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Oct 31

FDA Food Allergen Labeling

When consumers with food allergies are purchasing food products, they normally examine the food labels to make sure a product does not contain any ingredients that would cause them to have an adverse reaction. Milk, eggs, fish, shellfish, nuts, wheat, peanuts, and soybeans are all common ingredients considered “major food allergens” that can potentially cause life-threatening consequences for consumers with allergies. The U.S. Food and Drug Administration notes that each year in the United States, food allergies cause 30,000 visits to the emergency room, 2,000 hospitalizations, and 150 deaths. Because of these health concerns, food allergen labeling has emerged as an important area in federal regulation.

Every year, countless food product recalls are caused by “undeclared allergens”, which are major allergens not listed on product labels. A list of all current recalls, including those that were recalled due to food allergen labeling issues, can be found here. For example, The U.S. Food and Drug Administration (FDA) published notification of a recent recall of vegan gingersnap cookies, which were removed them from shelves when it was found that they contained tree nuts, milk, soy, and egg, none of which were listed on the product labels and therefore the products were not compliant with food allergen labeling regulations.

Federal law requires that food producers and distributors include allergy information on their labels. The Food Allergen Labeling And Consumer Protection Act of 2004 (FALCPA) governs the disclosure of certain allergens on food labels. The FALCPA only requires disclosure of 8 major food groups on labels, although there are over 160 foods that produce allergies in humans. However, the FDA has found that over 90% of food allergies are caused by the following 8 major food groups: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. In addition, on August 5, 2013, the FDA issued a final rule regarding the labeling of “gluten free” foods, which as also authorized by FALCPA as part of the laws on food allergen labeling. As of August 2014, the FDA has started to enforce this rule, just as they do with the other 8 major food allergens.

The Food Allergen Labeling and Consumer Protection Act requires that food products be labeled in very specific ways. There are two ways to label foods containing allergens. First, the common name of the allergen can be placed in the ingredient statement. Second, the food producer can include a “contains” statement, which includes the food source from which the major food allergen is derived. For example, the food label should look like this.

The FALCPA does not apply to “cross-contact” situations that may arise during manufacturing, such as shared equipment or processing lines. Food producers are encouraged to use food allergen advisory statements, such as “may contain [allergen]” or “produced in a facility that also produces [allergen].”

When a company violates the food allergen labeling requirements of the FALCPA, they may be subject to civil sanctions, criminal penalties, or both under the Federal Food, Drug, and Cosmetic Act. FDA may also request seizure of food products where the label of the product does not conform to FALCPA’s requirements. To avoid these heightened enforcement measures, many companies will opt to recall their products, as shown above.

Labeling your product requires intricate knowledge of many different statutes and regulations, such as FALCPA, the Federal Food, Drug, and Cosmetic Act, and the Food Safety Modernization Act (FSMA). We have previously blogged about the FSMA, food labeling, and the penalties for not complying with FDA regulations. For questions regarding food labeling and for inquiries about label reviews of your  product labels, please contact us at contact@giannamore-law.com.

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