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Food manufacturing and the allergic consumer: Accidents waiting to happen
Reviews and feature articles
Food manufacturing and the allergic consumer: Accidents waiting to happen
Issues regarding food manufacturing and labeling continue to be a major source of frustration and, unfortunately, risk for people with food allergy. Although it would seem that specific avoidance diets should be rather simple and straightforward, nothing could be further from the truth. Food-allergic patients must overcome significant obstacles on a day-to-day basis, including difficulties with the interpretation of food labels and neverending concerns about improperly or incompletely labeled foods. This issue of the Journal contains 2 timely and informative articles on these subjects. In one article, Joshi and colleagues1 report on a study in which they evaluated the ability of parents of foodallergic children to accurately read labels for the presence of 1 or more major food allergens.1 Realizing how poorly written labels are with respect to most common allergens, particularly as a result of the use of complex and ambiguous terms, one might have predicted that the results would be poor. In fact, they were absolutely dismal. This outcome is even more distressing given the fact that these were parents who had children with established food allergy and who presumably thus had experience in the interpretation of food labels. In fact, approximately one half of the families had previously seen a dietician and/or had been seen in the food allergy referral center that conducted the study. Accurate interpretation of the food labels ranged from just 7% for milk to 22% for soy, 54% for peanut, 88% for wheat, and 93% for wheat. Although some of these errors might be considered minor and might not have led to clinical reactions—such as the presence of the abbreviation DE (for Dairy Equipment) on the label of a product that was otherwise milkfree—others would have caused significant exposures with potentially severe reactions. In addition, it is important to note that some of the errors would have led to an unnecessary restriction of the child’s diet, such as the avoidance of soybean oil in a child with soy allergy. These results are especially troubling inasmuch as they are likely to reflect an overestimation of the actual ability of allergic consumers to read a label, in that these families had had more education on food allergy than most. Moreover, they had more time to study the labels in the From the Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine. Received for publication March 18, 2002; accepted for publication March 19, 2002. Reprint requests: Robert A. Wood, MD, CMSC 1102, Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, MD 21287. J Allergy Clin Immunol 2002;109:920-2. © 2002 Mosby, Inc. All rights reserved. 0091-6749/2002 $35.00 + 0 1/39/124889 doi:10.1067/mai.2002.124889
920
Abbreviation used FDA: Food and Drug Administration
setting of this study than would be typical of a hurried trip to the grocery store. In the second study, Vierk and colleagues, from the Center for Food Safety and Applied Nutrition of the US Food and Drug Administration (FDA), report on the recalls that occurred in 1999 for foods containing undeclared allergen(s).2 Of 659 food products recalled, 236 were recalled because they contained 1 or more undeclared allergens. These recalls involved from fewer than 200 to as many as 100,000 packages of the recalled food. The major reasons for the recalls were (1) ingredient statement omissions or errors and (2) contamination of products by undeclared allergens through equipment cross-contact. Of note, most of these recalls were initiated by consumers who identified the undeclared allergen, and in 34 instances allergic reactions were reported by the consumer who identified the problem food. In many ways, this information is of much greater concern than that presented in the first article. The issue of label interpretation is significant, and misinterpretation is undoubtedly a common cause of accidental allergic reactions; however, it is at least theoretically possible to teach patients to read and accurately interpret even the most confusing label. The issues that are highlighted by the second study are not necessarily surmountable even with education and constant vigilance; the labels on these foods were not just hard to interpret—they were wrong! Unfortunately, though the number of food recalls for undeclared allergen rose dramatically during the 1990s, the numbers presented in the article by Vierk et al are still likely to be a significant underestimate of the true problem. First, the mislabeled food had to be identified. In most cases, this meant either that it caused an allergic reaction or that its presence was obvious by sight or by taste. Second, only the 8 most common food allergens were included. Although it is appropriate to focus on these most common allergens, there are many allergens that are less common but just as important for patients who are allergic to those foods. Third, such FDA recalls are entirely voluntary; there might have been many, many more potential recalls that never occurred. The true magnitude of this problem is indeed hard to estimate. The FDA recently provided results of a series of inspections that were conducted in partnership with the Departments of Agriculture of Minnesota and Wisconsin.3 Eighty-five facilities, specifically including bakeries and candy and ice cream manufacturing facilities, were
