way in which serving size is determined based on the amounts normally consumed in a sitting: Reference Amount Customarily Consumed (RACC). Serving sizes are declared using household measures and are calculated differently for discrete units, large discrete units, non-discrete bulk products, and single-serving products.
Household measures are defined as cups, tablespoons, pieces, slices, and ounces that are commonly used in the home and are familiar to the consumer. In the declaration on the label, the common household measurement should be followed parenthetically with the metric weight or volume. For example, a cup of food weighing 245g would be declared as: 1 cup (245g).
Discrete units are products such as sliced bread, cookies, individually packaged cereals in a multipack, or similarly packaged products. If the product weighs 50% or less than the RACC, serving size is determined as the number of whole units most closely approximating the RACC. For example, the RACC for bread is 50g, so if a slice of bread is 22g, you would have to declare two slices as a serving.
If the product weighs more than 50%, but less than 67% of the RACC, the manufacturer may choose between declaring one or two units as a serving. So if a slice of bread weighs 28g, the manufacturer may choose either one slice or two slices as a serving.
Finally, if the product weighs 67% or more of the RACC, but less than 200%, the serving size would be one unit. For example, an 84g muffin would be about 153% of its 55g RACC. So, the entire muffin would be declared as a serving. Products over 200% of the RACC may be declared as a single serving or divided based on the rules for large discrete units.
Large discrete units are declared with “consumer friendly fractions.” These include 1/2, 1/3, 1/4, 1/5, 1/6, or a smaller fraction that can be found by dividing one of the previous fractions by 2 or 3. These fractions are most commonly found on foods such as pies, pizzas, and cakes. The serving size for this type of product would be found by dividing the total weight of the product by the RACC and finding the closest allowed division.
BULK PRODUCT. Examples of non-discrete bulk products are flour and sugar. They are declared in household units that are closest to the RACC, such as a cup or tablespoon. For example, the RACC for flour is 30g. If the manufacturer found that 1/4 cup of flour consistently weighed 28g, it would be declared as 1/4 cup (28g).
A package is considered to be a single serving if it contains less than 200% of the RACC for that product. However, if the food has a RACC of 100g (or ml) or more and the contents are between 150 to 200% of the RACC, the package can be declared as 1 or 2 servings.
There are several exemptions from nutrition labeling. The following do not have to provide nutrition labeling:
- Food sold in bulk or for further processing.
- Bakeries and delis that primarily prepare a food on-site.
- Food distributed to foodservice or restaurants for further preparation.
- Foods that provide no significant nutrition, such as plain coffee or tea.
- Fruits, vegetables, and fish are under a voluntary nutrition labeling program. FDA provides the nutrition values for the top 20 in each group. food that has no significant nutrition.
- Small businesses do not have to have nutrition information on their packages if they meet one of the two exemptions. First, if the business sells directly to a consumer and has total sales of less than $500,000 or food sales less than $50,000, the business is exempt. The second exemption is item specific: if a company employs fewer than 100 full-time employees and sells less than 100,000 units of a food, that food is exempt from nutrition labeling.
However, the exemption is negated for retail foods if any nutrition information is on the package or any claims are made about nutrients. Additionally, if a company wants to include nutrition on foods that would normally be exempt, it may, but the same rules for formatting of the nutrition panel must be followed. Again, for retail packages, if they include a nutrient claim on the label, the nutrition panel is then required to be present to support the claim.
CLAIMS. Claims are regularly found on packages. FDA regulates claims, and no claim may be made on a package without the agency’s approval or acceptance. Nutrient content claims describe the level of a nutrient found in a product. The two types are explicit and implied claims.
Explicit descriptors are those that clearly define the claim. An example would be “Cholesterol Free,” which clearly means that no cholesterol is present. Implied claims are less specific, and can be open to interpretation. A claim such as “High in Oat Bran,” implies the food is an excellent source of fiber and should meet the definition of that claim.
FDA has defined the terms that are regulated for use in claims. The nutrients or foods with which the terms may be used in conjunction also are defined, including:
- Light/lite – limited primarily to calories and fat.
- Free – can be used with sodium, sugars, calories, fat, and cholesterol.
- Very low – can be used with sodium only.
- Low – can be used with sodium, calories, fat, saturated fat, and cholesterol.
- High/good source – can be used with any nutrient with an RDI or DRV.
- Reduced – can be used with sodium, calories, fat, saturated fat, and cholesterol.
- More – can be used with fiber, protein, vitamins, and minerals.
- Less/fewer – can be used with sodium, calories, fat, saturated fat, and cholesterol.
Regulations require that the presence of a large amount of a “negative” nutrient in a food be disclosed on the label, if the label also contains a claim about another nutrient. The disclosure statement would be similar to the following: “See nutrition information for [negative nutrient(s) that exceed specified levels] content.” The “negative nutrient” levels are based on the RACC amount of the food and the serving size weight for the labeled food. However, meals and main dishes have different levels. The following are the disclosure levels for general foods:
- Sodium – 480mg
- Total fat – 13.0g
- Saturated fat – 4.0g
- Cholesterol – 60mg
Relative claims are those that compare a level of a nutrient in one food to the level in another food. Terms used include light, reduced, less, more, or modified. Packages with these claims must contain the quantitative amount for the nutrient in both foods, usually displayed in a table. The package must also contain the percent of change of the component mentioned in the claim.
Health claims provide information about the relationship between a nutrient or ingredient in a food and a health-related condition. The claim may be explicitly made or may be implied by the use of a symbol such as a heart. The disclosure nutrients previously mentioned in conjunction with nutrient content claims also affect health claims. If the prescribed levels of any of the “negative nutrients” are exceeded, the food is basically disqualified from making many of the approved health claims.
Approved health claims include the relationships between:
- Plant sterol/stanol esters and coronary heart disease.
- Calcium and osteoporosis.
- Lipids and cardiovascular disease.
- Dietary lipids and cancer.
- Sodium and hypertension.
- Soluble fiber from oats, psyllium, and barley and heart disease.
- Folate and neural tube defects.
- Sugar alcohols and dental caries.
- Soy protein and coronary heart disease.
ON THE PLANT FLOOR. Verification is an important step in the labeling program. After each print run, receiving personnel must verify labels to ensure the correct information has been printed. When brought to the packaging line, personnel must verify that the correct label is being used.
Employees responsible for destroying obsolete labels must be educated about the risks involved. It is not enough to simply discard obsolete labels. Each company needs a written procedure for disposing of labels to ensure that they are not used incorrectly. Furthermore, labels that are currently being used at the facility should be stored in a secure location to prevent intentional misuse.
SUMMARY. FDA and USDA regulate food labeling to ensure that consumers are informed. It’s critical that food labels comply with applicable standards and regulations. Before products leave your plant, make sure you’ve correctly listed the principal display and information panels, statement of identity, ingredient statement, net quantity of contents, responsible party, nutrition facts, claims, and other label statements to avoid legal ramifications and to ensure you’re delivering the most accurate product information to your consumers.
The author is Manager, Food Labeling, AIB International.