Comments for NutriSciences Blog http://blog.nutrisciences.net Innovation Is Our Science! Fri, 10 Sep 2010 07:55:21 +0000 http://wordpress.org/?v=2.7 hourly 1 Comment on Provexis wins unique EFSA health claim, but will the consumer understand it? by Dr Mark J. Tallon http://blog.nutrisciences.net/?p=217&cpage=1#comment-1682 Dr Mark J. Tallon Wed, 07 Oct 2009 16:02:36 +0000 http://blog.nutrisciences.net/?p=217#comment-1682 My belief is that EFSA are not correctly following Article 16(3c) of the regulation, which is to "give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer". The claim "helps maintain normal platelet aggregation", is not understandable to the average consumer either is platelet function as discussed (see 1.3 of submission). How have they come to the decision that it is understandable? In the end EFSA is giving an opinion, which is not legally binding and until we have a final view from the commission on the final wording is difficult to decide on weather this really is a position opinion at least from a marketing perspective... My belief is that EFSA are not correctly following Article 16(3c) of the regulation, which is to “give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer”. The claim “helps maintain normal platelet aggregation”, is not understandable to the average consumer either is platelet function as discussed (see 1.3 of submission). How have they come to the decision that it is understandable?

In the end EFSA is giving an opinion, which is not legally binding and until we have a final view from the commission on the final wording is difficult to decide on weather this really is a position opinion at least from a marketing perspective…

]]> Comment on Provexis wins unique EFSA health claim, but will the consumer understand it? by Ash http://blog.nutrisciences.net/?p=217&cpage=1#comment-1650 Ash Sat, 03 Oct 2009 22:55:28 +0000 http://blog.nutrisciences.net/?p=217#comment-1650 On what basis does EFSA propose wordings of claims? In the TOR, EFSA is requested to consider the claimed effect on the function, and provide advice on the extent to which the wording used to express the claim reflects the scientific evidence and complies with the criteria laid down in the Regulation. For claims for which a cause and effect relationship has been established, EFSA considers whether the proposed wording reflects the scientific evidence and complies with the criteria laid down in the Regulation (e.g. it should not refer only to general, non-specific health benefits of the food/constituent). If not, EFSA may propose an appropriate wording. It should be noted that the wording adopted by the Commission during authorisation may need to take into account aspects other than agreement with the scientific evidence, e.g. understanding by consumers. "Understanding by Consumers" EFSA have highlighted this so whilst they haven't give PXS the wording they suggested back in July, I'm certain it will be positive now and understandable to the average joe On what basis does EFSA propose wordings of claims? In the TOR, EFSA is requested to consider the claimed effect on the function, and provide advice on the extent to which the wording used to express the claim reflects the scientific evidence and complies with the criteria laid down in the Regulation.

For claims for which a cause and effect relationship has been established, EFSA considers whether the proposed wording reflects the scientific evidence and complies with the criteria laid down in the Regulation (e.g. it should not refer only to general, non-specific health benefits of the food/constituent). If not, EFSA may propose an appropriate wording. It should be noted that the wording adopted by the Commission during authorisation may need to take into account aspects other than agreement with the scientific evidence, e.g. understanding by consumers.

“Understanding by Consumers” EFSA have highlighted this so whilst they haven’t give PXS the wording they suggested back in July, I’m certain it will be positive now and understandable to the average joe

]]> Comment on Provexis wins unique EFSA health claim, but will the consumer understand it? by Dr Mark J. Tallon http://blog.nutrisciences.net/?p=217&cpage=1#comment-988 Dr Mark J. Tallon Sat, 29 Aug 2009 13:41:00 +0000 http://blog.nutrisciences.net/?p=217#comment-988 I think any comparisons (Fruitflow vs Asprin as you suggest) must be justified through scientific substantiation. These type of comparisons can be reviewed by independent bodies if used in advertising and the company/manufacture of say Aspirin did not believe or wants to question the claim. This could be carried out by the likes of the ASA by enforcing the guidance of the CAP code. In relation to the revised wording, we are still waiting... in the end EFSA are only opinion makers the EC then decide on the final outcome or how they use such advise. It is then the remit of the member states regulatory authorities to intemperate that outcome/decision and enforce where and when required. If the submitted health claim dossier was constructed correctly with the right trial design then they would be no need to press for a revision of the wording as they wording in the dossier would make the required marketing claims (consumer friendly)....However, many nutrition companies come to regulatory specialists like Nutrisciences with their science already in place i.e. we cannot provide guidance before the trial to target the claims with art 13/13.5 in mind. As such you may have to work with what you have...this may have been the case with whomever carried out the assessment and submission of the Provexis Fruitflow dossier! I think any comparisons (Fruitflow vs Asprin as you suggest) must be justified through scientific substantiation. These type of comparisons can be reviewed by independent bodies if used in advertising and the company/manufacture of say Aspirin did not believe or wants to question the claim. This could be carried out by the likes of the ASA by enforcing the guidance of the CAP code.

In relation to the revised wording, we are still waiting… in the end EFSA are only opinion makers the EC then decide on the final outcome or how they use such advise. It is then the remit of the member states regulatory authorities to intemperate that outcome/decision and enforce where and when required. If the submitted health claim dossier was constructed correctly with the right trial design then they would be no need to press for a revision of the wording as they wording in the dossier would make the required marketing claims (consumer friendly)….However, many nutrition companies come to regulatory specialists like Nutrisciences with their science already in place i.e. we cannot provide guidance before the trial to target the claims with art 13/13.5 in mind. As such you may have to work with what you have…this may have been the case with whomever carried out the assessment and submission of the Provexis Fruitflow dossier!

]]> Comment on Provexis wins unique EFSA health claim, but will the consumer understand it? by jnr123 http://blog.nutrisciences.net/?p=217&cpage=1#comment-979 jnr123 Wed, 26 Aug 2009 22:30:27 +0000 http://blog.nutrisciences.net/?p=217#comment-979 Since your article was published the share price in this company has substantially increased with hype and media attention despite no major news. What are your views on this as the EFSA opinion on revised wording is still not yet known? What do you make of the fact that it is being compared to aspirin but without the GI side effects? Since your article was published the share price in this company has substantially increased with hype and media attention despite no major news. What are your views on this as the EFSA opinion on revised wording is still not yet known? What do you make of the fact that it is being compared to aspirin but without the GI side effects?

]]> Comment on Provexis wins unique EFSA health claim, but will the consumer understand it? by Julian Mellentin http://blog.nutrisciences.net/?p=217&cpage=1#comment-618 Julian Mellentin Tue, 02 Jun 2009 17:22:12 +0000 http://blog.nutrisciences.net/?p=217#comment-618 The point "But will the consumer understand it?" is made perfectly. The language used in the claim is not consumer language and it's impossible to translate the claim into consumer language without straying far, far away from the approved claim. There's nothing in this claim approval that can help Sirco as a consumer food - as a medical food, maybe. The Sirco brand is now in its second incarnation, having been withdrawn from the market once before because of ultra-niche sales. With a marketing position based on this claim it can only stay ultra-niche. And that is precisely the risk that most functional foods in Europe face under the current health claim system. The point “But will the consumer understand it?” is made perfectly. The language used in the claim is not consumer language and it’s impossible to translate the claim into consumer language without straying far, far away from the approved claim. There’s nothing in this claim approval that can help Sirco as a consumer food - as a medical food, maybe. The Sirco brand is now in its second incarnation, having been withdrawn from the market once before because of ultra-niche sales. With a marketing position based on this claim it can only stay ultra-niche. And that is precisely the risk that most functional foods in Europe face under the current health claim system.

]]>