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Regulatory and Technical Information 
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  RELATED INFORMATION
Allergen Control GMPs

Allergen Control and Labeling Requirements

Each year the Food & Drug Administration (FDA) receives reports of consumers who experienced adverse reactions following exposure to an allergenic substance in foods. Food allergies are abnormal responses of the immune system, especially involving the production of allergen specific IgE antibodies, to naturally occurring proteins in certain foods that most individuals can eat safely.

In response to numerous complaints, at the beginning of 2006, a new food labeling law, the Food Allergen Labeling and Consumer Protection Act (FALCPA), took effect.

Under FALCPA, food labels are required to state clearly whether the food contains a "major food allergen." The law identifies as a major food allergen any of eight allergenic foods: milk; eggs; fish; crustacean shellfish; tree nuts such as almonds, walnuts, and pecans; peanuts; wheat; and soybeans. The law also identifies as a major food allergen any ingredient that contains protein derived from any of these eight foods.

Food manufacturers must comply with the law by identifying in plain English on their product labels the food source of any ingredient that is, or contains, protein from one of the eight foods or food groups mentioned above. FALCPA also requires identification of the type of tree nut (e.g., almonds, pecans, walnuts).

Manufacturers are also responsible for ensuring that food is not adulterated or misbranded as a result of the presence of undeclared allergens. Handlers and manufacturers must be sure that allergens are not added intentionally to food, but not declared on the label; or may be unintentionally introduced into a food product and consequently not declared on the label. An allergen may be introduced by the use of common equipment, rework practices or other manufacturing processes. Manufacturers must identify and implemented control(s) to prevent potential allergen cross-contact, e.g., dedicated equipment, separation, production scheduling, sanitation, proper rework usage (like into like).

Consumer resource for food allergy information

The Food Allergy & Anaphylaxis Network (FAAN) raises public awareness, provides advocacy and education, and advances research on behalf of all those affected by food allergies and anaphylaxis. Its membership includes families, dietitians, nurses, physicians, school staff, and representatives from government agencies and the food and pharmaceutical industries. FAAN serves as the communication link between the patient and others.

External Links:

The Food Allergen Labeling and Consumer Protection Act

FDA requirements on labeling and preventing cross contact of common food allergens

FDA requirements for inspections of manufacturers using ingredients that are considered allergens

Consumer support is provided by The Food Allergy & Anaphylaxis Network (FAAN) 

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