Nutraveris
Tuesday, May 22, 2012
Category : NEWS, CLAIMS | Author : experts | Comment : No Comments
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Regarding the new rejection of a health claim related to joint and glucosamine by EFSA, we can seriously wonder if a communication on articular benefits of a product will be possible at the end of the transition period conceded to dietary supplement manufacturers for ensuring the compliance of their communication tools with Regulation 1924/2006. This new EFSA opinion has once again rejected all the studies conducted in subjects with osteoarthritis, eliminating consequently the main part of the clinical studies substantiating the application. Therefore, except vitamin C, no ingredient will allow a communication on joint health from the end of 2012.
Nevertheless, thanks to the recent publication of the final and revised version of the guidance on the scientific requirements for health claims related to bone, joints, skin, and oral health, EFSA has specified several key points that will allow the design of new clinical studies potentially accepted by the experts for the substantiation of a health claim related to joint. Even if subjects with osteoarthritis are still rejected by EFSA, some very specific population subgroups may be accepted. Moreover, the experts have increased the number of questionnaire allowed for the assessment of articular discomfort and pain. Thanks to this final version of the guidance, new health claim applications related to joint may be conceivable in the future, but will need the setting up of new clinical studies in accordance with EFSA requirements.

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

Tuesday, March 27, 2012
Category : NEWS, CLAIMS, Non classé | Author : experts | Comment : No Comments
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ADRIA training in Paris 28 and 29/03/2012
Regulation applying to nutritional claims is becoming more complex in Europe and is changing. Nevertheless, health foods market is still increasing. Industrials have to find new solutions to innovate and communicate.
Cedric BOURGES, CEO at NUTRAVERIS, presents solutions to innovate in Europe, using ingredients with positive EFSA claims.
Interested by this training: contact@nutraveris.com
Thursday, January 26, 2012
Category : Non classé | Author : experts | Comment : [:en]1 Comment[:fr]1 commentaire »
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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.

Thursday, January 12, 2012
Category : NEWS, CLAIMS | Author : experts | Comment : No Comments
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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.].
Tuesday, August 30, 2011
Category : NEWS, CLAIMS, CONVICTIONS | Author : experts | Comment : No Comments
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In the 2nd batch, Melatonin could be used to claim on the alleviation of subjective feelings of jet lag with a 0.5 to 5 mg uptake. In the 3rd batch, Hydroxypropyl methylcellulose (HPMC) could be used to claim both on the reduction of post-prandial glycaemic responses and the maintenance of normal blood cholesterol concentrations with at least 5 g per day. In the 5th batch, Melatonin again, could be used to claim on the reduction of sleep onset latency with a 1 mg of melatonin uptake. However melatonin stays for a long time non authorized in food supplement and HPMC is only an additive authorized in vegetable capsules.
Since the last and 6th batch, monacolin K from red yeast rice can be used to claim on the maintenance of normal blood LDL- cholesterol concentrations. While 10 mg of monacolin K from fermented red yeast rice preparations should be consumed daily in order to obtain the claimed effect, this dosage is not possible in food supplement and 10 mg of monacolin correspond to a drug.

Then, while many allowed ingredients, interesting for industrials and the health nutrition market received negative opinion deeply damaging huge market in terms of employment and sales, one can be surprised by these anecdotal cases of accepted claims for unauthorized ingredients, therefore accepted but unusable claims !