The exact line Pugs used was:
Nature's Taste meets the requirements for GRAS (self determined) approval and is in the process of obtaining such approval!
I'd say that if take AZNT's word for it that Nature's Taste is a unique substance, created via 40 years of genetic engineering by Dr. Loricchio, then, by definition, it couldn't have been in widespread use to even qualify for GRAS status. Even assuming it's really stevia or some other "common" substance, AZNT still has to provide scientific evidence:
The usual mechanism to establish that scientific information is generally available is to show that the information is published in a peer-reviewed scientific journal. However, mechanisms to establish the basis for concluding that there is expert consensus about the safety of a substance are more varied. In some cases, publication in a peer-reviewed scientific journal of data (such as toxicity studies) on a test substance has been used to establish expert consensus in addition to general availability. In other cases, such publication of data and information in the primary scientific literature has been supplemented by: (1) Publication of data and information in the secondary scientific literature, such as scientific review articles, textbooks, and compendia; (2) documentation
of the opinion of an ``expert panel' that is specifically convened for this purpose; or (3) the opinion or recommendation of an authoritative body such as the National Academy of Sciences (NAS) or the Committee on Nutrition of the American Academy of Pediatrics (CON/AAP) on a broad or specific issue that is related to a GRAS determination.
vm.cfsan.fda.gov
Getting back to Pugs' statement, as AZNT has never released a single scientific study about Nature's Taste, and as we've all asked for it in the past, and as we know if there were one Pugs et al would have provided it for us, I'd have to conclude that the part "meets the requirements for GRAS" is an outright lie.
As for the phrase "is in the process of obtaining such approval", as they can't obtain approval from themselves, this clearly implies to me they've submitted an application to the FDA. Of course we also know from other things Pugs has written on RB that AZNT thought GRAS approval would be granted any day. Again, this implies an application was submitted. Janice proved a few posts back that as of 9/9/99, no such application is on file. Thus we must conclude this statement is a lie as well.
- Jeff |
