Each year, millions of Americans have allergic reactions to food. Although most food allergies cause relatively mild and minor symptoms,some food allergies can cause severe reactions, and may even be life-threatening.
There is no cure for food allergies. Strict avoidance of food allergens — and early recognition and management of allergic reactions to food — are important measures to prevent serious health consequences.
FDA's Role: Labeling
To help Americans avoid the health risks posed by food allergens, FDA enforces the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The Act applies to the labeling of foods regulated by FDA which includes all foods except poultry, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.
As a result, food labels help allergic consumers identify offending foods or ingredients so they can more easily avoid them.
What Are Major Food Allergens?
While more than 160 foods can cause allergic reactions in people with food allergies, the law identifies the eight most common allergenic foods. These foods account for 90 percent of food allergic reactions, and are the food sources from which many other ingredients are derived.
The eight foods identified by the law are
- Fish (e.g., bass, flounder, cod)
- Crustacean shellfish (e.g., crab, lobster, shrimp)
- Tree nuts (e.g., almonds, walnuts, pecans)
These eight foods, and any ingredient that contains protein derived from one or more of them, are designated as “major food allergens' by FALCPA.
How Major Food Allergens Are Listed
The law requires that food labels identify the food source names of all major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient (e.g., buttermilk) that is a major food allergen already identifies that allergen's food source name (i.e., milk). Otherwise, the allergen's food source name must be declared at least once on the food label in one of two ways.
The name of the food source of a major food allergen must appear:
- In parentheses following the name of the ingredient.
Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”
— OR —
- Immediately after or next to the list of ingredients in a “contains” statement.
Example: “Contains Wheat, Milk, and Soy.”
Severe Food Allergies Can Be Life-Threatening
Following ingestion of a food allergen(s), a person with food allergies can experience a severe, life-threatening allergic reaction called anaphylaxis.
This can lead to:
- constricted airways in the lungs
- severe lowering of blood pressure and shock (“anaphylactic shock”)
- suffocation by swelling of the throat
Each year in the U.S., it is estimated that anaphylaxis to food results in:
- 30,000 emergency room visits
- 2,000 hospitalizations
- 150 deaths
Prompt administration of epinephrine by autoinjector (e.g., Epi-pen) during early symptoms of anaphylaxis may help prevent these serious consequences.
Mild Symptoms Can Become More Severe
Initially mild symptoms that occur after ingesting a food allergen are not always a measure of mild severity. In fact, if not treated promptly, these symptoms can become more serious in a very short amount of time, and could lead to anaphylaxis.
Know the Symptoms
Symptoms of food allergies typically appear from within a few minutes to 2 hours after a person has eaten the food to which he or she is allergic.
Allergic reactions can include:
- Flushed skin or rash
- Tingling or itchy sensation in the mouth
- Face, tongue, or lip swelling
- Vomiting and/or diarrhea
- Abdominal cramps
- Coughing or wheezing
- Dizziness and/or lightheadedness
- Swelling of the throat and vocal cords
- Difficulty breathing
- Loss of consciousness
About Other Allergens
Persons may still be allergic to — and have serious reactions to — foods other than the eight foods identified by the law. So, always be sure to read the food label's ingredient list carefully to avoid the food allergens in question.
What To Do If Symptoms Occur
The appearance of symptoms after eating food may be a sign of a food allergy. The food(s) that caused these symptoms should be avoided, and the affected person, should contact a doctor or health care provider for appropriate testing and evaluation.
- Persons found to have a food allergy should be taught to read labels and avoid the offending foods. They should also be taught, in case of accidental ingestion, to recognize the early symptoms of an allergic reaction, and be properly educated on — and armed with — appropriate treatment measures.
- Persons with a known food allergy who begin experiencing symptoms while, or after, eating a food should initiate treatment immediately, and go to a nearby emergency room if symptoms progress.
Food Allergen “Advisory” Labeling
FALCPA's labeling requirements do not apply to the potential or unintentional presence of major food allergens in foods resulting from “cross-contact” situations during manufacturing, e.g., because of shared equipment or processing lines. In the context of food allergens, “cross-contact” occurs when a residue or trace amount of an allergenic food becomes incorporated into another food not intended to contain it. FDA guidance for the food industry states that food allergen advisory statements, e.g., “may contain [allergen]” or “produced in a facility that also uses [allergen]” should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading. FDA is considering ways to best manage the use of these types of statements by manufacturers to better inform consumers.
Reporting Adverse Effects and Labeling Concerns
If you think that you or a family member has an injury or illness that you believe is associated with having eaten a particular food, including individuals with food allergies and those with celiac disease, contact your healthcare provider immediately. Also, report the suspected foodborne illness to FDA in either of these ways:
Individuals can report a problem with a food or its labeling, such as potential misuse of “gluten-free” claims, to FDA in either of these ways:
- Contact MedWatch, FDA's Safety Information and Adverse Event Reporting Program, at 800-332-1088, or file a MedWatch voluntary report at www.fda.gov/MedWatch
- Contact the consumer complaint coordinator in their area. The list of FDA consumer complaint coordinators is available at www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators/default