Functional Technologies Receives FDA "No Questions" Letter on GRAS Status of Hydrogen Sulphide-Reducing Yeast
FDA responds to GRAS notices with letters indicating either that the notice provides a sufficient basis for the GRAS determination and the FDA has no questions regarding the conclusion, or that the notice does not provide a sufficient basis for the determination of GRAS.
2/16/2011 --- Functional Technologies Corp. announced that the U.S. Food and Drug Administration (FDA) has reviewed, and issued a "no questions" letter in response to, the Generally Recognized as Safe (GRAS) notification for the Company's Phyterra-branded hydrogen sulphide (H2S)-reducing yeast. Functional Technologies' subsidiary, Phyterra Yeast Inc., had submitted a Notice to the FDA, on the view that the yeast is considered GRAS for use in preventing the formation of H2S during the fermentation of alcoholic beverages including red and white wine, champagne, sherry, sake and other rice wines, and beer.
In the letter, the FDA indicates that based on the information provided, as well as other information available to it, the FDA has no questions at this time regarding the conclusion that Phyterra's H2S-reducing yeast is GRAS, under the intended conditions of use. In general, the FDA responds to GRAS notices with letters indicating either that the notice provides a sufficient basis for the GRAS determination and the FDA has no questions regarding the conclusion, or that the notice does not provide a sufficient basis for the determination of GRAS. As the positive response from the FDA included a thorough review of the product's development, absence of toxicity or allergenicity, and manufacturing process, the GRAS status of Phyterra's wine yeast underscores Functional Technologies' commitment to quality and safety in developing and releasing products to the market.
GRAS status is not required for the sale of the Company's H2S-reducing wine yeasts, which are already commercially available in the U.S. However, the Company's perspective is that the GRAS designation and receipt of the official response from the FDA facilitates more effective marketing and adoption of Phyterra's wine yeasts in the U.S. as well as in other countries, many of which are more receptive to products with GRAS status.
"We are very pleased with the FDA's confirmation of the GRAS designation of our product," said Mr. Garth Greenham, Functional Technologies' President and COO. "Our H2S-reducing wine yeasts have already been sold into a considerable number of wineries in the U.S. with highly positive results. GRAS status supports our entry into multiple fermented beverages and facilitates our access into global markets, a significant milestone in enhancing the commercial progression of our products."
