The U.S. Food and Drug Administration (FDA) announced the availability of the Final Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug and Cosmetic Act (Edition 5). This final guidance is replacing all previously issued draft and final guidances by FDA concerning allergen labeling. This final guidance expands the definition for some of the major allergens, such as “milk” and “egg,” while limiting the scope of the definition of a “tree nut.” The FDA also addresses issues concerning incidental additives, highly refined oils, dietary supplement products, certain specific packaging and labeling situations and, in a follow up “Q&A,” manufacturing concerns and enforcement deadlines. While guidance documents do not establish legally enforceable responsibilities, they do set forth the agency’s current thinking and can be treated as “recommendations,” unless specific regulatory or statutory requirements are cited.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (Public Law 108-282) established the initial labeling disclosure requirements for “major allergens.” The list was amended to add sesame as a major allergen by the Food Allergy Safety, Treatment, Education and Research Act of 2021 (FASTER Act) (Public Law 117-11). Currently, there are nine foods or food groups that are “major allergens” and must be disclosed on the label of food, including dietary supplements, if they are the food or intentionally added to the food as an ingredient. This is the current list:
Foods
Milk, Peanuts, Wheat, Soybeans, Sesame (added Jan. 1, 2023)
Food Groups (must identify type or species)
Fish (e.g., bass, flounder, cod), Crustacean shellfish (e.g., crab, lobster, shrimp), Tree nuts (e.g., almonds, walnuts, pecans) FALCPA labeling requirements apply to all packaged foods regulated by FDA, including dietary supplements, as well as bulk containers intended for further processing, labeling or repacking between companies. FALCPA does not apply to most meat, poultry, catfish and certain processed egg products (regulated by U.S. Department of Agriculture), alcohol products regulated by the Alcohol and Tobacco Tax and Trade Bureau or pet food or animal feed, OTC (over-the-counter) drugs, cosmetics or household cleaning products.
While there are at least 160 other foods that have been reported to cause allergic reactions in sensitive people, they are not required to list food sources under this law and are excluded from “Contains” statements.
Highly refined oils, which are intended to signify refined, bleached, deodorized oils, that are derived from major food allergens are exempt from allergen labeling. The source of all oils (whether highly refined or not), however, must be included as part of the common or usual name of the oil in the ingredient list (such as “soybean oil”).
FALCPA does not require the FDA to establish a threshold level for any food allergen disclosure, and none have been established to date.
New Definitions
Until now, FDA has taken the position that under FALCPA, the allergen “milk” was limited exclusively to milk from domesticated cows. As such, milk from other animals was not considered a major allergen and could not be placed in a “Contains” statement. In the final guidance, FDA has expanded the definition of “milk” under FALCPA to include milk from domesticated cows, goats, sheep or other ruminants (hoofed mammals with a four chambered stomach that digest plant matter through fermentation).
Milk from ruminant animals, other than cows, must be declared in the ingredient list by common or usual name, such as “goat milk” under ingredient labeling requirements. For food allergen labeling purposes, milk and milk ingredients from animals other than cows should, pursuant to FDA recommendation, also include the name of the animal source, such as “goat milk” and “whey (goat milk)” in the ingredient list or “Contains goat milk” in a separate “Contains” statement, or both.
Similarly, FDA has always taken the position that “eggs” as a major allergen was limited to domesticated chickens. Under the new final guidance, FDA is expanding FALCPA, to include eggs from domesticated chickens, ducks, geese, quail and other fowl.
Eggs from birds other than chickens, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “duck egg” under ingredient labeling requirements. For food allergen labeling purposes, egg and egg ingredients from birds other than chickens should, pursuant to FDA recommendation also include the name of the bird source, such as “duck egg” and “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate “Contains” statement, or both.
Additionally, manufacturers of foods and dietary supplements with milk from ruminant animals other than cows (e.g., goat milk), eggs from birds other than chickens (e.g., duck eggs), or an ingredient derived from such milk or eggs (e.g., whey from goat milk) need to consider such milk or egg as a major food allergen for the purpose of its manufacturing practices. Applicable manufacturing controls that address the major food allergen hazards include current good manufacturing controls, preventive controls, and/or hazard analysis and critical control point controls.
Regarding the scope of what FDA considers a tree nut under FALCPA, FDA has limited the definition to 12 types of tree nuts listed in Table 1 on page 15 of the guidance.
Only the tree nuts listed in Table 1 in the guidance are now considered by FDA to be “major food allergens” and are the only tree nuts that may be included in a “Contains” statement.
Of note to the dietary supplement industry is that FDA has limited the scope of “tree nuts” such as coconut and kola nut are no longer included.
FDA also addressed the question of whether other parts of a tree nut plant may be considered a major allergen. Basically, the determination will be based on whether an ingredient derived from a tree nut plant contains the allergenic protein from the tree nut. If so, then that plant part would also be treated as a major allergen under FALCPA.
Other Major Allergens
Regarding “fish,” FDA interprets this group to include:
• Jawless fish, such as hagfish and lampreys
• Bony fish, such as trout, flounder, bass, salmon, tilapia, cod, mackerel, tuna and grouper
• Cartilaginous fish, such as shark, rays, and skates.
