Following a national press ad stating, “Diabetone comprehensive nutritional support for people with diabetes shown to help maintain wellbeing in UK nutritional research”. The ASA reviewed the product claims following a complaint. In defence of the product Vitabiotics Ltd stated the product was a food supplement as stated on the packaging and not a medicine. Furthermore, they said they had research to support their claims surrounding each nutrient within the product as well as a trial on the whole product. However, following a review of the data the ASA drew the following conclusions: The...

With EFSA rejecting almost 80% of health claims submitted under article 13.1, industry is rightly concerned. However, these opinions are not yet law. Although EFSA has given its opinion and the commission intends to publish the list, the European parliament has still 3 months to look at the opinions and their implementation through the regulatory procedure with scrutiny, which could in theory mean a potential chance to block their adoption into law. If parliament finds that the legislation and its implementation is not inline with the mother regulation then they can veto it, essentially blocking...

Gaining a health claim is one thing but gaining one that makes sense to the general public is another. As part of the general conditions of article 13 claims (Art 13(1)ii) a health claim must be ‘well understood by the average consumer’. Claims must also protect the consumer from being misled, and balancing these two issues is causing some difficulties when the Commission is to provide guidance on the flexibility of claim wording. In a recent meeting between the Commission and Member States (MS) on the 12th April 2010, the issue of how flexible EFSA approved claim wording could be was discussed....

As part of the Nutrition and Health Claims Regulation (NHCR) EFSA was to implement and set the criteria for what is an acceptable nutrient profile for foods carrying an approved health claim. Nutrient profiles (Article 4) were added to the regulation to avoid a situation where using a health claim on label could potentially mask a poor nutritional status (i.e. high fat or high sugar) of a food product. As such the development of specific criteria governing the circumstances in which claims can be made are a vital component of the NHCR. Despite the requirement for nutrient profiles in the regulation...

According to a publication in the Journal ‘Food Policy’ researchers from Norway, Sweden, Denmark and Finland have shown that certain health claims can negatively influence the perception of a functional food. The researchers initiated a 30 minute online questionnaire, which was subsequently completed by 4612 respondents (All from Nordic countries). [An audio discussion about the research available on the link below] Online participants were shown four product descriptions. One of these had no health claim, and the other three carried claims that differed on structure, active ingredient,...

In the latest batch of 31 opinions (grouped from 416 submissions) from EFSA’s NDA panel we can see that this process of assessment is setting a precedent for the acceptance of only vitamins and minerals. The big losers are not unexpected antioxidants and probiotic based claims which have been rejected across the board. For the industry this is scary especially for the likes of the superfruit / smoothie market and giants such as Innocent, known for their use of the term Antioxidant on marketing materials and commercial communications. The opinions relate not only to the lack of characterisation...

As of the 19th of January 2010 ‘nutrition claims’ such as low GI, Isotonic and hypotonic are under threat by enforcement bodies throughout the EU. For those in the weight management or sports nutrition market, labelling and other forms of commercial communication using such claims could be removed by enforcement agencies. Under the terms of the Nutrition and Health Claims Regulation (EC No 1924/2006) those claims not currently contained within the 24 approved claims in the Annex (Article 8 ) cannot legally be maintained. The Annex of the regulation provides a list of specific nutrition...

Following the significant damage of the first wave of article 13.1 opinions by EFSA and subsequent 70% rejection rate, what can industry do now given EFSA will not re-assess these claims via the 13.1 process, even if new or additional data is available? Well there are potentially 2 routes, firstly is article 13.5 for newly developed scientific data (submitted via the procedures under art 15-18), or secondly via Article 13.4 for claims which meet generally accepted scientific evidence. Article 13.4 of the health claims directive (1924/2006) should be adopted in accordance with article 24(2) relating...

At last EFSA has released 94 opinions on a small batch of 523 health claims relating to over 200 food components. With 66% of the claims rejected (negative opinion) including the likes of glucosamine, the industry is again in turmoil - but it gets worse… According to Directorate-General for Health and Consumers (DG SANCO) the body which helps make sure traders, manufactures and food producers observe their legal obligations, commented that those given a negative opinion by EFSA have 6 months to comply and be removed from the market. In a recent exclusive interview with EU Food Law Weekly,...

LIPObind from Goldshield Ltd has been really pushed as a weight loss aid in 2009. Despite multiple cautions from the Advertising Standards Authority (ASA) over the past 2 years because of unsubstantiated product claims (including another for LIPObind only a month earlier), Goldshield are still marketing the product for weight loss…But at what cost? According to the September 16th ASA adjudication, LIPObind is still trying to market this product by function and name as a weight loss product. Although, LIPObind is classified as a Class IIa Medical Device the directive attached to this classification...