U S Food Allergen Labeling Requirements
The
Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (or Title
II of Public Law 108-282) is a law that was enacted in August 2004, which recommended
that producers of meat products, poultry products, and egg products, which are
regulated by the US Department of Agriculture (USDA), contact appropriate USDA
agency staff regarding the labeling of such products. There are eight major food allergen, or eight
foods/food groups that contain allergenic protein substances which can be derived
from one of those ingredients are under FALCPA can be one of the following:
a. Milkb. Eggc. Fishd. Crustacean shellfishe. Tree nutsf. Wheatg. Peanutsh. Soybeans
There are more than 160 foods have been identified to cause food allergies in sensitive individuals, where 90 percent of all food allergies account for so-called major food allergens. Hence, allergens other than the major food allergens are not subject to FALCPA labeling requirements. Nonetheless, all packaged foods regulated by the FDA under the FD&C Act labeled on or after January 1, 2006, must comply with FALCPA’s food allergen labeling requirements. FALCPA labeling requirements apply to foods made with any ingredient, including flavorings, colorings, or incidental additives (e.g., processing aids), that is, or contain a major food allergen. FALCPA’s labeling requirements extend to foods packaged by a retail or foodservice establishment that are offered for human consumption. However, FALCPA’s labeling requirements do not apply to foods provided by a retail food establishment that is placed in a wrapper or container in response to a consumer’s order -such as the paper or box used to convey a sandwich that has been prepared in response to a consumer’s order.
Nevertheless, molluscan shellfish such as oysters, clams, mussels, or scallops are not major food allergens under FALCPA. However, Crustacean shellfish such as crab, lobster, shrimp, or ingredients containing protein derived from Crustacean shellfish are major food allergens. Further, FALCPA requires that in the case of tree nuts, the specific type of nut must be declared, such as almonds, pecans, or walnuts, etc., and in the case of seafood, the species must be declared for fish (e.g., bass, flounder, or cod) and Crustacean shellfish (crab, lobster, or shrimp).
The following are considered “tree nuts” for purposes of section 201(qq), where a name listed as “common or usual name” should be used to declare the specific type of nut as required by section 403(w)(2).
Common or usual name Scientific name
Almond Prunus dulcis (Rosaceae)
Beech nut Fagus spp. (Fagaceae)
Chestnut (all major varieties) Castanea spp. (Fagaceae)
Chinquapin Castanea pumila (Fagaceae)
Coconut Cocos nucifera L. (Arecaceae (alt. Palmae)
Filbert/hazelnut Corylus spp. (Betulaceae)
Hickory nut Carya spp. (Juglandaceae)
Pecan Carya illinoensis (Juglandaceae)
Pine nut/Pinon nut Pinus spp. (Pineaceae)
Pistachio Pistacia vera L. (Anacardiaceae)
FALCPA Labeling Requirements
FALCPA requires food manufacturers to label food products made with an ingredient that is considered as a major food allergen in one of the ways shown at right. Single-ingredient foods must comply with the allergen declaration requirements in Section 403(w) (1). A single ingredient food that is or contains protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, or soybeans, may identify the food source in the name of the food (e.g., “all-purpose wheat flour”) or use the “Contains” statement format.
If a “Contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food. For example, if “sodium caseinate,” “whey,” “egg yolks,” and “natural peanut flavor” are declared in a product’s ingredients list, any “Contains” statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., “Contains milk, egg, peanuts”) in the same type (i.e., print or font) size as that used for the ingredient list.
The wording for a “Contains” statement may be limited to just stating the word “Contains” followed by the names of the food sources of all major food allergens that either are or are contained in ingredients used to make the packaged product. Alternatively, additional wording may be used for a “Contains” statement to more accurately describe the presence of any major food allergens, provided that the following three conditions are met:
- The word “Contains” with a capital “C” must be the first word used to begin a “Contains” statement. (The use of bolded text and punctuation within a “Contains” statement is optional.)
- The names of the food sources of the major food allergens declared on the food label must be the same as those specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus plural terms (e.g., walnut versus walnuts) and the synonyms “soy” and “soya” may be substituted for the food source name “soybeans.”
