FDA NORMS FOR FOOD LABELING

LABELING SUMMARY

Course Review

You have completed the Labeling course. You should now be able to:

• Name the basic elements required on the food label.
• Identify whether the mandatory elements on a particular label are in conformance with the regulations including necessary content, format, and placement.
• Name the eight major food allergens identified in the Food Allergen Labeling and Consumer Protection Act and evaluate labels for compliant allergen labeling.
• Identify a nutrient content descriptor and use guidance documents to determine compliance.
• Identify a health claim and use guidance documents to determine compliance.

Major Sections of a Label

There are a number of required sections for an FDA-compliant food label. In this lesson, we will examine each portion, and in the process build a sample food label using all of these criteria. These sections include:

Principal display panel Information panel Statement of identity Net content statement Ingredients statement

Place of business Nutrient panel Health claims Structure function claims Dietary supplements

Principal Display Panel The principal display panel (PDP) is the portion of the label the consumer sees when the product sits on the shelf. It gives consumers basic information to make an informed decision as to whether to purchase the product. 21 CFR 101 requires the PDP to have two mandatory elements: a statement of identity and the net quantity of contents. Statement of Identity 21 CFR 101.3(d) defines the statement of identity as: (1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) The common or usual name of the food; or, in the absence thereof, (3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. Generally, this is considered to be at least 1/2 the size of the largest print on the label. The statement of identity on the packaging shown here is "Buttermilk Pancake & All Purpose Baking Mix."

