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Food Allergies and FALCPA (1) 2004

Food allergy is a disease2 with a considerable impact on modern society. More than half of all Americans test positive in response to one or more allergens3 — double the percentage of 30 years ago. The highest response was to dust mites, 27.5%, while the lowest was to peanuts, 8.6%. (Journal of Allergy and Clinical Immunology, August 2005). Food allergies affect 6 to 7 million individuals4 in the United States (2 to 2.5%). According to the Louisiana State University Pediatric Allergy/Immunology Department, 6% of children5 suffer from food allergies, of which two million are of school age (Current Allergy and Asthma Reports, November 2005).

Certain sensitized consumers can develop serious or life-threatening allergic reactions if exposed to appropriate offending proteins. There is no known cure for food allergies; the only success is avoidance of the offending foods, together with pharmacological agents for symptomatic treatment, including self-administered epinephrine. The latter is of utmost importance in highly allergic subjects, because accidental exposure is not uncommon. Food allergy is the leading cause of anaphylaxis6 outside the hospital setting. Each year, approximately 30,000 individuals require emergency room treatment, 2,000 are hospitalized, and 150 die because of allergic reactions to food (FALCPA, 2004).7

Identifying the exact cause of a reaction to food may not be apparent straightway, as adverse reactions might be due to allergies, microbial or chemical food poisoning, psychological aversions, or specific non-allergic responses.

Most consumers use the terms food allergy and food intolerance interchangeably. Food intolerance (also known as non-allergic food hypersensitivity reaction) is an adverse food-induced reaction that does not involve the immune system. For example, individuals with lactose intolerance have a shortage of the enzyme lactase, which is needed to digest milk sugar. Individuals afflicted with the condition can develop nausea, cramps, bloating, gas, and diarrhea, which begin approximately 30 minutes to two hours after eating or drinking foods containing lactose. The severity of symptoms varies, depending on the amount of lactose each individual can tolerate.

A food allergy occurs when the immune system reacts to a certain food and includes those that involve immunoglobulin E (IgE)-mediated reactions and the gluten intolerance syndrome, celiac disease,8 which is thought to have a cellular immune mechanism. When the IgE antibodies react with proteins found in the food, histamine and other chemicals (called mediators) are released into the bloodstream and reach certain target organs such as skin (i.e., hives, swelling of the lips, tongue, and face), respiratory system (i.e., shortness of breath, wheezing), and the gastrointestinal tract (i.e., abdominal pain, vomiting), and can even cause heart failure. Allergic reactions can take place within minutes. If left untreated, these symptoms can be fatal in certain individuals. Food allergies are less common than food intolerance.



Congress recognized food allergies as a significant problem, and determined that allergic consumers or caregivers have to make appropriate food selections based on accurate labeling of food products.

On 25 June 1938, President Roosevelt signed the Federal Food, Drug, and Cosmetic Act (FFD&CA) that addressed, among other things, misbranded foods. Food Allergen Labeling and Consumer Protection Act of 2004 (P. L. 108-282) (FALCPA) amends the FFD&CA and requires that the label on a food product that is or contains an ingredient that contains a “major food allergen” declares the presence of the allergen as specified by FALCPA.9 The law also requires the FDA to issue a regulation to define and permit use of the term gluten-free.

FALCPA becomes effective January 1, 2006 for all packaged foods regulated under the FFD&CA. The new law provides details on requirements for food labeling if a product is made with ingredients that are or contain a major food allergen, as defined by the law. The law also includes a provision that directs the Secretary of Health and Human Services, or FDA by delegation, to consult with appropriate experts and stakeholders to define and permit the use of the term gluten-free in food labeling. A proposed ruling is anticipated by August 2006, while the final rule that defines the term gluten-free, and identifies the criteria that would enable the food industry to use that term voluntarily for labeling their products, is due two years later.

