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From: Food Quality & Safety magazine, April/May 2006

Allergens: A Potential Kiss of Death

Whether it’s from a Peanut or a Shellfish, the Issues Surrounding Allergens are Tough Nuts to Crack

by Mark A. Desorbo

She was just 15 and in love, and in a romantic interlude with her beau in early March, she stole what would be her last kiss. While a coroner said it was a lack of oxygen to her brain, it was initially believed that a peanut butter and jelly sandwich lingering on the pallet of her boyfriend was the culprit, for Christina Desforges, of Saguenay, Quebec, Canada, who was, incidentally, allergic to peanuts, and died in a Quebec hospital several days later.

At press time, however, Coroner Michel Miron refused to disclose the cause of death, saying he has yet to submit his final report to the provincial coroner’s office. But he told The Associated Press he hoped to end the “phobia” provoked by the case, which drew global media coverage.

Miron’s characterization seems to minimize the worldwide attention that food allergies get, and perhaps he is undermining the great efforts that are being carried out globally and locally to combat the threats allergens pose, for neither the concern nor the coverage has waned. In fact, it continues to intensify, as food allergies and allergen testing can present quite the quandaries for not just consumers, but for the food industry, too.

Label Laws

As of Jan. 1, FDA now requires food labels to clearly state if food products contain any ingredients that contain protein derived from the eight major allergenic foods, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans.

The new law is a provision of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which mandates that manufacturers are now required to identify in plain English the presence of ingredients that contain protein derived from in the list of allergenic foods or to say “contains” followed by name of the source of the food allergen after or adjacent to the list of ingredients.

According to the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), this labeling law will be especially helpful to children who must learn to recognize the presence of substances they must avoid. For example, if a product contains the milk-derived protein, “casein,” the product’s label will have to use the term “milk” in addition to the term “casein” so that consumers with milk allergies can clearly understand the presence of an allergen they need to avoid.

The FDA estimates that 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies. Approximately 30,000 consumers require emergency room treatment and 150 Americans die each year because of allergic reactions to food.

“The eight major food allergens account for 90 percent of all documented food allergic reactions, and some reactions may be severe or life-threatening,” Robert E. Brackett, Ph.D., CFSAN’s director, says in a statement. “Consumers will benefit from improved food labels for products that contain food allergens.”

The new law, however, does not require food manufacturers or retailers to re-label or remove products from grocery or supermarket shelves that do not reflect the additional allergen labeling as long as the products were labeled before the effective date.

FDA has cautioned consumers that there will be a transition period of “undetermined length” during which it is likely that consumers will see packaged food on store shelves and in consumers’ homes without the revised allergen labeling.

“We are in a transition period,” an FDA official, who refused to give her name, told Food Quality.

When it comes to allergens, there are two areas of interest, the FDA official explains. One is how is the food labeled and does the verbiage comply with the law and the other, where allergens play out in food production.

“One of the major considerations is cross-contact. That term means inadvertent contact,” she says, citing a chocolatier that makes both the plain and peanut variety under the same roof as an example.

Labeling requirements, however, do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact, which occurs when “residue or other trace amounts of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food.”

The FDA indicates that cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation or production equipment.

The new law, however, does not establish any particular provisions to address cross-contact and how it is to be handled.

“It strictly focuses on labeling,” the FDA official says of FALCPA.

According to the FDA, the law applies to all packaged foods sold in the U.S. that are regulated under the Food, Drug & Cosmetic Act (FD&C), including both domestically manufactured and imported foods. Raw agricultural commodities such as fresh fruits and vegetables are not affected by the mandate.

While the law only applies to food regulated by the FDA under the FD&C Act, producers of meat, poultry and egg products get legislation and guidance from USDA.

The USDA directive requires food manufacturers to indicate 12 groups of potential allergens by reference to the source allergen if they are used as an ingredient at any level in pre-packed foods, including alcoholic drinks.

The new rules also abolishes the “25 percent rule,” under which it was not mandatory to label components of compound ingredients if they made up less than 25 percent of the final food product. The new allergen labeling rules were fully implemented as of Nov. 25. Products not complying with the new legislation will be prohibited for sale in the European Union.

The list of potential allergenic ingredients and associated products include: Cereals containing gluten, crustacean, eggs, fish, peanuts, soybeans, milk and dairy products, nuts and nut products, celery, mustard and products thereof, sesame seeds and sculpture dioxide and sulfites at concentrations of more than 10 mg/kg or 10 mg/l expressed as SO2.

Vexing Verbiage

The operative word when it comes to allergens and food products is “contains.”

If a “contains” statement is used on a food label, the statement must include the names of the food sources of all major food allergens used as ingredients in the packaged food, the FDA stipulates.

