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FDA Violations

Is the GRAS Food Safety process a Racket?

— April 21, 2015

A 1958 law offers food companies who want to market new ingredients in their products a way to bypass extensive and costly FDA safety testing. The law provides the option for companies to demonstrate that the ingredient in question has been deemed “Generally Regarded As Safe” (GRAS) by a consensus panel of scientists and experts. An eye-opening report conducted by the Center for Public Integrity found, however, that an alarmingly small circle of experts populate these panels, and one expert in particular, Joseph Borzelleca, has served on 41 percent of 379 panels that been convened since 1998. The report also notes that three-fourths of the panels conducted involved at least one of 10 particular scientists, of whom each has served in over a dozen panels. In addition, several of these panelists have served similar roles for tobacco companies, an issue that I will cover more in-depth tomorrow.

Although there are other ways to be granted GRAS status, the panel method is by far the most popular, with two-thirds of publicly available GRAS determinations made by a, typically 3-member, panel. The experts make their determinations upon convening and reviewing safety data, both published and unpublished. The procedure for GRAS rules is in a state of flux at the moment. A tentative agreement for the process was approved in 1997, and began in 1998. Although never officially finalized, the practical use of the rule is that anybody can petition the FDA to grant an ingredient as GRAS if it passes the accepted criteria, such as an approving panel. In an October, 2014 settlement with the Center for Food Safety, however, the parties agreed for the FDA to finalize the official GRAS rule by August, 2016. If the FDA fails to meet that deadline, they may be placed under court order to do so.

For their part, many of the frequent panel members strongly defend the process and deny any accusations of wrongdoing. “If you’re good at something, of course you’re going to be in demand,” says the 84 year-old Borzelleca. Another frequent panel member, John Thomas, also defends the process, stating, “As long as you adhere to science-based review, then I don’t think there’s a better peer-reviewed process in place.” James T. Heimbach, who has made over 100 GRAS determinations, also defends the shallow pool of experts, saying “There’s a reason you keep going back to the same people, and that’s because these are people with sterling reputations, impeccable credentials and they know what they’re doing.” For what it’s worth, the 379 panels that the Center for Public Integrity analyzed only represent a fraction of the total determinations because companies are not required to make these determinations public.

Questions about the insular nature of GRAS panels have been raised before, most notably by a 2010 Government Accountability Office (GAO) report that cited financial conflicts of interest, among other things, to be of great concern with the GRAS process. A 2013 Pew Charitable Trust assessments concurred, stating that “financial conflicts of interest were ubiquitous” in the system. The interim between the settlement and the FDA’s deadline, should give advocacy groups a strong opportunity to influence the pending regulations. One group, the Natural Resources Defense Council (NRDC), has been especially active in urging Congress to look into FDA food-safety procedures. “The GRAS loophole gives industry the upper hand,” said Maricel V. Maffini, co-author of a seminal 2014 report by NRDC advocating against the GRAS system. NRDC, the Center for Science and the Public Interest, along with other groups just published a scathing 80-page report claiming that the GRAS process “violates the law.” Laura MacCleery, an attorney for the Center for Science in the Public Interest calls it “funding bias on steroids.”


Center for Public Integrity/NPR – Chris Young and Erin Quinn

Center for Science in the Public Interest

Food Safety News – Lydia Zuraw

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