MHRA – 2005

Several European food supplement companies were given a ‘Final Determination’ by the Medicines and Healthcare Products Regulatory Agency (MHRA), formerly the Medicines Control Agency (MCA). This decision was taken as the MHRA felt that the supplements produced by a range of companies contained a medicinal ingredient. Final determinations by the MHRA require removal of the product from the market, without the opportunity to sell through existing stock. In addition to damaging consumer confidence and brand confidence, this often results in a significant financial burden for the retailer and supplement manufacturer. While most companies immediately removed their products from the market, one company asked for Alimentarius to review the scientific data on the disputed food ingredient. An extensive search of published scientific data and the Alimentarius database clearly showed the ingredient in question was not medicinal. Alimentarius presented its’ evidence and scientific reasoning to the MHRA in an oral hearing. After considering the evidence the MHRA agreed that the ingredient in dispute was not medicinal and could be legally sold in food supplements. The company that used Alimentarius to overturn the MHRAs ‘Final Determination’ became the dominant supplier of this supplement and a range of products that contained it. Alimentarius is the only food law consultancy that has successfully overturned a ‘Final Determination’ by the MHRA.