On September 17, Spherix Incorporated, formerly known as Biospherics Inc., the technology innovation firm, last week reported several discussions with officials of the US Food & Drug Administration (FDA) concerning tagatose, the company's new low-calorie sweetener.
In response to inquiries from shareholders and the public, Dr. Gilbert V. Levin, Spherix CEO, spoke with several FDA officials to clarify the status of the product. Over the past several years, an Expert GRAS Panel had reviewed extensive safety data of tests performed on the sweetener as a food product and found it to be GRAS (Generally Recognised As Safe).
A public announcement of the finding was made on April 11, 2001. Then the entire safety data package was submitted to the FDA with a voluntary request for its review under the new and experimental GRAS Notification Program.
As the FDA has not yet published its review of these data, shareholders and consumers have made numerous inquiries to the company and the FDA. In last week's discussions, the FDA assured Spherix that the amount of time taken to conduct a review has no bearing on what the conclusion will be.
The FDA official stated that 80 per cent of submittals to the GRAS Notification Program take longer than 90 days for the review, but very few take more than 180 days to complete.
The GRAS Notification Program is an exploratory and voluntary service available to companies that have already self-determined that a food product is GRAS, as Arla Foods did for tagatose. Arla is the firm into which Spherix's tagatose licensee for food use, MD Foods, was merged last year.
The FDA pointed out that Arla has been free to sell the product in the US since April 11, 2001. However, as an additional assurance to potential users, Arla elected to request the review. When a review is completed, public announcement of the result is made on the next monthly update of the website maintained by the FDA Notification Program .
According to the FDA official, the tagatose data file constituted "a thoughtful submittal, and that no additional information has been requested."