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December 20, 2005
Effective January 1, 2006, the Food and Drug Administration (FDA) is requiring food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods. As a result of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), manufacturers are required to identify in plain English the presence of ingredients that contain protein derived from milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans in the list of ingredients or to say "contains" followed by name of the source of the food allergen after or adjacent to the list of ingredients.
This labeling will be especially helpful to children who must learn to recognize the presence of substances they must avoid. For example, if a product contains the milk-derived protein, casein, the product's label will have to use the term "milk" in addition to the term "casein" so that those with milk allergies can clearly understand the presence of the allergen they need to avoid.
It is estimated that 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies. Approximately 30,000 consumers require emergency room treatment and 150 Americans die each year because of allergic reactions to food.
"The eight major food allergens account for 90 percent of all documented food allergic reactions, and some reactions may be severe or life-threatening," said Robert E. Brackett, PhD, Director of FDA's Center for Food Safety and Applied Nutrition. "Consumers will benefit from improved food labels for products that contain food allergens."
FALCPA does not require food manufacturers or retailers to relabel or remove from grocery or supermarket shelves products that do not reflect the additional allergen labeling as long as the products were labeled before the effective date. As a result, FDA cautions consumers that there will be a transition period of undetermined length during which it is likely that consumers will see packaged food on store shelves and in consumers' homes without the revised allergen labeling.
For more information about FALCPA, visit FDA's food allergy page at Information about Food Allergens.
The Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) in the United States Department of Agriculture (USDA) held a public meeting on December 15, 2005 in Chicago, IL (see 70 FR 67490). The purpose of this meeting was to gain public input on ideas and to solicit information on an approach for providing consistency and predictability with respect to which of the two agencies should have jurisdiction over certain types of food products that contain meat and poultry as ingredients. Among the types of products under consideration are bagel dogs, pizzas, natural casings, traditional closed-face sandwiches, bread products made with less than 50% meat or poultry, dried poultry soup mixes, and flavor bases/flavors.
The approach presented to the meeting attendees and discussed in the November 7, 2005 Federal Register Notice (70FR67490) of the public meeting was to determine the contribution of the meat or poultry ingredient to the food. Does it characterize the food, i.e., is it a primary component of the food? Or does it just flavor the food because it is present in such a low amount or is indistinguishable as meat or poultry? In general, if the meat or poultry contributes to the basic nature of the food, the product would be under FSIS jurisdiction. If the meat or poultry ingredient just provided flavor, the product would be under FDA jurisdiction. Under this scheme, closed-face sandwiches would move to FSIS jurisdiction because the sandwiches are consumed for the meat or poultry, in other words, the meat or poultry characterize the food and contribute to the basic nature of the product. All pizzas would move to FDA jurisdiction because the meat or poultry component is used for flavoring, and the other ingredients (dough, sauce, cheese) characterize the food.
If this approach is implemented, there will be changes in jurisdiction that FDA anticipates will have an impact on industry, consumers, and the agencies. FDA is asking for specific comment on eight questions asked in the Federal Register notice to help delineate the scope of the impact. This information, in combination with the comments presented at the public meeting, will be used in determining how to proceed.
The docket, No. 05-013N, is open for an indefinite period and comments can be submitted electronically to the following address:
The Food and Drug Administration (FDA) has published a summary report describing the activities and findings of the FDA's Security Surveillance Assignment (Summary Report: FDA Security Surveillance Assignment, October - November 2004 Final).
This assignment, completed over six weeks during the months of October and November 2004, was designed to be national in scope, integrate food safety and defense activities, and involve Federal, state, local, and industry partners. It also served as a prototype for integrating food defense and food safety inspections, sample collection and laboratory testing, compliance and enforcement activities, and logistics for domestic and imported foods including Prior Notice of Imported Foods targeting.
The two major goals of this assignment were to test preparedness and promote deterrence. While it is difficult to measure the level of deterrence that this assignment afforded, there was a significant increase in food defense coverage, awareness, and preparedness achieved by the preventive activities of FDA and state inspectors at multiple and targeted points in the food distribution system and through the communication with industry. Furthermore, this assignment and the lessons learned from it have laid a foundation for integrating food defense and food safety into FDA's compliance programs. This now translates into FDA's current approach of integrating food defense into ongoing food safety assignments.
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Office of Food Safety, Defense, and Outreach |
CFSAN Web site: http://www.cfsan.fda.gov/ |
