Food ingredient labels and allergens: what does the law say?
In the United States, two major laws govern food allergen labeling for FDA regulated foods: The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education and Research Act of 2021 (FASTER). These laws cover food allergen labeling for certain pre-packaged foods that fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The laws require that top 9 food allergens that are intentional ingredients be listed in the ingredients list on the label in plain language.
What does that really mean for people who are trying to avoid food allergens, though? Let’s break this down:
What counts as a pre-packaged food for allergen labeling purposes?
A pre-packaged food is packaged by its manufacturer before it is put on a food retailer’s shelf or sold in an online store. Freshly made foods that are packaged on site by a customer or staff after a customer places an order– such as fresh baked breads or cakes from a store bakery, fresh sliced meat from a deli, food from a store salad bar, etc., are not considered pre-packaged foods and are not subject to the same allergen rules as pre-packaged foods.
Fresh food served at a restaurant is also not considered pre-packaged (even if you get it packaged for takeout) and is not subject to the FDA’s allergen labeling rules, although restaurants in certain states or municipalities may be subject to state or local laws about disclosing allergens to customers.
Which pre-packaged foods are regulated by the FDA?
The FDA regulates labels on most pre-packaged packaged foods you buy in the United States, but there are important exceptions. The United States Department of Agriculture, or USDA is responsible for regulating labels on some types of pre-packaged fresh meats, dairy, eggs, and and produce. For the most part, the Food Safety and Inspection Service, the department of the USDA in charge of food safety, follows the FDA’s lead on its recommendations to food manufacturers about allergen labeling, but the USDA is not explicitly required by law to require plain language labeling for top allergens in the same way way the FDA is; the FALCPA and FASTER laws mentioned above were written by Congress to apply specifically to the FDA not the USDA. You can read more about how the USDA handles food allergen labeling on the FSIS website.
The U.S. Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) is responsible for regulating labels on pre-packaged alcoholic beverages. The ATF does not currently require makers of alcoholic beverages to label them for food allergen content. In order to find out whether alcoholic beverages contain food allergens, consumers in the U.S. have to contact the manufacturer, ask for that information and hope they are willing to provide it. Common food allergens like dairy, egg, tree nuts, and fish may be used in the production or flavoring of alcoholic beverages and this may not be obvious to consumers.
What counts as a top 9 allergen?
Top allergens are those foods that the government considers people most likely to be allergic to. Foods currently considered to be top 9 allergens in the United States are: Peanuts, tree nuts, dairy, eggs, soy, wheat, fish, crustacean shellfish, and sesame.
Dairy includes cow’s milk and all its derivatives, such as cheese, cream, butter, and ghee.
Tree nuts, according to the FDA, are a very broad food category that includes almonds, beech nuts, Brazil nuts, butternuts, cashews, chestnuts, coconut, hickory nuts, pecans, pine nuts, pistachios, walnuts, and more. It is possible– in fact, it’s fairly common– to be allergic to one or two types of tree nut but not be allergic to the other types.
Note that crustacean shellfish– such as lobsters, shrimp, and crabs– are considered to be on the top 9 allergen list, but molluskan shellfish– such as oysters, shallots, and clams– aren’t.
What counts as plain language on food labels?
“Plain language” means using clear, obvious, specific wording that most people who speak English can easily understand. So for example, if sesame is included in a product as an intentional ingredient, it should be listed as “sesame” not as “spices” or “natural flavors.” If casein, a protein derived from milk, is included in a product as an intentional ingredient, a more commonly used word like “milk” or “dairy” should appear somewhere on the ingredient label, because it’s not common for people to know what the word “casein” means.
An allergen can be declared in plain language on a food label in one of two ways. It can be included in the ingredients list, or in a separate statement that starts with the word “contains.”
So for example, consider a box of pre-packaged cookies that contain wheat flour and butter– both top allergens– as an ingredient. The manufacturer could list the ingredients like this:
Ingredients: Flour (wheat), sugar, butter (milk), vanilla extract, salt.
Or the manufacturer could write the label like this:
Ingredients: Flour, sugar, butter, vanilla extract, salt.
CONTAINS: WHEAT, MILK
It is not required that manufacturers use a “contains” statement on the label to specifically list top allergens, so do not assume that a product without a “contains” statement does not contain top allergens.
It is also not required that food manufacturers list top allergens in bold, capitalized, or colored text to make them stand out on a label, although some companies choose to do so voluntarily, or to comply with other countries’ allergen labeling laws.
To check a product for top allergens, you must read the entire ingredient statement.
What is an intentional ingredient?
The U.S. laws that require food manufacturers to list top allergens on the ingredient labels of FDA regulated pre-packaged foods only require that manufacturers list intentional ingredients– ingredients that the company meant to include in the product. Packaged foods makers are not required to put warnings on an ingredient label if there is a possibility that a traces of a food allergen might end up in a product accidentally due to multiple flavors or varieties of foods being made or packaged on shared equipment or in a shared facility.
How often do foods really contain accidental ingredients?
