The fact that the FDA announced that it would not prepare a draft of the report for the menthol subcommittee demonstrates that when provided with overwhelmly convincing data and arguments , the FDA will modify its position.
It is for this reason that stakeholders must express their views on the five controlling issues which resulted from the first menthol subcommittee meeting and are delineated on this post http://www.thecre.com/tpsac/?p=561 .
It is imperative that stakeholders assist CRE in the construction of a “public docket” by providing relevant scientific and legal analysis on this forum at http://www.thecre.com/dqa/ which will provide the basis for demanding further modifications to TPSAC procedures.
Simply type your post and press “send”—no registration needed. The forum has the capability which allows you to submit documents.
N. B. CRE appreciates the public comments we received on the issue raised by GSK regarding smokeless tobacco at http://www.thecre.com/tpsac/?p=570
While it is commendable that the FDA staff will not be preparing the report on the science, it is disconcerting that they have seemingly booted off the non-voting member of the subcommitte by not allowing them to participate.
This does not seem to be appropriate nor in the best interest of understanding the available science. I believe CRE should continue to raise this concern. Some of the best minds on the science surounding menthol are the non-voting members. They are supposed to participate in every way on the panel other than to vote.
I was going to have a lengthy comment re the non-voting members but see that someone else has already covered the topic.
Therefore, I would only add that the FDA has said he non-voting members might not be included on the menthol subcommittee due to trade secrets. It would seem readily apparent that while there may well be trade secrets in regards to how individual companies market their products, that would not be a concern whatsoever regarding the science.
The FDA should allow full participation of the non-voting members on the menthol subcommittee as they summarize and reach conclusions on the scientific finds of menthols effects but may well exclude those members when they address marketing aspects.
Thank you for making this forum available for those of us who are concerned about the secrecy and direction of the FDA.
Qs: What kind of information forms the basis for exclusion? Who determines what is a trade secret? Can FDA issue a waiver to allow participation? Until resolved, can the industry continue participation in the process? If the industry is relegated to a “Minority Report”, whan and how is it presented to be allowed under FACA?