Food Recalls and Mislabeling: How to Avoid Mistakes Before Products Hit the Shelves

Spring is often a time that allergy sufferers dread. But for those who are allergic to food ingredients, that dread can be a daily occurrence.

Following ingestion of a food allergen, a person with food allergies can experience anaphylaxis, which can lead to constricted airways in the lungs; severe lowering of blood pressure and shock ("anaphylactic shock"); and suffocation by swelling of the throat.

Each year in the U.S., it is estimated that anaphylaxis to food results in 30,000 emergency room visits, 2,000 hospitalizations and 150 deaths.

Sometimes even vigilant food-label reading doesn’t offer protection.

For example, in March 2008, two major food labels recalled products that contained ingredients not disclosed on the nutritional labels. The first, "America’s Choice® Classic Caesar Dressing", made by Bay Valley Foods, included undeclared fish, soy and wheat. Ultimately, Bay Valley Foods recalled 535 cases of "America's Choice® Classic Caesar Dressing" because some of the bottles produced in February 2008 had an incorrect ingredient label on the back of the bottle (the incorrect label on the back included ingredient and nutrition information for Chunky Blue Cheese Dressing and did not declare the presence of fish, soy and wheat).

The second product, Bass Pro Shops Uncle Buck's Light 'N Krispy Fish Batter Mixes by Williams Foods, Inc., contained undeclared milk. Williams Foods Inc. recalled 22 ounce canisters of Bass Pro Shops Uncle Buck's Light 'n Krispy Original and Light 'n Krispy Hot & Spicy Fish Batter Mixes and 8 ounce pouches of Bass Pro Shops Uncle Buck's Light 'n Krispy Original Fish Batter Mix because the products contain undeclared milk (as part of a minor component of added natural flavors). The problem was discovered by Williams Foods during a routine label review.

To help Americans avoid the health risks posed by food allergens, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004, which applies to all foods regulated by the U.S. Food and Drug Administration (FDA), both domestic and imported that were labeled on or after January 1, 2006. (FDA regulates all foods except meat, poultry and certain egg products.)

Before this law, the labels of foods made from two or more ingredients were required to list all ingredients by their common, or usual, names. The names of some ingredients, however, do not clearly identify their source. Now, the labels must clearly identify the source of all ingredients that are — or are derived from — the eight most common food allergens, which account for 90 percent of food allergic reactions. The eight foods identified by the law are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.

These eight foods, and any ingredient that contains protein derived from one or more of them, are designated as "major food allergens" by the law and food labels must identify the food source of all major food allergens. Unless the food source of a major food allergen is part of the ingredient's common or usual name (or is already identified in the ingredient list), it must be included in one of two ways. The name of the food source of a major food allergen must appear in parentheses following the name of the ingredient--examples: "lecithin (soy)," "flour (wheat)," and "whey (milk)"; or immediately after or next to the list of ingredients in a "contains" statement--example: "Contains Wheat, Milk, and Soy."

The Bay Valley Foods incident could have been avoided with quality control checks, such as the checks that Williams Foods conducted to catch their own error.

However, in both cases an outside perspective could have prevented the recalls. Companies such as VCI LLC offer compliance services that meet FDA standards, as well as expertise in validation, production, quality, and R&D.

VCI offers manufacturers a proactive approach to getting it right the first time--before a product even hits the shelf--thus negating the need for a reactive response down the road.

Call (734) 274-4680 or email us at Ask VCI to find out how VCI can help you.

Alternatively, call Dr. Norm Howe, Sr. Partner, directly at 734.740.9924