“For example, if sodium caseinate, whey, egg yolks and natural peanut flavor are declared in a product’s ingredients list, any ‘contains’ statement appearing on the label immediately after or adjacent to that statement is required to identify all three sources of the major food allergens present (e.g., ‘Contains milk, eggs, peanuts’) in the same type (i.e., print or font) size as that used for the ingredient list,” the CFSAN guidance indicates.

CFSAN even provides guidance on wording, noting that the verbiage for a “contains” statement may be limited to just stating the word followed by the names of the food sources of all major allergens that are in the ingredients of the packaged product.

On the other hand, the FDA indicates, additional wording may be used for a “contains” statement to more accurately describe the presence of any major food allergens, provided that the following three conditions are met:

  • The word “contains” with a capital “C” must be the first word used to begin a “contains” statement. (The use of bolded text and punctuation within a “contains” statement is optional.)
  • The names of the food sources of the major food allergens declared on the food label must be the same as those specified in the FALCPA, except that the names of food sources may be expressed using singular terms versus plural terms (e.g., walnut versus walnuts) and the synonyms “soy” and “soya” may be substituted for the food source name “soybeans.”
  • If included on a food label, the “contains” statement must identify the names of the food sources for all major food allergens that either are in the food or are contained in ingredients of the food.

Are there penalties for non-compliance?

You bet, says the FDA. Under the FD&C Act, a company and its management may be subject to civil sanctions, criminal penalties or both if the firm’s packaged food products do not comply with labeling requirements.

“A food that is improperly labeled is misbranded,” the FDA official says. “A misbranded food can be seized. Companies can be sanctioned and prosecuted. We cannot order a company to do a recall, but we do, however, have a fair amount of influence.”

Arising Allergens

The new federal guidelines indeed reveal the complexity of food allergen management. For the consumer, it is even more perplexing.

“There are two levels to this, one is the true allergies and the other is intolerances,” says Bruce Ritter, CEO of ELISA Technologies Inc. (Gainesville, Fla.), and a member of AOAC Food Allergen Task Force.

Food allergies and food intolerances are not one in the same. According to the FDA, food intolerance is an adverse food-induced reaction that does not involve the immune system. Lactose intolerance is one example. A person with lactose intolerance lacks an enzyme that is needed to digest milk sugar. When the person eats milk products, symptoms such as gas, bloating and abdominal pain may occur. A “food allergy” occurs when the immune system reacts to a certain food, says Ritter.

The most common form of an immune system reaction, he explains, happens when the body creates immunoglobulin E (IgE) antibodies to the food.

And when these IgE antibodies react with the food, histamines and other chemicals called mediators can cause hives, asthma or other symptoms of an allergic reaction, the most dangerous of which is anaphylaxis.

Food allergies are indeed a growing public health and food safety concern in the U.S., and many agencies, federal and consumer alike, report a doubling of food allergies over the past decade, due largely in part to the peanut.

According to National Institutes of Health Diseases (NIH; Bethesda, Md.), allergies are the sixth leading cause of chronic disease in the U.S., costing the health care system $18 billion annually. In 2002, the NIH reported that approximately 14 million office visits to health care providers were attributed to allergic rhinitis.

According to The Food Allergy & Anaphylaxis Network (FAAN; Fairfax, Va.), approximately 11 million Americans suffer from food allergies, with 6.5 million allergic to seafood and 3 million allergic to peanuts or tree nuts, which include, almonds, pecans and walnuts. FAAN also indicates that approximately 2 million school-aged children have food allergies.

In fact, the young lady in Quebec who died fits snugly into another FAAN statistic, too: Teens and young adults with peanut or tree nut allergies and asthma appear to be at increased risk for severe or fatal allergic reactions.

Often thought to afflict just children and young adults, allergies remained poised to strike at any point in one's life, according to a recent article in The New York Times.

The Times article notes that hay fever has been diagnosed in an estimated 14 percent of American adults, or nearly 30 million people, according to a large survey financed by Altana Pharma, a pharmaceutical company. Another 3.5 percent have allergies to food. That number may be even greater because experts believe that many never seek a diagnosis.

Those who develop allergies as adults probably experienced an allergic episode earlier in life, but do not recall the allergic episode, the Times article indicated. In babies and toddlers, allergies tend to take the form of eczema, and children suffering from seasonal allergies tend to be less bothered by a runny nose than adults. In many children, the allergies fade during the adolescent years, only to return later.

In other cases, adult allergy sufferers have no history of allergic sensitivity.

