The Health Products Regulatory Authority (HPRA) said products being promoted as food intolerance tests cannot diagnose such conditions and advised people not to act on their results without advice from a doctor or registered dietitian.
It warned that attempting to self-diagnose a suspected food intolerance using a test kit alone could result in a delay in identifying and treating other medical conditions.
HPRA also emphasised the ‘clear distinction’ between food intolerance and food allergies.
“[A] negative food intolerance test result does not mean that someone is not allergic to that food. Confusing a negative food intolerance test result with a food allergy could pose serious risks if a person then goes on to consume that food type and to have a subsequent reaction.”
People should not rely on results of test kits
Dr Lorraine Nolan, chief executive at HPRA, said the only valid way to diagnose intolerance is to eliminate foods following clinical advice and reintroduce a suspected food on a phased basis to determine if symptoms return.
“Food intolerance is a term that has emerged to describe various unpleasant conditions such as indigestion and bloating that can occur after eating certain foods. People should not rely on the results of these test kits on their own regardless of how they are labelled and promoted,” she said.
“Any examination relating to a person’s ability to digest or ‘tolerate’ foods should be made in careful consultation with a doctor or dietitian. It should not be based on these tests alone as to do so could lead to a misdiagnosis or the removal of important nutrients in the diet.
“Removing a range of foods from your diet without expert advice on how this should be managed can result in nutritional deficiencies among vulnerable populations and impaired growth in children which can have important long-term health consequences."
The authority said it had reviewed products on the market to examine validity due to increased availability in recent years.
The review of medical devices referred to as food intolerance tests included the most commonly used such as immunoglobulin G (IgG) tests which are based on a blood sample or these based on hair and saliva samples.
It found the tests will not diagnose intolerance to a certain food type but will detect previous exposure to a food.
HPRA said while this information may be used to help determine the types of food which a particular person has eaten in the past, it does not indicate intolerance.
Tests examined as part of the HPRA’s review are available through certain nutritional, food intolerance and health centres and via pharmacies.
It also looked at kits that can be used in the home such as those available via the internet and those offering a postal based service.
Stakeholder consultation
HPRA consulted with stakeholders including the Pharmaceutical Society of Ireland, the Irish Pharmacy Union, the Irish Food Allergy Network and other experts.
The Irish Food Allergy Network (IFAN) welcomed the review on food intolerance tests and the advice to the public not to rely on them.
The Pharmaceutical Society of Ireland (PSI) informed pharmacists they should not offer food intolerance testing services to diagnose food intolerance.
The pharmacy regulator said the only clinically valid method for diagnosis and treatment of food intolerance is an elimination diet.
Niall Byrne, registrar of the PSI, said tests or health checks should only be done by pharmacists or offered in pharmacies where there is an established clinical and scientific evidence base and where the validity, accuracy and reliability of the test can be assured.
“As regulated healthcare professionals, pharmacists are a trusted source of advice for the public on medicines and health matters in the community and, following…publication of the HPRA notice, pharmacists should no longer offer food intolerance testing services to diagnose food intolerance.”
VIDAS and mini VIDAS warning
Meanwhile in other news, bioMérieux has identified pump clogging and displacement of the colour-coded SPR label (DOT) may occur with VIDAS and mini VIDAS instruments.
This could contribute to pipetting failures which may lead to erroneous results for any assay performed on the VIDAS and mini VIDAS systems due to a decrease in the volume pipetted.
VIDAS and miniVIDAS instruments are multi-parametric immunoassay systems. BioMérieux said more than 3,000 food labs have chosen VIDAS for routine analyses.