inspected. When labels were studied for accuracy by comparison of raw ingredients with finished product labels, 25% of the establishments were found to have omitted raw ingredients, including peanuts and tree nuts, from the final labels. Some firms had procedures in place to verify label accuracy, and 15% even of those were found to have label discrepancies. When product samples were analyzed for egg and peanut allergens through use of highly sensitive immunoassays, 25% of the 73 products analyzed for peanut and 10% of the 45 products analyzed for egg tested positive for residual allergen. Of the companies that did not have procedures in place to verify label accuracy, 38% in Minnesota and 64% in Wisconsin were found to have undeclared egg and/or peanut allergens in their products. Although these data are striking and suggest that the presence of undeclared allergens is rampant, they still do not provide information as to the magnitude of the problem from a clinical standpoint. Allergic reactions have been documented to occur as a result of the presence of undeclared food allergens,2,4-8 yet it is likely that much of this exposure is below the threshold of response for most patients. It would seem that our offices and emergency rooms would be full of patients with inexplicable allergic reactions if this were a major clinical problem. On the other hand, it is certainly possible that patients do regularly experience mild or more subtle reactions, such as abdominal pain or exacerbations of atopic dermatitis, from these low-level exposures. Hopefully, answers to the questions raised by these considerations will become more clear once we are able to establish accurate information on the threshold doses that will cause an allergic reaction for each major allergen.9 This is an area of active research, and it should be possible at least to determine levels below which the vast majority of allergic people will not react. However, it is also important to recognize that even that information will not provide a completely clear picture. In addition to the rare patients who might react at levels below a proposed threshold, there are significant issues regarding the effects of low-level exposure on allergic sensitization and the natural history of food allergy. For example, could it be that the apparently rising prevalence of peanut allergy is due in part to an increased exposure to peanut early in life from the unknowing use of contaminated foods? And could it also be that some children have more persistent food allergy because of chronic exposure from inaccurately labeled food products? These questions will be even harder to answer. It should be noted that these issues are not unique to the United States and that we are far better off than most of the rest of the world in this regard.10,11 In the greater part of Europe, an ingredient does not even have to appear on a label if it constitutes less than 25% of the product. It has been proposed that this level be dropped to 5%; that would be an improvement, but it would barely make a difference for the food-allergic consumer. Under those guidelines, it would seem almost impossible for someone with food allergy to eat anything without first calling the food product’s manufacturer to ensure its safety.
Wood 921
What, then, can and should be done? For our patients with food allergy, education remains the key. Until labeling for food allergens is made clearer and more straightforward, it is essential that all patients with food allergy be provided with the resources to accurately interpret food labels as well as to make informed decisions about restaurants and other food sources. It is in fact likely that restaurants, bakeries, and other eating establishments present far greater risks for mislabeled or contaminated food than do food manufacturers. Because of these inevitable pitfalls, it is also essential that education be directed toward the emergency treatment of food-allergic reactions in the event of accidental exposure. Several recommendations appear obvious. Immediate efforts should be directed toward the creation of clear, unambiguous labeling for food allergens. Simple terms should be used to identify major food allergens in an ingredient list, and the presence of an allergen should be clearly stated on the product label. For example, there is no good reason that not all foods containing