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....

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...

A recent research trial carried out at the University of Exeter (UK) has suggested that dietary supplementation with beetroot juice reduces the oxygen cost of exercise and ultimately extends the ability of athletes to exercise for longer. However, despite multiple functional food and scientific journals reporting with glowing recommendations on the trial, are there some errors in the design of the trial, which mean its conclusions are critically flawed? The trial was based on the premise that beetroot juice is a rich nitrate source and as such could provide nitrate anion’s, which convert...

FDA alleged ‘Body-building’ products contained unapproved food additive, new dietary ingredient and these products will now be destroyed The U.S. District Court for the Eastern District of Michigan, Southern Division, today entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements. At the request of the FDA, U.S. Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC, of Brighton, Mich. The seized products were marketed for use by body builders and distributed...

The first of May see’s the FDA releases a public warning after 23 reports of serious health problems following the use of Hydroxycut containing products. Some within the industry are calling this the next ephedrine fiasco with suggestions of a huge fall out across the weight loss industry damaging an already damaged consumer confidence in such products. Iovate Health Science has agreed to withdraw 14 associated products from the market according to the FDA press release. The 23 reports received by the FDA range from elevated liver enzymes to liver failure and one report of death of a 19 year...

In March 09 Powerade® (Coca-Cola) launched “the complete sports drink” marketing campaign platforming their new product ‘ION4′as better than other sports drinks due to the inclusion of 2 additional electrolytes (0.5% of RDA - calcium and magnesium ). However, Powerade rival and market leader Gatorade® (PepsiCo) have filed a lawsuit against Powerade citing deceptive copy claims and billboard which show the Gatorade bottle and a tagline saying the drink is “incomplete” and missing ingredients found in Powerade. Gatorade has been incensed by several false claims from Powerade...