Food allergies: Analytical deficiency, labelling ‘muddle’ and access to testing

The Coalition for Equal Access to Allergy Testing (CEAAT), which also includes FAACT (Food Allergy and Anaphylaxis Connection Team), wants to eliminate inappropriate insurance coverage barriers to guidelines-based care.

CEAAT said it wants to improve early intervention for patients with allergies, ensuring they have equal access to all medically recommended tests and receive care according to National Institutes of Health (NIH) guidelines including NIAID Food Allergy Guidelines.

Improve testing access​

The coalition’s mission is to work with federal and state agencies, policy makers, clinicians, public health organizations and patients to advocate for and establish policies designed to improve patient access to allergy testing as recommended by national guidelines.

Dr Inderpal Randhawa, a founding member of CEAAT, said allergies impact a growing number of Americans, but children and minorities are disproportionately impacted and may have trouble accessing the care they need.

“Unfortunately, those impacted the most are not always able to receive the best available care and CEAAT is well positioned to help the most disadvantaged Americans receive the high quality healthcare they deserve.”​

CEAAT said many Medicaid and Medicare allergy testing policies have placed restrictions on allergy blood tests, which are recognised as equivalent with skin prick tests by the NIH, peer-reviewed medical and scientific literature.

Call for increased action on food allergies​

Meanwhile, Michael Walker, of the Government Chemist, and co-authors have published a paper in the journal Analyst​ looking at key measurement challenges in allergen analysis.

Recommendations are primarily addressed to DG Santé, the Health and Food Safety Directorate of the European Commission. However, support from food authorities, businesses and National Measurement Institutes is also called for.

Professor Chris Elliott, from Queen's University Belfast and an author on the paper, said the supply chain is highly vulnerable to fraud involving food allergens, risking consumer health and reputational damage to the industry.

“Cross-contamination during production, processing and transport is also a problem. While efforts have been made to improve food labelling and introduce the concept of threshold quantities for allergens, these depend on being able to accurately detect and quantify allergens in the first instance. Gaps in the current system mean that it is difficult to achieve this.”​

They include bioinformatics studies to get relevant markers or allergenic proteins within allergenic foods, reference methods for these allergens and appropriate reference materials which can support threshold decisions.

Walker et al said all current analytical approaches show deficiencies that jeopardise accurate results particularly in terms of the risks of false positive and false negative reporting.

The lack of agreed limits below which only the most sensitive allergic subjects might react is viewed as preventing the development of evidence-based allergen management strategies that are understood by clinicians, patients and industry, they added.

“The most probable basis for such law would be allergen elicitation thresholds which are not possible without allergen reference materials.”​

Most routine analysis is by Enzyme Linked Immunosorbent Assay (ELISA) enabling detection and (semi-) quantification. Polymerase Chain Reaction (PCR) assays are also used in allergen risk assessment and management.

For both techniques detection is less of an issue but sound quantification remains elusive, said the study.

Application of liquid chromatography and tandem mass spectrometry (LC-MS/MS) is also still recent in the field.

“It is possible to detect proteins and peptides with a high degree of sensitivity and resolving power, providing protein composition, structure and sequence information, and MS has the potential for a wide linear dynamic range, and absolute identification and quantification of allergens,” ​said the researchers.

“However the techniques require a high level of expertise and costly equipment; extraction and cleanup steps are necessary and the methods can be laborious and time.”​

The team said a lot can be learned from what led to the ‘gold standard’ reference material for gliadin (gluten), described in the Working Group on Prolamin Analysis and Toxicity (WGPAT).

WGPAT prepared a gliadin reference material by extraction from milled wheat kernels representing a specific year's harvest of the most commonly grown cultivars in three European countries.

Walker et al suggested a pump priming workshop within the next year to support development of a consortium bringing together the analytical, food science and clinical communities with patient support groups, representatives of food manufacturers, and regulatory agencies.

