Colorado State University Extension
SafeFood Rapid Response Network
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NEW ALLERGEN LABELING REQUIREMENTS FROM THE FDA
Edited by: Stephanie Wallner, M.S., Mary Schroeder, M.S., R.D, Pat Kendall, Ph.D., R.D., Colorado State - Fall 2006
For people with food allergies, it can be difficult to completely avoid foods containing substances that cause allergic reactions. Food labels can be hard to read or confusing, and often don't clearly list common allergens dangerous to those with food allergies. An estimated 2% of adults and 5% of infants and children in the United States have true food allergies, and 30,000 people are taken to emergency rooms annually as a result of allergic reactions to food - so allergens in food should be taken seriously by both consumers and manufacturers.
As of January 1, 2006, the Food and Drug Administration (FDA) now requires food labels to clearly list any ingredients derived from the eight main food allergens: milk, eggs, fish, Crustacean shellfish, peanuts, tree nuts, wheat, and soybeans. This requirement comes as part of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), an amendment to the Federal Food, Drug, and Cosmetic Act, and states that food manufacturers must use plain language to identify the eight main food allergens on labels (1). Because these allergens account for over 90% of documented food allergies in the U.S. (1), most consumers with food allergies will benefit from the new labeling requirements.
The new FALCPA guidelines require manufacturers to label allergens in one of two ways (2). The first is to add a "contains" statement next to the ingredient list that identifies the types of allergenic foods contained in the product (e.g., "Contains milk and wheat"). The other option is to place the food source in parentheses next to any ingredient derived from one of the eight potentially offending foods classes, for example, sodium caseinate (milk), albumin (egg). The name of the allergen only needs to appear once in the ingredient statement. For example, if a product contains both milk and a milk-derived ingredient such as whey, the manufacture is not required to define whey as also being a milk product. In the case of nuts and seafood, the new law requires that the specific type of nut (e.g., peanuts, almonds, cashews) or species of fish (e.g., cod, bass) or shellfish (shrimp, lobster) be specified. Also, the presence of such ingredients must be listed even if they are contained only in colorings, flavoring agents or spice blends used in the product.
Despite these helpful label additions, consumers with food allergies should still be aware that products labeled before January 1, 2006, can remain on shelves; FALCPA does not require them to be removed and relabeled according to the new rules. There are also certain exemptions to the new labeling requirements. For instance, highly refined oils derived from food allergens and raw agricultural products such as fruits and vegetables are exempt. Manufacturers may apply for an exemption for any product by petitioning the Secretary of Health and Human Services; this petition process requires scientific evidence showing that the food does not contain any allergenic protein or cause an allergic response.
The law applies to pre-packaged foods sold in retail and food-service establishments, but not to products or meals ordered in restaurants or delis. It's up to the consumer to ask questions about ingredients and preparation methods when eating at restaurants, delis or any place outside the consumer's home.
Finally, the new law does not specifically address gluten, only wheat. Gluten describes a group of proteins found in certain grains (wheat, barley, rye) that is not tolerated by persons with celiac disease. The new law does requires the FDA to issue a proposed rule that would allow voluntary use of the term "gluten free" by August 2006 and to have a final rule on "gluten free" in place by August 2008.
The FDA cautions consumers to continue to read labels carefully and ask questions if ingredient information is unclear while products labeled before the new requirements remain on the market. More information on FALCPA and its specific requirements can be found in a detailed report available at http://www.cfsan.fda.gov/~dms/alrgact.html.
Sources:
- U.S. Food and Drug Administration FDA News. Available at: http://www.fda.gov/. Accessed April 3, 2006.
- U.S. FDA/CFSAN Advice to Consumers: Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers. Available at: http://www.cfsan.fda.gov. Accessed April 3, 2006.
