Osaka gets FDA GRAS no objection for D-BHB ingredient

By Stephen Daniells

- Last updated on GMT

© Eva-Katalin / Getty Images
© Eva-Katalin / Getty Images

Related tags Sports nutrition Sports nutrition products ketones

The US Food and Drug Administration has issued a letter of no objection to Osaka Gas Chemicals regarding the GRAS status of the company’s D-beta-hydroxybutyric acid (D-BHB) ingredient.

Osaka Gas will now officially launch the ingredient into the US market, which is marketed under the brand name Oketoa.

Among other things, the ingredient is reported to increase levels of blood ketones without consumption of the excess calories and fat associated with a typical low-carb diet.


The GRAS notification (GRN 001032) detailed the use of D-BHB as an ingredient at levels up to 6 g per serving in sports and nutritional beverages or powder, sports and nutrition bars, and sports and nutrition gels.

 “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,” stated the no-objection letter.

According to Osaka, Oketoa is produced from sugar via a natural, patented, non-GMO precision fermentation process.

‘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.

“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.”


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