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New ingredient approved by FDA -- but what is Sweetmyx?

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NOTE: This article is no longer current. For an updated report on S617, also known as Sweetmyx, please click here.

Senomyx, a company that produces flavor modifiers, announced today that its product Sweetmyx (formerly known as S617), has received "Generally Recognized As Safe" (GRAS) status from the FDA. Sweetmyx, a "flavor modifier" that makes sweeteners taste sweeter, joins a previous version of Sweetmyx (S9632), two "bitter blockers," four "savory flavors," and other sweetness enhancers in the company's product lineup.

GRAS status is automatically granted to food additives in use prior to 1958 -- these items have been "grandfathered in" and have not been required to prove their safe use. In order for a new food additive to be deemed GRAS, the manufacturer notifies the FDA that it believes the additive is safe for its intended use; the FDA may accept the notification and deem the additive GRAS, deny the additive GRAS designation, or request more information. Receiving GRAS status means that the manufacturer does not have to go through the usual approval process for substances added to foods. As of January 2006, 18 percent of the substances for which GRAS notices were submitted to the FDA were chemicals.

Senomyx can now market Sweetmyx without contending with food additive regulations, and has already signed exclusive deals with PepsiCo and Firmenich to distribute the product globally. Because Sweetmyx is not a sweetener, but a substance that tricks the brain into thinking a sweetener is sweeter than it is, it will likely replace some portion of the sweeteners already used in Pepsi products. (It cannot fully replace a sweetener, but can reduce the amount of sweetener needed to generate the same level of sweet taste.)

Because the composition and manufacture of Sweetmyx are trade secrets, neither the company nor the FDA will disclose exactly what Sweetmyx is. Indeed, due to a lag in the posting of GRAS notices on the FDA website, the GRAS notice for Sweetmyx is not yet available to the public. The scientific community has already observed that "the ability of intestinal sweet taste receptors to activate the incretin response in humans without transport of sugars through the intestinal wall is not entirely clear." Indeed, artificial sweeteners such as saccharine and acesulfame potassium have been shown to induce the creation of fat, despite not actually being sugar. Additionally, researchers such as Dr. Lewis Cantley have pointed out the problems of tricking the brain into thinking it is receiving more glucose than it actually is. GRAS designation does not mean that Sweetmyx is good for humans; rather, it means that the FDA has accepted Senomyx's argument that it causes no direct harm. It remains to be seen how it will fare in the marketplace.

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