milk protein have the word milk on their labels; the consumer should not have to search for (and know the meaning of) a word such as casein, whey, or lactoglobulin. If an allergen is contained in a spice or natural flavoring, this should also be clearly stated. Precautionary statements that include such a term as “May contain” or “Processed in the same facility as” should be used only when appropriate; they should not be used as blanket statements to replace good manufacturing practices. These efforts are all reasonable and could be implemented in short order with appropriate guidance from the FDA. However, even when these labeling issues have been resolved, issues of contamination and incomplete or inaccurate labeling will still need to be addressed. Some companies have spent the time and money to make their foods safe, and they can serve as models for others. The operative word, however, is money. All of these measures are costly and will most likely not be embraced by the average food manufacturer. It will therefore be necessary for the FDA to implement a more formal system to help ensure food safety for the allergic consumer. This will have to include specific guidelines for food labeling and manufacturing as well as a system of formal inspections involving use of the assays that are now available to measure the major food allergens. Similar recommendations are in fact proposed in the article by Vierk and colleagues, who work for the FDA.2 Fortunately, there really does seem to be much more interest and movement at the FDA with regard to food allergens than there ever has been before.12 It is worth noting, however, that recommendations very much like these were proposed in a similar editorial a full 10 years ago.13 It is now time to gather all available resources and work together to make certain that another 10 years does not pass without significant progress on these critically important issues. Robert A. Wood, MD Baltimore, Md
Reviews and feature articles
J ALLERGY CLIN IMMUNOL VOLUME 109, NUMBER 6
922 Wood
J ALLERGY CLIN IMMUNOL JUNE 2002
Reviews and feature articles
REFERENCES 1. Joshi P, Mofidi S, Sicherer SH. Interpretation of commercial food ingredient labels by parents of food-allergic children. J Allergy Clin Immunol 2002;109:1019-21. 2. Vierk K, Falci K, Wolyniak C, Klontz KC. Recalls of foods containing undeclared allergens reported to the US Food and Drug Administration, fiscal year 1999. J Allergy Clin Immunol 2002;109:1022-6. 3. Food Safety and Applied Nutrition, Office of Scientific Analysis and Support. Food allergen partnership. January 2001. Available at: www.cfsan.fda.gov/~dms/alrgpart.html. Accessed February 24, 2002. 4. Gern JE, Yang E, Evrard HM, Sampson HA. Allergic reactions to milkcontaminated “nondairy” products. N Engl J Med 1991;324:976-9. 5. Jones RT, Squillace DL, Yunginger JW. Anaphylaxis in a milk-allergic child after ingestion of milk-contaminated kosher-pareve-labeled “dairyfree” dessert. Ann Allergy 1992;68:223-7. 6. Kemp SF, Lockey RF. Peanut anaphylaxis from food cross-contamination. JAMA 1996;275:1636-7. 7. McKenna C, Klontz KC. Systemic allergic reaction following ingestion of undeclared peanut flour in a peanut-sensitive woman. Ann Allergy Asthma Immunol 1997;79:234-6.
8. Altschul AS, Scherrer DL, Munoz-Furlong A, Sicherer SH. Manufacturing and labeling issues for commercial products: relevance to food allergy [letter]. J Allergy Clin Immunol 2001;108:468. 9. Taylor SL, Hefle SL, Bindslev-Jensen C, Bock SA, Burks AW Jr, Christie L, et al. Factors affecting the determination of threshold doses for allergenic foods: how much is too much? J Allergy Clin Immunol 2002;109:24-30. 10. Schappi GF, Konrad V, Imhof D, Etter R, Wuthrich B. Hidden peanut allergens detected in various foods: findings and legal measures. Allergy 2001;56:1216-20. 11. Eigenmann PA. Food allergy: a long way to safe processed foods. Allergy 2001;56:1112-3. 12. Falci KJ, Gombas KL, Elliot EL. Food allergen awareness: an FDA priority. Available at: www.cfsan.fda.gov/~dms/alrgawar.html. Accessed February 27, 2002. 13. Hamburger RN. Misleading hazardous food labels. Ann Allergy 1992;68:200-1.
Bound volumes available to subscribers Bound volumes of The Journal of Allergy and Clinical Immunology are available to subscribers (only) for the 2002 issues from the Publisher, at a cost of $107.00 for domestic, and $128.00 for international subscribers for Vol. 109 (January-June) and Vol. 110 (July-December). Shipping charges are included. Each bound volume contains a subject and author index, and all advertising is removed. The binding is durable buckram with the journal name, volume number, and year stamped in gold on the spine. Payment must accompany all orders. Contact Mosby, Subscription Customer Service, 6277 Sea Harbor Dr, Orlando, FL 32887; phone (800) 654-2452 or (407) 345-4000. Subscriptions must be in force to qualify. Bound volumes are not available in place of a regular journal subscription.
