A major European supplement brand ran a high profile advertising campaign in the mainstream press. This focused on promoting the company and its newly extended supplement range. As the company had a long established relationship with an advertising agency they used them to prepare some of the adverts with the majority being prepared by Alimentarius. Both set of adverts made a range of marketing claims some of which were challenged by the Advertising Standards Authority (ASA). Unlike Alimentarius, the advertising agency did not have evidence to support the claims in their marketing. This resulted in these adverts being pulled, an adjudication against our client by the ASA, and resulting in damage to the brand and consumer confidence.
Amino acids have a fundamental role in nutrition and numerous research studies support their role in general health as well as enhancing both mental and physical performance. There is a wealth of peer reviewed scientific data on healthy humans demonstrating the benefits of amino acid supplementation. Despite this, a report from the Scientific Committee on Food (SCF) concluded the addition of amino acids to foods was not necessary except to improve protein quality. The SCF report titled on ‘Composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen’ was submitted to the European Commission and as a consequence they released directive (SANCO D4/HL/mm/D440182). This stated :-
‘The addition of amino acids is permitted solely for the purpose of improving the nutritional value of the proteins and only in the proportions necessary for that purpose’
If written into EU law this would have been potentially catastrophic for the functional food industry and consumers, as it would have removed amino acid supplements from the European market. It would also have meant that many products with added amino acids would need to be reformulated to remove them and their associated health claims. Such products include mainstream fat loss supplements, ready to drink energy products, recovery drinks, energy bars, energy gels and protein bars.
As experts in amino acid metabolism and regulatory issues relating to dietary supplements, Maximuscle approached Alimentarius to write their position statement on the amino acid fortification of foods. We prepared this document using peer reviewed scientific data and highlighted numerous cases where amino acid fortification of foods was required for reasons other than improving the nutritional value of proteins. The position statement provided by Alimentarius was subsequently adopted by the European Specialist Sports Nutrition Alliance (ESSNA) to overturn EU directive (SANCO D4/HL/mm/D440182). This has allowed health, energy, sports performance, recovery and muscle building products to remain on the market without reformulation. It has also ensured that foods and supplements can continue to be fortified with amino acids. A full copy of the position position statement on amino acid fortification can be obtained here.
Creatine is one of the most important nutrients for the sports nutrition market and is a key ingredient in sports performance, muscle building and recovery products. It is typically supplemented in 5g daily doses, but to quickly attain maximal tissue creatine levels it can also be ‘loaded’ by supplementing 20g of creatine per day for 5 days.
In 2001 the Scientific Committee on Food (SCF) provided the European Commission with a report on ‘Composition and specification of food intended to meet the expenditure of intense muscular effort, especially for sportsmen’. This report claimed that data were lacking regarding the safety of creatine and that ingestion of more than 2-3g of creatine daily for prolonged periods may not be safe. In 2004 a report complied by the French food safety agency (Agence Française de Sécurité Sanitaire des Aliments, or AFSSA) questioned the safety of creatine loading and long-term creatine supplementation. As a consequence the European Commission released directive (SANCO D4/HL/mm/D440182) limiting the recommended conditions of use for creatine in supplements to 3g per day. This would have been potentially catastrophic for the sports nutrition industry and consumers. Although this low dose supplementation can produce some health benefits, higher doses are needed to produce the performance effects claimed on most products. Therefore, limiting creatine supplementation to 3 g would make most products too deficient in creatine to produce the claimed effects, indirectly removing legitimate creatine ‘health claims’ from the European market.
As experts in both creatine metabolism and regulatory issues relating to dietary supplements, Maximuscle Ltd. approached Alimentarius to write their position statement on creatine safety and toxicity. We prepared this document using peer reviewed scientific data and addressed all the safety concerns expressed by the SCF and AFSSA. Our report demonstrated that creatine monohydrate supplementation at 5 g per day is safe for periods of 5 to10 years. The position statement also showed that in contrast to the unsubstantiated claims in the 2004 AFSSA report, creatine loading was both justified and safe.
