View source for Talk:Benefit-risk assessment of food supplements

== 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



There are a few things I am not yet happy with --[[User:Jouni|Jouni]] 07:49, 13 December 2010 (UTC):
* Tier II should contain also other possible approaches than just those that are now mentioned. Also it should be clear that assessments are not bound to those approaches, but it is possible to use other approaches as well if they are better for a particular situation.
* The BRAFO thinking is mostly embedded in Tier III, but it is not yet written out, only mentioned. This needs more description.
* The current Tier IV (Information use) is not really a tier, as it happens at all tiers. This should be embedded in other tiers, and Tier IV should be removed.
* It is possible to reach a practical conclusion after any of the tiers, and therefore stop. This is not spelled out clearly.
* Practical examples are needed, but they are not yet available.

== 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|Skype meeting in July 2010.|Lbucchini|project=Plantlibra}}

{{todo| Distribute the Bepraribean manuscripts if allowed. DL 30 June 2010.|Jouni Tuomisto|project=Plantlibra}}

{{todo| Provide a plan for validation of RBA. DL 31.7.2010|Jouni Tuomisto|project = Plantlibra}}

== Comments on the BRA method for food supplements - Hylo ==

1. In the Scope section it is stated that the valuations and expectations are in line with what a typical user of PFS would think. Which is the definition of “typical user”? Does it mean the consumer?

2. In the Scope section, it is stated that a good method for making benefit/risk assessments for plant food supplements offers a clear guidance for a relevant authority to evaluate nutrition and health claims of a PFS. We believe that the assessment of claims should not be part of the benefit/risk assessment. The BRA should use the outcome of the claim assessment and not to perform it.

3. It is attempted to develop a methodology for making benefit-risk assessment for plant-based supplements which is as much as context-independent as possible. We think the methodology can be context-independent as long as it is fully relevant to the specifics of plant-food supplements 

4. In the description of the methodology for BRA of plant-food supplements it is specified that the assessment is performed to inform to society in order to make wise decisions about the issue. More specifically, what do we consider as a “wise decision”? how do we define them?

5. In Tier II some decision criteria are listed. Can we add other approaches and, if yes, how many? And how do we choose the decision criterion among those listed for the benefit-risk assessment?