Study finds food companies have 'undue influence' over vouching for safety of additives

By Andrew M. Seaman

NEW YORK (Reuters Health) - U.S. food companies have "undue influence" in vouching for the safety of common additives such as salt, trans fats and artificial sweeteners, according to an analysis released on Wednesday that calls for better oversight of the additive process, which is currently self-governed by industry.

An analysis of all 451 notices of additive safety voluntarily submitted to the U.S. Food and Drug Administration between 1997 and 2012 were submitted by people who had a vested interest in the outcome of those safety assessments.

"If the company makes the decisions or picks the people, there are a lot of possibilities for undue influence," said Thomas Neltner, of the Pew Charitable Trusts in Washington, D.C., who led the study published in JAMA Internal Medicine.

Additives are typically used as flavor or color enhancers or as preservatives. Under current practices, companies are allowed to decide whether their additives can be classified as GRAS - generally recognized as safe - and only voluntarily tell the FDA about their decisions.

Neltner, director of Pew's food additives project, and his colleagues suggest the GRAS program reduce the risk of conflicts of interest by adopting rules that exclude people with ties to industry from submitting safety notices.

They also suggest that FDA require companies to notify the agency of all GRAS determinations and conflicts of interest and release that information to the public.

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 manufacturers send the FDA a notice that they believe their additive is safe, the agency responds with a letter that affirms the GRAS determination or says the notice did not provide enough evidence for the decision.

"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," said Marion Nestle, a professor of nutrition, food studies and public health at New York University, who wrote an editorial accompanying the study.

In response to concerns raised by members of Congress about the GRAS 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 synthetic flavoring agent that was linked to liver cancer in mice.

The GAO reported that the FDA's oversight process does not help ensure the safety of all new GRAS determinations.

Neltner's group analyzed the 451 notices of additives that were submitted to the FDA for review. About 22 percent were made by an employee of the food additive manufacturer and about 13 percent by employees of consulting firms hired by manufacturers.

Another 64 percent were submitted by food safety expert panels whose members were picked by either manufacturers or consulting firms to evaluate the additive. None of the panels, which included an average of four people, were selected by third parties, the study found.

Neltner's study also found that 10 experts served on 27 or more panels. One of them was a member of 128 panels, about 44 percent of the total.

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," the group said in a statement.

"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 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 FDA said adding 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."

The FDA says it plans to issue guidance to the food industry on meeting the GRAS criteria that companies believe the additive is generally recognized as safe for its intended use.

(Editing by Genevra Pittman, Julie Steenhuysen and Bill Trott)

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