Under FALCPA, Congress designated protein derived from one of eight foods or food groups as “major food allergens: milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts, soybeans.” FALCPA further requires declaration of the specific type of tree nut (e.g., almonds, pecans, or walnuts), the species of fish (e.g., bass, flounder, or cod), and the kind of crustacean shellfish (e.g., crab, lobster, or shrimp). The eight foods or food groups account for 90 percent of all documented IgE-mediated food allergies worldwide and most severe reactions to foods. An estimated three million Americans (1.1%) are allergic to peanuts or tree nuts.10

FALCPA’s requirements apply to all packaged foods sold in the U.S. that are regulated under the FFD&CA, including both domestically manufactured and imported foods. Raw agricultural commodities, such as fresh fruits and vegetables in their natural state, are not affected by FALCPA. Enforcement in the form of civil or criminal penalties, or both, apply to any company and its management if one of its packaged food products does not comply with the FALCPA labeling requirements, in accordance with FFD&CA. FDA may also request seizure of food products if the label of the product does not conform to FALCPA’s requirements. In addition, FDA is likely to request that a food product containing an undeclared allergen be recalled by the manufacturer or distributor.

According to FALCPA, ingredients subject to the new allergen labeling law are:

  1. Eight major food allergens;

  2. Any food ingredient that contains protein derived from a major food allergen;

  3. Incidental additives and flavors.

However, the new labeling law also allows for exceptions and those include:

  1. Any highly refined oil derived from a major food allergen;

  2. Any food ingredient exempt from labeling under a petition or notification process specified in the law.

Under the petition process (21 U.S.C. 343(w)(6)), an ingredient might be exempted if the petitioner demonstrates that the ingredient “does not cause an allergic reaction that poses a risk to human health.” FALCPA establishes a process under 21 U.S.C. 343(w)(7) by which any person may file a notification containing scientific evidence demonstrating that an ingredient “does not contain allergenic protein.” The scientific evidence must include the analytical method used, and the ingredient must be derived by the specified method. FDA has 90 days to object to a notification. Absent an objection, the food ingredient is exempt from FALCPA’s labeling requirements for major food allergens. FDA is required to post to a public site notifications received under 21 U.S.C. 343(w)(7), within 14 days of receipt of a notification.

To date, the only exemption notification received by the FDA is from Mead Johnson Nutritionals for extensively hydrolyzed casein (milk), filed September 30, 2005. FDA is in the 90-day window for evaluating the notification and has not yet responded.

Interestingly, FALCPA does not require FDA to establish a threshold level for any food allergen. Nevertheless, FDA is placed in the position where it has to consider a threshold level for one or more food allergens in the context of reviewing a petition or a notification submitted to request that an ingredient be exempt from FALCPA’s labeling requirements. FDA charged The Threshold Working Group with this task. The Working Group final report, published in June 2005, summarizes the current state of scientific knowledge regarding food allergy and celiac disease, including information on dose-response relationships for major food allergens and for gluten, respectively. The report presents data needed to evaluate various approaches to establishing thresholds that would be scientifically sound and efficacious in relation to protection of public health. The Working Group final report identifies four approaches that could be used to establish thresholds:

  1. Analytical methods-based: Thresholds are determined by the sensitivity of the analytical method(s) used to verify compliance.

  2. Safety assessment-based: A “safe” level is calculated using the No Observed Adverse Effect Level (NOAEL) from available human challenge studies and an appropriate Uncertainty Factor applied to account for knowledge gaps.

  3. Risk assessment-based: Examines known or potential adverse health effects resulting from human exposure to a hazard; quantifies the levels of risk associated with specific exposures and the degree of uncertainty inherent in the risk estimate.

  4. Statutorily-derived: Uses an exemption articulated in an applicable law and extrapolates from that to other potentially similar situations.


The Working Group report indicates that variable patient responses make it difficult to conclude that a particular processing or cooking procedure affects allergenicity in all cases.