Dr. Michael Blaiss, a past president of the American College of Allergy, Asthma and Immunology, said that 30 to 40 percent of the population inherits a genetic predisposition to allergies. “I don’t think anyone knows what tips people over,” Dr. Blaiss told the Times.

There are a host of sources geared for consumers who are allergy sufferers. For example, FAAN actually has a Web site, www.fanteen.org that provides advice for teens and food allergies, while Living Without, a quarterly consumer magazine, provides lifestyle guidance for people with allergies and food sensitivities.

“Part of what’s changing is people are reading labels,” Ritter says. “They want to know what’s in there. They want to know what’s in their food.”

Insidious Immunological Incidents

But the issues surrounding allergens get even more insidious.

The allergen issue, Ritter points out, is also mired in controversy, most notably when it comes to autism and pediatric vaccinations. It is believed that thimerosol, which is comprised of nearly 50 percent mercury and is added to vaccinations to inhibit bacterial growth, causes not only allergies in children, but autism as well.

“The mercury has toxicological property and mercury loves neurological tissue. It goes through every part of your body, but it specifically likes the neurological tissue and the mercury stunts it,” Ritter explains. “With food allergies, the immune system is stimulated and one of the side effects of the mercury is gut-permeability. It inhibits certain enzymes from breaking down proteins.”

Moreover, mercury is a deadly toxin that has been linked through numerous and repetitive scientific studies to a vast array of diseases, including multiple sclerosis, Alzheimer’s, Parkinson’s, cardiovascular, gastrointestinal and autism/attention deficit disorder in children as well as increased aggression/violence in young adults, according to www.mercuryfreehealth.org, a resource on the health hazards of mercury exposure from silver fillings and thimerosol preservative in vaccines. Emblazoned on the site’s thimerosol page is a quote from Baton Rouge, La.-based family practitioner Dr. Stephanie Cave, who has testified on the dangers mercury in vaccines before the House Committee on Government Reform. It reads: “By age two, American children have received 237 micrograms of mercury through vaccines alone, which far exceeds current EPA safe levels of .1 mcg/kg per day. That’s one-tenth of a microgram, not one microgram.”

U.S. Rep. Dave Weldon, R-Fla., and Sen. Joe Lieberman, D-Mass., continue to demand a reexamination to determine if there is a link between mercury in vaccines and autism. Weldon, along with U.S. Rep. Carolyn Maloney, R-N.Y, have also reintroduced legislation that would eliminate mercury from vaccines.

“From a broader perspective, we’re dealing with not just anaphylaxis, we’re dealing with autism, bloated bellies and these kids who are not healthy,” Ritter adds.

Ritter is rather impassioned about allergens and autism and the issues surrounding the dilemmas each present, saying he is disappointed that federal regulators make no effort to surveil and weed out allergens. His fervor stems from regular contact with not only parents of children with allergies, but also parents of autistic children, who purchase gluten tests kits from ELISA Technologies.

“I talked to a mother of an autistic child a few years ago and she really opened my eyes,” he says. “She got hooked up with some doctors…and they told her if she got the gluten out of the kid’s diet and, his behavior would get better. It worked. At the age of 7, she had her first conversation with him. When she said that, something happened to me.” Time after time, Ritter has heard that if such proteins as lactose and gluten are removed from an autistic child’s diet, their behavior improves.

The Next Step in QA Testing?

Food companies and processors alike can take steps to minimize allergen threats to consumers.

The HAVen Gluten Flow Through Test from Hallmark Analytical, which is distributed by ELISA, allows non-technical users to detect the presence of gluten in food and raw materials, in surface swabs, in partially-processed foods and finished products. It is sensitive enough to confirm gluten levels in a wide range of food commodities and products that are within the Codex guidelines. The test can also help validate and verify gluten levels in raw materials prior to their use in manufacturing; the effectiveness of gluten-free manufacturing processes and clean-down routines; and the gluten-free status of finished products.

ELISA also offers EZ Check, a swab method that Ritter calls an entry level product, which allows food companies to conduct preliminary tests for allergens on its own.

Neogen Corp. (Lansing, Mich.) also offers food allergen test kits to detect almond, egg, gliadin, hazelnut, milk, peanut and soy residues. Neogen’s Alert and Veratox test kits are sandwich-enzyme-linked ELISAs. The company’s Reveal food allergen test is a single-step lateral flow immunochromatic assay. Each of the test kits compare samples against known levels of allergen, and Neogen says each requires only a minimal amount of training and equipment. Officials at Neogen did not return calls from Food Quality.

“Even though the legislative pressure has been great, it’s a disappointment that the regulatory pressure isn’t there,” Ritter says. “There are tools out there, and these types of tests are the next step in quality testing.”

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