Net Quantity of Contents 21 CFR 101.105 states the following: (a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. Generally, solid foods should be listed by weight in terms of pounds and/or ounces. Liquid foods should be expressed in a fluid measure, such as fluid ounces. Statutes require that the measurements also be listed using the metric system. On our Buttermilk Pancake packaging, the net quantity of contents is given as being Net Weight 32 oz (2 lb) 907g. Knowledge Check Which of the following principal display labels would pass FDA regulations?               The correct answer is Gardenburger Meatless Riblets. The Meatless Riblets have a statement of identity in the form of "Meaty-Tasting BBQ Soy Ribs," which explains clearly what the product is. ("Meatless Riblets" is the product name but would not qualify as a statement of identity.) The net contents are listed as being "2 riblets, Net Wt 10 oz (284g)." For Myntz, while the net contents are given correctly with "1.75oz (50g)" the packaging does not contain a statement of identity, only the product name and health claims. A corrected version of the Myntz product is shown below, giving a statement of identity of "breathmints." Build Your Own Label: Part 1 Throughout this course, you'll be building your own FDA-compliant label for a food item, using the information you have learned up until this point. Each of these Build Your Own Label activities will show three options, where ONLY one is the correct answer and the other two are incorrect.                                    The correct answer is Spin Foods Wonder Wheat Bites.(Last one) LaMantia Meals Tastee Wheat Cruncherz is missing the required weight of the food. General Foods Tastees includes the weight but fails to do so in metro, and also does not include either the common or usual name of the food or an appropriately descriptive term. Information Panel When discussing food labeling, most consumers instantly think of the information label. The CFR states: The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel. All information required to appear on the label of any package of food under §§101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter. In other words, any mandatory elements from the information panel may appear on the principal display panel instead (although the reverse is not true). There is also a requirement that there should be no intervening material between the elements. Ingredients One of the mandatory elements on the information panel is the ingredient declaration. All ingredients must be listed on the information panel. In determining the order to list the ingredients, 21 CFR 101.4 explains that they "shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel." Additionally, "The descending order of predominance requirements [...] do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., 'Contains __ percent or less of ___' or 'Less than __ percent of ___.' The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate." This "2 percent" rule does not remove the requirement that ingredients must be declared regardless of their level. Designation of Ingredients The CFR states that the "name of an ingredient shall be a specific name and not a collective (generic) name." Ingredient listings cannot list items under vague terms like, "Meat" or "Seafood." If there is an ingredient that has an established name but contains two or more ingredients within it, all sub-ingredients must also be listed. A product that lists ketchup as an ingredient could be declared, "ketchup (tomatoes, vinegar, sugar, salt)" in order to comply to the law. Sub-ingredients do not have to be listed if they are also a primary ingredient; for example, if salt was listed elsewhere in the ingredients it would not need to be listed as a sub-ingredient of ketchup. In the example shown here, the listing "Cheese Powder" is not acceptable; the ingredients for the cheese powder must also be listed in case of allergens. We'll discuss allergens in more detail later in this course. Designation of Ingredients: Oils An exception to the sub-ingredient rule involves oils. Because the type of oils used in a product such as vegetable oil are not a characterizing ingredient of the main product, manufacturers can use "and/or" when listing the possible types of oils that might be included in the vegetable oil. Not all of these oils may actually be present, but in case of allergies all possible ones are listed. Designation of Ingredients: Food and Drugs Not all the labeling requirements are in 21 CFR 101. Foods containing aspartame or sorbitol must contain warnings, per 21 CFR 172 and 21 CFR 184. § 172.804  Aspartame ...(2) The label of any food containing the additive shall bear, either on the principal display panel or on the information panel, the following statement: PHENYLKETONURICS: CONTAINS PHENYLALANINE The statement shall appear in the labeling prominently and conspicuously as compared to other words, statements, designs or devices and in bold type and on clear contrasting background in order to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. § 184.1835  Sorbitol ...(e) The label and labeling of food whose reasonably foreseeable consumption may result in a daily ingestion of 50 grams of sorbitol shall bear the statement: “Excess consumption may have a laxative effect.” Knowledge Check Which of the following ingredient lists would be FDA-compliant? 1) Ingredients: Meatless riblet, barbecue sauce. 2) Ingredients: Meatless riblet (protein, gluten, oil, natural hickory smoke flavor, yeast extract, vegetable gum, salt, water, sodium metabisulfate), barbecue sauce (high fructose corn syrup, water, tomato puree, molasses, distilled vinegar, salt, modified food starch, natural smoke flavor, spices, dried onion, dried garlic, cayenne pepper). 