Dáil Éireann Debate, Tuesday - 18 June 2024
357. Deputy Alan Dillon asked the Minister for Health the reason over-the-counter probiotic berberine is now unavailable and only available as a prescription or over the counter in Northern Ireland; and if he will make a statement on the matter. [26042/24]
View answerThe matter outlined relates to a borderline product issue between a food supplement and a medicine. There are currently no medicines containing berberine authorised for the Irish market. Food supplements containing Berberine are available on the EU market.
Food Safety Authority of Ireland (FSAI) Guidance ‘Food Supplements – Legislative Guidance 2024’ clarifies that the definition of a food specifically excludes medicinal products. This guidance also goes on to highlight that the responsibility of retailers to ensure that food supplements under their control would not meet the definition of a medicine.
It also advises the use of the Health Products Regulatory Authority (HPRA) classification process as a tool to address questions prior to placing a food on the market. Separately, the HPRA is aware that the European Food Safety Authority (EFSA) is conducting a safety review of products containing berberine which remains ongoing. To date EFSA has noted general concerns regarding the use of these products including potential interactions with medicines which could modify their effects and/or lead to adverse effects.
The HPRA recently requested market action on products containing berberine brought to its attention that were placed on the market in Ireland as food supplements. This action was taken having regard to previous considerations by the HPRA’s Borderline Products Classification Committee which had considered certain products containing berberine to be more appropriately classified as medicines given the identified pharmacological effects, in addition to an identified concern regarding potential carcinogenicity.
The HPRA continues to review this position and is engaging directly with relevant stakeholders with regard to products containing berberine in the management of this borderline issue.