Food manufacturing and the allergic consumer: Accidents waiting to happen
Issues regarding food manufacturing and labeling continue to be a major source of frustration and, unfortunately, risk for people with food allergy. Although it would seem that specific avoidance diets should be rather simple and straightforward, nothing could be further from the truth. Food-allergic patients must overcome significant obstacles on a day-to-day basis, including difficulties with the interpretation of food labels and neverending concerns about improperly or incompletely labeled foods. This issue of the Journal contains 2 timely and informative articles on these subjects. In one article, Joshi and colleagues1 report on a study in which they evaluated the ability of parents of foodallergic children to accurately read labels for the presence of 1 or more major food allergens.1 Realizing how poorly written labels are with respect to most common allergens, particularly as a result of the use of complex and ambiguous terms, one might have predicted that the results would be poor. In fact, they were absolutely dismal. This outcome is even more distressing given the fact that these were parents who had children with established food allergy and who presumably thus had experience in the interpretation of food labels. In fact, approximately one half of the families had previously seen a dietician and/or had been seen in the food allergy referral center that conducted the study. Accurate interpretation of the food labels ranged from just 7% for milk to 22% for soy, 54% for peanut, 88% for wheat, and 93% for wheat. Although some of these errors might be considered minor and might not have led to clinical reactions—such as the presence of the abbreviation DE (for Dairy Equipment) on the label of a product that was otherwise milkfree—others would have caused significant exposures with potentially severe reactions. In addition, it is important to note that some of the errors would have led to an unnecessary restriction of the child’s diet, such as the avoidance of soybean oil in a child with soy allergy. These results are especially troubling inasmuch as they are likely to reflect an overestimation of the actual ability of allergic consumers to read a label, in that these families had had more education on food allergy than most. Moreover, they had more time to study the labels in the From the Division of Allergy and Immunology, Department of Pediatrics, Johns Hopkins University School of Medicine. Received for publication March 18, 2002; accepted for publication March 19, 2002. Reprint requests: Robert A. Wood, MD, CMSC 1102, Johns Hopkins Hospital, 600 North Wolfe Street, Baltimore, MD 21287. J Allergy Clin Immunol 2002;109:920-2. © 2002 Mosby, Inc. All rights reserved. 0091-6749/2002 $35.00 + 0 1/39/124889 doi:10.1067/mai.2002.124889
920
Abbreviation used FDA: Food and Drug Administration
setting of this study than would be typical of a hurried trip to the grocery store. In the second study, Vierk and colleagues, from the Center for Food Safety and Applied Nutrition of the US Food and Drug Administration (FDA), report on the recalls that occurred in 1999 for foods containing undeclared allergen(s).2 Of 659 food products recalled, 236 were recalled because they contained 1 or more undeclared allergens. These recalls involved from fewer than 200 to as many as 100,000 packages of the recalled food. The major reasons for the recalls were (1) ingredient statement omissions or errors and (2) contamination of products by undeclared allergens through equipment cross-contact. Of note, most of these recalls were initiated by consumers who identified the undeclared allergen, and in 34 instances allergic reactions were reported by the consumer who identified the problem food. In many ways, this information is of much greater concern than that presented in the first article. The issue of label interpretation is significant, and misinterpretation is undoubtedly a common cause of accidental allergic reactions; however, it is at least theoretically possible to teach patients to read and accurately interpret even the most confusing label. The issues that are highlighted by the second study are not necessarily surmountable even with education and constant vigilance; the labels on these foods were not just hard to interpret—they were wrong! Unfortunately, though the number of food recalls for undeclared allergen rose dramatically during the 1990s, the numbers presented in the article by Vierk et al are still likely to be a significant underestimate of the true problem. First, the mislabeled food had to be identified. In most cases, this meant either that it caused an allergic reaction or that its presence was obvious by sight or by taste. Second, only the 8 most common food allergens were included. Although it is appropriate to focus on these most common allergens, there are many allergens that are less common but just as important for patients who are allergic to those foods. Third, such FDA recalls are entirely voluntary; there might have been many, many more potential recalls that never occurred. The true magnitude of this problem is indeed hard to estimate. The FDA recently provided results of a series of inspections that were conducted in partnership with the Departments of Agriculture of Minnesota and Wisconsin.3 Eighty-five facilities, specifically including bakeries and candy and ice cream manufacturing facilities, were
