Exporting to the US? Discover the mandatory requirements that are minimizing severe and fatal food-reactions in millions of people.
Dated: 1 May 2006
BY DR IOANA CARABIN WOMEN’S HEALTH SCIENCES INSTITUTE PHILLIP CASTERTON BURDOCK GROUP
 Food allergies have a considerable impact on modern society. Each year, they are the leading cause of anaphylaxis, a severe type of allergic reaction requiring immediate hospitalization. Each year in the United States, it is estimated that approximately 30,000 individuals require emergency room treatment, 2000 are hospitalized, and 150 die because of allergic reactions to food.
There is no known cure. As a result, consumers can only avoid offending food(s) and use pharmacological agents. In fact, the US Congress determined that allergic consumers or caregivers have to make appropriate food selections based on accurate labeling of food products. Therefore, Congress passed the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which came into effect on January 1, 2006.
Under FALCPA, the US Congress designated protein in, or derived from, any of eight foods or food groups (i.e. tree nuts, peanuts, wheat, milk, egg, fish, crustacean shellfish, and soybeans) as major food allergens. In fact, the eight food groups account for 90% of all documented IgE-mediated food allergies worldwide. (See 'Mechanism' box.)
FALCPA requires that the label on a food product that is, or contains, a major food allergen, to declare its presence. These requirements apply to all packaged foods sold in the US—both domestically-manufactured and imported, including conventional foods, dietary supplements, infant formula, and medical foods—all of which are considered 'food' by the FDA (US Food & Drug Administration). Enforcement in the form of civil and/or criminal penalties, applies to any food company that does not comply with the FALCPA labeling requirements.
Several of the new food-labeling requirements are unprecedented, as they demand declaration of the specific type of tree nut (e.g. almonds, pecans, walnuts, cashews), the species of fish (e.g. bass, flounder, or cod), and the kind of crustacean shellfish (e.g. crab, lobster, or shrimp). Under the new law, food allergens can be labeled either within a statement of ingredients or in a separate statement, but the label must include the common or usual name of the allergen.
FALCPA allows for two exceptions to these requirements: (1) any highly-refined oil derived from a major food allergen, or any ingredient derived from such highly-refined oil, and (2) any food ingredient exempt from labeling under a petition or notification process specified in the law.
A major issue in implementing FALCPA relates to threshold levels, and the existence of levels below which it is unlikely that an allergic individual would experience an adverse effect.
There are differences amongst food allergens, both in their potential to elicit allergic reactions; and the severity of the reactions they cause. This brings up several questions: How do we define an ‘allergic response’? Do all allergic responses pose an equal risk to human health? And do allergens occur in a food either in a form or at a level that is too low to cause harm?
Adverse Effect Levels
In peanuts, the Lowest Observed Adverse Effect Level (LOAEL) can range from 2 mg to as high as 100 mg of protein. Studies conducted with hazelnuts—the most commonly-studied tree nut—report LOAELs ranging from 1 mg to 30 mg. |
Mechanism
An allergic reaction occurs when immunoglobulin E (IgE) binds with certain food allergens (i.e. proteins) to produce protein-specific IgE antibodies. When the IgE antibodies react with proteins found in the food, histamine and other chemicals (called mediators) are released into the bloodstream. Mediators reach certain target organs, causing visible reactions, including those involving the skin or mucous membranes (e.g. hives, swelling of the lips, tongue, and face), the respiratory tract (e.g. shortness of breath, wheezing), or gastrointestinal tract (e.g. abdominal pain, nausea, vomiting). They can even be a cause of heart failure.
The good news is that not all adverse reactions to food are allergies; some may be due to food intolerance. Food allergy is less common than food intolerance. Establishing the exact cause of a reaction to food may not be an easy task because adverse reactions may result from microbial, or chemical food poisoning, psychological aversions, or a non-specific non-allergic response.
US consumers have welcomed the Congressional action, because approximately 3.7% of adults over the age of 18 years have food allergies. The number of children afflicted with food allergies is also considerable. Amongst the total US population, FALCPA estimates that 0.8% of children under three years of age are allergic to peanuts, and 0.2% are allergic to tree nuts. In adults over 18 years of age, those percentages are 0.6% for peanuts, and 0.5% for tree nuts. Although peanuts and tree nuts are not the cause of most allergic reactions, they tend to cause significantly more severe reactions than other food allergens, and are the most common cause for fatal reactions in the US. |
Detection and measurement
At times, it can be difficult to measure allergenic proteins in a wide variety of foods. For example, allergens might represent only minor components of complex, heterogeneous foods. Yet the food matrix can sequester allergens, inhibiting their detection, without significantly affecting allergenicity. Also, there is difficulty in estimating the amount of a food allergen, particularly when there is more than one allergenic protein.
