People with food allergies must easily recognize foods containing major allergens such as milk, eggs, fish, crustacean shellfish, peanuts, tree nuts and wheat. Food labels must clearly indicate where these allergens originate.
Businesses that fail to abide by food industry requirements risk suffering financial and reputational harm. To help these food businesses, two sets of fact sheets have been prepared as guides.
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
Since there is no cure for food allergies and those suffering must avoid eating anything containing their allergen, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) requires all food products to list major allergens such as milk, eggs, fish, crustacean shellfish, tree nuts, wheat and soybeans as major allergens. Any product containing an undeclared major allergen violates federal food, Drug, and Cosmetic Act regulations and should be reported accordingly.
FALCPA requires allergens be listed either in an ingredients list or on packaging with either its common English name or via a “Contains” statement. When listing allergens within ingredients lists or “Contains” statements, their common English names must appear; when used for packaging labels as “Contains,” this statement must immediately follow or adjacent to each ingredients list entry on a package.
When listing an allergen, companies must also specify its source: tree nuts such as almonds, pecans or walnuts; fish (cod, bass and flounder); crustacean shellfish such as crab, lobster or shrimp – these details are essential to consumers with food allergies whose symptoms often result from eating certain kinds of food items.
These allergen labeling requirements apply only to food products regulated by the Food and Drug Administration, not alcohol beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau. AAFA continues its advocacy efforts for mandatory allergen labeling of all alcoholic beverages.
The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is the United States government body responsible for overseeing an array of medical, food and health-related products, such as pharmaceutical drugs, vaccines, dietary supplements, over-the-counter and prescription medicines, veterinary remedies, tobacco, electromagnetic radiation emitting devices and cosmetics.
The Food and Drug Administration’s mandate encompasses setting safety standards, protecting public health, enforcing existing laws, as well as providing educational materials to consumers and guidance to regulated industries regarding compliance with all relevant laws and regulations.
In 1906, with the passage of the Pure Food and Drug Act to address manufacturer abuse in consumer product markets, the Food and Drug Administration was officially created as an agency known as the Bureau of Chemistry; later rebranded to become known as Food and Drug Administration in 1930. White Oak, Maryland-based Environmental Protection Agency operates over 200 field offices and several laboratories throughout the country. The Food and Drug Administration is funded through federal, state and industry user fees collected from manufacturers; more than half of its budget comes from this source. Oversight for its activities falls to the Department of Health and Human Services; products regulated by FDA account for 20% of consumer purchases in the U.S.
Allergen Threshold Levels
Allergen threshold levels provide essential insight for effective food allergy management. They help identify whether a certain food should carry a warning label stating it may contain allergens or contains allergens and direct regulatory and industry efforts toward foods which pose real threats to allergic consumers.
Establishing thresholds for food allergies can be a complex undertaking, involving various approaches that should ultimately produce clinically and epidemiologically sound thresholds. Romer Labs UK sales director Richard Fielder notes, in order to reach meaningful thresholds that meet clinical need there needs to be robust testing methods with international harmonized results that provide meaningful thresholds.
As there has been little agreement on an allergy threshold level that will not cause an objective allergic reaction, many consumers and food industry workers now tend to avoid foods containing even trace amounts of allergens such as gluten. Voluntary precautionary labelling with warnings such as “may contain” has become common practice; behavioral research demonstrates this significantly impacts the quality of life for people living with food allergies.
To address these concerns, scientists from around the world working in various disciplines have come together under the banner of VITAL Scientific Expert Panel (VSEP) to create and apply clinical thresholds to food allergens. Furthermore, Codex Alimentarius Commission asked this committee to review and clarify provisions related to allergen labelling in General Standard for Labelling Prepackaged Foods as well as create guidance on precautionary allergen labelling (PAL).
Cross-Contamination
Cross-contamination with allergenic food can occur anywhere, whether at home or a restaurant. To minimize cross-contamination risks, practices such as keeping foods separate, frequently washing hands and changing disposable gloves as well as cooking and storing in appropriate containers can all help lower risk of contamination. It’s also wise to store raw meat and poultry separately in sealed plastic bags within your grocery cart or refrigerator and using separate cutting boards for each food – this helps stop juices dripping onto ready-to-eat products and contaminating them further!
Some may be unaware of how small amounts of allergens can make them sick, which is why it is essential to use caution when dining out and communicate your allergies clearly to staff members. Also make sure you ask pertinent questions regarding ingredients, preparation methods and storage if applicable.
Allergens must be clearly listed on food labels by law. This includes the most prevalent allergens – peanuts, tree nuts, wheat (celiac disease), milk, egg, soy and crustacean allergens such as fish. Alternatively, the food industry can opt to include precautionary labeling that indicates their product does not contain any of the listed allergens but was processed at an allergenic facility.
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