Undeclared allergens are a leading cause of FDA food safety recalls. More than 1/3 of all FDA recalls for food product safety issues are due to unlabled top food allergens that wind up in food products by mistake. Allergens can accidentally be added to foods by mistake in a number of ways. Trace amounts of allergens may be transferred from one flavor or variety of food to another due to those foods being produced or packaged in a shared space or on shared equipment. Undeclared allergen issues can also be caused by mistakes in labeling foods. Wholesale ingredient suppliers might mislabel the raw ingredients that food manufacturers use to produce their product. A company might make a mistake and omit an intentional ingredient from their ingredients list after a packaging design change or recipe change. In a facility where different variations of the same type of product are packaged, one food product might be accidentally placed in packaging meant for a different food product (for example, a company might mistakenly put peanut butter cookies in boxes meant for sugar cookies).
Because so many food safety recalls in recent years have happened due to undeclared top allergens, the U.S. Congress and the FDA have recently tightened food safety rules and recommendations for food manufacturers. The FDA now asks food manufacturers to treat allergen safety with the same level of care that they treat food safety concerns for other potential food safety hazards, like bacterial contamination. That does not mean that the risk of accidental allergen contamination of pre-packaged foods has been eliminated, however. Food manufacturers are still adapting to this new guidance and it’s not clear yet how much allergen control has improved.
What are the rules for putting warnings like “may contain” or “made on shared equipment” on food ingredient labels?
These allergen advisory warning labels on foods are voluntary and unregulated. There is no legal standard for when or how a company should apply statements such as “may contain,” “made on shared equipment,” or “made in a shared facility” on a food label. There is no rule that a company must put an allergen cross contact warning on a food label if there is a known risk of allergen cross contact. Companies that use allergen advisory labels on packaged foods are doing so entirely at their own discretion.
What are the rules for “free from” statements like “peanut-free” or “gluten-free”?
For the most part, unfortunately, “free from” statements about allergens are entirely unregulated. The exception is for gluten (which is a component of wheat, a top allergen). Under FDA labeling rules for gluten, companies that put “gluten-free” labels on their products must be able to prove that those products actually do not contain traces of gluten above a certain threshold (20 ppm).
It is important for people who manage wheat allergy to note, though, that an item that is gluten-free is not necessarily wheat free. Gluten-free means the product is meant to be free from one specific wheat protein, gluten. But other ingredients derived from wheat may be present in a gluten-free product.
When it comes to other top allergens, there are no rules guiding the use of free from allergen statements like “soy free” or “dairy free”. No testing is required to prove such claims, and products with these “free from” claims are not required to be made in special allergen-free environments.
For allergens other than gluten, is perfectly legal for a food manufacturer to market a product as “allergen free” even if the manufacturer is aware there may be a cross contact risk because the product is made in a shared space with products containing top allergens. Some companies even make very confusing labeling choices like putting a statement that says “Tree nut free” on the front of a product, and a warning statement that says “Made on shared equipment with tree nuts” on the back.
What about other food allergens that are not on the top 9 allergen list?
Unfortunately, the rule about using plain language to identify ingredients only applies to top 9 food allergens. This means that companies can list other food allergens using ambiguous language like “spices,” “natural colors,” or “natural flavors.”
There are hundreds of foods that are known to cause allergic reactions in people. A person can theoretically develop an allergy to almost any type of food protein, and in some cases, as in the case of alpha-gal allergy, to certain food sugars.
If you have an allergy to a food outside of the top 9 food allergen list– like garlic, or strawberries, or mustard, or pork– it can be challenging to verify whether a pre-packaged food is safe for you to eat. You may have to contact food makers directly on a regular basis to find foods that are safe.
Are there any other food allergen labeling loopholes to be aware of?
Yes. Refined vegetable oils– like refined soy oil or refined peanut oil– are not considered part of the top 9 allergen list for labeling purposes even if they are derived from top 9 allergens. This is because most allergic reactions to food are triggered by proteins in food, and refined oils have had most of the proteins removed. However, there is no official standard for what type of oil counts as “refined,” and companies that make refined oils or use them in their products are not required to test them for traces of allergenic proteins.
How can I find out more information about allergens that might be in a food than what I can find on the label?
Food manufacturers may offer more information about allergens on their company website, either in a special allergy section or in their regular FAQ section. You can also try contacting a food manufacturer by phone, email, or social media.
You can also ask other people who manage food allergies what they know about how various food makers handle allergens; this can be a good way to discover brands that are especially allergy-friendly. But keep in mind that it is always safest to verify any second-hand information you find this way by checking the company website or contacting the food maker yourself..
Allergen cross contact: what it is and why it matters
Allergen cross contact (sometimes called allergen cross contamination) is the term for what happens when a food allergen is accidentally introduced into a food that does not contain that allergen as an intentional ingredient, due to the use of shared utensils, shared equipment, or a shared food preparation area.
For example, if you bring a nut-free apple pie to a family party, and a family member uses a knife to cut a pecan pie, then uses the same knife to cut the nut-free apple pie, traces of pecan might be transferred to the apple pie, making the apple pie no longer nut-free, due to allergen cross contact.
If a local bakery makes a batch of donuts that contains dairy and egg, and then uses the same spoon and bowl to mix up the batter for a second batch of donuts using a vegan recipe, without washing the equipment in between batches, traces of dairy and egg will be introduced into the “vegan” donuts, meaning they are not actually egg or dairy free. This is another example of allergen cross contact.
Unless adequate care is taken to prevent allergen cross contact, it can happen anywhere food is prepared, served or eaten. Because people with food allergies can be sensitive to very small amounts of their food allergens, even minor cases of allergen cross contact can sometimes cause severe allergic reactions.