The forensic implications of food hypersensitivity - a review of cases in United Kingdom courts: January 2014-February 2020.

AIMS: Food allergy is a major public health concern. Failures of food allergen avoidance and the consequences for those with food hypersensitivity (allergies, intolerances and coeliac disease) have a forensic context. The aim of this study was to collate and analyse the use of action in the United Kingdom (UK) courts as redress following adverse food allergy reactions or failures of allergen management. METHODS: Details of prosecutions during the study period (1 January 2014 to 31 January 2020) were recorded from regular key word Internet searches. National and local news reports were primary sources, along with commentary from enforcement and regulatory professionals. Information was also collected from coroners' inquests by attending hearings and direct contact with coroners and participants in the hearings. Freedom of Information requests were made to local authority enforcement departments. In several cases, the authors had direct involvement in investigations. RESULTS: From 2014 to 2020, there was an increase in reports. Seventy prosecutions were recorded as well as two associated appeals and two applications for Hygiene Emergency Prohibition Notice. This resulted in 68 convictions; seven individuals received custodial sentences, three of which were suspended although one individual had a tagged curfew imposed. Fines ranged from £50 to £93,000. Details of the law applied and the evidence gathering processes are reported. CONCLUSION: Legal action, including landmark prosecutions for Gross Negligence Manslaughter and Preventing Future Deaths reports from coroners, with salience of criminal penalties, has led to changes in labelling law and improved allergen management practices better to protect the interests of patients with food hypersensitivities. A central system of collation of such data, and on 'near misses', will enable more focused root cause analysis to further improve allergen management and reduce patient risk.

How does dose impact on the severity of food-induced allergic reactions, and can this improve risk assessment for allergenic foods?: Report from an ILSI Europe Food Allergy Task Force Expert Group and Workshop.

Quantitative risk assessment (QRA) for food allergens has made considerable progress in recent years, yet acceptability of its outcomes remains stymied because of the limited extent to which it has been possible to incorporate severity as a variable. Reaction severity, particularly following accidental exposure, depends on multiple factors, related to the allergen, the host and any treatments, which might be administered. Some of these factors are plausibly still unknown. Quantitative risk assessment shows that limiting exposure through control of dose reduces the rates of reactions in allergic populations, but its impact on the relative frequency of severe reactions at different doses is unclear. Food challenge studies suggest that the relationship between dose of allergenic food and reaction severity is complex even under relatively controlled conditions. Because of these complexities, epidemiological studies provide very limited insight into this aspect of the dose-response relationship. Emerging data from single-dose challenges suggest that graded food challenges may overestimate the rate of severe reactions. It may be necessary to generate new data (such as those from single-dose challenges) to reliably identify the effect of dose on severity for use in QRA. Success will reduce uncertainty in the susceptible population and improve consumer choice.

Eating out with a food allergy in the UK: Change in the eating out practices of consumers with food allergy following introduction of allergen information legislation.

BACKGROUND: Strict allergen avoidance is important in day-to-day management of food allergy and avoidance when eating outside the home can present particular difficulties. EU legislation (EU FIC) introduced in December 2014 aimed to improve food allergen information provision for customers by requiring retailers of non-prepacked foods to provide information related to the content of one or more of 14 specified food allergens within their foods. OBJECTIVES: To investigate the impact of EU FIC on the behaviours, experiences and attitudes of consumers with food allergy when eating out. METHODS: As part of longitudinal research, participants with food allergy from across the UK took part in either (A) pre and post legislation in-depth interviews, or (B) pre and post legislation surveys. In-depth interviews were carried out with 28 participants pre and post legislation and analysed using the framework approach. Self-report surveys were completed by 129 participants pre and post legislation, and responses were subject to quantitative analyses. RESULTS: Improvements in allergen information provision and raised awareness of food allergy in eating out venues were reported following introduction of EU FIC. Whilst participants favoured written allergen information, they expressed greater confidence in communicating with eating out staff and in trusting the allergen information that they provided. Improvements were judged to be gradual, sporadic or inconsistent in implementation. CONCLUSION & CLINICAL RELEVANCE: For many participants, the "ideal" eating out experience was one in which a range of information resources were available and where written allergen information was complemented by proactive and accommodating staff within an allergy-aware environment. Whilst the onus is on legislators and food providers to ensure that adequate allergen information is provided, clinicians play an important role in encouraging patients with food allergy to pursue their legal right to make allergen enquiries to avoid accidental allergen ingestion when eating out.

Can we identify patients at risk of life-threatening allergic reactions to food?

