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Breaking news: Senomyx product Sweetmyx not deemed GRAS by FDA

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Earlier today, it was reported that Sweetmyx, a flavor enhancer from Senomyx, had been granted Generally Recognized As Safe (GRAS) status by the FDA. GRAS status means that a substance added to food is not regulated as a food additive; rather, the FDA accepts the company's assertion that the substance will not harm humans if used as intended. At 9:00 Eastern Time, the FDA released a statement to the effect that Sweetmyx has not been deemed GRAS.

Senomyx sent out a press release on March 11th, which was carried by PR Newswire and picked up by media outlets including Yahoo! Finance, indicating that Sweetmyx had received GRAS status. Reuters reports that Senomyx's share price increased 26 percent on the news. However, a subsequent announcement by the FDA rejects Senomyx's assertion and clarifies that a third party hired by Senomyx has declared the product GRAS, a finding that confers no legal benefit on the product. The FDA states, "In fact, the agency had not made this determination, nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient." The agency further admonishes Senomyx, "When making a GRAS determination, companies should not state or imply that the FDA has made a GRAS determination on their food ingredients."

All GRAS notices received by the FDA are accessible via the agency's search tool. Information provided for each record includes the GRN number, the substance in question, the status of the notice (pending, proceeding unquestioned by the FDA, no longer under evaluation by the FDA), the intended use of the substance, the basis on which the requester asks for GRAS status, the name of the requester / notifier, the date of filing, and the date of closure (if closed).

UPDATE (March 13, 2014): According to a search of the FDA GRAS notice database, none of Senomyx's products has received GRAS status from the federal government, nor has Senomyx filed a GRAS notice for any of its products. This stands in stark contrast to the company's claim that several Senomyx products were granted GRAS status, including four savory flavors, a sucralose-enhancing ingredient (S2383), a sugar modifier (S6973), a Sweetmyx predecessor (S9632), and two bitter blockers. It is unclear whether such misstatements constitute an action investigable by the SEC.

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