Designation
A GRAS designation typically exists in one of three forms:
- Self-affirmed. The manufacturer of this chemical or substance had performed all necessary research, including the formation of an expert panel to review safety concerns, and is prepared to use these findings to defend its product's GRAS status.
- FDA-pending. The manufacturer has performed all the aforementioned due diligence, and submitted to the Food & Drug Administration for GRAS approval.
- No comment. The FDA has reviewed a product's GRAS claim and responded with "no comment"; i.e., no further challenges on the product's GRAS status.
A recent innovative GRAS notification for baobab dried fruit pulp successfully demonstrated safety to the FDA by using detailed analyses of the nutritional and phytochemical components in Baobab, without resorting to animal safety data.
This alternative approach, which not only saves unnecessary animal experiments but also saves hugely in the costs involved for approval, was used for the first time in a similar way to obtain "novel food" approval in the EU. Both approaches were pioneered by English scientist Dr John Wilkinson, in conjunction with Phytotrade Africa.
A list of the GRAS notices filed since 1998 can be found on the FDA website GRAS inventory.
Read more about this topic: Generally Recognized As Safe
Famous quotes containing the word designation:
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—Ivan Sergeevich Turgenev (1818–1883)