  1. Peanuts. Extracts of roasted peanuts have been shown to bind IgE from patients at 90-fold higher levels than do similar extracts of raw peanuts. These findings suggest that thresholds for boiled or fried peanuts may be higher than for roasted or raw peanuts. However, the vast majority of peanuts consumed whole or in processed foods in the U.S. are roasted.

  2. Milk. Pasteurization and homogenization did not reduce allergenicity in skin prick tests. However, boiling milk for ten minutes reduced IgE binding of several of the allergenic proteins.

  3. Egg. Both soft and hard-boiling of eggs decreased, but did not eliminate, antigen binding of rabbit antiserum to ovomucoid and ovalbumin.

  4. Fish. Boiling of ten different species of fish failed to eliminate allergenicity. IgE binding of allergenic proteins from canned fish was reduced by 98 to 99% compared to boiled fish.

  5. Shellfish. Boiling does not reduce reactivity of shrimp allergens.

  6. Soy. Heating soybeans at 100ºC for 60 minutes does not completely eliminate IgE binding to allergenic soy proteins. Various soybean products — including sprouts, soy sauce, hydrolyzed soy protein tofu, miso, and lecithin all retained IgE-binding activity.

  7. Tree nuts. Protein extracts of several hazelnut-containing products demonstrated less IgE binding than raw hazelnut extracts, suggesting that processing reduced, but not eliminated allergenicity.


Three of the major food allergens identified in the FALCPA are actually 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, and the available analytical methods are currently unable to distinguish between species in a group. Therefore, the Working Group suggests it may be necessary to consider total protein levels from all species in a group, rather than the level of protein from each species. Further, it has been determined that an individual allergic to one species is also likely to also be allergic to other species in the group.

Although not likely to be useful for routine screening or testing, techniques such as Liquid Chromatography/Mass Spectrometry (LC/MS) are being used to identify specific allergenic proteins in complex food matrices. According to the Working Group, these approaches may be useful either as confirmatory tests or for characterization of foods containing several allergens.

FALCPA, enacted in August 2004, becomes effective January 1, 2006, for all packaged foods regulated under the FFD&CA. Although industry is arduously preparing to comply with the new allergen labeling law and meet the deadline, there remain many unresolved issues, including establishment of thresholds and specifics on how to reduce or eliminate cross contact. These unresolved issues require immediate attention from the FDA.


1FALCPA – Food Allergens Labeling and Consumer Protection Act, 2004.

2Disease – a condition of the living animal or plant body that impairs normal functioning (Webster Dictionary, 2004).

3 An allergen is an antigen, to which IgE-antibodies will bind.

4According to Food Allergy Labeling Guidelines (Grocery Manufacturers Association, 2005).

5 This number varies depending on the source.  For example, Food Allergen Labeling and Consumer Protection Act (FALCPA) estimates that 4% of the total population have IgE-mediated food allergies, while Food Allergy Research and Resource Programme at

estimates that approximately 2 percent of adults and about 5 percent of infants and young children in the United States suffer from food allergies.

6The term is commonly used to denote the immediate, transient kind of immunologic (allergic) reaction characterized by contraction of smooth muscle and dilation of capillaries due to release of pharmacologically active substances (histamine, bradykinin, serotonin, and slow-reacting substance), classically initiated by the combination of antigen (allergen) with mast cell-fixed, cytophilic antibody (chiefly IgE); the reaction can be initiated, also, by relatively large quantities of serum aggregates (antigen-antibody complexes, and others) that seemingly activate complement leading to production of anaphylatoxin, a reaction sometimes termed “aggregate anaphylaxis” (Stedman’s Medical Dictionary, 1995).

7Food Allergen Labeling and Consumer Protection Act (FALCPA), 2004.

8Definition – celiac disease is an immune-mediated disease that causes damage to the gastrointestinal tract, central nervous system, and other organs (FALCPA, 2004).

9FALCPA defines a “major food allergen” as one of eight foods or a food ingredient that contains protein derived from one of those foods.

10Food Allergy Research and Resource Programme at

11FDA regulates all foods except meat products, poultry products, and egg products.

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