[Allergen Management] The Year in Review

With E. coli recalls, FDA’s new Food Protection Plan and general food safety taking the top news spots in 2007, allergen concerns often ended up in the backseat in the media. But the topic continued to hold a place at industry conferences, in research and with industry advocates.

Among the key topics of 2007 were:

GLUTEN-FREE. January. With public comments due by April, FDA proposed defining of the term “gluten-free” for voluntary use in food labeling in response to the Food Allergen Labeling and Consumer Protection Act of 2004, which directs the secretary of Health and Human Services to propose, and later make final, a rule to define and permit the use of the food labeling term “gluten-free.”

The proposed definition of gluten is: the proteins that naturally occur in a prohibited grain and that may cause adverse health effects in persons with celiac disease. Prohibited grain would be defined as wheat species of the genus Triticum; rye of the genus Secale; barley, genus Hordeum; and crossbred hybrids of wheat, rye or barley.

FDA does not currently have any regulation that defines the term “gluten-free,” but it has not objected to the use of the term on food labels, provided that the claim is truthful and not misleading. The proposed definition of gluten-free is that a food bearing this claim in its labeling cannot contain any ingredients that are a prohibited grain; derived from a prohibited grain (that has not been processed to remove gluten); derived from a prohibited grain and processed to remove gluten, with 20 parts per million (ppm) or more gluten remaining in the food; or 20 ppm or more gluten.

FOOD ALLERGY FATALITIES. March. A report on fatalities from food-induced anaphylaxis suggested that little progress has been made in effectively preventing and treating food allergy reactions over the past five years. The findings support earlier statistics showing that adolescents and young adults are at highest risk for fatalities. Among the areas noted as needing improvement is that of focusing more attention on the reading of labels and avoiding of allergens. The report, which appears in the April 2007 issue of the Journal of Allergy and Clinical Immunology, looked at 31 individuals who died as a result of their food allergies.

“These statistics are disturbing,” said Anne Muñoz-Furlong, founder and CEO of the Food Allergy & Anaphylaxis Network (FAAN), “because they show we are not making the progress we hoped to in preventing food allergy-related deaths or in protecting teens, the highest at-risk group for fatal reactions. It's going to take more awareness and action to make a difference.”

The foods primarily responsible continue to be peanuts and tree nuts with the most common food sources being restaurant or food service items with hidden allergens (46 percent) and packaged food with undeclared allergens (27 percent). Desserts, particularly cookies and bakery items, and Chinese food such as egg rolls, caused a significant number of the reactions.

AN ALLERGEN-FREE PEANUT? May. A press release from a U.S. food company was distributed in May claiming that its product contained allergen-free peanuts, based on testing which revealed the nuts to be free of aflatoxin — “the mold in conventional peanuts that is linked to food allergies and illness.” In response, Steve L. Taylor, director of the University of Nebraska’s Food Allergy Research & Resource Program disputed the claim, explaining that although aflatoxin is a potentially toxic substance that can be produced on peanuts that are contaminated by certain types of mold, its levels in peanuts are constantly monitored and strictly controlled. “But, more importantly,” he said, “aflatoxin has nothing to do with the allergenicity of peanuts.”

“Just because a peanut is aflatoxin-free doesn’t mean that it’s allergen-free,” Muñoz-Furlong said. Even a peanut that’s free of aflatoxin can still cause allergic reactions in those who are allergic to peanuts.” Individuals with peanut allergy should continue to avoid all peanut products and speak to their doctor if they have any questions.

NIH FOOD ALLERGY RESEARCH. June. Citing the increasing prevalence of food allergies in U.S. children and adults, particularly in the area of peanut allergy, an expert panel of national and international food allergy experts was convened at the request of Congress to address issues in food allergy research. In its report, the National Institutes of Health (NIH) panel examined the current state of NIH-funded food allergy research and developed and prioritized a list of recommendations on key opportunities and research directions.

Among the panel’s recommendations was engagement of NIH and FDA to resolve impediments to the design and conducting of food allergy clinical trials. Additional recommendations related to NIH-funded research included: conducting of clinical trials evaluating promising new approaches to preventing and treating food allergies; investigation of epidemiological and genetic causes for food allergy and associated diseases; facilitation of basic and pre-clinical research studies on allergen structure and animal models of food allergy; and determination of the feasibility of an international registry of food-induced allergic reactions that could be used to facilitate clinical study
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ALLERGEN RECALLS. October. Recalls are continuing to increase. Twenty-five percent of these are due to allergens, and the industry saw an almost 200 percent increase in 2006. Such statistics were detailed in a Worldwide Food Expo seminar by Gayle Prince, recent retiree of Kroger. Prince, the “dean of recalls,” who handled all the company’s product recalls during his tenure, said he expects this increase to continue as consumers become more attune to foodborne illness and allergens, regulatory agencies increase their focus, and law firms specializing in foodborne illness continue to grow. While much of his presentation focused on recalls for foodborne illness, the effect of allergen recalls are just as impactful. For example, similar problems occurring a few years back would often have gone undetected, Prince said. But today, “the foodborne disease detectives have become very good.”

