Provexis PLC
28 February 2007
28 February 2007
Provexis plc ('Provexis')
Fruitflow(R) Clears FDA GRAS Review Process
Provexis, the nutraceutical company that develops scientifically-proven
functional and medical foods, is delighted to announce that the US Food and Drug
Administration ('FDA') has no objection to the conclusion that the Fruitflow(R)
heart-health technology is Generally Recognized As Safe ('GRAS'), clearing the
way for its use in the USA.
On 9 March 2006, Provexis announced that an independent Expert Panel affirmed
that in their view Fruitflow(R) was safe for consumption in the United States.
On 9 August 2006, Provexis served a comprehensive safety notice to the FDA,
together with the aforementioned Expert Panel report in accordance with US
regulation governing Substances Generally Recognized As Safe. Provexis can now
confirm that it has received the formal response from the FDA which confirms
that they have no objection to the conclusion that Fruitflow(R) is GRAS under
the intended conditions of use. These conditions, as detailed in the Provexis
notice to the FDA, include the addition of Fruitflow(R) to fruit juices,
fruit-flavoured drinks and yoghurt drinks.
Commenting on this positive development Provexis CEO Stephen Moon said:
'The clearance of this regulatory hurdle is an important step in the development
of our Fruitflow licensing strategy and one which further strengthens the
first-class scientific and regulatory platform underpinning our heart-health
technology. I am delighted that we have received the best possible response from
the FDA and I expect it to be an important catalyst for our licensing activity
in the USA.'
For further information please contact:
Stephen Moon, CEO Tel: 020 8392 6634
Provexis plc
END
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