Anaphylaxis has been defined as a 'severe, life-threatening generalized or systemic hypersensitivity reaction'. However, data indicate that the vast majority of food-triggered anaphylactic reactions are not life-threatening. Nonetheless, severe life-threatening reactions do occur and are unpredictable. We discuss the concepts surrounding perceptions of severe, life-threatening allergic reactions to food by different stakeholders, with particular reference to the inclusion of clinical severity as a factor in allergy and allergen risk management. We review the evidence regarding factors that might be used to identify those at most risk of severe allergic reactions to food, and the consequences of misinformation in this regard. For example, a significant proportion of food-allergic children also have asthma, yet almost none will experience a fatal food-allergic reaction; asthma is not, in itself, a strong predictor for fatal anaphylaxis. The relationship between dose of allergen exposure and symptom severity is unclear. While dose appears to be a risk factor in at least a subgroup of patients, studies report that individuals with prior anaphylaxis do not have a lower eliciting dose than those reporting previous mild reactions. It is therefore important to consider severity and sensitivity as separate factors, as a highly sensitive individual will not necessarily experience severe symptoms during an allergic reaction. We identify the knowledge gaps that need to be addressed to improve our ability to better identify those most at risk of severe food-induced allergic reactions.

Is food allergen analysis flawed? Health and supply chain risks and a proposed framework to address urgent analytical needs.

Food allergy is an increasing problem for those affected, their families or carers, the food industry and for regulators. The food supply chain is highly vulnerable to fraud involving food allergens, risking fatalities and severe reputational damage to the food industry. Many facets are being pursued to ameliorate the difficulties including better food labelling and the concept of thresholds of elicitation of allergy symptoms as risk management tools. These efforts depend to a high degree on the ability reliably to detect and quantify food allergens; yet all current analytical approaches exhibit severe deficiencies that jeopardise accurate results being produced particularly in terms of the risks of false positive and false negative reporting. If we fail to realise the promise of current risk assessment and risk management of food allergens through lack of the ability to measure food allergens reproducibly and with traceability to an international unit of measurement, the analytical community will have failed a significant societal challenge. Three distinct but interrelated areas of analytical work are urgently needed to address the substantial gaps identified: (a) a coordinated international programme for the production of properly characterised clinically relevant reference materials and calibrants for food allergen analysis; (b) an international programme to widen the scope of proteomics and genomics bioinformatics for the genera containing the major allergens to address problems in ELISA, MS and DNA methods; (c) the initiation of a coordinated international programme leading to reference methods for allergen proteins that provide results traceable to the SI. This article describes in more detail food allergy, the risks of inapplicable or flawed allergen analyses with examples and a proposed framework, including clinically relevant incurred allergen concentrations, to address the currently unmet and urgently required analytical requirements. Support for the above recommendations from food authorities, business organisations and National Measurement Institutes is important; however transparent international coordination is essential. Thus our recommendations are primarily addressed to the European Commission, the Health and Food Safety Directorate, DG Santé. A global multidisciplinary consortium is required to provide a curated suite of data including genomic and proteomic data on key allergenic food sources, made publically available on line.

EAACI Food Allergy and Anaphylaxis Guidelines. Protecting consumers with food allergies: understanding food consumption, meeting regulations and identifying unmet needs.

Individuals suffering from IgE-mediated food allergy usually have to practise life-long food allergen avoidance. This document aims to provide an overview of recent evidence-based recommendations for allergen risk assessment and management in the food industry and discusses unmet needs and expectations of the food allergic consumer in that context. There is a general duty of care on the food industry and obligations in European Union legislation to reduce and manage the presence of allergens alongside other food hazards. Current evidence enables quantification of allergen reference doses used to set-up reliable food safety management plans for some foods. However, further work is required to include a wider variety of foods and to understand the impact of the food matrix as well as additional factors which affect the progression and severity of symptoms as a function of dose. Major concerns have been raised by patients, carers and patient groups about the use of precautionary 'may contain' labelling to address the issue of unintended presence of allergens; these therefore need to be reconsidered. New and improved allergen detection methods should be evaluated for their application in food production. There is an urgent requirement for effective communication between healthcare professionals, patient organizations, food industry representatives and regulators to develop a better approach to protecting consumers with food allergies.

How do peanut and nut-allergic consumers use information on the packaging to avoid allergens?

