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FDA Requires Better Labeling for Food Allergens

Date: Sep 01, 2004


Sometimes it can be the simple laws that can cause companies the most work and consternation. This may be the case with the newly enacted Food Allergen Labeling and Consumer protection Act of 2004. Now, that's not to say that it's a bad idea; several million people in the U.S. suffer food allergies. Congress estimated about 2% of the adult population and up to 5% of infants and young children. Some 30,000 people require emergency hospital treatment and as many as 150 die each year.

This new law hopes to reduce those numbers by giving food allergy sufferers adequate notice that a processed food product contains an ingredient that is made from or contains a major food allergen.

There are eight major food allergens recognized by the law: milk, egg, fish, shellfish, tree nuts, wheat, peanuts and soybeans. If a food product contains one of these allergens or an ingredient derived from one of these foods, the law requires that the product be labeled clearly with this information. Ingredient is a broadly defined term that includes flavorings, colorings and incidental additives.

As FDA explains it, if a product contains the milk-derived protein casein, the product's label would have to use the term "milk" in addition to the term "casein" so that those with milk allergies would clearly understand the presence of an allergen they need to avoid. In the case of nuts, fish or shellfish, the law requires processors to go one step farther and identify the specific type of nut or species of fish.

The new law requires identification of the food source as an adjunct to information already required, not as a substitute. Thus, in the example above, use of the term "casein" in the ingredient statement will still be required; but now food processors will also need to include-either within or after the ingredient statement-the appropriate disclosure concerning the food source from which the allergen is derived.

There are some exceptions. No special labeling will be required if the common or usual name of the food ingredient uses the name of the food source from which the allergen is derived, or in some cases, the name of the food source appears elsewhere in the ingredient labeling statement. Thus, if the product is labeled as containing "egg whites," it does not also have to say that it contains "eggs."

Additionally, the law excludes as covered food ingredients highly refined oils made from one of the named food groups, or ingredients derived from such oils. Under the law, a person can petition FDA to exempt such food ingredients from the allergen labeling requirements by demonstrating through scientific evidence that the ingredient does not cause an allergic response that poses a risk to human health. FDA is required to act on the petition in 120 days.

Alternatively, a person can file a notification with FDA to exempt such an ingredient from the allergen labeling requirements if it can be shown that the ingredient does not contain an allergenic protein or that FDA has already determined that the ingredient does not cause an allergic response that poses a risk to human health. These notifications are effective in 90 days from the date of filing unless FDA interposes an objection.

Finally, the law makes clear that although it is addressing labeling requirements for major allergens, it is in no way limiting FDA's authority, past or present, to require label or labeling for other food allergens.

The new labeling requirements apply to any food that is labeled on or after Jan. 1, 2006.

Used with permission. Copyright FOOD & DRUG PACKAGING, September, 2004.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com