3) Ingredients: Meatless riblet (soy protein concentrate-hydrated, wheat gluten-hydrated, canola oil, natural hickory smoke flavor, yeast extract, vegetable gum, salt, water, sodium metabisulfate), barbecue sauce (high fructose corn syrup, water, tomato puree, molasses, distilled vinegar, salt, modified food starch, natural smoke flavor, spices, dried onion, dried garlic, cayenne pepper). The correct answer is:(3rd one) Ingredients: Meatless riblet (soy protein concentrate-hydrated, wheat gluten-hydrated, canola oil, natural hickory smoke flavor, yeast extract, vegetable gum, salt, water, sodium metabisulfate), barbecue sauce (high fructose corn syrup, water, tomato puree, molasses, distilled vinegar, salt, modified food starch, natural smoke flavor, spices, dried onion, dried garlic, cayenne pepper). If there is an ingredient that has an established name but contains two or more ingredients within it, all sub-ingredients must also be listed. Ingredient listings cannot list items under vague terms like "protein" or "gluten." Food Allergens One current enforcement priority is a failure to declare ingredients that cause adverse reactions. Determining that a food fails to declare an allergenic ingredient or other ingredient is often difficult to do without observing the ingredients used to produce the product or analyzing the product. Additionally, you should look for labeling deviations such as the use of EU designation for a color, or the use of a generic term such as "fish" or "nut" to describe an ingredient. Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the FD&C Act to establish labeling requirements for all FDA-regulated packaged foods that are made with ingredients that either are, or contain a major food allergen, as defined by FALCPA. The law requires specific label declarations for major food allergens in all packaged foods under FDA’s purview, except raw agricultural commodities and ingredients exempt under the definition of a major food allergen, such as highly refined oils and other ingredients. Products with labels that do not comply with FALCPA requirements may NOT be legally introduced into interstate commerce in the U.S., because such products would be considered misbranded under section 403(w)(1) of the Act. Definition of Major Food Allergen FALCPA provides a two-part definition for a major food allergen. First, a major food allergen means the following foods: milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans. These eight foods are believed to account for 90% of all food allergies in the U.S. Second, a major food allergen means a food ingredient that contains a protein derived from one of these foods, with the following two exceptions: A highly refined oil derived from one of these foods or an ingredient derived from such a highly refined oil AND A food ingredient exempt under a petition or notification process specified in the law. FALCPA does not further define "highly refined oils," but the Senate Committee Report that accompanied the bill that became FALCPA states that the term is intended to signify refined, bleached, and deodorized oils. Definition of Food Source of a Major Food Allergen FALCPA defines the names of the major food sources of the major food allergens as well. For some, the name of the food source is the same as the name of the allergen (milk, eggs, wheat, peanuts, soybeans) because in each case the source is already revealed by the identity of the major food allergen. In the case of the collective terms for the three other major food allergens (tree nuts, fish, and Crustaceans), their food source names are: The specific types of tree nuts (such as almonds, pecans, or walnuts), The specific types of fish (such as bass, flounder, or cod), and The specific types of Crustaceans (such as crab, lobster, or shrimp). Label Declarations of Major Food Allergens (1 of 2) The law provides a choice of two ways to label a food that contains a major food allergen as an ingredient. The first option is to identify the presence of major food allergens within the ingredient list. Using this method, the common or usual name of a major food allergen that doesn’t identify the name of its food source must be immediately followed parenthetically by that name. For example, if "whey" was the only ingredient listed on a food label that contained milk protein, it would have to be accompanied by the term "milk" in parentheses immediately after the term “whey.” Label Declarations of Major Food Allergens (2 of 2) The second option is to include a separate summary statement—commonly referred to as a “Contains” statement—immediately following or adjacent to the list of ingredients in a print size no smaller than that used for the ingredient list. The word “Contains” must be followed by a complete list of the food source names for all major food allergens used as ingredients in the packaged food, whether or not some of those food source names were already disclosed within the ingredient list. For example, a “Contains” statement might read “Contains milk and egg” for a food made with the ingredients “whey” and “egg whites.” When Food Allergen Labeling Is Required There is a combination of two situations when FALCPA labeling requirements apply: When the common or usual name of an ingredient that is a major food allergen does not already identify its food source name AND When that major food allergen’s food source name is not already identified elsewhere in the list of ingredients for another "allergenic" ingredient. FALCPA requires that the presence of each major food allergen used as an ingredient be disclosed at least once on the label in plain English terms. While some manufacturers are voluntarily labeling their products with statements such as "may contain (insert name of allergenic ingredient)," this precautionary labeling should NOT be used in lieu of adherence to FALCPA requirements. The "may contain" statement is allowed by a policy decision, but it does not satisfy FALCPA's requirement to have a "Contains" listing on the label. The FDA urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the identified food. Ingredients Subject To FALCPA Labeling Requirements FALCPA’s labeling requirements includes declaring any incidental additives, such as processing aids, flavors, and colors, that contain a major food allergen. Spices are not mentioned in the legislative language for FALCPA because no spice is derived from one of the food sources of a major food allergen. However, if a seasoning mix or blend of spices contains a major food allergen as an ingredient or processing aid (such as wheat flour used as a flow agent), then its presence would