The FDA GRAS publication includes a history of the GRAS process. As I read it, self-determined GRAS status became the basis for establishing the category of "dietary supplements". In other words, you don't have to seek FDA approval for substances you wish to market as a dietary supplement.
In 1974, the agency proposed to clarify the criteria for GRAS status, the differences between GRAS status and food additive status...
vm.cfsan.fda.gov
So, if AZNT wants to make a claim that they have self-determined that Nature's Taste is safe for use as a dietary supplement, they are free to do so at their own risk. However, in order to use the product in food products, such as sports drinks, they do indeed have to get FDA GRAS approval via the scientific criteria I cited a few posts back.
Thus, if you wish to interpret Pugs' statement that AZNT need only self-determine Nature's Taste is safe to get FDA GRAS approval to use it in food products, then, again, it must be interpreted as false and/or misleading.
- Jeff |
