Functional Technologies Corp.
TSX VENTURE : FEB

Functional Technologies Corp.

February 10, 2011 07:00 ET

Functional Technologies Receives FDA "No Questions" Letter on GRAS Status of Hydrogen Sulphide-Reducing Yeast

VANCOUVER, BRITISH COLUMBIA--(Marketwire - Feb. 10, 2011) - Functional Technologies Corp. (TSX VENTURE:FEB) (the "Company") today 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."

About Phyterra™ Yeast

Hydrogen sulphide (H2S) is a gaseous by-product naturally emitted during fermentation, and is associated with a distinct rotten-egg odour. A well-recognized and widespread industry problem that has long plagued global winemaking, H2S can also form other reactive compounds that further add to the undesirable odours and flavours of the wine product. There are indications that even very low levels of H2S can mask the desirable sensory attributes sought by winemakers. Standard approaches to remove or reduce H2S from tainted wine can be expensive and time-consuming, and can negatively affect product quality. All Phyterra™ wine yeast strains possess a proprietary attribute that disables the yeast's ability to form H2S during the fermentation phase, making them a robust preventive solution requiring no changes to existing production processes. Importantly, there are no negative impacts to the sensory attributes desired by the winemaker. The Company refers to its H2S-reducing technology as a "platform technology" since, as opposed to the customary selling propositions of most yeast strains, it can be applied to any strain of yeast and hence has very wide commercial opportunities. This H2S-preventing yeast technology has been exclusively in-licensed from the University of California at Davis.

About Functional Technologies Corp.

Functional Technologies develops and commercializes proprietary technologies that enhance the natural properties of yeast and algae – nature's microscopic workhorses. Our scientists apply novel techniques to these micro-celled organisms to resolve significant health and quality problems, and generate new opportunities in the global food, beverage and healthcare industries. Our first commercial products are the Phyterra™ line of proprietary yeast strains, designed to reduce the formation of foul-smelling hydrogen sulphide and the carcinogen urethane in wines and other fermented products. With a head office in Vancouver, BC Functional Technologies Corp. has R&D facilities in Prince Edward Island and a U.S. sales office in Napa Valley, CA. For more information, please visit www.functionaltechcorp.com.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

  • Functional Technologies Corp.
    Connie Chen, PhD
    VP, Corporate Development and Communications
    +1.647.282.5038
    www.functionaltechcorp.com