Food Allergen Labeling Consumer Protection Act (FALCPA) of 2004

Leonard Bielory | 14 July, 2021

            Food Allergen Labeling Consumer Protection Act (FALCPA) of 2004

Are there exceptions to FALCPA labelling? It is also important to realize that sesame, mustard, molluscs and shellfish, such as oysters, clams, mussels or scallops, are not required to be labeled as a major allergen under FALCPA. They are required for labeling in Canada. However, even in United States, these foods must be declared on the ingredient list if they have a technical or functional effect in the product with the exception that they can be hidden in terms such as flavorings on occasion. They cannot be identified in the “contains” statement so consumers must look for them in the ingredient list.

FALCPA affects all packaged foods sold in the United States: conventional foods, vitamins and dietary supplements, infant formula and foods, medical foods, and all retail and food-service products packaged for sale.

Exclusions from FALCPA include: prescription and over-the counter drugs, personal care items (such as cosmetics, shampoo, mouth wash, toothpaste or shaving cream), pet foods and supplies, any food products regulated by the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) (meat and poultry products and whole eggs), any food product regulated by the Alcohol and Tobacco Tax and Trade Bureau. Although the USDA FSIS encourages food companies to follow FALCPA, they are not obligated to do so.

Some things made from certain food sources are exempt from labels. For example, highly refined oils from soybean are exempt from source labeling. Raw agricultural products (corn, rice) may contain low levels of a different allergenic crop (soybean, wheat) due to shared farm equipment and are not labeled. Some ingredients including spices and colorants do not have to be labeled unless they are any of the big eight allergens.

How dangerous are precautionary labels or “may contain” statements? You may also see Precautionary Allergen Labels (PAL), more commonly known as “may contain” statements. In contrast to the regulations imposed by FALCPA, PALs are voluntary, not standardized, and not mandated by law in the United States or any other country. Companies may use PALs to signify that there may be some risk of unintentional contamination of their product with certain allergens. Some foods labeled with PALs have little or no contamination, for others it can be fairly high or on occasion. Similar to PALs, restaurants may provide precautionary statements (e.g. “We cannot guarantee that…”). The inconsistency and vagueness of PALs are particularly problematic because they do not provide you with a clear sense of how risky ingesting the food is. A contrasting analogy can be made during risk evaluation of crossing the street. Anyone can be at risk of an accident when crossing a road, but usually it is obvious how much traffic there is and how dangerous it might be to cross at any given time (e.g. walk sign versus stop sign). Therefore, until there are better and more standardized PAL practices, many choose to avoid foods that have a PAL or “may contain” statement.  

Because PAL statements are voluntary, many different wordings are used in PAL statements. If PALs are used, they are legally required to be truthful and not misleading. No matter the language, it does not change the amount of risk. Common examples of PALs include (where X can be peanut, tree nut, egg, milk, etc.):

a. May contain X

b. Made in a facility that uses or processes X

c. Made on shared equipment with X

d. Not guaranteed to be free of X

What about international food labels, or when I travel?Food products made in other countries still have to comply with FALCPA if they are officially imported into and sold in the United States. Other countries have different labelling practices and laws.  

In addition to the eight allergens covered by FALCPA, in Canada additional allergens are mandated to be labeled in “contains” statements: sesame, molluscan shellfish (snails, octopus, clams and scallops), mustard and sulfites (a preservative). In Japan, buckwheat, peanut, milk, egg, shrimp and crab must be labeled.