Three commercial peanut test kits—BioKits Peanut Testing Kit (Tepnel), Veratox for Peanut Allergens (Neogen Corp), and RiDASCREEN Peanut (R-Biopharm GmbH)—can assist manufacturers in rapidly evaluating whether their food processing operations are adequate to prevent the inclusion of peanut products in foods declared to be peanut-free. The test kits can also be used to determine whether food processing plant cleanup operations are sufficient to avoid cross-contamination, and whether the finished product is peanut-free. Approximately 40 analyses can be performed with each kit, and the cost per kit ranges from $450 to $650. Users can decide which test kit method to use based on validated performance results, cost, time and ease of use.
Processing effects
An area that requires further investigative work is that of allergen alterations as a result of processing or cooking. The processing of peanuts suggests that thresholds for boiled or fried peanuts may be higher than for roasted or raw peanuts, at least for the three major peanut allergens. Extracts of roasted peanuts have been shown to bind IgE from patients at 90-fold higher levels than do similar extracts of raw peanuts.
Similarly, processing of tree nuts reduces, but does not completely eliminate allergenicity as demonstrated by less IgE binding of hazelnut-containing products than raw hazelnut extracts. Several cases of anaphylaxis have been described for other processed nut-containing products, suggesting that processed tree nuts in general retain allergenic activity. Roasting, blanching, autoclaving, or microwaving, did not change the ability of animal antisera to bind almond proteins.
Cross-contact and cross-reactivity
Additional food-product-sampling challenges also occur because of the nature of food production and the presence of highly variable food matrices. For example, it has been shown that allergenic ingredients may not be evenly distributed throughout processed foods, and that within whole foods there is no homogenous distribution of allergenic proteins. In addition, cross-contact may result in a heterogeneous distribution of allergens within or on a food. For example, the addition of nuts to chocolate can take place on a production line where nut-containing and nut-free products are processed sequentially. In such a case, cross-contact is most likely to occur at the beginning of a production run for the nut-free product.
Collective allergens
FALCPA identified three of the major food allergens as actual groups of foods: crustaceans, fish, and tree nuts. It is possible that proteins from two or more species within each of these 'collective allergens' might be present in a food. It may be necessary to consider total protein levels from all species in a group, rather than the level of protein from each species. More importantly, an individual allergic to one species is likely to also be allergic to other species in the group.
Issues for the food industry
FALCPA has been in effect since January 1, 2006; however, there remain numerous fundamental and complex unresolved issues that affect both industry and consumers.
1. Quantitative food allergens thresholds are not known and have not been established.
2. Currently-available commercial assays are designed for the detection of food allergens, not specific allergenic proteins.
3. Food ingredients may contain little to no protein, but are required to be labeled as an allergen if they are derived from allergenic food.
4. Scientific evidence must be used to assert that ingredients are free of allergenic proteins and qualify for the exemption process review.
5. 'Problem ingredients' commonly used in foods or food processing may include soy lecithin, soy sauce, wheat starch, Worcestershire sauce, starter cultures, lactoferrin, lysozyme, fish gelatin, caramel, butter, butter oil, diacetyl, tocopherol / Vitamin E, xanthan gum, sorbitol, lactitol, maltitol, amino acids, enzymes, vinegars, flavors, and natural essences derived from allergenic food such as tree nuts.
6. At a practical level, important product sampling questions that need to be considered by manufacturers include whether the allergen is likely to be heterogeneously distributed within the batch; which batches should be tested; the number of samples per batch that should be tested; which portion of a run should be tested; and how to obtain a specific degree of confidence (e.g. 95% confidence) that no allergen is present.
Issues for consumers
1. The labeling will present a challenge to consumers who have previously eaten food products without an adverse reaction, and now will see many more allergens listed on packages.
2. Because FALCPA does not contain an exemption for major allergens that may be present in seemingly inconsequential quantities, consumers will have no way of knowing whether (a) the food formulation has changed, (b) the manufacturer received new information indicating that a major allergen may now be present in the food, or (c) the manufacturer is only adding the name of the major allergen, because an ingredient derived from an allergen has always been used, but was not previously labeled as an allergen.
The issues described are complex and resolution will require significant amount of research and time. Meanwhile, the food industry will have to comply with requirements set forth by law for all packaged foods sold in the United States, including conventional foods, dietary supplements, infant formula, and medical foods. However, the food industry must remain vigilant to new scientific findings that might impact the labeling requirement of their products.
The health issues surrounding food allergy and labeling of products are multifaceted, and they are not limited to the United States. Lessons learned from implementation of FALCPA represent valuable tools to countries around the globe, as they focus their efforts on the food allergy issues affecting their populations.
While the most severe allergic reactions occur when peanuts and tree nuts are consumed, public health officials across the world must not concentrate their efforts on those foods alone, but recognize food allergy in general, as an increasingly important threat to the well being of an enlarging percentage of the general population.
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