Making Sense of Allergen Terminology
According to the Centers for Disease Control & Prevention, food allergies are on the rise. That’s why it’s so important to understand allergen terminology and pay careful attention to product labels, especially if you have food allergies.
While the FDA admits that there are more than 160 foods that can cause allergy, they only require that eight “major food allergens” be identified on food and supplement labels. This is because these eight allergens, according to the FDA, “account for over 90 percent of all documented food allergies in the U.S. and represent the foods most likely to result in severe or life-threatening reactions.”
Via the Food Allergen Labeling and Consumer Protection Act (FALCPA) the eight allergens identified are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. The FALCPA requires that the specific type of tree nut be declared on the label in parentheses (e.g., almonds, pecans, or walnuts), as well as the species of fish (e.g., bass, flounder, or cod) and shellfish (e.g. crab, lobster, or shrimp). The FALCPA applies to all packaged foods and supplements that are sold in the US and regulated by the Federal Food, Drug, & Cosmetic Act.
You will note, that gluten is not one of the eight allergens. As any person with celiac disease knows, even if something is labeled “wheat free” it does not guarantee it is gluten free. However, more and more food and supplement manufacturers are now taking the step to test and certify their products gluten free, making it much easier for those with gluten intolerance.
Labels on foods and dietary supplements regulated by the FDA must list ingredients that contain one or more of the major food allergens in one of two ways:
1. The common or usual name of the major food allergen must be followed by the food source in parentheses in the list of the ingredients. This will occur the first time the major food allergen is listed and does not have to be repeated each time the name of the specific food allergen appears.
Examples: “lecithin (soy),” “flour (wheat),” and “whey (milk)”
2. There may be a section after or near the ingredient list called “Contains”. After the word “Contains”, there must be listed the name of the food source from which the major food allergen is derived.
Example: “Contains Wheat, Milk, and Soy.”
If a dietary supplement does not list any allergens on the label, then you may assume that it does not contain any of the eight major allergens.
If a product is labeled as “allergen free” then the manufacturer is basically claiming that it does not contain any of the eight allergens listed in the FALCPA. However, to be clear, the term “allergen free” is not actually defined by the FDA, and general claims stating “allergen free” or “no allergens” are considered to be too broad in nature, and do not meet the labeling standards. Why? Because people can be allergic to things other than the eight common allergens – like corn for example. A statement on the label that something is “allergen free” is good marketing, enhances consumer awareness about their product, isn’t misleading if indeed the product is free of the eight major allergens, and there is nothing inherently wrong with the statement. It’s just not very accurate.
Use of the statement “free of ”or “does not contain”, followed by the list of foods or substances, is the best way for manufactures to label their products, giving the consumer better information to help them make a choice whether or not to purchase the product. This statement implies that the manufacturer has high confidence or has taken the important step of testing the raw materials or finished product to ensure these allergens do not exist in the product.
The term hypoallergenic is also often used. This term is defined in the dictionary as “designed to reduce or minimize the possibility of an allergic response, by containing relatively few or no potentially irritating substances.” Similar to the term “allergen free”, it is not a guarantee against all allergenicity. However, supplement manufacturers may utilize this term to let the consumer know they are dedicated to reducing or eliminating allergens in their products as much as possible, and may clarify it further for the consumer by stating their hypoallergenic products are “free of all common allergens,” specifically referring to the eight identified by the FDA. However, it’s still most helpful to the consumer, when “free of” or “does not contain” statements are utilized on each product as well.
High quality supplement manufacturers may test raw materials and finished products for certain allergens, for example, gluten or soy, in order to label their product “gluten free” or “soy free”. They may often go even further to test raw materials to ensure they contain no common allergens at all, and these products may be labeled “Free of all common allergens”. As required by the FDA, each dietary supplement label should provide information needed to make informed buying decisions.
Many high-quality supplement manufacturers now include corn, gluten, yeast and other allergen ingredients in their “does not contain” statements, along with the eight major allergens. The more information that is available to the consumer, the better, and more and more manufacturers are now making an effort to put this information on the label. Still, the bottom line is, when in doubt, don’t assume. Ask!
Benede S, Blazquez A, Chiang D, et al. EBioMedicine. 2016;7:27-34.
Gupta RS, Warren CM, Smith BM, et al. JAMA Network. 2019;2(1).
Food Allergy Research & Education. Food Labels. https://www.foodallergy.org/education-awareness/advocacy-resources/food-labels
US Food & Drug Administration. Dietary Supplement Labeling Guide. https://www.fda.gov/food/dietary-supplements-guidance-documents-regulatory-information/dietary-supplement-labeling-guide