05.08.23
Osaka Gas Chemicals received a letter from the FDA in response to a GRAS (generally recognized as safe) self-affirmation notice submitted for its proprietary D-β-hydroxybutyric acid (D-BHB) ingredient, branded as Oketoa.
Oketoa is the only D-BHB ingredient produced from sugar through a patented non-GMO precision fermentation process, according to the company.
“Based on the information that Osaka Gas provided, as well as other information available to FDA, we have no questions at this time regarding Osaka Gas’ conclusion that D-BHB is GRAS [Generally Recognized As Safe] under its intended conditions of use,” the letter from FDA read.
“We are pleased with the U.S. FDA’s response to our GRAS Self-Affirmation safety submission for OKETOA and we are excited to introduce this ingredient into the U.S. market,” said Dr. Mariko Kato, deputy research director of Osaka Gas Chemicals.
“Our high-quality, naturally and precision fermented D-BHB ingredient is perfectly suited as a functional ingredient in food and beverage applications for a multitude of energy support applications, including high performance nutrition,” Kato continued.
According to the company, D-BHB is studied for its ability to increase levels of blood ketones without the excess calories and fat associated with a low-carb diet. Oketoa, throughout the fermentation process, uses non recombinant bacteria, and no organic solvents throughout manufacturing. All raw materials used in the production are food grade, and impurities are removed in the fermentation both.
Oketoa is the only D-BHB ingredient produced from sugar through a patented non-GMO precision fermentation process, according to the company.
“Based on the information that Osaka Gas provided, as well as other information available to FDA, we have no questions at this time regarding Osaka Gas’ conclusion that D-BHB is GRAS [Generally Recognized As Safe] under its intended conditions of use,” the letter from FDA read.
“We are pleased with the U.S. FDA’s response to our GRAS Self-Affirmation safety submission for OKETOA and we are excited to introduce this ingredient into the U.S. market,” said Dr. Mariko Kato, deputy research director of Osaka Gas Chemicals.
“Our high-quality, naturally and precision fermented D-BHB ingredient is perfectly suited as a functional ingredient in food and beverage applications for a multitude of energy support applications, including high performance nutrition,” Kato continued.
According to the company, D-BHB is studied for its ability to increase levels of blood ketones without the excess calories and fat associated with a low-carb diet. Oketoa, throughout the fermentation process, uses non recombinant bacteria, and no organic solvents throughout manufacturing. All raw materials used in the production are food grade, and impurities are removed in the fermentation both.
