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FDA Allergen Labeling Rules

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Allergen labeling rules that were established by the Food Allergen Labeling and Consumer Protection Act of 2004 require food manufacturers to notify consumers if the food in a package contains protein from a major food allergen.

There are eight foods included in this group: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soy. If any of these are an ingredient, the label must state that it is present in the food.

The U.S. Food and Drug Administration (FDA) determined that the law was needed after foods in a random test of baked goods, ice cream and candy showed that 25 percent of the foods tested did not list peanuts or eggs as ingredients on their labels even though they were present in the foods.

Eight foods cause 90 percent of food allergies

According to the FDA, 160 different food allergies have been identified, but the eight foods that are included in the major food allergen group cause 90 percent of the documented food allergy reactions in the country. They also cause the most life-threatening allergic reactions, which require emergency medical treatment with epinephrine.

How foods must be labeled

Food manufacturers must label their products in one of two ways if a major food allergen is used to make the food:

  1. The common name of the ingredient can be in parentheses after listing the chemical or manufacturer name. This method may be used if the ingredient does not appear anywhere else on the ingredient listing.
  2. Another way to warn consumers that potentially harmful food allergens are included in the food is to write that it either contains or may contain one or more of the major allergens.

Foods that are exempt from the labeling rules

Some foods are not required to be labeled according to this law. They include fresh fruits and vegetables as well as highly refined oils from the
eight major food allergens. Other foods are exempt from labeling requirements if they have been
shown to not contain ingredients that can cause an allergic reaction to peanuts or to any one of the seven additional foods in the major food allergen group.

Food labeling rules do not apply to restaurant foods

The FDA food labeling rules apply only to foods that are packaged FDA-regulated foods. Since these rules do not apply to restaurants, bakeries and other eateries, it is possible that foods at these places may contain proteins from any of the eight foods that most often cause food allergies. Before eating at these places, consumers should speak with managers to be sure that prepared foods do not contain foods that will cause them problems.

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