Allergen Labeling Law
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), identified the following eight foods as major food allergens:
- Milk
- Eggs
- Fish
- Shellfish
- Tree nuts (e.g., almonds, walnuts, pecans)
- Peanuts
- Wheat
- Soybeans
At the time of the law's passage, these eight major allergens accounted for 90 percent of food allergies and serious allergic reactions in the U.S. Recently, however, President Biden signed the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (the FASTER Act) into law. The new law makes Sesame the ninth major food allergen and, as of January 1, 2023, it must be labeled as the other major food allergens listed above.
The FASTER Act also requires that within 18 months, (late December, 2022) the Secretary of Health and Human Services submit a report to Congress that describes ongoing Federal activities, and recommendations and strategies to expand, enhance, or improve them, related to:
- Surveillance and collection of data on the prevalence of food allergies and severity of allergic reactions for specific food or food ingredients, including the identification of any gaps in such activities,
- Development of effective food allergy diagnostics,
- Prevention of the onset of food allergies,
- Reduction of risks related to living with food allergies, and,
- Development of new therapeutics to prevent, treat, cure, and manage food allergies;
The report is also to include recommendations for the development and implementation of a regulatory process and scientific framework that would allow for the timely, transparent, and evidence-based modification of the definition of "major food allergen."
FALCPA requires that foods or ingredients that contain a "major food allergen" be specifically labeled with the name of the allergen source. The Food and Drug Administration (FDA) enforces the provisions of this law in most packaged food products including dietary supplements. This requirement does not include meat, poultry, and certain egg products (which are regulated by the U.S. Department of Agriculture); alcoholic beverages (subject to Alcohol and Tobacco Tax and Trade Bureau labeling regulations); raw agricultural commodities; drugs; cosmetics; and most foods sold at retail or food service establishments that are not pre-packaged with a label.
Using Allergen Labels
People with food allergies should carefully check labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient already identifies that allergen's food source name (for example, buttermilk). Otherwise, the allergen's food source must be declared at least once on the food label in one of two ways:
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."
Retail and food-service establishments that package, label, and offer products for human consumption must meet FALCPA's labeling requirements. However, these labeling requirements do not apply to foods that are placed in a wrapper or container (such as paper or a box for a sandwich) following a customer's order at the point of purchase.
Advisory Statements
Consumers may also see advisory statements such as "may contain [allergen] or "produced in a facility that also uses [allergen]." These are used to address "cross-contact," which can occur when multiple foods with different allergen profiles are produced in the same facility using shared equipment or on the same production line. They may result from ineffective cleaning, or from dust or aerosols generated in the production process.
FDA guidance for the food industry states that advisory statements should not be used as a substitute for adhering to current good manufacturing practices and must be truthful and not misleading.
What to Do If Symptoms of an Allergic Reaction Occur
Symptoms of food allergies typically appear from within a few minutes to a few hours after a person has eaten the food to which he or she is allergic. A severe, life-threatening allergic reaction is called anaphylaxis.
Symptoms of allergic reactions can include:
- Hives
- 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
People with a known food allergy who begin experiencing any of these symptoms should stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention. Some of these symptoms are not always due to a food allergen. So, it is important to seek proper care and diagnosis from a healthcare provider to determine if the symptoms were due to a food allergen.
Food Allergies Can Be Life-Threatening
While most symptoms from food allergies are mild and limited to skin or digestive discomfort, some may progress to 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 and larynx
Symptoms of anaphylaxis may start out as relatively mild but, if not treated promptly, symptoms can become life-threatening in a short amount of time. Recognizing early symptoms of anaphylaxis and prompt injection of the drug epinephrine and other medical intervention can help prevent life-threatening consequences.
It is important to understand that a mild allergic reaction does not always mean the allergy is mild. Any allergic reaction has potential to lead to anaphylaxis. Allergic individuals are advised to always monitor symptoms and seek medical care if needed when symptoms occur.
Reporting Adverse Reactions and Labeling Concerns
If you or a family member has had an allergic reaction after eating an FDA-regulated food or food product with unclear labeling or a possible undeclared allergen, discuss this with your health care provider. Keep any food packages because they may contain important information.
Report the suspected reaction or labeling concerns to the FDA in one of these ways:
- Consumers and manufacturers can submit reports detailing product reactions or other complaints to an FDA Consumer Complaint Coordinator for the state where the food was purchased. View a list of FDA Consumer Complaint Coordinators.
- For non-meat food products (cereals, fish, produce, fruit juice, pastas, cheeses, etc.), call the FDA at 1-888-SAFEFOOD (1-888-723-3366).
- For meat, poultry and egg products, call the USDA Meat and Poultry Hotline at 1-888-MPHotline (1-888-674-6854).
- Submit a report using FDA's MedWatch Online reporting form for consumers.
Reports submitted to FDA should include as much information as possible:
- Who is reporting the incident and who was affected? Please provide names, addresses, and phone numbers.
- The name and address of the place where the product was purchased.
- A clear description of the reaction, including:
- Date the reaction occurred.
- All symptoms experienced.
- How long after the product was consumed the reaction occurred.
- Medications used to treat the symptoms.
- Whether the reaction required further medical care, and if so, what kind. Please provide contact information for the doctor or hospital.
- A complete description of the product, including date of purchase, and any codes or identifying marks on the label or container, such as lot number, expiration date, and UPC code.
- Photos of the product, label, ingredient statement, and lot code.
Consumer reports of adverse events help FDA identify problem products and better protect all consumers.