inspected. When labels were studied for accuracy by comparison of raw ingredients with finished product labels, 25% of the establishments were found to have omitted raw ingredients, including peanuts and tree nuts, from the final labels. Some firms had procedures in place to verify label accuracy, and 15% even of those were found to have label discrepancies. When product samples were analyzed for egg and peanut allergens through use of highly sensitive immunoassays, 25% of the 73 products analyzed for peanut and 10% of the 45 products analyzed for egg tested positive for residual allergen. Of the companies that did not have procedures in place to verify label accuracy, 38% in Minnesota and 64% in Wisconsin were found to have undeclared egg and/or peanut allergens in their products. Although these data are striking and suggest that the presence of undeclared allergens is rampant, they still do not provide information as to the magnitude of the problem from a clinical standpoint. Allergic reactions have been documented to occur as a result of the presence of undeclared food allergens,2,4-8 yet it is likely that much of this exposure is below the threshold of response for most patients. It would seem that our offices and emergency rooms would be full of patients with inexplicable allergic reactions if this were a major clinical problem. On the other hand, it is certainly possible that patients do regularly experience mild or more subtle reactions, such as abdominal pain or exacerbations of atopic dermatitis, from these low-level exposures. Hopefully, answers to the questions raised by these considerations will become more clear once we are able to establish accurate information on the threshold doses that will cause an allergic reaction for each major allergen.9 This is an area of active research, and it should be possible at least to determine levels below which the vast majority of allergic people will not react. However, it is also important to recognize that even that information will not provide a completely clear picture. In addition to the rare patients who might react at levels below a proposed threshold, there are significant issues regarding the effects of low-level exposure on allergic sensitization and the natural history of food allergy. For example, could it be that the apparently rising prevalence of peanut allergy is due in part to an increased exposure to peanut early in life from the unknowing use of contaminated foods? And could it also be that some children have more persistent food allergy because of chronic exposure from inaccurately labeled food products? These questions will be even harder to answer. It should be noted that these issues are not unique to the United States and that we are far better off than most of the rest of the world in this regard.10,11 In the greater part of Europe, an ingredient does not even have to appear on a label if it constitutes less than 25% of the product. It has been proposed that this level be dropped to 5%; that would be an improvement, but it would barely make a difference for the food-allergic consumer. Under those guidelines, it would seem almost impossible for someone with food allergy to eat anything without first calling the food product’s manufacturer to ensure its safety.
Wood 921
What, then, can and should be done? For our patients with food allergy, education remains the key. Until labeling for food allergens is made clearer and more straightforward, it is essential that all patients with food allergy be provided with the resources to accurately interpret food labels as well as to make informed decisions about restaurants and other food sources. It is in fact likely that restaurants, bakeries, and other eating establishments present far greater risks for mislabeled or contaminated food than do food manufacturers. Because of these inevitable pitfalls, it is also essential that education be directed toward the emergency treatment of food-allergic reactions in the event of accidental exposure. Several recommendations appear obvious. Immediate efforts should be directed toward the creation of clear, unambiguous labeling for food allergens. Simple terms should be used to identify major food allergens in an ingredient list, and the presence of an allergen should be clearly stated on the product label. For example, there is no good reason that not all foods containing milk protein have the word milk