- If included on a food label, the “Contains” statement must identify the names of the food sources for all major food allergens that either is in the food or are contained in ingredients of the food.
Nutrition Labeling
Even when using the tabular display, the nutrition information must be set off in a box. 21 CFR 101.9(d)(1)(i)
The name may be placed above the box that encloses the nutrition information. 21 CFR 101.9(c) & (d)
There is no requirement that any information other than the net quantity of contents and statement of identity be printed parallel to the base of the package. However, the FDA urges manufacturers to strive for consistency of presentation of nutrition information in the market and place the Nutrition Facts label so that it is readily observable and legible to the consumer at the point of purchase.
The vertical format may be broken in either of the following ways: (1) placement of the footnote to the right of the panel or (2) all vitamins and minerals that are listed voluntarily (i.e., after iron) may be moved to the top right of the panel along with the footnote. 21 CFR 101.9(d)(11)
Nutrient Declaration
FDA considers information that is required or permitted in the Nutrition Facts label that is on the front label or elsewhere on the package outside the Nutrition Facts label to be a Nutrient Content Claim (NCC). In such cases, the package label must comply with the regulations for nutrient content claims. 21 CFR 101.13(c)
In addition to the nutrients shown on the label as regulated, manufacturers may add calories from saturated fat, polyunsaturated fat, monounsaturated fat, potassium, soluble and insoluble fiber, sugar alcohol, other carbohydrate, vitamins, and minerals for which Reference Daily Intake (RDI’s) have been established, or the percent of vitamin A that is present as beta-carotene. 21 CFR 101.9(c)
Only those nutrients listed in FDA’s nutrition regulations, as mandatory or voluntary components of the nutrition label, may be included in the Nutrition Facts label. 21 CFR 101.9(c)
In addition to the nutrients shown on the sample labels in the guidance document, other nutrients (listed in FDA’s regulations, e.g., thiamin) must be included in a food’s Nutrition Facts label if the nutrients are added as a nutrient supplement to the food, if the label makes a nutrition claim (such as a NCC) about them, or if advertising or product literature provides information connecting the nutrients to the food. 21 CFR 101.9(a), 21 CFR 101.9(c), 21 CFR 101.9(c)(8)(ii)
Generally, FDA only requires that the label declare the vitamins A, C, and the minerals calcium and iron. The other enrichment vitamins and minerals must be declared when added directly to the packaged food (e.g., enriched bread), but not when the enriched product is added as an ingredient to another food. It is necessary to declare the other vitamins and minerals in the ingredient list. However, if unenriched flour is used, and the enrichment nutrients are added separately, those nutrients (i.e., thiamin, riboflavin, niacin, and folic acid) would have to be declared on the Nutrition Facts label. 21 CFR 101.9(c)(8)(ii)(A)(B) and 21 CFR 101.9(c)(8)(iv)
The caloric value of a product containing less than five (5) calories may be expressed as zero or to the nearest five (5) calorie increment (i.e., zero (0) or five (5) depending on the level). Foods with less than five (5) calories meet the definition of “calorie-free,” and any differences are dietarily insignificant. 21 CFR 101.9(c)(1)
Calories must be shown as follows:50 calories or less--Round to nearest 5-calorie increment:E.g., Round 47 calories to “45 calories.”Above 50 calories--Round to nearest 10-calorie increment:E.g., Round 96 calories to “100 calories.”
To determine the total fat content of food, add the weight in grams of all lipid fatty acids in the food (e.g., lauric, palmitic, stearic fatty acids) and expressed them as triglycerides.
Total fat = Weight of all individual fatty acids + weight of one unit of glycerol for each three fatty acids. 21 CFR 101.9(c)(2)
The total fat less than 0.5g is negligible because it is present at a level below 0.5 g. The level of fat is expressed as 0 g. Calories from fat would also be expressed as zero. 21 CFR 101.9(c)(1)(i), 21 CFR 101.9(c)(2)
Below 0.5 grams total fat per serving: Use the declaration 0 grams for total fat. 0.5 grams to 5 grams total fat: Use 0.5 gram increments rounded to the nearest 1/2 gram.
