The failure and solutions to the Food Allergen Labeling Consumer Protection Act and MA Allergen Awareness Law—Felix I. Zemel
A recent report by the National Institute of Allergy and Infectious Diseases stated that as many as 5% of children under 5 years old and 4% of teenagers and adults currently suffer from food allergies in the United States . These numbers are nearly double those that were estimated merely one decade ago . Food allergies annually result in about 30,000 patient visits to hospital Emergency Departments, 2,000 hospitalizations, and 150 deaths [2,10]. 90% of these adverse health effects are caused by one of 8 “major food allergens”: peanuts, tree nuts, milk, soy, crustacean shellfish, fish, eggs, and wheat . It was also determined that about half of the allergic reactions occurred as a result of prepared foods, and of those about 75% resulted from food prepared at a restaurant . As a result of these startling numbers, the First Session of the 108th U.S. Congress enacted the Food Allergen Labeling Consumer Protection Act of 2004, which requires packaged food manufacturers to properly label products with the common name of any of the major food allergens that the food could potentially have had cross-contact with.
The Commonwealth of Massachusetts took allergen awareness regulation a step further when Governor Patrick signed the Act Relative to Food Allergy Awareness in Restaurants into law in January 2009. In this new amendment, the legislature required “all food establishments that cook, prepare, or serve food intended for immediate consumption either on or off the premises” to comply with multiple requirements related to posting a specific allergen notice on the establishments menu and menu board; post an allergy awareness poster in a conspicuous place for all food handlers to see; and for all certified food protection managers to view a 30-minute training video and for all other food handlers to view a 10-minute video about allergen awareness [3,11]. These regulations were to be implemented at various points in time (October 1, 2010 for the poster and signage; Feb 1, 2011 for the video).
Critique of the FALCPA and the MA Allergen Awareness Law
Both the FALCPA and the MA Allergen Awareness law have similar a similar goal: to decrease the morbidity and mortality of individuals resulting from accidental exposure (more specifically, ingestion) of food allergens to which they may be allergic. The method by which they each plan to achieve this goal is rooted deep within the Health Belief Model and the Theory of Reasoned Action.
The Health Belief Model, the basic premise of which is described by Rosenstock (1974) is that “…in order for an individual to avoid action to a disease he would need to believe (1) that he was personally susceptible to it, (2) that the occurrence of the disease would have at least a moderate severity on some component of his life, and (3) that taking a particular action would in fact be beneficial by reducing his susceptibility to the condition or, if the disease occurred, by reducing its severity, and that it would not entail overcoming important psychological barriers such as cost, convenience, pain, embarrassment” . Salazar (1991) described the Theory of Reasoned Action by explaining that “behavioral change ultimately is the result of changes in beliefs, and that people will perform behavior if they think they should perform it…” . Following the Health Belief Model, the logic behind the FALCPA and the MA Allergen Awareness Law was that if individual consumers was warned of the risks inherent in the consumption of particular packaged or prepared foods, that they would inherently choose not to consume those foods because their susceptibility to have an allergic reaction would be much greater and less beneficial than avoiding the food altogether. This would also follow the Theory of Reasoned Action, whereas once the belief is put in place that consumption of these particular foods is harmful, that the consumer would choose not to take the risk, and would thus forgo consuming the product.
The FALCPA has now been in effect for approximately 6 years. A variety of research studies have been performed in recent years to determine the effects (if any) that mandatory labeling of packaged foods has had on the behavior of individuals with food allergies [7,14,15,24,28]. The result of the research is startling. Researchers found that individuals with food allergies were significantly more likely to purchase a product with an allergen warning label in 2006 (after the enactment of the FALCPA) than in 2003 (prior to the enactment of the FALCPA) . The research further showed that there were significant differences in the individuals’ likelihood of avoiding particular products based on the types of labeling that was placed on the packaging. Food manufacturers, especially large ones, have one big thing in common with large tobacco manufacturers: they “want to help the community”. The labeling on packaging for food originally started as a voluntary addition to food labels by manufacturers. Similar to the anti-smoking campaigns, where tobacco companies like Phillip Morris donated millions of dollars to fund inherently flawed campaigns to stop children from smoking, food manufacturers placed labels with allergen warnings ranging from “may contain…” to “may contain traces of…” to “manufactured in a facility that also uses…” to the greatest extreme of “packaged in a facility that also packages products containing…” . As can be understood, the marketing specialists at large food manufacturing companies understand the basics of advertising theory and framing. Ogilvy (1964) said it well when he stated “a good advertisement is one which sells the product without drawing attention to itself. By utilizing different forms of framing, the food manufacturers were able to balance their perceived interest in preventing allergic reactions to their products while also not jeopardizing their bottom lines.
