ALLERGIC INGREDIENTS MAY NOT BE ON FOOD LABELS

WASHINGTON, DC—A joint federal and state investigation of 85 food manufacturers suggests that 25% of the companies made foods with allergenic ingredients that were not included on the product label and only about half verified the accuracy of their labels.[1]

The Food and Drug Administration (FDA) produced these findings with the aid of the Minnesota Department of Agriculture and the Wisconsin Department of Agriculture, Trade, and Consumer Protection. The three agencies formed the Food Allergen Partnership in 1998 because of increases in allergen-related food recalls and in concern about cross-contamination of processed foods with allergen residue.

“I am not really surprised by these findings,” commented Clifton Furukawa, MD, a Professor of Pediatrics at the University of Washington, Seattle, and a member of the Board of Directors of the American Academy of Allergy, Asthma, and Immunology. “We know allergens may not be on the label, so we [must educate] our patients and make sure they know what to do when they are exposed.”

The cross-contamination may be unintentional, pointed out Dr. Furukawa. This can occur when the same equipment or utensils are used to manufacture allergen-free and allergen-containing products, especially when there is insufficient equipment cleaning between product changeovers. In its investigation, the Food Allergen Partnership found unintentional cross-contamination to be the main reason for the presence of unlabeled food allergens, FDA spokesperson Sebastian Cianci told RESPIRATORY REVIEWS.

MANUFACTURERS WERE RANDOMLY SELECTED

Between September 1999 and March 2000, the partnership randomly inspected small- to large-sized manufacturers of ice cream, baked goods, and candy in Minnesota and Wisconsin. The manufacturers completed a questionnaire on production practices and allergenic ingredients. Although peanut and egg allergens were the main focus of the investigation, the questionnaire also asked about other food allergens: milk, tree nuts, wheat, soybeans, sulfites, yellow dye No. 5, and cotton, poppy, and sunflower seeds.

During inspections, the ingredients used in each product were compared with those on the product label. If an ingredient was not on the label, a product sample was sent to a state laboratory to be analyzed for allergens by enzyme-linked immunosorbent assay (ELISA). Such analysis was also done in cases in which allergen cross-contamination was a possibility. ELISA was considered positive if it revealed an allergen content of 10 parts per million or more.

The FDA or state agencies had discussions with representatives of companies found to have Good Manufacturing Practice violations and product samples with unlabeled allergens. Recalls were initiated, if it was deemed necessary, and companies with egregious violations received a warning letter from the state that included a request to provide a written allergen control plan. Follow-up inspections for violators took place in July and August 2000.

MANY COMPANIES MADE AN EFFORT

During the initial inspections, the partnership obtained 118 product samples; 73 were analyzed for unlabeled peanut allergen and 45 for unlabeled egg allergen. ELISA was positive in 18 (25%) of the samples analyzed for peanut allergen and in five (11%) of those tested for egg allergen.

Before the inspections, about half the companies had been trying to ensure label accuracy, mostly with the help of private consultants and sometimes by checking off ingredients as they were added to each product batch. These companies typically discarded old labels after changing recipes.

To prevent allergen cross-contamination, some companies had been producing allergen- and non–allergen-containing products on different days. Others made allergen-containing products only at the end of the week or the end of the final production shift. They then disassembled and thoroughly cleaned their equipment, making sure to review and verify documentation of the cleaning before resuming production. However, these practices were far from universal.

Many companies changed their operating procedures as a result of inspection findings. Nearly half instituted additional measures to prevent cross-contamination, 23% started verifying label accuracy, 20% stopped reusing existing products, and 15% began testing finished products for unlabeled allergens. Many improved and began documenting equipment sanitation.

HOW TO IMPROVE THE SITUATION

To prevent omission of allergens from food labels, the FDA has released an allergen inspection guide and is creating a compliance policy guide. These guides will help FDA staff and field investigators inspect food manufacturers for proper labeling and allergen cross-contamination and outline the appropriate actions for violations. The FDA has also held workshops to provide current information about food allergens to food manufacturers.

—Timothy Begany