Allergen labelling: A complete muddle?​

Dr Lisa Ackerley, special adviser to Acoura, a risk management firm, described allergen labelling as a ‘complete muddle’ and said it needs addressing ‘urgently’.

“The guidance from the FSA is that only two statements should be used where precautionary allergen labelling is needed and these are: “May contain xxx and “Not suitable for someone with x Allergy,” ​she said.

“However, currently there are over 40 different precautionary allergen labels being used, which is causing considerable confusion for the customer and also people in the hospitality industry who have to “translate” these messages so that they make sense to their customers.​

“Currently the “may contain” or precautionary labelling statement should be used only when there is a real possibility that contamination may have taken place. For example, where the same line is used in the factory for two different products with one containing an allergen.  ​

“Where production is in a different part of the factory and there is no likely cross contamination of ingredients then it should not just be necessary to use this type of labelling.” ​

Dr Ackerley said this effectively means the customer either narrows their diet dramatically, or throws caution to the wind and ignores all such messages.

“For example take a product with no nuts in the ingredient list, yet labelled “made in a factory that uses nuts” – how does a nut allergic customer assess whether this is a danger to someone them?  The question the customer really wants answering is “if this food safe for me to eat or not?,” ​she said.

“A severe allergic reaction could mean hospitalization and even death, so the customer really doesn’t want to play “Russian Roulette” with their food.”​

In terms of risk mitigation, Dr Ackerley encouraged buyers to carry out detailed audits at their supplier’s sites.

“Ensuring your suppliers are certified to BRC’s Global Standard for Food Safety version 7, or an equivalent, should also always be a pre-requisite,” ​she said.

“Random ingredient testing can help too, particularly if you have specific concerns. That said, no one single practice is fool-proof, so buyers need to have a holistic approach to ensuring their supply chain is secure. ​

“Additionally, while the most recent allergen legislation passed on by the EU impacts on all its members, that doesn’t mean buyers should consider EU sourced food to be less of a risk than non-EU.”​

Mixed findings for FSA and Allergy UK survey​

A survey by the FSA and Allergy UK​ found one in four people has suffered a reaction while eating out in a restaurant or cafe since allergen labelling legislation came in one year ago.

The EU Food Information for Consumers (FIC) legislation means businesses have to make information on 14 allergens available to consumers. They can do this verbally through explanations by staff or signposted to where or how more information can be found.

It also found nearly one in five (19%) of these resulted in a hospital visit.

More than half (58%) of allergic consumers said their overall experience of eating out has improved and just 6% said it has got worse.

However, more than two-thirds (69%) experienced staff not understanding the severity of an allergy, and how easily a mistake can cause a reaction.

A similar number (68%) had seen staff with a lack of knowledge of the menu or the food – including confusing eggs with dairy, or assuming the customer was asking for gluten-free rather than avoiding lupin (a grain commonly used in place of wheat).

Dr Chun-Han Chan, food allergy expert at the FSA, said in general, the situation is improving for the two million food allergic consumers in the UK.

“However, our survey has found that this isn’t true for everyone, and that many establishments aren’t yet providing the information that their customers need. ​

“The number of people suffering from food allergies and intolerances has increased in the last decade, so it’s clear that it is not something businesses can ignore. Allergies can be fatal, and this is why it is vital food businesses give their customers information they can trust.”​

Allergy research​

In terms of research, work at Northwestern Medicine​ found that low-income families of children with food allergies spend 2.5 times more on emergency department and hospitalization costs nationally.

The team, which included staff from Northern Illinois University (NIU), analyzed a national survey of 1,643 caregivers of food-allergic children and found children from low socioeconomic backgrounds had lower odds of being diagnosed by physician.

Ruchi Gupta, an associate professor of pediatrics at Northwestern University Feinberg School of Medicine, said the study also shows disparities in managing food allergies.

“The first line management for food allergy is prevention, but costs for special foods and epinephrine auto injectors can be a barrier for many families. Some patients may not have access to allergen-free foods and cannot afford to fill their prescription.​”