Nutraveris, the European-leading scientific & regulatory consultancy in nutrition & health, is going global in February with a new US office in Morristown, NJ, aiming to help US companies seize the huge potential of the European market.

“All is about focusing on solutions rather than on problems when developing business in Europe”. says Cédric Bourges, CEO of Nutraveris. “When asked about their international development projects, more and more US companies brush aside the European market, saying that complex, demanding and unclear rules make it too complicated. However, companies that take the plunge quickly realize that these hurdles are easily overcome”.

To make business easier for US companies, Nutraveris developed a database, Nutraveris On Line, which gives a quick access to regulatory status of more than 2,100 ingredients on 132 health applications. In addition, Nutraveris experts provide support on product authorization processes, EFSA health claims and novel foods dossiers. “These issues have been scaring off some companies from the EU, but for an expert company installed in this market since 2005 as Nutraveris, they can be managed very quickly”, said Mr Bourges. “We look forward to helping US dietary supplement companies & ingredient suppliers develop their business in Europe”.

Follow Nutraveris on Nutraingredients-USA.com:
http://www.nutraingredients-usa.com/Industry/Nutraveris-establishes-NJ-office-to-bridge-US-EU-divide

The English authorities has analyzed whether the claim “Powerade ION4 hydrates better than water” in ad was misleading and could be substantiated.
Beverage Services Ltd, trading as Coca-Cola Great Britain (CCGB) believed they could fully substantiate the claim “hydrates better than water”. They explained that Powerade ION4 was an isotonic sports drink aimed at individuals taking part in intense physical exercise.
They provided some excerpts from 13 studies and reviews published between 1973 and 2010 which, they believed, demonstrated the effects of sodium, carbohydrates and taste on hydration, and therefore supported their claim that the product “hydrates better than water”.
They also provided letters from two experts in the field, together with the scientific dossier

The authorities considered the excerpts of the 13 studies provided by CCGB. All of these studies had been published in recognized journals and supported the arguments made by CCGB. Also, they considered the letters from the experts.
They considered that ad made it clear that the context in which Powerade ION4 hydrated better than water was during very energetic and sustained exertion.
Finally, the authorities considered that the claim “Powerade ION4 hydrates better than water” had been substantiated and concluded that the ads were not misleading.

This negative opinion for glucosamine and joint in article 13.5 follows previous rejections. EFSA has already issued an opinion on glucosamine and reduced rate of cartilage degeneration and reduced risk of development of osteoarthritis pursuant to Article 14 with an unfavourable outcome. The Panel has also already issued an opinion on glucosamine alone or in combination with chondroitin sulphate and maintenance of joints pursuant to Article 13(1) with a similar unfavourable outcome.

Nevertheless, EFSA acknowledges :

• The characterization : The food constituent that is the subject of the health claim is glucosamine, is sufficiently characterised.

• The health relationship : The claimed effect is “contributes to the protection of joint cartilage exposed to excessive motion or loading and helps to improve the range of motion in joints”. Maintenance of joints is a beneficial physiological effect.

• The target population : The target population proposed by the applicant is healthy individuals exposed to excessive load on the joints.

But EFSA continues to reject the scientific substantiation. The Panel considers that the evidence provided does not establish that patients with acute knee injury are representative of the target population (healthy individuals exposed to excessive load on the joints) with regard to the status of joint tissues, or that results obtained in studies on subjects with acute knee injury can be extrapolated to the proposed target population.

For joint (as well as for other applications), we anticipated and expressed long time ago in an interview for Nutraingredients that it is essential to prove the efficacy of an ingredient in healthy subjects. The selection of study subjects is essential for the use of the results in a health claim file. Moreover, we implemented our advices and get positives results on joint in healthy subjects.

All claims are accessible online on Nutraveris’on line.

For any question about joint, clinical study or health claim application, contact our experts.

The NDA Panel delivered an opinion on the scientific substantiation of a health claim related to diacylglycerol oil and reduction of body weight, submitted pursuant to Article 13.5 of Regulation 1924/2006. The food constituent, diacylglycerol (DAG) oil is sufficiently characterized in relation to the claimed effect. Furthermore EFSA defined that weight loss is a beneficial physiological effect for overweight subjects. Indeed, few ingredients received a positive opinion for their beneficial effect on body weight like glucomannan. But EFSA gave a negative opinion to DAG like hypo-caloric snacks (KOT products) for weight reduction last September.
However, the results from six randomized controlled trials with respect to the effect of DAG oil (as a replacement of TAG oils) on body weight are inconsistent and apparently unrelated to the DAG dose, study size or study duration, and the evidence provided in support of mechanisms by which DAG oil could exert the effect in humans is not convincing. One unpublished meta-analysis on the effects of DAG oil (as compared to TAG oils) on body weight in humans was also provided. The meta-analysis had potential sources of bias and did not provide additional informations for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of DAG oil and a reduction in body weight.
This opinion shows that more clinical studies are required to obtain a positive opinion from NDA panel related to ingredient effects on weight loss and the experts of Nutraveris can help you to put in place clinical study to obtain favorable claim.

References: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to diacylglycerol (DAG) oil and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(12):2469. [17 pp].
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of a health claim related to “hypo-caloric snacks (KOT products)” and “contributes to reduce adipocyte size at the abdominal level in the context of a low-calorie diet” pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(9):2381. [10 pp.].
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the substantiation of health claims related to konjac mannan (glucomannan) and reduction of body weight (ID 854, 1556, 3725), reduction of post-prandial glycaemic responses (ID 1559), maintenance of normal blood glucose concentrations (ID 835, 3724), maintenance of normal (fasting) blood concentrations of triglycerides (ID 3217), maintenance of normal blood cholesterol concentrations (ID 3100, 3217), maintenance of normal bowel function (ID 834, 1557, 3901) and decreasing potentially pathogenic intestinal microorganisms (ID 1558) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2010;8(10):1798. [27 pp.].