Allergens can cause life-threatening reactions. FNS collaborates with food businesses and the Institute of Child Nutrition to educate on best practices for handling allergens during food preparation.
Our technical guidance details the different labelling rules applicable to prepacked and unpackaged food (including buffets). Advice is given on including allergen information as well as advisory statements in labelling requirements.
FALCPA
As someone living with food allergies, you must read every label carefully when buying packaged food products. Ingredients and manufacturing processes change without warning, meaning even products you’ve purchased hundreds of times could contain hidden allergens that need to be carefully considered before purchase. You must read both the ingredients list as well as any possible “may contain” statements which usually appear after the ingredients list.
The Food Allergen Labeling and Consumer Protection Act (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require major food allergens be listed on FDA-regulated foods in either of two ways: either through their inclusion as ingredients in ingredient lists using their common or usual name or through use of an “Contains” statement if an identifiable amount exists within a food product.
“Contains” statements must include all foods that contain major food allergens in their ingredient lists. Since they allow synonyms for allergens like peanut, soybean and soya beans as allergens in these statements, such as seeing “peanut,” “soybean” or “soya,” alongside milk for instance.
FALCPA exempts molluscan shellfish (such as oysters, clams and mussels) from its list of major allergens; therefore they cannot be identified using their common names. Furthermore, any “Contains” statement must exclude ingredients that do not fall under this category such as spices, flavorings and preservatives.
Food Allergen Labeling and Consumer Protection Act of 2004
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) introduced new labeling requirements for major food allergens. Labels must clearly display both allergen name as well as any common or usual names for those allergens that must appear, either parenthetically or within an ingredient list of food products containing allergens. Manufacturers are required to employ preventative controls within their facilities to reduce cross-contact between foods containing allergens and non-allergenic food products.
FALCPA also mandates food companies to disclose the type of tree nut (e.g. almonds or walnuts), species of fish (e.g. bass, flounder or cod) or Crustacean shellfish used to make their product in order to help consumers avoid purchasing products contaminated with allergenic proteins that they are allergic to. This helps consumers make informed choices and avoid purchasing foods containing allergens which they might be sensitive to.
Manufacturers may choose to include voluntary “precautionary” statements on the label of their product, which could read “may contain…” or “produced in a facility with…” These non-regulated statements can be misleading as their wording can vary and could lead to consumers believing that products containing allergens have not been manufactured from the same facility as the food they are purchasing.
Under FALCPA, manufacturers may petition the Secretary of Health and Human Services for relief from labeling requirements by providing scientific evidence that their production method does not produce food allergens that cause serious adverse reactions in allergy sufferers.
The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) plays an essential role in protecting public health through rigorous scientific evaluations, clinical trials, and post-market surveillance. Their regulatory scope includes human and veterinary medications; vaccines and other biological products intended for human use; medical devices; our nation’s food supply; cosmetics; dietary supplements; electronic devices that emit radiation; and tobacco products.
As part of its mission, the FDA conducts inspections and sampling to ensure manufacturers comply with labelling rules established in food law (Opens in new window). These include identifying 14 major allergens such as celery, eggs, fish, milk, peanuts, molluscs sesame seeds wheat soya beans sulphur dioxide or sulphites at concentrations over 10 parts per million.
The FDA employs an inspector team that acts as its “eyes and ears.” They can visit production and warehousing facilities, investigate complaints, illnesses or outbreaks and review documentation of products where physical examination or sample collection would be difficult or inappropriate. Furthermore, this team engages in enforcement activities designed to stop sales of untested or potentially hazardous products; when needed they can even take legal action to force recalls.
Threshold Levels
Threshold levels are used by insurance companies to set maximum amounts of coverage for certain risks and ensure customers do not assume too much risk, keeping premiums affordable. They are also utilized in medicine where threshold levels help determine whether patients should get vaccination against contagious diseases like measles; for instance, 95% vaccination coverage must be achieved to achieve herd immunity – thus helping reduce outbreak risk while protecting those unable to be immunized due to health reasons.
Allergen thresholds are essential in managing food allergies safely, both individually and population-wide. High quality individual threshold data can assist allergy management efforts by informing decision making on introducing foods with precautionary allergen labelling (PAL) for those allergic individuals. Thresholds may be obtained via various sources, including low-dose double-blind placebo controlled food challenge (DBPCFC) studies or dose distribution modeling.
Determining these thresholds, however, can be a complicated endeavor and requires thorough consideration of a range of factors like allergen concentration in food and the likelihood of allergic reaction. Furthermore, exposure levels differ among individuals of various health statuses and age groups, which could influence threshold levels.
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