Category: Food Law

Our client, a major European brand made a number of on pack health claims for its range of fat loss, weight management and sports supplements. The claims included ‘increasing muscle size, increasing lean body mass, increasing muscle strength, increasing muscle power and reducing body fat. Claims on product packaging fall under the regulatory control of the Trading Standards Institute (TSI) and they challenged if there was scientific evidence to support the claims. Alimentarius provided scientific substantiation for the claims on each product, ensuring they could remain on sale without re-labeling or regulatory action.

A complaint was sent to the Advertising Standards Authority (ASA) questioning if several health claims in a clients marketing copy could be substantiated. The health claims had been prepared by Alimentarius and were supported with high quality, placebo controlled, research trials on humans. The supporting scientific data was sent to the ASA, who agreed that there was sufficient evidence to substantiate the effects claimed on the product. This made it unnecessary for our client (and its retailers) to change the product claims in magazines, catalogues, or websites.

The Irish Medicines Board (IMB) took action against one of Europe’s biggest sports supplement brands by physically removing products from retailers shelves. This was done on the basis that the IMB felt the high levels of some vitamins in the product were unsafe. Alimentarius were given just two weeks notice to prepare a detailed scientific dossier to demonstrate the safety of the vitamins in question. The IMB accepted the safety data provided by Alimentarius, clarified that there were no issues with the product and subsequently stated that IMB would take no further action. This allowed our client to maintain its retail presence and minimise damage to the brand caused by the highly publicised actions of the IMB.

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.