This creatine opinion was subsequently adopted by the European Specialist Sports Nutrition Alliance (ESSNA) and was used to overturn the EU directive. This has allowed sports and muscle building products to provide conditions of use that are appropriate to produce the claimed performance effects. The ESSNA position statement is still the most comprehensive document on creatine safety and toxicity available. As such it is widely referenced to support the safety of creatine products by companies such as Lucozade. It also formed part of the evidence reviewed by the European Food Safety Authority (EFSA) when providing their positive article 13.1 opinions on creatine and performance. A summary of the ESSNA position statement on creatine safety and toxicity can be obtained here and a full copy of the report here.
A major European supplement brand was accused of selling anabolic steroids by the Irish Medicines Board (IMB). The IMB were removing the manufacturers supplements from retailers’ shelves causing them considerable distress and concern from customers. Alimentarius were asked to review the available evidence on the compound in question and prepare a positional statement. In addition to providing extensive human safety data Alimentarius clearly demonstrated that the compound in dispute was not an anabolic steroid. The IMB concurred with the position statement of Alimentarius and our clients products were quickly returned to the retailers, minimising commercial damage and restoring consumer confidence in the brand.
Alimentarius were approached by a major European supplement brand with product listings in all the major UK supermarkets. They asked Alimentarius to review the tax status of a range of functional food products that were sold throughout the EU. We provided a series of strategic changes that resulted in the core product range legitimately being moved from the standard rate of VAT to being zero rated for tax in several EU member states. This made the products more competitive in the European market and also increased their profitability both for our clients and retailers.
Alimentarius asked to review the UK tax status of the product range produced by a major European functional food brand sold in the UK. After detailed consultation with HM Revenue & Customs (HMRC), Alimentarius suggested a serious of strategic changes for our clients products. These were inexpensive to implement and allowed several of the brands core products to legitimately be moved from VAT at the standard rate to a zero VAT rating. This made the products more competitive and resulted in better margins for retailers, resulting in a considerable increase in sales.
A major European supplement brand wanted to sell its’ supplement range into the Italian market. These included energy drinks, recovery drinks, energy bars, protein bars, protein powders and ergogenic aids. The process required registration of each product with the Italian authorities (Ministero Della Salute) and the provision of a scientific dossier to support each product. Alimentarius assembled all the scientific dossiers required for the registration process and the products were successfully registered without the need for any supplemental data. This saved the clients a substantial amount of time and money, allowing the products to be launched at the most commercially beneficial time of the year. Our clients brand went on to establish itself as a leading sport supplement brand in the Italian market.
A major European sports supplement brand wanted to extend the sale of its’ products into Greece. The supplements included energy bars, protein bars, protein drinks, energy drinks, fat loss products, multivitamins, minerals and herbs. This required registration of each product with the Hellenic Food Authority (EFET) and the provision of a scientific dossier for each product. Alimentarius were provided just a few weeks to assemble all the scientific evidence needed for the registration process. We were able to meet this deadline because of our experience in product registration and extensive nutritional research library. All the products were successfully registered with the Hellenic Food Authority without the need for any additional data and our client went on to establish itself as the leading sport supplement brand in the Greek market.
A global supplement brand wanted to import its’ products into Australia. They contacted a regulatory expert specializing in Australian food law, who advised that several of the supplements would need to undergo re-labeling and/or reformulation. Alimentarius liaised with Australian regulatory experts and quickly identified several routes that allowed the supplements to legally enter the Australian market without reformulation or re-labeling. Alimentarius were able to save their clients a substantial amount of time and the costs of reformulation; accelerating successful entry of the products into the Australian market.
A journalist for a major sports magazine published a negative review about an energy bar. The bar manufacturer complained to the UK Press Association, who requested the magazine provide evidence to support the opinions expressed by the journalist in the review. The author was unable to provide evidence to support the comments in the review and the magazine contacted Alimentarius for assistance. Although we had no involvement in the publication of the original review we were able to provide scientific substantiation for the journalists opinions. This was sufficient to satisfy both the Press Association and the bar manufacturer and avert legal action against the magazine.