By Andrew M. Seaman
NEW YORK | Wed Aug 7, 2013 9:03am EDT
(Reuters Health) - All of the notices U.S. regulators received to vouch for the safety of common food additives between 1997 and 2012 were submitted by people who had a vested interest in the outcome of those assessments, according to a study published in JAMA Internal Medicine on Wednesday.
The analysis found that all of the 451 notifications voluntarily submitted to the Food and Drug Administration (FDA) during that time were made by people who had relationships with manufacturers of food additives, which include salt, trans fats and artificial flavors and sweeteners.
"If the company makes the decisions or picks the people, there are a lot of possibilities for undue influence," said Thomas Neltner, the study's lead author from The Pew Charitable Trusts in Washington, D.C.
Under current practices, companies are allowed to decide whether or not their food additives are "generally recognized as safe" or GRAS and only voluntarily tell the agency about their decisions.
"If they never tell the agency, there's a chance for harm," Neltner, director of Pew's food additives project, added.
In a previous study, Neltner and his colleagues estimated that about 43 percent of the 10,000 or so additives allowed in food were on the FDA's GRAS list, with other additives approved through other means or not submitted to the FDA. Manufacturers made their own safety determinations for about 1,000 additives without ever notifying the agency.
When a manufacturer submits a notice to the FDA, the agency responds with a letter that affirms the GRAS determination or one that says the notice didn't provide enough evidence for the decision.
In response to concerns raised by members of Congress about the program, the Government Accountability Office (GAO), a federal watchdog agency, issued a report in 2010. It found multiple instances of the FDA prohibiting an additive previously recognized as GRAS, including cinnamyl anthranilate, a flavoring agent that was linked to liver cancer in mice.
The GAO found the "FDA's oversight process does not help ensure the safety of all new GRAS determinations." "What we wanted to do is see if that was true. So we looked at where the light was the best. We looked at the 451 notices that were submitted (to the FDA) for review," Neltner said.
Of the safety assessments, about 22 percent were made by an employee of the food additive manufacturer and about 13 percent by employees of manufacturer-hired consulting firms.
Another 64 percent were submitted by expert panels whose members were picked by either manufacturers or consulting firms. None of the expert panels, which included an average of four people, were selected by third parties, write the researchers.
Also, Neltner and his colleagues found that 10 experts served on 27 or more panels. One of those was a member of 128 panels, about 44 percent of the total.
In a statement to Reuters Health, the Grocery Manufacturers Association, a trade organization, said GRAS determination is an important part of the FDA's current regulatory framework and that it is "a very thorough and comprehensive process.
"We also recognize that the GRAS process, like any other, can be improved. That is why we are committed to working with the FDA and other stakeholders to identify ways of strengthening the GRAS review process so that it can continue to help ensure the safety of our food supply, just as it has done for decades," it continued.
The FDA said in a statement to Reuters Health that it encourages companies to submit their GRAS determinations, because it is a way to ensure the decisions are based on "sound data and information."
"For example, the addition of caffeine to a widening array of products like chewing gum, waffles, and syrup is an example of where notification of a company's GRAS determination would have been useful for both government and industry," said the statement.
The FDA added that it plans to issue guidance to industry on meeting the GRAS criteria.
According to the GAO, the GRAS notification program still operates under an interim status, because the last change to the process in 1997 was never finalized.
"The good news is that once the FDA gets the documentation, it does its job and encourages manufacturers of questionably safe additives to withdraw their notices. But then what happens? Who knows," Marion Nestle, a professor of nutrition, food studies and public health at New York University, told Reuters Health in an email.
"We need a better food safety system in this country and the conflicts of interests in (GRAS) additive approvals are a good place to start," Nestle, who wrote an editorial accompanying the study, added.
Neltner and his colleagues recommend that the GRAS program minimize conflicts of interest by modeling policies off of the rules set for other panels, including drug advisory committees.
They also write that the FDA should require that it be notified of all GRAS determinations and conflicts of interest, then release that information to the public.
"Right now the safety of the food is dependent on the integrity and competency of the company (that people) are buying their food from. The more they know about the company making the food they're buying, the more reliable it will be," Neltner said.
SOURCE: bit.ly/MbBLb9 JAMA Internal Medicine, online August 7, 2013.