Food allergy is a serious and growing public health issue. Recent data suggest that approximately 15 million Americans have food allergies, including one in every 13 children. Every three minutes, a food allergy reaction sends someone to the emergency room. The U.S. Centers for Disease Control report that food allergies result in more than 300,000 ambulatory-care visits a year among children under the age of 18.
The most serious reaction to a food allergy is anaphylaxis, an exaggerated immune response that can lead to severe rashes, pronounced swelling, particularly of the throat and tongue, and a precipitous drop in blood pressure that can be fatal. Teenagers and young adults with food allergies are at the highest risk of fatal food-induced anaphylaxis.
Eight foods account for 90 percent of all reactions: Milk, eggs, peanuts, tree nuts, soy, wheat, fish, and shellfish. Even trace amounts of a food allergen can cause a reaction.
“Currently, the FDA is weighing the issue of preventive controls and food allergen thresholds—matters of great importance to the food allergy community,” says John Lehr, CEO of the nonprofit advocacy organization, Food Allergy Research & Education (FARE), McLean, Va. “In January, the FDA requested public comment on a new proposed rule on preventive controls called Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food. It would improve safety across the food system by reducing the risks from all hazards in manufactured foods.”
The regulations would include specific requirements for preventing the unintended presence of allergens, generally referred to cross-contact, including requiring companies to identify areas of concern and to implement plans to prevent cross-contact.
Another major issue of concern is the mislabeling of food. “Prior to 2004, there was no requirement in the law specifically requiring that food allergens be labeled,” says Lehr. “Then with the passage of the Food Allergen and Labeling Consumer Protection Act (FALCPA) by Congress, companies were required to declare the eight major allergens.” However, Lehr points out, even though the legislation has been in place for several years, there are still recalls for undeclared allergens, “So there is still a significant problem.”
Helping to address the problem, FARE offers a website with a list of resources for industry, and for members of the food allergy community. “We also have staff members who address industry groups on a regular basis, speaking to employees about the food allergic consumer’s perspective,” says Lehr. “We also host the annual meeting of the Food Allergy & Anaphylaxis Alliance, a group of advocacy organizations around the world.” This year’s meeting, which will be held in early October, includes an industry day that brings together regulatory officials, representatives of the food industry, and allergy advocates to discuss issues in food allergy safety.
Even trace amounts of a food allergen can cause a reaction.
Establishment of Thresholds Key
“There is a large range in individual threshold doses,” says Steve Taylor, PhD, director of the Food Allergy Research and Resource Program, University of Nebraska-Lincoln. “If you just look at peanut allergy alone, some people have to eat several peanuts, or a hand full to get sick. Other people would react to small specks.” For specific measures of what induces an allergic reaction there is enough published data out there, Dr. Taylor thinks, to get a consensus on how much is too much—insofar as food production is concerned—and how that threshold, or reference dose should be the industry standard for the detection and prevention of cross-contact.
Yet, precise regulatory guidelines are lacking. “None of the public health agencies have established regulatory reference doses so, in the absence of official action, everybody continues to work towards zero, which of course you can never achieve.”