on their labels; the consumer should not have to search for (and know the meaning of) a word such as casein, whey, or lactoglobulin. If an allergen is contained in a spice or natural flavoring, this should also be clearly stated. Precautionary statements that include such a term as “May contain” or “Processed in the same facility as” should be used only when appropriate; they should not be used as blanket statements to replace good manufacturing practices. These efforts are all reasonable and could be implemented in short order with appropriate guidance from the FDA. However, even when these labeling issues have been resolved, issues of contamination and incomplete or inaccurate labeling will still need to be addressed. Some companies have spent the time and money to make their foods safe, and they can serve as models for others. The operative word, however, is money. All of these measures are costly and will most likely not be embraced by the average food manufacturer. It will therefore be necessary for the FDA to implement a more formal system to help ensure food safety for the allergic consumer. This will have to include specific guidelines for food labeling and manufacturing as well as a system of formal inspections involving use of the assays that are now available to measure the major food allergens. Similar recommendations are in fact proposed in the article by Vierk and colleagues, who work for the FDA.2 Fortunately, there really does seem to be much more interest and movement at the FDA with regard to food allergens than there ever has been before.12 It is worth noting, however, that recommendations very much like these were proposed in a similar editorial a full 10 years ago.13 It is now time to gather all available resources and work together to make certain that another 10 years does not pass without significant progress on these critically important issues. Robert A. Wood, MD Baltimore, Md
Reviews and feature articles
J ALLERGY CLIN IMMUNOL VOLUME 109, NUMBER 6
922 Wood
J ALLERGY CLIN IMMUNOL JUNE 2002
Reviews and feature articles
REFERENCES 1. Joshi P, Mofidi S, Sicherer SH. Interpretation of commercial food ingredient labels by parents of food-allergic children. J Allergy Clin Immunol 2002;109:1019-21. 2. Vierk K, Falci K, Wolyniak C, Klontz KC. Recalls of foods containing undeclared allergens reported to the US Food and Drug Administration, fiscal year 1999. J Allergy Clin Immunol 2002;109:1022-6. 3. Food Safety and Applied Nutrition, Office of Scientific Analysis and Support. Food allergen partnership. January 2001. Available at: www.cfsan.fda.gov/~dms/alrgpart.html. Accessed February 24, 2002. 4. Gern JE, Yang E, Evrard HM, Sampson HA. Allergic reactions to milkcontaminated “nondairy” products. N Engl J Med 1991;324:976-9. 5. Jones RT, Squillace DL, Yunginger JW. Anaphylaxis in a milk-allergic child after ingestion of milk-contaminated kosher-pareve-labeled “dairyfree” dessert. Ann Allergy 1992;68:223-7. 6. Kemp SF, Lockey RF. Peanut anaphylaxis from food cross-contamination. JAMA 1996;275:1636-7. 7. McKenna C, Klontz KC. Systemic allergic reaction following ingestion of undeclared peanut flour in a peanut-sensitive woman. Ann Allergy Asthma Immunol 1997;79:234-6.
8. Altschul AS, Scherrer DL, Munoz-Furlong A, Sicherer SH. Manufacturing and labeling issues for commercial products: relevance to food allergy [letter]. J Allergy Clin Immunol 2001;108:468. 9. Taylor SL, Hefle SL, Bindslev-Jensen C, Bock SA, Burks AW Jr, Christie L, et al. Factors affecting the determination of threshold doses for allergenic foods: how much is too much? J Allergy Clin Immunol 2002;109:24-30. 10. Schappi GF, Konrad V, Imhof D, Etter R, Wuthrich B. Hidden peanut allergens detected in various foods: findings and legal measures. Allergy 2001;56:1216-20. 11. Eigenmann PA. Food allergy: a long way to safe processed foods. Allergy 2001;56:1112-3. 12. Falci KJ, Gombas KL, Elliot EL. Food allergen awareness: an FDA priority. Available at: www.cfsan.fda.gov/~dms/alrgawar.html. Accessed February 27, 2002. 13. Hamburger RN. Misleading hazardous food labels. Ann Allergy 1992;68:200-1.
Bound volumes available to subscribers Bound volumes of The Journal of Allergy and Clinical Immunology are available to subscribers (only) for the 2002 issues from the Publisher, at a cost of $107.00 for domestic, and $128.00 for international subscribers for Vol. 109 (January-June) and Vol. 110 (July-December). Shipping charges are included. Each bound volume contains a subject and author index, and all advertising is removed. The binding is durable buckram with the journal name, volume number, and year stamped in gold on the spine. Payment must accompany all orders. Contact Mosby, Subscription Customer Service, 6277 Sea Harbor Dr, Orlando, FL 32887; phone (800) 654-2452 or (407) 345-4000. Subscriptions must be in force to qualify. Bound volumes are not available in place of a regular journal subscription.