On September 17, 2024, the Food and Drug Administration (FDA) released a summary report finding that 13 of 210 retail dark chocolate-containing products labeled “dairy-free” actually contained milk allergens. The FDA has labeling requirements for products that contain certain allergens, and it allows voluntary allergy-free claims on products that do not contain allergens.
The U.S. Center for Disease Control and Prevention (CDC) estimates that 6.2% of U.S. adults and 5.8% of U.S. children have a food allergy, or an adverse reaction involving the immune system that occurs soon after eating a certain food. The symptoms of a food allergy can range in severity from hives and lip swelling to more severe life-threatening symptoms, called anaphylaxis, that can lead to swollen airways or digestive issues. There is currently no cure for food allergies, so consumers with food allergies must actively avoid the food to which they are allergic. Though more than 160 foods have been identified to cause food allergies, only nine have been identified by the Federal government as “major food allergens,” accounting for the vast majority of reactions. The major food allergens include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
In terms of the “dairy free” dark chocolate, food products with such a claim are presumed to be totally free of milk allergens. In this instance, the 13 dairy-positive dark chocolate products did not meet the standard. In this context, this article will discuss FDA required allergen declarations as well as its rules around voluntary allergy claims.
Federal Legislation
Since there is no current cure for food allergies and food allergic consumers must avoid eating foods containing the allergen they are allergic to, it is important for food labels to identify the potentially dangerous allergens that a food product may contain. Recognizing this, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). FALCPA modified the Federal Food, Drug, and Cosmetics Act (FDCA) to require foods or ingredients that contain a “major food allergen” be specifically labeled with the name of the allergen source. Under FALCPA, 8 foods were identified as major food allergens – milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In 2021, Congress passed the Food Allergy Safety, Treatment, Education and Research Act (FASTER) which declared sesame as the 9th major food allergen. FALCPA exempts raw agricultural commodities, highly refined oils derived from one of the major food allergens, ingredients derived from such highly refined oils. FALCPA and FASTER do not apply to food regulated by the USDA’s Food Safety and Inspection Service; however, FSIS does try to remain consistent with FDA’s allergen labeling requirements. FSIS’s regulation of allergens is discussed later in this article.
FDA Labeling Requirements
The FALCPA established the requirement that labels identify the food source of all major food allergens used to make the food. FALCPA provides that this requirement is met if the common or usual name of an ingredient already identifies that allergen’s food source name. For example, buttermilk whose common name already includes the word milk would not be required to have an additional statement proclaiming it “contains milk.” For foods whose common name does not identify the allergen, the allergen’s food source must be declared at least once on the food label in either of two ways. First, the allergen could be listed in parentheses following the name of the ingredient. For example, in a prepackaged muffin made with flour, the ingredient list could state “flour (wheat).” This would satisfy the requirement because wheat, the allergen, is declared along with flour, its food source. Second, the allergen could be declared immediately after or next to the list of ingredients in a “contains” statement. For example, a chocolate peanut butter cup which contains peanuts, milk, and soy, could have a statement right under the ingredients list which says, “contains peanuts, milk, and soy.”
Additionally, foods that contain tree nuts, fish, or crustacean shellfish are required to declare the type of tree nut and the species of fish and crustacean shellfish.
Cross-Contact and Good Manufacturing Practices
Along with accurately labeling the allergen’s presence in foods, food manufacturers are also required to follow good manufacturing practices and implement appropriate preventative controls to prevent allergen cross-contact. Allergen “cross-contact” is defined as the unintentional incorporation of a food allergen into a food. 21 C.F.R. § 117.3. Practices such as failure to adequately clean shared equipment and failure to properly segregate allergens may lead to allergen cross-contact contamination. The FDA’s “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food” rule established requirements for facilities that manufacture, process, pack or hold human food. Among the requirements are measures to prevent allergen cross-contact. For example, the regulations for the good manufacturing practices for equipment and utensils require that “seams on food-contact surfaces must be smoothly bonded or maintained so as to minimize accumulation of food particles . . . and thus minimize the opportunity for . . . allergen cross-contact.” 21 C.F.R. § 117.40(b).