E.g.: 0.5 g, 1 g, 1.5 g, 2 g, 2.5 g, 3 g, 3.5 g, 4 g, 4.5 g, 5 g
E.g., 5 g, 6 g, 7 g, etc.
Calculate the percent daily value (DV) for the appropriate nutrients and Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant and Lactating Women. The percent Daily Value is based on the amount of the nutrient present in the product. 21 CFR 101.9(c)(8)(iv) & (c)(9)
When less than 0.5 grams of dietary fiber or saturated fat is present in a serving of a product, the amounts would be shown as zero on the label. However, when the % DV is calculated based on an actual unrounded fiber or saturated fat content of 0.2 grams per serving, the calculation yields 1 percent. In such cases, the % DV be expressed as zero in these cases to avoid consumer confusion.
Total carbohydrate is calculated by subtracting the weight of crude protein, total fat, moisture, and ash from the total weight of the sample of food. 21 CFR 101.9(c)(6)
Dietary fiber must be listed as a subcomponent under total carbohydrate. 21 CFR 101.9(c)(6)
To calculate sugars for the Nutrition Facts label, determine the weight in grams of all free monosaccharides and disaccharides in the sample of food. 21 CFR 101.9(c)(6)(ii)
Suppose a product contains less than 1 gram of dietary fiber per serving. In that case, fiber is to be expressed as “Less than 1 gram” or “Contains less than 1 gram,” or the manufacturer has the option not to list dietary fiber and include the following statement at the bottom of the table of nutrients: “Not a significant source of dietary fiber.” Protein can be expressed to the nearest whole gram (i.e., 1 g), or the label can state “less than 1 gram” or “Contains less than 1 gram.” The “< “symbol may be used in place of the words “less than” (21 CFR 101.9(d)(7)(i)). 21 CFR 101.9(c)(6)(i), 21 CFR 101.9(c)(7)
When a claim is made on the label or in labeling about sugar alcohol or sugars that sugar alcohols are present in the food, the listing of sugar alcohol is required. 21 CFR 101.9(c)(6)(iii)
The nutrient values declared on the Nutrition Facts label are based on the product’s nutrient profile, as packaged, rounded as required by regulation. Rounding rules are provided in 21 CFR 101.9(c)
The vitamins and minerals that are permitted to be listed voluntarily. If potassium is listed, it should be listed in bold type directly under sodium. Voluntary vitamins and minerals (i.e., those other than vitamin A, vitamin C, calcium, and iron) should be declared horizontally or vertically following the required vitamins and minerals in the order listed in 21 CFR 101.9(c)(8)(iv), 21 CFR 101.9(c)(5) and 21 CFR 101.9(d)(8)
FDA has not stated how a company should determine the nutrient content of their product for labeling purposes. Therefore, there is no prohibition from using “average” values for its product derived from databases if a manufacturer is confident that the values obtained meet FDA’s compliance criteria. Regardless of its source, a company is responsible for the accuracy and the compliance of the information presented on the label.
The use of a database that has been accepted by the FDA affords a firm some measure of security in that the agency has stated that it will work with industry to resolve any compliance problems that might arise for food labeled on the basis of database that the agency has accepted. Use the FDA Nutrition Labeling Manual: A Guide for Developing and Using Databases is available online.
Firms are responsible for the accuracy of the Nutrition Facts label, and there is no assurance that the data from a competitor’s product is valid for another product. Products of similar nature are not necessarily equivalent in ingredients and nutrient value. If FDA found a product to be out of compliance because a firm merely copied its competitor’s label, the firm would be hard-pressed to prove that they labeled the product “in good faith.”
Section 101.9(h)(1) allows the nutrition information for assortments of the same type of food (e.g., mixed nuts or mixed fruits) that are intended to be consumed at the same time to be specified for each component or as a composite value. Therefore, if it is reasonable to assume that a consumer would eat an assortment of the nuts or fruits offered, a single composite analysis may be used to determine the nutrient composition.
References:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide
