On March 11th, Senomyx issued a press release stating that its sweetness enhancer, Sweetmyx (also known as S617), had been accorded GRAS (Generally Recognized As Safe) status. Multiple media outlets interpreted this to mean that the FDA had approved Sweetmyx, and the company's stock price appreciated 26 percent on the "approval" news, but both the FDA and Senomyx subsequently clarified that the designation had come from the Food & Extra Manufacturers Association (FEMA), a trade group.
The confusion regarding GRAS status is the result of a gray area in the law. During the 1970s, when previously-designated GRAS substances known as cyclamate salts were found to have potential negative health consequences, the Nixon administration's FDA developed procedures for manufacturers to issue GRAS notices to the FDA, which the federal agency could either affirm or deny. In 1997, a budget-conscious FDA issued a proposed rule that would have made GRAS notices and affirmations voluntary rather than mandatory.
But the rule was never made final. According to the Code of Federal Regulations Title 21, Section 170, the law that is still on the books provides for GRAS notices and affirmations. The CFR states, "The Commissioner, either on his own initiative or on the petition of an interested person, may affirm the GRAS status of substances that directly or indirectly become components of food."
On its website, trade group FEMA refers to four occasions when the FDA has "acknowledg[ed] in the Federal Register [...] that FEMA GRAS substances were 'approved for inclusion in the FDA GRAS review process.'" However, all four occasions were prior to 1980 -- well before the founding of Senomyx -- and nothing in the Code of Federal Regulations confers regulatory status upon FEMA. Rather, FEMA is merely a submitter of scientific data to be considered as part of FDA's determination of GRAS vs. food additive status. The volumes of the Federal Register cited by FEMA (41, 42, 43, and 44) are not accessible via the Government Printing Office's website, which only goes back to volume 60 (1995).
FEMA itself does not provide links to archived versions of the Federal Register documents in question. Indeed, the trade group does not appear to have its own email server; FEMA Senior Adviser and General Counsel John Hallagan can be reached instead at his personal email address, Hondobear@aol.com. The "Scientific Secretary to the FEMA Expert Panel" and the "Scientific Director" can be reached at their corporate email addresses for Verto Solutions, the DC lobbying firm where they work.
Apparently, a subsection of the food manufacturing industry is operating under a proposed FDA rule from 1997 that never achieved "final" status. It is likely that neither food consumers nor investors in Senomyx have a precise understanding of what "GRAS" means. This reporter has contacted PepsiCo regarding the clarification made by the FDA and any implications it has for the beverage giant's future plans involving Senomyx-developed substances; an update will follow when a reply is received.