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New Food Allergen Labeling Law Raises Questions for Packaging Suppliers

Date: Jan 09, 2006


New labeling provisions in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which went into effect on January 1, 2006, require more complete and clearer labeling of foods that contain the eight most common food allergens or ingredients derived from them when these ingredients contain allergenic protein. However, because the law does not establish any thresholds for labeling, or otherwise provide guidance, it is not clear whether food companies need to account for components of packaging that are derived from one of the eight allergens.

The eight major food allergens currently covered by the FALCPA are: (1) milk; (2) eggs; (3) fish (e.g., bass, flounder, or cod); (4) crustacean shellfish (e.g., crab, lobster, or shrimp); (5) tree nuts (e.g., almonds, pecans, or walnuts); (6) wheat; (7) peanuts; and (8) soybeans. These eight allergens are said to be responsible for 90 percent of all allergic reactions associated with food. Approximately two percent of adults and five percent of infants and young children are believed to suffer from some form of food allergy.

Under the FALCPA, the term "major food allergen" is defined as either one of the eight allergens listed above or an ingredient that contains protein derived from one of the allergens. The problem is that some materials used in packaging also are derived from these allergens. For example, some types of paperboard and plastic packaging contain soy-derived glues and polymers, wheat-derived starches for glues and coatings, and casein-derived coatings or additives. The Food and Drug Administration (FDA) has cleared 36 soy-derived indirect food additives as safe for use.

Food products that consist of one or more of the listed foods or that contain ingredients that bear or contain (or are derived from) one of these foods must be labeled to indicate the presence of the allergen in plain English. The law specifically provides that spices, flavorings, colorings, or "incidental additives" that are or that bear or contain (or are derived from) a major food allergen also must adhere to the new labeling requirements.

Highly refined oils that are derived from any of the major food allergens and ingredients from those highly refined oils are statutorily exempt from the labeling requirements. Additionally, the FALCPA includes a petition process to exempt certain food ingredients if it can be shown that although the food ingredient contains allergenic protein, it does not cause an allergic response that poses a risk to human health. Alternatively, the law provides a more straightforward notification exemption process in cases in which it can be shown that the food ingredient does not contain allergenic protein, or a determination has been made by the FDA, under a premarket approval or notification program authorized by Section 409 of the federal Food, Drug, and Cosmetic Act, that the ingredient does not cause an allergic response that poses a risk to human health.

Because the FALCPA currently requires food labels to identify "incidental additives" derived from one of the eight allergens and does not distinguish between direct and indirect food additives or exempt food contact materials from its labeling requirements, food products packaged in materials containing one or more of the eight major food allergens may be subject to the FALCPA labeling requirements. 1 On the other hand, if it can be appropriately confirmed that no protein from one of the allergens is present in the food contact material, labeling would not be required.

Food companies have expressed concern to the FDA that the law as written would require labeling for ingredients derived from a listed allergen even if present at such low levels as not to pose a realistic concern, and have suggested that the FDA establish thresholds below which labeling will not be required. Industry is concerned that without such thresholds over-labeling will result, unnecessarily reducing an allergen sufferer's food choices.

The FDA also has been asked to clarify the status of packaging under the FALCPA, with the agency being urged to grant a blanket exemption from FALCPA labeling requirements for all packaging materials. However, guidance from the FDA, on this matter, has so far not been forthcoming.

The FALCPA also directs the Secretary of Health and Human Services to report to Congress on a number of issues, including how foods are unintentionally contaminated with allergens and whether good manufacturing practices could eliminate cross-contamination. Further, the law directs the FDA to use the inspection authority under Section 704 of the federal Food, Drug, and Cosmetic Act to ensure that food manufacturers are taking appropriate steps to prevent unintended cross-contamination, among other things. Nonetheless, the FDA's Center for Food Safety and Applied Nutrition announced earlier this year that it was lowering the priority of its allergen compliance and enforcement efforts.

1Although FDA has clarified that FALCPA is not applicable to allergens that are unintentionally added to food as a result of cross-contact, the presence of allergens in food from packaging may not necessarily be considered unintentional and, thus, this exception would not apply. Cross contact is explained by the FDA as resulting from "customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment." See Questions and Answers Regarding Food Allergens, including Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 2), Question 18, available by clicking here.