The US Food and Drug Administration (FDA), who is the enforcing authority for the FALCPA stated that “advisory labels must be truthful and not misleading” . After the adoption of the FALCPA, the food manufacturers took advantage of this requirement even more. Pieretti et al (2009) found multiple violations of the FDA where manufacturers labeling packages with nonspecific verbiage, such as those described above, but then included derivatives of one of the top 8 allergens in the ingredients list. The manufacturers technically are not lying or misleading, because they are still warning the consumer of the risk of exposure to a potential allergen, but they are also downplaying the severity of the risk. When applying this to the Health Belief Model, the downplayed severity makes the individual consumer feel less susceptible to the adverse health effect and causes him/her to decide that maybe the risk is worth taking—resulting in him/her purchasing and subsequently consuming the food (following the Theory of Reasoned Action). Examples of this deceptive practice are when the ingredients list items like gelatin, but do not specify if it is pork, beef, or fish gelatin—as fish is one of the top 8 allergens. Another common practice was listing lecithin in the ingredient line, without listing its source (soy, sunflower seeds, eggs, or rice .
Similar to the fact that manufacturers are misleading individuals into believing that their risk of ingestion of a food that they may be allergic to is low, but they also list these items in understanding that individuals do not necessarily know all of the foods and other products that are derived from common allergens. If food manufacturers properly apply advertising and marketing theory through framing products’ perceived risk in particular settings, then they gain the trust of the individuals. A common item that the lack of labeling specific items as allergens has is that it also attempts to account for individuals not knowing if a particular ingredient is a derivative of one of the allergens that must be labeled. This is the major flaw of the MA Allergen Awareness Law. Although retail food establishments must post notice in all of their menus and on their menu boards telling the consumer “before placing your order, please inform your server if a person in your party has a food allergy” and have their staff be trained in allergen awareness, the law does not account for lack of basic knowledge on the part of both ends of the transaction. There is a common misconception that mayonnaise is a dairy product, leading many people to avoid due to milk allergy or lactose intolerance. In actuality, mayonnaise is based on eggs, which is a totally different food allergen (although 72% of individuals with an egg allergy also have a milk allergy ).
If neither party in the transaction knows that a particular food is a derivative of specific allergens, then the labeling requirement mandated by Massachusetts law is pointless. When applying the Health Belief Model and the Theory of Reasoned Action to a situation where neither party knows that an item like mayonnaise is derived from eggs, the following situation can be potentially fatal to the consumer: (1) the consumer notifies his/her server that (s)he is allergic to eggs, and asks the server if the tuna salad sandwich had eggs in it; (2) the server asks the cook if the tuna salad sandwich has eggs, the cook thinks that mayonnaise is dairy-based and tells the server that there were no egg ingredients in the tuna salad sandwich; (3) the server relays this message to the consumer, who subsequently purchases the tuna salad sandwich, has an anaphylactic reaction to the eggs in the mayonnaise resulting in respiratory arrest. In the preceding scenario, the consumer used the Health Belief Model to frame his risk in ingesting eggs. When he was told that there were no eggs in the tuna salad sandwich, the Theory of Reasoned Action made him decide that the potential risk of an allergic reaction was low resulting in him purchasing and consuming the tuna salad sandwich and having a severe allergic reaction to the egg that he did not know was even in the product.
These flaws are inherent in an intervention that relies so heavily on individual knowledge and understanding. It is also because of this lack of understanding of the differences and the lack of specificity in the labels that are places on packages of food that consumers are paying less and less attention to the labels. The Health Behavior Model and Theory of Reasoned Action were originally required in order to make it simpler for individuals who have particular food allergies to know which foods to avoid and which ones are safe. The fact that there is no consistency in the verbiage used on labels and that manufacturers are not listing (or framing in such a way that the individual consumer perceives a smaller risk than actually exists) decreases confidence of individuals who have food allergies, resulting in them not paying attention to the labels at much higher levels that existed prior to the enactment of the FALCPA. The lack of knowledge by food handlers makes is impossible for consumers to make a proper reasoned choice of purchasing/consuming the food item or not.
