Talk:Benefit-risk assessment of food supplements
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Comments on the BRA method draft as of 10 December
- "Use" of information is present in all tiers I-III through participation. Therefore it does not fit well as the last piece in the tier/phase thinking.
- Perhaps the tieredness could be considered as combining two perspectives as different levels of abstraction in the same method: a) contentual and participatory assessment-management perspective as the big picture, and b) procedural BRAFO-type tiered approach as the information production tier/phase/aspect within the big picture. Some sort of tieredness exists on both levels.
- In tier II the considered decision criteria only cover a relatively limited set of all possible issues in the "big picture" referred to above. It does, however, fit well with the BRAFO-type tiered approach thinking.
- A PFS-related decision as a walk-through example would be great to illustrate how the big picture and the analysis view merge seamlessly
Plantlibra WP5 meeting 3.6.2010
WP5 discussion (Luca, Jouni, Trevor, Bernard, Gary, Corrado)
- L: A new meeting soon for WP5.
- B: EFSA will soon submit a proposal of BRA of health based on Brafo and Qalibra.
- J: Bepraribean is working on BRA.
- L: Ask Bepraribean whether we can look at the papers.
- Article review (Feb 2011?)
- Are we/should we look at plants/supplements/compounds?
- L: Consumers ask: is the plant safe to use or not? Bernard: No, the question is about the product. Industry can get rid of adverse compounds in a plant product even if it is present in a plant. This is what should be characterised in the BRA.
- J: Who is the user? Luca: We need to provide science-based tools to industry or administration. We will not make extra effort to make BRAs accessible to the consumers (even if they might use results of BRA).
- Do you think benefit and efficacy is the same?
- B: EFSA asks: is there scientific evidence that there is a positive health effect?
- B: with benefits there is a problem because there is no common currency. How to measure "10% increase in physical performance?"
- L: What is the question?
- B: Risk manager is the user. Efficacy part is the thing. The safety of products is in the hands of manufacturers, but member states are not happy about this.
- B: We need to move from poor efficacy to RBA, including safety.
- C: We must separate R and B.
- B: Many botanicals are actually overlapping medicine, but they are marketed as food=to everyone.
- B: EFSA: if you target ill people, the product is seen as medicine.
- B: What is the level of proven evidence (e.g. must be human evidence).
- B: Method is about quality of data.
- B: It's all about claims of health benefits.
- J: Can we use scientific method?
- No support, example not understood
- C: If there is risk, case is closed
- L: Meeting in September?
- J: We can have meeting but the discussion must be wider
- C: Examine EFSA documents
- B: There is approach for risk reduction (BRAFO, EFSA), but there is not one for benefits. That's where this project is needed.
- C: Do something and test whether it works in reality.
- T: What about risks of overconsumption?
- L: Well start with the EFSA document, and have a meeting via skype in July
- L: We need to get ideas about positive health effects. How much do people rate some benefits (in money?)
- J: We need to think what we want to measure with benefits: before you get it or after you got used to it.
- L: Provide a plan for validation. !
- B: Factor 10 uncertainty for intraindividual variability for benefits as well?
- G: Does not work, because benefits are not safety issue.
TODO: {{#todo:Skype meeting in July 2010.|Lbucchini|Plantlibra}}
TODO: {{#todo: Distribute the Bepraribean manuscripts if allowed. DL 30 June 2010.|Jouni Tuomisto|Plantlibra}}
TODO: {{#todo: Provide a plan for validation of RBA. DL 31.7.2010|Jouni Tuomisto|Plantlibra}}