Using conflict-of-interest criteria developed by the Institute of Medicine, the researchers analyzed 451 "generally recognized as safe," or GRAS, determinations that the food industry submitted to the U.S. Food and Drug Administration (FDA) between 1997 and 2012.
The results of their analysis, which were published in JAMA Internal Medicine, showed that:
- 22% of those safety assessments had been made by employees who worked directly for the manufacturer of the additive,
- 13% had been made by employees of consulting firms hired by the additive manufacturer, and
- 64 had been made by an expert panel selected by either the manufacturer or its consulting firm.
- None of the 451 safety assessments had been made by a panel of independent experts.
These findings “are alarming,” writes Marion Nestle, professor of nutrition, food studies and public health at New York University, in a commentary that accompanied the study. “An astonishing 100% of the members of 290 expert panels included in their review worked directly or indirectly for the companies that manufactured the additive in question. Even more alarming, the experts on these panels form a tight professional cadre. Although 850 people served on the panels, 10 experts served on 27 panels or more, and one of these 10 participated in three-quarters of the panels. The scientific substantiation used by manufacturers to support GRAS status is highly conflicted.”
The Pew researchers believe that about a thousand food additives are currently in the food supply without the FDA’s knowledge.
“From 1997 to 2012, we found only one instance when the agency sought to obtain a GRAS safety determination that it had not received a notification for,” the researchers note in their report. “In 2010, the FDA sent letters to four companies inquiring whether they had determined that the use of caffeine in alcoholic beverages was GRAS. The FDA has affirmed caffeine as GRAS in cola-type drinks. The agency was reacting to reports of serious injuries or deaths among young people consuming the beverages. In fact, none of the four companies had made GRAS determinations. A year later, in 2011, one company submitted a GRAS notice that the agency found insufficient. Subsequently, the FDA issued warning letters to all four firms directing them to stop the use of caffeine in alcoholic beverages until the agency formally approved it. All companies appear to have removed caffeine from such products.”
In a second study, published in the journal Reproductive Toxicology, the Pew researchers reported significant and troubling gaps in the data used to make safety recommendations for chemicals added to foods and food packaging.
They found that two-thirds of additives deemed safe by the food industry or the FDA have not been tested on lab animals. In addition, only one in eight of the additives the FDA has recommended undergo assessment for reproductive or developmental toxicity has been evaluated for those effects.
“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,” writes Nestle. “It also raises questions about conflicts of interest in other regulatory matters. By focusing attention on one blatant example, this study performs a great public service.”