A new intervention must be developed that builds upon the existing interventions by eliminating their flaws of misleading labeling of which ingredients are actually allergens, lack of knowledge of the ingredients in particular items by consumers and/or food handlers, and the lack of consistency in the verbiage of labels on packaged foods—which allows manufacturers to frame the perception of risk to the consumer however the manufacturer wants. These practices show application of a large variety of social and behavioral theories that manufacturers utilize in order to manipulate decisions made by consumers . If an intervention is successful at addressing these flaws, then its odds of effectiveness are greater.
A proposed intervention
As stated earlier, the three lethal flaws in the FACLPA and the MA Allergen Awareness Law were manufacturers’ use of misleading labeling information, a lack of knowledge by individuals and food handlers, and inconsistency in the labeling verbiage. A successful intervention can utilize the basic framework and social and behavioral theories that exist in the original flawed ones, but improve them by applying other theories and practices in order to eliminate the inherent flaws. In order for this to happen, a comprehensive view of the problem must be observed. The flaws described above were rooted in the ability of food manufacturers to utilize social and behavioral science theories in an effort to subvert the intentions of laws. These same social and behavioral science theories are used in the following intervention to subvert the subversions by food manufacturers in order to get closer, if not totally, to decrease or eliminate the number of deaths and injuries of individuals caused by accidental ingestion of food products to which they are allergic. This intervention addresses the flaws by implementing the following items: creation of a series of “symbols” indicating the allergen of concern; standardizing the verbiage permitted for use on FALCPA-mandated labels; and mandatory review of all menus (and changes thereof) by the local board of health (or other government subdivision charged with enforcement of food service codes) before the implementation of a new menu or any changes thereof. Through the addition of these interventions to the FALCPA and the MA Allergen Awareness Law, the flaws that are causing gaping holes in the effectiveness of those regulations can be resolved, resulting in a potential decrease of the incidence of morbidity and/or mortality of individuals as a result of accidental allergic reactions to food allergens.
The use of universally-accepted symbols has been successfully implemented in a variety of public health campaigns through the years. Two symbols that come to mind the quickest are the universal symbols of two hands being washed with soap and water, and the international symbol for no smoking. When people see these two symbols, they can be expected to think about the meaning of the change and then weigh their options and use reasoned action to make a final decision leading to a final action. This application of the Theories of Reasoned Action and the Health Belief Model can be directly applied to the concerns about allergen awareness. Many restaurants list items on their menus with different asterisks, stars, check-marks, or other symbols to send the reader a particular message without wasting the space for words. A common symbol used for this is the () symbol used in menus to indicate an item is heart-healthy. An easy to implement intervention is to first develop what is to become a universally accepted indicator of a particular food allergen—say an picture of an egg, soybean, fish, peanut, tree nut, or crustacean shellfish (like a lobster), a gallon of milk, or a stalk of wheat—and then mandate that restaurants and producers of packaged foods label each of their menu [or packaged] items with one or more of the symbols in order to portray which allergen a consumer is at risk of coming into contact with.
The creation of these symbols will have benefits on multiple levels. The first benefit is that it will better illuminate the potential risks if the particular food item is consumed. This can then be translated through cognitive functioning into a belief about if the person should choose to make one action or another, letting the Theory of Reasoned Action take control. Although there are many factors, such as herd behavior, that can confound the reasoning process, the basic premise of the Health Behavior Model and Theory of Reasoned Action still stand. It can be assumed that if a person is a member of a particular group that is heading to a restaurant, (s)he is more likely to take heed of a warning that is blaring on the menu next to the name of the item than of wording that tells the consumer to notify his/her server if (s)he has a food allergy or a label on a bag of chips that states “this product was packaged on a line that also packages soy products” when lecithin is listed as one of the ingredients just a couple of lines above. Herd behavior often takes control over the individual when in a group setting, invalidating many of the theories that make up individual behavior change models, but the potential of their strength is potentially significantly lessened with proper signage and forced awareness [23,25].
