FDA Overwhelmed by Scores of New Food Additives
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By Kimberly Kindy,
The Washington Post
August 18, 2014

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

And in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show. “We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food.

The FDA has received thousands of consumer complaints about additives in recent years, saying certain substances seem to trigger asthmatic attacks, serious bouts of vomiting, intestinal-tract disorders and other health problems.

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At a pace far faster than in previous years, companies are adding secret ingredients to everything from energy drinks to granola bars. But the more widespread concern among food-safety advocates and some federal regulators is the quickening trend of companies opting for an expedited certification process to a degree never intended when it was established 17 years ago to, in part, help businesses.

Increase in GRAS Food Additives
A voluntary certification system has nearly replaced one that relied on a more formal, time-consuming review — where the FDA, rather than companies, made the final determination on what is safe. The result is that consumers have little way of being certain that the food products they buy won’t harm them.

“We aren’t saying we have a public health crisis,” Taylor said. “But we do have questions about whether we can do what people expect of us.”

In the five decades since Congress gave the FDA responsibility for ensuring the safety of additives in the food supply, the number has spiked from 800 to more than 9,000, ranging from common substances such as salt to new green-tea extracts. This increase has been driven largely by demand from busy Americans, who get more than half their daily meals from processed foods, according to government and industry records.

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Within the past six months, top officials at the FDA and in the food industry have acknowledged that new steps must be taken to better account for the additives proliferating in the food supply. The Center for Food Safety, an advocacy group, has responded more aggressively; it sued the FDA this year, saying the agency has abdicated its oversight of the additives approval process. The Grocery Manufacturers Association also provided seed money this spring to create a research center at Michigan State University to deal with the rising concerns over additives.

For new, novel ingredients — or when approved additives are used in new ways — the law says companies should seek formal FDA approval, which must be based on rigorous research proving the additive is safe. The agency uses the phrase “food additive,” in a narrow legal sense, to apply to substances that get this approval.

But many other additives are common food ingredients — vinegar is considered a classic example. The law allows manufacturers to certify, based on research, that such ingredients are already Generally Recognized as Safe, or GRAS. 

For both types of additives, FDA scientists initially conducted detailed reviews of the company’s research. The agency also published its own evaluation of that research in the Federal Register.

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This oversight system shifted dramatically in 1997. In response to a shortage of staff members and complaints from industry that the process was too cumbersome and did not improve food safety, the FDA proposed new rules. The agency told companies that were going the GRAS route — which turned a years-long process into one of months — that they no longer would have to submit their research and raw data. The companies can share just a summary of their findings with the agency.

In part, FDA officials hoped that by streamlining the GRAS notification process, companies that previously avoided informing the agency of new additives would be encouraged to keep the government in the loop, current and former agency officials said.

The changes didn’t work out as planned. For starters, most additives continued to debut without the FDA being notified.

Moreover, companies that did choose to go through the FDA oversight process largely abandoned the formal approval route, opting instead for the new, cursory GRAS process, even for additives that could be considered new and novel, according to agency documents and an analysis of those records by the Natural Resources Defense Council.

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“They created a side door,” said Tom Neltner, a chemical engineer with the NRDC who has co-authored six academic articles about the FDA additives process over the past four years.

An average of only two additive petitions seeking formal approval are filed annually by food and chemical companies, while the agency receives dozens of GRAS notifications, according to an NRDC analysis of FDA data. Hundreds of other food chemicals and ingredients have been introduced without notifying the FDA at all, according to agency officials, trade journals and food safety groups.

FDA officials, food safety advocates and the food industry all agree there are problems. There are too many cases in which the agency is not notified of new additives or the science remains secret. But there’s no consensus about how to fix the system. Industry trade groups say that the additives in today’s foods do not pose a public safety risk, but most agree improvements for better tracking and oversight are needed.

“It’s the right time to take a step back,” said Leon Bruner, the Grocery Manufacturers Association’s chief science officer. “There are problems with transparency. How can we be sure that the FDA is aware of ingredients?”

Safety Claims Not Evaluated
When the manufacturer of a vegetarian line of foods called Quorn first approached the FDA in 1986, the company asked that the agency give formal additive approval for a protein-rich fungus the company makes in large fermentation vats. Marlow Foods dubbed its new fungal ingredient “mycoprotein.”

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Fifteen years passed without the FDA moving on the petition. Internal FDA documents, obtained through a Freedom of Information Act request, show no sign of the agency evaluating the safety claims made in the petition. Because the FDA declined interview requests about Quorn products, it is unclear why the petition sat for so long.

After the long delay and without withdrawing the original petition, Marlow filed a GRAS notification with the FDA in 2001, saying the firm had hired a group of experts who had determined that mycoprotein was safe. Under the rules, the notification did not — nor did it have to — cite every study the company had conducted.

A study that was not mentioned was an unpublished “large scale volunteer trial” from the late 1970s. During the trial, nearly 5 percent of the 200 participants reported feeling ill after eating several “test meals,” according to the study, which was obtained by The Washington Post. Four had “more severe reactions,” including two who started to “vomit violently,” another who became “violently sick” and another who “experienced nausea and vomiting” after eating Quorn products that contain mycoprotein. The study says that the “reactions” could have been caused by a response to mycoprotein.

In a prepared statement, Quorn said the study had been shared with the FDA but was not cited in the GRAS submission because “it was a small study and at that time nearly 25 years old and more recent data was relevant and important to the submission.” The statement also said “many research studies” had been undertaken, and all were shared with the FDA and other regulators.