Analysis reveals conflicts of interest in GRAS process
by Jeff Gelski
WASHINGTON — Conflicts of interest often arise in Generally Recognized as Safe (GRAS) status determinations for food additives, according to an analysis appearing on-line Aug. 7 in JAMA Internal Medicine
“Between 1997 and 2012, financial conflicts of interest were ubiquitous in determinations that an additive to food was GRAS,” the analysis said. “The lack of independent review in GRAS determinations raises concerns about the integrity of the process and whether it ensures the safety of the food supply, particularly in instances where the manufacturer does not notify the FDA of the determination. The FDA should address these concerns.”
The analysis involved researchers from the Pew Charitable Trusts in Washington, the University of Cincinnati, Tufts Univ. in Medford, Mass., and the Univ. of California in San Francisco. They investigated 451 GRAS notifications sent to the US Food and Drug Administration from 1997 to 2012. They used conflict of interest criteria developed by an Institute of Medicine committee.
The researchers found 22.4 percent of the safety assessments were made by an employee of an additive manufacturer, 13.3 percent were made by an employee of a consulting firm selected by the manufacturer, and 64.3 percent were made by an expert panel selected by either a consulting firm or the manufacturer.
“Our results do not prove that the conflicts of interest that we identified actually compromise the GRAS decision process, although they raise such concerns,” the researchers said.
Martin Hahn, a partner at Hogan & Lovells US LLP and based in Washington, said the term “conflict of interest” concerned him. The law does not give companies the ability to decree that their ingredient is GRAS, he said. While the FDA may have no objection to a GRAS notice from a company, it is not a decision that binds the FDA.
Conflicts of interest might come into play with food advisory companies or government employees more so than with the GRAS process, Hahn said. The GRAS process is a notification program as opposed to an approval program, he said.
Companies generally self-affirm an ingredient as GRAS and then send their research to the FDA, although notifying the FDA is optional.
Marion Nestle, Ph.D., Paulette Goddard professor in the Department of Nutrition, Food Studies and Public Health at New York Univ., provided invited commentary in JAMA Internal Medicine
“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,” she said.
Later in her commentary she said, “How is it possible that the FDA permits manufacturers to decide for themselves whether their food additives are safe?”
Hahn said the FDA has the legal authority to determine if an ingredient already on the market is safe for human consumption.
The researchers said from 1997 to 2012 they found one instance when the FDA sought to obtain a GRAS safety determination that it had not received a notification for. In 2010 the FDA sent letters to four companies inquiring whether they had determined the use of caffeine in alcoholic beverages was GRAS.
Hahn said this track record confirms the food and beverage industry is responsible. The FDA rarely has been forced to take action against the industry.
The researchers also found certain individuals, most with advanced educational degrees, served on several GRAS panels. 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, Dr. Nestle said in her commentary.
Hahn compared serving on a GRAS panel to a lawyer arguing a case before the US Supreme Court. Only a select few lawyers have experience working in front of the Supreme Court. Companies or individuals presumably would want to hire one of those lawyers for a Supreme Court case.
“Does that mean that these people are biased and somehow the Supreme Court is giving them preferential treatment?” Hahn asked. “Absolutely not.”
Likewise, food companies want to fill their GRAS panels with people familiar with the FDA GRAS process. They want people who know what the FDA wants in a GRAS filing.
“It’s not surprising that people will continue to go back to that well because these people are a proven entity,” Hahn said. “You pay a premium to get people with that kind of experience.”
Hahn has a bachelor’s of science degree in food technology from The Ohio State Univ. and a juris doctor degree from Northwestern Univ.. He is a member of the DC chapter of the Institute of Food Technologists. His practice focuses on a variety of regulatory issues, including GRAS, affecting different segments of the food industry.
“I think it’s a mistake to think that all the FDA does is look at a GRAS notification and rubber stamp it,” Hahn said. “They will ask questions, and if you have not done your homework, they will reject it.”