Learning from FDA Food Allergen Recalls and Reportable Foods
Seven years after the Food Allergen Labeling and Consumer Protection Act[1] (FALCPA) went into effect, unlabeled allergens continue to be the leading cause of recalls and a leading cause of reportable foods for U.S. Food and Drug Administration (FDA)-regulated foods. The presence of unlabeled allergens presents a significant health hazard for food-allergic consumers, and allergen recalls represent an economic burden for industry and a resource need for FDA.
Allergic consumers rely on food labels to be complete, clear and accurate so that they can avoid exposure to foods or ingredients that can provoke potentially life-threatening reactions. This is particularly important because data from the U.S. Centers for Disease Control and Prevention (CDC) show that the number of food-allergic consumers is increasing as are the number of hospital visits related to food allergies and allergic reactions.2 To help food-allergic consumers find and understand the information they need, FALCPA designated those food allergens of greatest public health concern in the U.S. as the major food allergens (milk, egg, peanut, soy, fish, crustacean shellfish, wheat and tree nuts), described the two formats that can be used to declare the presence of major food allergens and required the use of the common or usual name of the food source for the major food allergens (e.g., declaring milk when casein is used as an ingredient). FALCPA also requires the declaration of major food allergens that are components of flavorings, colorings and incidental additives.
What Is the Reportable Food Registry?
The Reportable Food Registry (RFR) program collects and reviews reports from industry (mandatory) and public health officials (voluntary) regarding potentially harmful foods or animal feeds. Depending on the circumstances of a particular event, the RFR can be an early warning signal of an adulterated food or feed and can help trace the reportable food through the supply chain. In addition, FDA uses data from the RFR to help protect public health by tracking patterns of food and feed adulteration. Detailed data metrics can be found online in the Annual RFR Reports at www.fda.gov/ReportableFoodRegistry.
A reportable food is defined as an article of food or feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. Thus, reportable food(s) includes those foods that meet the definition of a Class I recall situation. However, it is important to note that a responsible party [the person(s) who registers a food facility under Section 415 of the Food, Drug & Cosmetic Act and reports to the RFR] does not have to submit a reportable food report if all of the following three criteria are met:
1. The adulteration originated with the responsible party; AND
2. The responsible party detected the adulteration prior to any transfer to another person of the article of food; AND
3. The responsible party corrected the adulteration or destroyed or caused the destruction of such article of food.