Crustaceans subject to FALCPA are aquatic animals that have jointed legs, a hard shell and no backbone, such as crab, crayfish, lobster, prawns and shrimp.
The ingredient list should identify fish ingredients by the market or common name provided in FDA’s Seafood List as the “species” of fish or crustacean shellfish. For the “Contains” statement, in addition to one of these names being used, manufacturers may use the generic name, e.g., “salmon” for chum salmon or “flounder” for tropical flounder.
As to the remaining major allergens, “wheat” continues to mean any species in the genus Triticum. Finally, there have not been any changes made to the definition or inclusion of the major allergens soybeans (soy or soya), peanuts and sesame.
Label Disclosure
There are two ways to disclose the presence of major allergens under FALCPA. The first method is in the statement of ingredients. Using this method, the identity of the major allergen ingredient(s) must be part of the name of the ingredient or follow the name of the ingredient, if the ingredient does not reveal the major allergen.
• For example—Wheat flour or Flour (wheat); Natural Peanut Flavor or Natural Flavor (Peanut); Soy Lecithin or Lecithin (soy)
• The ingredient statement would need to include the type of any tree nut or the species of any fish or crustacean shellfish when present in a product.
The second method of label disclosure would be using a “Contains” statement. The word “Contains” with a capital “C” must be the first word used to begin a “Contains” statement with the use of bold text, punctuation or additional information being optional. The “Contains” statement must be located immediately after or next to the list of ingredients using the same type as the list of ingredients.
Most importantly, when used, the “Contains” statement must identify the names of all major food allergens that either are in the food or are contained in ingredients of the food.
For example—Contains: Milk, Wheat, Soy, Egg, Peanuts
The same requirements apply to dietary supplements, except that the statement of ingredients allows for allergen disclosure within the Supplement Facts box or in the statement of ingredients (or other ingredients). Again, if a “Contains” statement is used it must list all major allergens in the product.
Other Label Issues
Generally, the ingredients comprising spice, flavorings and colors do not need to be individually disclosed on product labels. However, if any ingredient comprising spice, flavorings and/or colors is a major allergen, the presence of the major allergen would be required on the label.
Specifically, you could declare it parenthetically after the term “spice(s)” or “Natural Flavor” in the ingredient list, or in a separate “Contains” statement, or both. For example,
“Spices (sesame)” or “Contains Sesame”
“Natural Flavor (Peanut)” or “Natural Peanut Flavor” or “Contains Peanut.”
Incidental additives, including processing aids, are “technical” ingredients added to a food that are exempt from being declared in the ingredient list (21 CFR 101.100(a)(3)). Here too, such ingredients, while exempt from ingredient labeling, are not exempt from the food allergen labeling requirements. Thus, if a major allergen is included as a processing aid or incidental additive If not declared as an ingredient must appear in “Contains” statement.
Other Issues
If labeled “not for individual or retail sale,” the unit containers in a multiunit food package are exempt from certain labeling requirements including an ingredient statement under 21 CFR 1.24(a)(14). However, the individual packages are not exempt from allergen labeling requirements. If the food is or contains a major food allergen, a “Contains” statement must be used on each of the inner labels.
No labeling is needed, including allergen labeling, if the individual unit is an unlabeled inner sleeve intended solely for protection of the product, such as sleeves of crackers, and does not contain any written, printed or graphic matter.
Voluntary statements providing information that certain allergens are absent from the product (e.g., “allergen-free” claims) are permitted, but must be truthful and not misleading. If a specific allergen free claim is included on the label, FDA would expect that the company has taken specific steps to ensure that there is no possible amount of the allergen present from any potential unintended cross-contact.
Firms may also choose to voluntarily place allergen advisory statements on products to alert consumers to the possible presence of major food allergens due to cross-contact. Some examples of allergen advisory statements include, “may contain [allergen],” or “produced in a facility that also uses [allergen].”
Allergen advisory statements are not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.
Obviously, a label may not have contradictory allergen statements such as a “peanut free” claim and a “produced in a facility that uses peanuts.” Finally, any voluntary allergen advisory statement must be truthful and not misleading.
Need to Relabel?
Based on the changes that have been made by FDA’s new guidance some labels may require revisions. For example, if a label uses a “Contains” statement that includes coconut or kola nut, which were previously considered major allergens, but no longer, they will need to be removed from the “Contains” statement.
Alternatively, allergen disclosures may need to be revised to include “milk” disclosures from ruminant animals other than cows, or egg disclosures from birds other than chickens.
While firms must follow the major food allergen requirements, the agency understands the implications of making label changes and that firms have been relying on previous guidance. The agency specifically stated, “Given those circumstances, FDA recognizes that product labels might be corrected the next time they are printed. Alternatively, the firm may choose to use a sticker to cover the outdated labeling.”VR
Steven Shapiro is of counsel to Rivkin Radler LLP (rivkin.com) and a partner of Ullman, Shapiro & Ullman, LLP (usulaw.com). His practice focuses on the dietary supplement/natural products industries with a particular emphasis on FDA and FTC compliance issues including labels, labeling and advertising claims.