Another intervention that will decrease the numbers of people ignoring the allergen warning labels on food packaging is forced consistency. At the onset of the MA Allergen Awareness Law, many foodservice companies did exactly what large food manufacturers still do about labeling the allergen warnings on the packaging: they applied advertising and marketing principles in order to frame the apparent risk in a much lower light. In anticipation of this behavior occurring the MA legislature added verbiage into the actual statute that all foodservice establishments in the Commonwealth of Massachusetts must have on all of their menus in order to maintain compliance with the law. The FALCPA must be amended where the law should mandate specific verbiage for labels on packaged foods.
Framing is used to bias individuals into thinking a particular way about a particular topic . Its effects can be devastating to an improperly designed or implemented public health intervention, as is seen with the FALCPA. Research shows that people had much higher rates of paying attention to labels that stated “may contain…” or “may contain traces of…” labels versus ones that had convoluted statements like “packaged in a facility that also packages products containing…” (89% and 85% in 2006 versus 59% in 2006, respectively) . Based upon the startling differences in responses between the three ways of saying the same thing (with different implications), the legislature should only allow one or two versions of the allergy warning label on packaged foods.
In addition to the consistency in the verbiage, the government must give further guidance in order to avoid what can easily be construed as misleading and untruthful labeling practices by food manufacturers. Regulations must be strengthened along with the verbiage too also require that derivatives of the 8 top food allergens be placed under the same category as the main food allergen. This would be alleviated somewhat if the wording so convoluted as “packaged in a facility that also packages products containing…” would be eliminated and the standardized labeling verbiage were put into place instead.
This leads into the final prong of the new intervention: local approval of menus and menu labeling for foodservice establishments. This is both its own intervention, but it brings the previous two together as well. Currently in Massachusetts, each of the 351 cities and towns has its own board of health that has the ability to create its own regulations, as long as they do not conflict with state or federal laws or regulations by weakening them. One of the primary responsibilities of local boards of health or health departments is the licensing and subsequent inspection of all foodservice establishments within its perimeter. Among the duties included in this is plan review and annual renewal of foodservice licenses.
Menus are a vital part of the foodservice establishment’s food service and safety plans. As was stated earlier, labeling of items containing major food allergens with symbols is imperative to bringing better awareness to the risks involved in consuming a particular food item. It was shown how this labeling plays into the decision making process by an individual consumer and applied to an action through use of the Health Behavior Model and the Theory of Reasoned Action. As was described earlier, food manufacturers use either deceptive practices or just lack the knowledge to know exactly what items contain major food allergens. Because of this, the verification must be made during the preliminary steps to the establishments’ opening: during plan review.
Local boards of health and health departments must implement a regulation that all menus must be properly labeled with appropriate symbols to indicate risks of consumption, and should require that all foodservice establishments provide the board of health or health department with a list of all of the ingredients in each particular item on the menu in order for the person reading the plans to verify that the warning symbols are correct. Foodservice establishments should not be permitted to change items on their menu without the prior approval from the local board of health of the particular food items. This would not preclude establishments from having rotating specials or other food items, if the list of ingredients for each of the rotating items was submitted and approved during the plan review.
The mandatory approval from the local board of health or health department will also eliminate any bias resulting from framing or other advertising methods utilized by businesses to subvert the attempts at improving the public’s health. Maintaining and improving the public’s health should be a priority of not just the policymakers or individual activists, but also of those who are interfacing with the public. Businesses have shown that they favor market forces much more than the potential for improving health. Marketing campaigns by businesses frame items in such a way that not only do they subvert the law, but they also place susceptible members of the public at risk of serious adverse health effects or death due to their negligence and greed. A public health intervention that counteracts the marketing and framing techniques utilized by businesses benefits the public’s health dramatically.
(1) Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, et al. Guidelines for the diagnosis and management of food allergy in the United States: Report of the NIAID-sponsored expert panel. J Allergy Clin Immunol 2010 December;126(6, Supplement 1):S1-S58.
(2) Buchanan R, Dennis S, Acheson D, Assimon SA, Beru N, Bolger P, et al. Approaches to establishment thresholds for major food allergens and for gluten in food: A report by the Threshold Working Group. The Center for Food Safety and Applied Nutrition, Food and Drug Administration 2006 March.
(3) Bureau of Environmental Health/Food Protection Program, Massachusetts Department of Public Health. Q&As for MDPH Allergen Awareness Regulation. 2010 19 August.
(4) De Martino B, Kumaran D, Seymour B, Dolan RJ. Frames, biases, and rational decision-making in the human brain. Science 2006 4 August; 313:684-687.