have to be declared on both: The label for the seasoning mix or blend if sold as such AND The label of any other fabricated food that includes the seasoning mix or blend as an ingredient. Knowledge Check Is the following label compliant with FALCPA? Answer is No This label is NOT compliant with FALCPA. This is because the common or usual names of the ingredients “flour,” “Ovalbumin” and a “natural flavor” (which, in this case, contains peanut proteins) do not disclose the food source names of the major food allergens: wheat, egg, and peanuts. Although the milk protein “whey” also is listed as an ingredient, the major food allergen “milk” is already disclosed on the label twice as “milk chocolate” and as its sub-ingredient “milk.” Therefore, it is not necessary to again identify “milk” by parenthetically stating it after the term “whey.” The following are two options of how to make the label's ingredient list FALCPA compliant. Name and Place of Business Another mandatory element on food labeling is the name and place of business of the manufacturer, distributor, or packer. This information must be located in a conspicuous place on the label. For the name, in the case of a corporation the corporate name must be used, although it may be preceded or followed by the particular division responsible for the product. In the case of an individual, partnership, or association, the name under which business is conducted must be used. If the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as “Manufactured for ___”, “Distributed by ___”, or any other wording that expresses the facts. The place of business must include a street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. Nutrition Label Introduction Unless a product falls into the category of a nutrition labeling exemption, a food product must contain a nutrition label. As defined in 21 CFR 101.9(d)(12), if the food package has more than 40 square inches of space available for labeling, and at least 3 continuous vertical inches, it should use the full vertical format of a nutrition label. The next screens will explain the different possible formats for the nutrition label, and its mandatory nutritional requirements. Nutrition Label Display There are no specific size requirements for the nutrition label. However, the “Nutrition Facts” heading must be in a type size larger than all other print size in the nutrition label and generally set the full width of the nutrition facts label. Minimum type sizes of 6 point and 8 point are required for the other information in the nutrition label, and there are minimum spacing requirements between lines of text. Nutrition Facts label is boxed with all black or one color type printed on a white or neutral background. The illustration below indicates an example of the graphics FDA uses to display the Nutrition Facts label. Nutrition Label Horizontal Display If there is not sufficient continuous vertical space to accommodate the required components of the nutrition label, the nutrition label may be presented in a tabular, horizontal display instead. Please note that all of the information from the previous, vertical display is included in this horizontal display; it has merely been reformatted. The footnote on the Percent Daily Values is no longer directly under the listing of vitamins and minerals, but is instead set off to one side. Nutrition Label Required Values Nutrition labels must list the following values: Calories Total fat Saturated fat Trans fat Cholesterol Sodium Total carbohydrate Dietary fiber Sugar Protein Vitamin A Vitamin C Calcium Iron Saturated fat, trans fat, cholesterol, dietary fiber, sugar, vitamin A, vitamin C, calcium, and iron may be omitted from the list of nutrients and included in a single sentence when present at “zero” levels in a food. This is done by putting the label statement (“Not a significant source of _________”) immediately below (if present) the listing of vitamins A and C, calcium, and iron. When the statement “Not a significant source of_____________” is used for more than one nutrient, nutrients must be listed in the order in which they would have been listed in the regular format. Trans Fatty Acids Since January 2006, the inclusion of trans fats have been required in the nutrition label. Nutritional labels should not list a percentage daily value for trans fats. The FDA is currently handling any issues relating to trans fats claims on a case by case basis. Nutrition Labeling Exemptions While nutrition labeling is required on most foods, 21 CFR 101.9(j) provides 18 nutrition labeling exemptions. Some of these exemptions include: Insignificant amount of nutrients (e.g., tea) Bulk foods. Medical foods. Raw fruits, vegetables, and fish. Packages with less than 12 square inches. Foods from small businesses. Small Business Exemptions (1 of 2) 21 CFR 101.9(j)(18) defines small businesses able to obtain a nutritional labeling exemption as ones that: Employ less than 100 full-time equivalent employees Sell (or anticipate to sell) less than 100,000 units of a specific product annually in the U.S. Firms file a notice with FDA each year for the nutrition labeling small business exemption. The Center for Food Safety and Applied Nutrition (CFSAN) reviews the notices and enters the information into a database. A list of firms can be viewed on the FDA web site. This only includes the firm name, city, state, country, and renewal date. Exemptions are product specific. Some small businesses may have some products that do not qualify for the exemption, due to nutritional claims or not being of a low enough volume. Small Business Exemptions (2 of 2) FDA employees can, if necessary, gain access to a firm’s entire Small Business Nutrition Labeling Exemption Notice. For security reasons, your District Director must request this access. Health Claims Under 403(r) of the FD&C Act, a food is misbranded if the label bears a nutrient content claim or health claim that has not been defined. A health claim is a claim that expressly, or by implication, characterizes the relationship of any substance, such as a specific food or component of a food, to a disease or health-related condition. There are three types of health claims that may be made on food labels: Nutrition Labeling and Education Act (NLEA) claims Food and Drug Administration Modernization Act (FDAMA) claims Qualified health claims NLEA claims are defined in the Code of Federal Regulations, while FDAMA claims and qualified health claims are not.   