Voluntary Allergen Information on Food Products
Though food manufacturers are required to follow the measures established to prevent allergen cross-contact, there might still be a product that bears a disclaimer saying, “produced in a facility that also uses [allergen].” This declaration is called an “allergy advisory statement.” These are voluntary statements that may only be used in certain situations if a manufacturer has incorporated good manufacturing processes in their facility and taken every precaution to avoid cross-contact, but cross-contact is unavoidable. The FDA states that allergy advisory statements, like “may contain [allergen],” should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading. Thus, a food manufacturer cannot disobey allergen cross-contact requirements, print a disclaimer on their packaging and assume they are free of any responsibility.
A manufacturer can also use a voluntary “allergen-free” claim to show to consumers that certain allergies are absent from the product. There are currently no regulations defining specific conditions or allergen levels a product must meet to make a “free” claim. The one exception is for gluten which, though not considered one of the “major food allergens,” does have a defined threshold it must be under for a product to claim it is “gluten-free.” 21 C.F.R. 101.91. For example, for a product to bear a “gluten-free” claim, the product must contain less than 20 parts per million of gluten. However, since there is no regulatory definition for other allergy-free claims, the FDA does not look at the level of allergen present, but instead assumes the product is free of all allergens it claims to be free of. For example, if a food product claims it is “peanut-free,” the FDA would expect there is no peanut allergens present in the product. In addition, allergen-free claims, like all food labels must be truthful and not misleading. The FDA states that use of both an allergy-free claim and an allergy advisory statement for the same allergen on a product should be avoided because it provides inconsistent information to consumers.
USDA Regulations
The FALCPA and the FASTER Act did not amend the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act as they amended the FDCA. However, the USDA’s FSIS, the agency that handles food safety for USDA, encourages the use of allergen statements consistent with the FALCPA. FSIS requires meat, poultry, or egg products to declare all its ingredients in an ingredient statement and supports the practice of including voluntary statements on labels to alert consumers of the presence of specific ingredients. Similar to the FDA’s allergen labeling requirements, in FSIS’ Allergens – Voluntary Labeling Statements guidelines, FSIS supports the use of phrases declaring the presence of allergens, such as “contains milk, wheat, soy” following the ingredients statement and the inclusion of statements like “whey (from milk)” in the ingredient statement. Additionally, voluntary statements about the product’s manufacturing environment may be used if the manufacturer cannot reasonably eliminate allergens through good manufacturing practices and effective sanitation standard operating procedures. Like the FDA, FSIS states that a declaration about the product’s environment is not a replacement for failing to follow good manufacturing and sanitation practices.
FDA Dark Chocolate Report
The sample collection and analysis FDA completed on retail dark chocolate-containing products revealed that 13 of the 210 tested products contained milk allergens while bearing a “dairy-free label.” Because the FDA does not define “dairy-free,” there is no level of milk allergens that can be present in a product with that label. Instead, the FDA considers the claim “dairy-free” to mean that the product is completely free of milk allergens. Thus, since 13 of the 210 tested “dairy-free” products contained milk allergens, those 13 products are not in compliance with the FDA’s regulations.
Additionally, of the 13 dairy-positive products, each of their labels warned that the product was manufactured in a facility where milk was processed. However, the inclusion of this statement does not change the meaning of the label claim “dairy-free,” nor does it absolve the manufacturer from responsibility should a milk-allergic consumer consume the product. Following the results of sample collection and analysis, FDA is working with the product manufacturers to ensure the manufacturer’s products are safe and in compliance with applicable regulations. Though the products were not in compliance with FDA’s regulations, the FDA states it is unaware of any consumer adverse reactions associated with the 13 dairy-positive products. The 13 products came from three manufacturers, two of which have already removed the “dairy-free” claim from their products and one which has agreed to remove the claim if its analysis shows the cause of milk’s presence in the product could not be determined and eliminated.
To learn more about FDA’s regulation of food allergens, click here to read its Major Food Allergen Labeling and Cross-contact Draft Compliance Policy Guide.
For an article discussing the most recent addition to “the big nine,” click here to read NALC article, “Sesame Allergen Labeling – The Big-9?”