(5) Fleischer DM, Conover-Walker MK, Matsui EC, Wood RA. The natural history of tree nut allergy. J Allergy Clin Immunol 2005 November; 116(5):1087-1093.
(6) Green TD, LaBelle VS, Steele PH, Kim EH, Lee LA, Mankad VS, et al. Clinical characteristics of peanut-allergic children: Recent changes. Pediatrics 2007 December;120(6):1304-1310.
(7) Hefle SL, Furlong TJ, Niemann L, Lemon-Mule H, Sicherer S, Taylor SL. Consumer attitudes and risks associated with packaged foods having advisory labeling regarding the presence of peanuts. J Allergy Clin Immunol 2007 July; 120(1):171-176.
(8) Hefle SL, Taylor SL. Food allergy and the food industry. Curr Allergy Asthm R 2004 January; 4(1):55-59.
(9) Link BG, Phelan J. Social conditions as fundamental causes of disease. J Health Soc Behav 1995; Extra Issue:80-94.
(10) Lowey N. Public Law 108-282: Food Allergen Labeling and Consumer Protection Act of 2004. 2004 2 August; H.R. 3684(108th Congress, First Session).
(11) MA Department of Public Health. 105 CMR 410.500: State Sanitary Code, Chapter X--Minimum sanitation standards for food establishments. 2010 9 June.
(12) McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA 1993 10 November; 270(18):2207-2212.
(13) Ogilvy D. How to build great campaigns. In: Ogilvy D, editor. Confessions of an advertising man New York: Atheneum; 1964. p. 89-103.
(14) Ong PY. Are allergy advisory statements helpful to patients with food allergy? J Allergy Clin Immunol 2008 3 January; 121(2):536-537.
(15) Pieretti MM, Chung D, Pacenza R, Slotkin T, Sicherer SH. Audit of manufactured products: Use of allergen advisory labels and identification of labeling ambiguities. J Allergy Clin Immunol 2009 August;124(2):337-341.
(16) Rona RJ, Keil T, Summers C, Gislason D, Zuidmeer L, Sodergren E, et al. The prevalence of food allergy: A meta-analysis. J Allergy Clin Immunol 2007 July 12, 2007;126(3):638-646.
(17) Rosenstock IM. Historical origins of the health belief model. Health Education Monographs 1974;2(4):328-335.
(18) Salazar MK. Comparison of four behavioral theories: A literature review. AAOHN Journal 1991 March;39(3):128-135.
(19) Savage JH, Kaeding AJ, Matsui EC, Wood RA. The natural history of soy allergy. J Allergy Clin Immunol 2010 March;125(3):683-686.
(20) Savage JH, Matsui EC, Skripak JM, Wood RA. The natural history of egg allergy. J Allergy Clin Immunol 2007 December;120(6):1413-1417.
(21) Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of peanut and tree nut allergy in the United States determined by means of a random digit dial telephone survey: A 5-year follow-up study. J Allergy Clin Immunol 2003 December;112(6):12-3-12-7.
(22) Skolnick HS, Conover-Walker MK, Koerner CB, Sampson HA, Burks W, Wood RA. The natural history of peanut allergy. J Allergy Clin Immunol 2001 February;107(2):367-374.
(23) Sornette D. "Herd" behavior and "crowd" effect. In: Sornette D, editor. Why stock markets crash: critical events in complex financial systems Princeton: Princeton University Press; 2003. p. 91-114.
(24) Taylor SL. Reply: Are allergy advisory statements helpful to patients with food allergy? J Allergy Clin Immunol 2008 21 January; 121(2):537.
(25) Thaler RH, Sunstein CR. Chapter 3: following the herd. In: Thaler RH, Sunstein CR, editors. Nudge: improving decisions about health, wealth, and happiness New Haven: Yale University Press; 2008. p. 53-71.
(26) U.S. Food and Drug Administration. Food allergen labeling and Consumer Protection Acto of 2005 questions and answers. 2009; Available at: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm106890.htm. Accessed December 5, 2010.
(27) Vadas P, Wai Y, Burks W, Perelman B. Detection of peanut allergens in breast milk of lactating women. JAMA 2001 4 April; 285(13):1746-1748.
(28) Vierk KA, Koehler KM, Fein SB, Streeet DA. Prevalence of self-reported food allergy in American adults and use of food labels. J Allergy Clin Immunol 2007 25 April;119(6):1504-1510.