News Category: Regulatory news
HPRA advises those concerned about a potential intolerance to seek advice from a health professional
The Health Products Regulatory Authority (HPRA) today states that products being promoted as food intolerance tests cannot diagnose food intolerance conditions and advises people not to act on the results of these tests without expert advice from a doctor or registered dietitian. The HPRA has undertaken a review of these products on the market to examine their validity due to an increased availability in recent years and can confirm that there is no single test to diagnose food intolerance. It is advising people not to rely on the results of these test kits alone to detect a condition or to remove certain food groups from their diet. If anyone is suffering from gastrointestinal issues or believes they could be intolerant of a certain type of food they should consult a doctor or dietitian. Attempting to self-diagnose a suspected food intolerance using a test kit alone could potentially result in a delay in identifying and treating other medical conditions.
According to Dr Lorraine Nolan, Chief Executive, HPRA, there is no scientifically valid test to detect food intolerance and that the only valid and safe way to diagnose food intolerance is to eliminate foods following clinical advice and then 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. 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 HPRA’s scientific review of medical devices commonly referred to as food intolerance tests included the most commonly used test kits in Ireland such as immunoglobulin G (IgG) tests which are based on a blood sample. It found that these tests will not diagnose intolerance to a certain food type but rather will detect previous exposure to a food. While this information may be used to help determine the types of food which a particular person has eaten in the recent past, it does not indicate intolerance. The various tests examined as part of the HPRA’s review are available through certain nutritional, food intolerance and health centres and via certain pharmacies. It also reviewed test kits that people can use in their own home such as those available via the internet and those offering a postal based service.
The HPRA has consulted widely on this issue with a number of stakeholders including the Pharmaceutical Society of Ireland, the Irish Pharmacy Union, the Irish Food Allergy Network, and other experts. It has also today published an update to its existing guidance on this issue (Information Notice: IN2018-01) which is available to members of the public who may have questions or concerns about food intolerance testing. Individuals who have experienced an adverse effect as a result of using these tests can report this to the HPRA at email@example.com.
The HPRA wishes to emphasise that there is a clear distinction between food intolerance and food allergies as the latter can be potentially life-threatening. It stresses that food intolerance tests have no role in the diagnosis of a food allergy. The HPRA warns that 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.
The HPRA is the competent authority for the regulation of medical devices and monitors their safety and effectiveness once on the market. It does not approve or certify medical devices for sale in Ireland.
Weber Shandwick PR (01) 679 8600
Siobhan Molloy/Rachel Galligan (086) 817 5066 / (087) 791 9901
NOTE TO EDITORS:
The HPRA does not regulate the provision of testing services, the settings in which these services are provided, or the types of clinical claims made by organisations and individuals, outside of those under the responsibility of the medical device (IVD) manufacturer.
The HPRA’s advice to consumers is that they should:
- Gastrointestinal symptoms can have many different causes – some benign and some serious. Anyone who is concerned should, as a first step, consult with your doctor who will be able to take your history, examine you and advise you on the most appropriate next step. Once other conditions are ruled out, and if appropriate for the individual, a doctor or registered dietitian may recommend a trial elimination diet to determine the possible existence of an intolerance to a particular food type.
- Never rely on the results from products promoted as food intolerance tests for the purpose of a diagnosis or as the basis for dietary change. This is especially important with regards to vulnerable populations such as children, women of child bearing potential and the elderly, for whom maintenance of a nutritionally balanced diet is particularly important.
- Be aware of the distinction between food intolerance and food allergy, which represents a completely different condition and which can be life-threatening.
- Be aware that some products, often claiming to have health benefits, may have little or no scientific evidence of this benefit. People with concerns about their health should in the first instance seek advice from their healthcare professional.
- Exercise care when purchasing health products or services over the internet or through postal services.
For further information, see the HPRA's published consumer advice leaflets:
(1) Self-test products’ and
(2) ‘Buying medical devices online’, both of which are available on the HPRA website, www.hpra.ie.