FDA issues GRAS no objection letter for Sweegen's Bestevia Reb-M - which starts with the leaf, then undergoes 'enzymatic conversion'

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California-based SweeGen has received a GRAS no objections letter from the FDA for the use of its Bestevia branded Reb-M - manufactured from stevia leaf extracts converted to Reb M using enzymes – for use as a general purpose sweetener for food and beverage applications in the US.

The announcement follows a tie up with ingredients giant Ingredion, which recently became the exclusive global distributor of Sweegen’s stevia-based sweeteners in all markets except China (where it is a non-exclusive distributor).

According to the GRAS notification (GRN 667), submitted last year by Sweegen affiliate Blue California, Bestevia Reb-M 95% is "synthesized from Stevia rebaudiana Bertoni extract by genetically modified yeast."

The 'bioconversion' process involves a "novel multi-step biosynthesis pathway process to manufacture high purity rebaudioside M (Reb-M 95%) using a strain of yeast from the Saccharomycetaceae family that contains uridine 5’-diphospho-glucuronosyltransferase enzymes that facilitate the transfer of the glucuronic acid to small molecules via glycosidic bonds.”

Unlike Cargill’s EverSweet product, which is made using a genetically engineered strain of yeast that converts sugars to the steviol glycosides Red D+M, the Sweegen process begins with stevia leaf extracts, and then uses enzymes from yeast to convert them to Reb M, one of the most 'sugar-like' tasting steviol glycosides (the components of the stevia leaf that make it sweet).

The notification adds: “This microorganism [the yeast] contains several enzymes that carry out multiple steps of glucose addition to naturally occurring steviol glycosides, eventually converting them to Reb M.”

As the yeast is not present in the final product (it is completely removed) and would serve as a processing aid, SweeGen is describing Bestevia Reb M as ‘Non-GMO’ on its website.

Our proprietary production pathway starts with the natural stevia leaf 

Sweegen has not responded to detailed questions about the process, but the company sent FoodNavigator-USA a statement explaining that: “Our proprietary production pathway starts with the natural stevia leaf and uses non-GMO technology. Our Bestevia Reb-M is of high purity and offers great taste while being produced cost-efficiently compared to other technologies."

Asked how end users might describe Bestevia on an ingredients list/food label, it said: “Sweegen’s non-caloric Reb-M combined with its great sugar-like taste enables food and beverage companies to reduce or completely cut sugar in their products, though it is entirely our customers’ decision as to when and how to announce their products that use our Bestevia Reb-M as an ingredient.”

Asked who owned the intellectual property surrounding SweeGen’s products, it said: “SweeGen has an exclusive license from Conagen [a corporation majority owned by SweeGen president Steven Chen] for production methods of Reb-M.” 

In a letter from the FDA dated February 17, 2017, the agency said it had reviewed the application and has no further questions regarding the the safety of Bestevia Reb-M.

"Having received the No Objection Letter from the FDA, SweeGen and our valued distribution partner Ingredion, are now able to support food and beverage companies in the United States to meet consumer demand for reduced and no sugar products made with a new, high-purity, great tasting stevia sweetener,” said Sweegen president Steven Chen.

"There’s no magic bullet in the natural sweeteners industry, but the products are getting better and better as we’ve moved from second generation extracts, which were all about high purity Reb A, to third generation products, which started hitting the market about two years ago, and are all about blends of the five glycosides with the highest commercial value: Reb A, B, C, D and M."

Alex Woo, Ph.D. chief executive at consultancy W2O Food Innovation 


According to Sweegen’s website: "Our production process starts with first generation natural steviol glycosides as the substrates, we add natural enzymes to convert them into next generation sweeteners through enhanced fermentation.

"The result is a natural compound (Reb-M, Reb-D or any other targeted steviol glycoside) that can be isolated and further purified for use as a sweetener in food and beverage products for the global consumer.

"The fermentation process does not change the natural molecule of the steviol glycoside and the end product can be confirmed as natural using isotopic analytical methods that can differentiate a natural ingredient from a synthetic product."

As a result, Sweegen's products "represent the next generation of stevia sweeteners," claimed Anthony DeLio, Ingredion’s chief innovation officer. "Along with our current sweetener offerings, these great-tasting sweeteners give us even more options to help our customers develop on-trend products that meet consumer demands for healthier foods and beverages with less sugar."

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