“If there was one word in the dictionary that would explain why we have recalls, it would be complacency,” Prince said. With many of the preventive controls similar for foodborne illness and allergens, allergen prevention should include a focus on:

• raw materials, requiring allergen programs by all suppliers;
• formulations, identifying any allergenic ingredients;
• GMPs and inspection for allergen control;
• cross-contamination controls, such as cleaning between runs and separating of allergenic ingredients;
• incorporation of a thorough labeling program, verifying labels against the formulation, ensuring labels are consistent with changeover, and using online scanners for accuracy;
• sampling of initial product after a changeover — holding product until results are attained;
• proper handling and controls in rework.

AND IN 2008? FAAN co-founders Anne Muñoz-Furlong and Terry Furlong have announced their plan to retire in the second half of 2008. “FAAN is in a strong position internally and is well-poised for continued growth,” Muñoz-Furlong said. “This is a great time to step down and turn over the reins to new leadership.” Since its inception in 1991, FAAN’s mission has been that of awareness, education, advocacy and research, with the results that more Americans are aware of food allergy today, a large array of educational tools are available, legislation has been passed to help those with allergen avoidance and food allergy research has made great strides.

“Anne Muñoz-Furlong has inspired a lasting movement in the U.S. and around the world. She has combined science-based decision making, passion, commitment and organizational skills in creating and establishing FAAN,” said Frank Yiannas, chairman of the board of the directors of FAAN. “Thanks to Anne and Terry, we have an extremely solid foundation to continue to advance our mission.” The board has created a search committee to ensure an orderly transition and continued service, and Muñoz-Furlong will work with the new CEO during a transition period.

The author is Staff Editor of QA magazine.

How Much Do You Know about Food Allergies?

As a member of the food processing industry, you undoubtedly know “all about” allergens and their significance as a food safety hazard. But how much do you really know about food allergies? If you were asked by a customer — or an employee — would you be able to name the top eight food allergens? List potential symptoms? Define anaphylaxis? Know when a reaction is life threatening? Test yourself (or your employees) on the questions below — then read the answers for a full understanding of why these allergens are such a hazard.

WHAT IS A FOOD ALLERGY? A food allergy is an immune system response to a food that the body mistakenly believes is harmful. When the body decides a food is harmful, it creates antibodies so the next time the food is eaten, the immune system releases “protective” chemicals. These chemicals then trigger a cascade of allergic symptoms that can affect the respiratory system, gastrointestinal tract, skin or cardiovascular system. Although an individual can be allergic to any food, such as fruits, vegetables and meats, there are eight foods that account for 90 percent of all food-allergic reactions: milk, eggs, peanuts, tree nuts (such as walnut, cashew), fish, shellfish, soy and wheat. The most serious of potential allergic reaction is anaphylaxis.

WHAT IS ANAPHYLAXIS? Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. While common causes also include medication, insect stings and latex, food allergy is believed to be the leading cause of anaphylaxis outside hospitals, causing an estimated 30,000 emergency room visits each year in the U.S.

WHAT ARE THE SYMPTOMS? An anaphylactic reaction may begin with a tingling sensation, itching or a metallic taste in the mouth. Other symptoms can include hives, a sensation of warmth, wheezing or other difficulty breathing, coughing, swelling of the mouth and throat area, vomiting, diarrhea, cramping, a drop in blood pressure or a loss of consciousness. The symptoms may begin within several minutes to two hours after exposure to the allergen, but life-threatening reactions can get worse over a period of several hours.

Anaphylaxis is very likely to occur when any one of the following happens minutes to hours after ingestion of the food allergen:

• A person has skin symptoms or swollen lips and either difficulty breathing or reduced blood pressure.
• A person exposed to a suspected allergen experiences two or more of the following: skin symptoms or swollen lips, difficulty breathing, reduced blood pressure, gastrointestinal symptoms (e.g., vomiting, diarrhea or cramping).
• A person exposed to a known allergen experiences reduced blood pressure.

In some reactions, the symptoms go away, only to return two to three hours later. This is called a “biphasic reaction.” Often these second-phase symptoms occur in the respiratory tract and may be more severe than the first-phase symptoms. Studies suggest that biphasic reactions occur in about 20 percent of anaphylactic reactions.

WHAT CAUSES ALLERGIC REACTIONS? The bodies of most people with allergies make IgE antibodies, tiny molecules that are like antennae that can detect the food to which that person is allergic. These antennae sit on cells called “mast cells,” which are spread throughout the body. Mast cells are filled with chemicals, some of which are histamine. When the person eats the food to which he or she is allergic, proteins (the part of the food that causes the allergy) attach to the IgE on the mast cell. This causes the mast cell to explode, sending chemicals throughout the body, which then cause the symptoms of the allergy.

HOW IS A FOOD ALLERGY TREATED? Can it be cured? Strict avoidance of the allergy-causing food is the only way to avoid a reaction. Reading ingredient labels for all foods is the key to maintaining control over the allergy. There currently are no medications that cure food allergies. Although most people do outgrow food allergies, those caused by peanuts, nuts, fish and shellfish often are lifelong.

— Compiled from information from Food Allergy and Anaphylaxis Network (FAAN).