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An Intro to The Food Allergen Labeling And Consumer Protection Act

By now most Americans have seen allergy-warning labels on various food items. But they probably know very little about the Food Allergen Labeling and Consumer Protection Act, the legislation that authorized the Food and Drug Administration to regulate those labels. Here’s an introduction to that Act and the regulations that followed.

Why regulate food allergens?

Millions of Americans suffer from food allergies, including children. Before the labeling requirements, it was estimated that 30,000 people required emergency care due to allergic reactions. Approximately 150 people died each year. While food manufacturers were required to list ingredients, the FDA found major allergens weren’t always listed. FDA sampled baked goods, ice cream, and candy in Minnesota and Wisconsin in 1999. It discovered that 25 percent of those foods failed to list peanuts or eggs as ingredients. Congress passed FALCPA in 2004 to address this dangerous discrepancy.

FALCPA modified the Federal Food, Drug, and Cosmetic Act to require standard labeling on food that contains a “major food allergen.” Although the FDA has identified more than 160 foods as causing allergies, the eight major food allergens cause 90 percent of all documented reactions. These include milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans.

How does it work?

Under FALCPA, food manufacturers may choose one of two options for identifying any major allergens. The first option allows the producer to list the allergen within the ingredient list, if it isn’t already included. For example:

Ingredients: Enriched flour (wheat flour, malted barley, niacin, reduced iron, thiamin mononitrate, riboflavin, folic acid), sugar, partially hydrogenated soybean oil, and/or cottonseed oil, high fructose corn syrup, whey (milk)eggs, vanilla, natural and artificial flavoring) salt, leavening (sodium acid pyrophosphate, monocalcium phosphate), lecithin (soy), mono-and diglycerides (emulsifier)


As you can see, the label clearly identifies the major allergens. That way, a person with allergies doesn’t have to recognize all the ingredients that could contain their allergen. For example, “enriched flour” contains wheat flour. A person with a wheat allergy, doesn’t have to remember that enriched flour has wheat. Because of FALPCA, it’s clearly written within the ingredient list.

The other option is to list allergens separately. So you may see a label that says, “contains wheat, milk, and eggs.” I’ve also noticed statements of “may contain wheat, milk, and eggs,” though these aren’t required. Again, this makes it exceptionally clear to someone with allergies that the product contains that allergen. The goal is to make identifying these ingredients as easy as possible for those with allergies, especially kids.

In case you’re wondering, FALCPA applies to foods packaged and sold in the U.S., as well as imported food. Raw agricultural commodities, like fresh fruit and vegetables, are exempted from the FALCPA requirements. Highly refined oils are as well. And foods that aren’t packaged, or are only packaged upon purchase, generally aren’t regulated.

The FDA conducts random sampling of food packaging to ensure compliance. The FDA may recall mislabeled foods.

Public Impact

It’s hard to overstate how important this labeling is for people suffering from allergies and also the people caring for them. Having the major allergens clearly indicated on the label allows them to enjoy pre-packaged food like the rest of us. Without it, many of them would have to cook from scratch, at home, all the time. That’s not a bad thing, but it’s obviously more time consuming and costly. The FALPCA makes life a little easier and safer.

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