Allergen Labeling on the Horizon

June 2005

Allergen Labeling on the Horizon

By Neal D. Fortin
Contributing Editor

The law places a burden on food manufacturers to warn consumers of any dangers associated with the consumption of their products, including notifying them of potential allergic characteristics. Even diligent label readers can inadvertently be exposed to allergens; existing laws allow generic listing of colors, flavors and spices which, depending on the source, might contain "hidden" allergens.

"The prevalence of food allergy is growing and probably will continue to grow along with all allergic diseases," says Dr. Robert A. Wood, director of the pediatric allergy clinic at John Hopkins Medical Institutions, Baltimore. Under the Food Allergen Labeling and Consumer Protection Act (FALCPA), food manufacturers must declare the common name for allergenic substances for food labeled on or after Jan. 1, 2006. The eight requiring labeling are: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts and soybeans.

What is required?
Labeling must identify the major allergens by their common name in two formats: a statement, "Contains allergen food source" immediately after or adjacent to the list of    ingredients in a font size no      smaller than the ingredients listed, or print allergen source name in parentheses in the list of ingredients immediately after the ingredient, e.g., "casein (milk)."

If the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, it is exempt from this rule, but not if the name of the food source appears as part of the name of an ingredient that is not a major food allergen.

Flavorings, colorings and incidental additives are subject to these new labeling requirements if they contain any of the eight allergens, despite exemptions listed in other laws.

Exemptions include "highly refined oils," due to an absence of detectable protein. Unfortunately, the act does not define the term. The Senate FALCPA report notes that "highly refined oils" are refined, bleached, deodorized oils, but this does not provide much guidance, so firms should ensure oils are free of major allergen proteins.

Food manufacturers may petition for exemption from the requirements for other foods, or file a notification instead, if they can provide scientific evidence that the ingredient does not contain allergic protein.

More to come
In FALCPA, Congress directs FDA to work to improve our nation's approach to food allergens by defining "gluten free" to help consumers with celiac disease and to report on the issues of food contamination with food allergens and the use of "may contain" label advisories. FDA is given the authority   to require by regulation further labeling of food allergens. Congress also requested that the Centers for Disease Control and Prevention improve upon the data collection on the prevalence, incidence and treatment of food allergies.

Reducing the incidence of food allergic reactions and liability is important to regulatory officials and the food industry. Furthermore, this new law likely will expand the    marketplace for food choices for allergic consumers.

Neal D. Fortin is an attorney concentrating in food and drug law as well as a professor in food and drug law at Michigan State University. For more information, visit his websites: www.fortinlaw.com or www.foodlaw.org .

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