BACKGROUND: Recent legislation has sought to improve the information printed on packaged foods relevant to the safety of food allergic consumers. We aimed to understand the complex risk assessment decisions made by peanut and nut-allergic adults when purchasing food, with particular reference to use of printed package information. METHODS: The behaviour and 'thinking aloud' of 32 participants were recorded during their normal food shop, followed by a semi-structured interview. During the interview they were given 13 potentially problematic packaged foods, and asked if they would purchase the product and what their reasons were. Transcribed data from the shop, interview and 13-product task were analysed to explore use of allergy advice boxes, ingredients lists and other packaging information. RESULTS: Some participants used the ingredients list as their primary check for allergens, but most used the allergy advice box. Package-based information was generally considered reliable, but some supermarket and brand labels were trusted more than others. Images and product names were used to draw inferences about the presence of nuts. A number of improvements were suggested by participants, particularly a request for more 'nut free' labelling. CONCLUSIONS: Food labels were used in conjunction with nonpacket-based strategies (e.g. previous experience) to make choices. External factors (e.g. trust of manufacturer) informed interpretation of and confidence in labels. Images and product names, not intended by manufacturers as an allergen risk assessment aid, were also used to inform choices.

How do teenagers manage their food allergies?

BACKGROUND: The peak incidence of deaths from anaphylaxis associated with nut allergy occurs in teenagers and young adults. During adolescence, the management of food allergy shifts from being the responsibility of parents to that of the young person. This is a group who therefore need special attention in the clinic. OBJECTIVE: This study aimed to understand the practical challenges that teenagers with food allergy experience using a qualitative approach and generate potential interventions for tackling these. METHODS: Teenagers aged 1118 years with food allergy completed a questionnaire about their food allergy and underwent a focused, semi-structured interview with open questions guided by a priori topic areas. Interviews were recorded, transcribed and analysed using a thematic approach. RESULTS: The study enrolled 18 teenagers with a median age of 15 years (10 females); the most common food allergens were peanuts and tree nuts. Three key themes emerged: avoidance of allergens, preparation for reactions and the treatment of reactions. The majority of teenagers reported eating foods labelled as 'may contain' an allergen as they perceive that they are actually very unlikely to contain an allergen. Many of the teenagers only carried their self-injectable adrenaline when they thought they are particularly at risk of a reaction. Some do not know how to appropriately treat an allergic reaction. More than half believed that educating other students at school about the seriousness of food allergies would make it easier to live with their food allergy. CONCLUSIONS: A significant number of teenagers demonstrate risk-taking behaviour in the management of their food allergies. Teenagers also felt it would be helpful for their peers to be educated about food allergy. This novel strategy might help them to avoid trigger foods and enable teenagers to access help more readily if they suffer a reaction.

Sesame allergy in Britain: a questionnaire survey of members of the Anaphylaxis Campaign.

Sesame is a major allergen in countries where it is a common food. It was noted that an increasing number of members of the UK charity, the anaphylaxis campaign, were reporting allergy to sesame. This study, sought to examine features of sesame allergy among members of the Anaphylaxis Campaign (which supports those at potentially life-threatening risk from allergies) focusing on clinical symptoms and features of the foods implicated. A physician-designed questionnaire was sent by post to 400 members of the Anaphylaxis Campaign who reported avoidance of sesame. Two hundred and eighty replies were received (70%). Twenty-three replies (7%) were excluded and 96 replies (24%) came from subjects who avoided sesame but had never reacted to it. One hundred and fifty people (54%) reported 288 reactions to sesame. 89% of reactive subjects reported other atopic diseases and notably 84% were also nut/peanut allergic. One in six (17%) had suffered potentially life-threatening symptoms, with 65% of severe reactions happening on first known exposure. The age of first reaction ranged from 6 months to 65 yr. The majority of reactions reported (91%) involved foods or dishes which had sesame as a deliberate ingredient, rather than sesame as an accidental contaminant. Respondents represented a well-informed and highly selected group of people at risk from potentially life-threatening allergies. Sesame should be identified clearly as an ingredient and separately from nuts and peanuts when it may be an allergen contaminant. People at potential risk need clear allergy diagnosis and informed guidance to enable them to avoid this key allergen more easily.

Food allergen avoidance--the patient's viewpoint.

The profile of potentially fatal food allergies has altered in recent years. The vigilance required for allergen avoidance when shopping or eating out depends on information which is often hidden or misleading. Families with allergic children suffer social exclusion and stress, made worse by a serious shortage of specialist patient care. Those who die are usually teenagers and young adults who suffer from severe allergic asthma or anaphylaxis after eating away from the home. A recognised manufacturing standard would endorse businesses seeking to remove the risk of allergen cross-contamination, whilst the integration of allergy into training for caterers and environmental health professionals would influence and inform foodservice businesses.