Health Claims Authorized Under NLEA Health claims that are authorized under NLEA are listed in 21 CFR 101.72 through 101.83. The categories include: § 101.72 - Health claims: calcium, vitamin D, and osteoporosis. § 101.73 - Health claims: dietary lipids and cancer. § 101.74 - Health claims: sodium and hypertension. § 101.75 - Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease (CHD). § 101.76 - Health claims: fiber-containing grain products, fruits, and vegetables and cancer. § 101.77 - Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. § 101.78 - Health claims: fruits and vegetables and cancer. § 101.79 - Health claims: folate and neural tube defects. § 101.80 - Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries. § 101.81 - Health claims: soluble fiber from certain foods and risk of coronary heart disease (CHD). § 101.82 - Health claims: soy protein and risk of coronary heart disease (CHD). § 101.83 - Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD). An example of a model health claim statement is “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors." FDAMA Health Claim FDAMA health claims are based on authoritative statements made by an appropriate scientific body (from the U.S. Government, the National Academy of Sciences (NAS), or any of NAS's subdivisions) which are used by a firm in a notification to FDA to demonstrate significant scientific agreement. FDAMA claims that have been accepted by FDA are posted on the internet, and include the exact language that must be used in the claim. Qualified Health Claims In recognition of the first amendment's freedom of speech guarantee, FDA is using regulatory discretion to provide for the use of qualified health claims. These claims are considered "qualified" because the language used must indicate the degree of evidence that is available to substantiate the claim. An example of a qualified health claim for walnuts is: Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content. All of the letters issued that allow qualified health claims, on conventional foods or supplements based on regulatory discretion, are posted on the Internet. These claims are subject to change if FDA obtains evidence that a claim is not valid.   Nutrient Content Claims Claims that characterize the level of a nutrient in a food, such as "fat free," are nutrient content claims. Only claims that have been defined by FDA may be used by manufacturers. FDA-defined claims include: High, Good Source Free, Low More, Reduced, Light (fat or sodium) Very Low (sodium) Lean, Extra Lean (seafood & game meats) High Potency When any of these terms (or their synonyms) are used to describe a level of a nutrient, you have a nutrient content claim. The Food Labeling Guide includes two charts that describe the nutrient content claims that have been defined by FDA. Products labeled with undefined claims are misbranded. Other Nutrient Content Claims Truthful, non-misleading statements about the amount of a nutrient in a food are permitted. However, statements cannot imply that the amount of the nutrient present is a lot or a little. It is acceptable for a label to state "5 grams of carbohydrates" because it does not imply a level, but "only 5 grams of carbohydrate" implies that the level is low and is therefore misbranded. Additionally, the term "free" is a defined nutrient content claim that has not yet been defined for trans fats. "0 grams of trans fat" is acceptable but "trans fat free" is not. Nutrient claims must also match the reference amount customarily consumed; a manufacturer cannot state on the front of a product, "200 mg of potassium!" when that amount is actually for consuming the entire amount (consisting of multiple servings) contained in the packaging. Structure Function Claims Claims about the effect of a nutrient on the normal structure, function, or general wellbeing of the body are structure function claims. These claims may be used on conventional foods and dietary supplements. Unlike nutrient content and health claims, a structure function claim does not trigger a nutrition panel requirement on an item otherwise exempt. Structure function claims do not discuss specific diseases. Examples of structure function claims include: Fiber maintains bowel regularity Calcium builds strong bones Promotes relaxation Helps maintain healthy cholesterol levels Knowledge Check (1 of 2) Instructions: Read the statement below, then select which category of claim it applies to. Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke. 1) FDAMA Health Claim 2) Qualified Health Claim 3) Structure Function Claim Answer is  1) "Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke" is an FDAMA health claim. FDAMA health claims are based on authoritative statements made by an appropriate scientific body. Unacceptable Claims Nutrient content claims and health claims have criteria that must be met, and in most cases CFSAN needs analysis to determine if a food does not qualify for a claim. However, there are times when the label provides sufficient information to determine that a food does not qualify for a claim; for example a "fat free" product that declares 3 grams of fat per serving would not meet the definition for a fat free food. Dietary Supplement Claims One enforcement priority is for products represented as conventional foods that are labeled as a dietary supplement. Course Review You have completed the Labeling course. You should now be able to: Name the basic elements required on the food label. Identify whether the mandatory elements on a particular label are in conformance with the regulations including necessary content, format, and placement. Name the eight major food allergens identified in the Food Allergen Labeling and Consumer Protection Act and evaluate labels for compliant allergen labeling. Identify a nutrient content descriptor and use guidance documents to determine compliance. Identify a health claim and use guidance documents to determine compliance.