Study: Conflicts of Interest Taint Self-Affirmed GRAS Determinations

A recent study that investigated possible conflicts of interest with regard to food ingredients self-affirmed as GRAS (Generally Recognized as Safe) found that literally all of the determinations submitted to the U.S. Food and Drug Administration (FDA) from 1997-2012 lacked independent review, according to an article on

Since 1958, food additive manufacturers have been able to self-affirm new ingredients as GRAS. While GRAS ingredients are exempt from FDA supervision, many manufacturers voluntarily submit to the FDA their scientific findings affirming the safety of an ingredient as a way to ensure consumer confidence and more effectively market foods and beverages that include the additive.

The study, which was conducted by the Pew Health Group and recently published in the Journal of the American Medical Association (JAMA), found that over the last 15 years nearly 36 percent of the 451 GRAS notices presented to the FDA were written either by employees of an additive manufacturer or a consulting firm hired by the manufacturer. The remaining determinations were conducted by an expert panel selected by a consultancy or the manufacturer.

“Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS,” wrote the authors of the study.

The study highlights several other concerns, notably that ingredient manufacturers are not legally required to submit self-affirmed GRAS determinations to the FDA. Moreover, the authors of the study claim that the FDA does not have the means to inspect the quality of the findings, and even if the agency did express concerns about a self-affirmed determination, an ingredient manufacturer can pull its notification and take the additive to market without having to resubmit a report.

Dr. Marion Nestle, professor in the department of nutrition, food studies and public health at New York University, called the findings of the study “alarming.” Nestle wrote a commentary to accompany the report in JAMA.

“An astonishing 100 percent of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question,” Nestle told the website. “The lack of independent review in GRAS determinations raises serious questions about the public health implications of unregulated additives in the food supply, particularly the additives that the FDA does not even know about.”

Despite significant concerns raised by the study, some consulting firms that work with ingredient manufacturers to self-affirm new additives as GRAS claim that the authors provided no evidence that the current system has led to harmful substances landing in the marketplace. As such, some question the value of new regulation or, as the study recommended, “a standing expert panel selected by a third party for GRAS determinations.”

“You’ve… got to look at whether the costs of introducing new regulation are commensurate with the benefits given that public health issues are not pushing this issue,” Dr. Bob McQuate, CEO of GRAS Associates, told the website.