"Dear Colleague" Letter About the "Food Allergen Partnership"
March 26, 2001
Recently the Food and Drug Administration’s Minneapolis District Office released a study entitled, "Food Allergen Partnership."
This study focused on 85 firms chosen at random within the States of Minnesota and Wisconsin. The partnership was comprised of State and FDA field investigators and was set up, in part, to respond to the need to collect data on the observed increase in food allergen-related recalls across the country.
The partnership looked for the presence of peanut and egg allergens on food processing lines in the ice cream, bakery and candy industry. Label verification, rework procedures, cross-contact prevention, and in general, allergen-control procedures used were reviewed in inspected firms.
A major finding of the study demonstrated that 18 out of 73, or 25%, of final food product samples tested positive for peanut allergens even though peanuts were not declared on the product label.
For the last two years the Agency has been actively involved in a process of increasing allergen awareness within the food industry. This year, more attention is being paid to the allergen issue in response to these recent findings, and allergens are on the "A" list of activities in the Center for Food Safety and Applied Nutrition Program Priorities.
Later this year, the Agency intends to hold a workshop with the industry, consumers, trade associations and consumer advocate groups to discuss allergen label issues and to find the best ways to improve the identification of food allergens within the ingredient list. This will include discussions of current incidental ingredient and collective naming exemptions.
The Agency continues to be concerned over the continued finding of undeclared allergens. FDA encourages the food industry to redouble its effort to be vigilant on food processing lines. FDA will be issuing an allergen inspection guide to its field offices to provide investigators with an inspection tool designed to identify industry problem areas that could result in undeclared allergens. In addition, FDA will develop interactive training programs for investigators. Later this year, FDA will also publish, for public comment, a draft Food Allergen Compliance Policy Guide addressing needed industry manufacturing and labeling practices for food allergen control.
Addressing the very real issue of food allergens needs to be a priority for us all. It is an important public health risk that, with proper attention, can be effectively reduced.
Dennis E. Baker
Associate Commissioner For Regulatory Affairs
Joseph A. Levitt
Center for Food Safety And Applied Nutrition