While food manufacturers can request an FDA review of new ingredients before they are added to products — and they sometimes do — they are not required to do so.
The Food and Drug Administration’s “hands-off approach” to food additives, including those found in ultraprocessed foods and energy drinks, may allow unsafe ingredients to enter the nation’s food supply, according to the authors of an editorial published Thursday.
The paper, in the American Journal of Public Health, comes as lawmakers and public health groups allege that the FDA has failed to take quick action to protect the public from certain additives — including brominated vegetable oil and red dye No. 3 — in food products.
In July, the FDA banned the use of brominated vegetable oil after studies had shown that it could be potentially harmful to the liver and heart, and may be linked to neurological problems. The ingredient had already been banned in the U.K., the European Union, India and Japan.
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The agency has also come under scrutiny over its regulation of common ingredients such as caffeine after two people died after drinking Panera’s highly caffeinated “Charged Lemonade” drinks.
“The FDA really needs to re-evaluate our system,” said Jennifer Pomeranz, associate professor of public health policy and management at the NYU School of Global Public Health and the lead author of the new editorial. “We cannot say that our food supply is safe.”
Pomeranz and her co-authors focused on the FDA’s designation of “Generally Recognized as Safe,” or GRAS, which is used by the agency to label ingredients that outside experts widely consider safe for use in foods. Ingredients deemed GRAS don’t need to undergo FDA approval before being used.
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The rule was intended to simplify the use of common ingredients like salt and vinegar by avoiding a lengthy approval process while also freeing up the FDA’s limited resources.
Their review of the use of GRAS found, however, that over the years, food companies began using the rule as what Pomeranz called a “loophole” to add new substances — including natural sweeteners, preservatives and ingredients that enhance the texture of foods — that had not been fully vetted by the agency. Some companies have also used the rule to justify adding higher levels of caffeine to their products, she said.
While food manufacturers can request an FDA review of new ingredients before they are added to products — and they sometimes do — they are not required to do so.
From 1990 to 2010, an estimated 1,000 substances were labeled GRAS by manufacturers and were used without notifying the agency, Pomeranz said, citing earlier research. Since then, she added, there have likely been many more ingredients added to the nation’s food supply without the FDA’s oversight.
“We have no idea how many substances are in the food supply based on this self-GRAS mechanism,” Pomeranz said. “The food industry has basically made their own decisions about what is GRAS.”
The FDA did not immediately respond to a request for comment.
Xaq Frohlich, an associate professor of history at Auburn University in Alabama who was not involved in the report, said that until a few years ago, the FDA’s attention to food issues had been “really minimal.”
That’s partly because a substantial portion of the FDA’s budget comes from fees that pharmaceutical companies pay to have it review drugs, he said, meaning that food regulation and oversight often gets “sidelined.”
The agency still actively works to prevent food contamination and issue recalls, he said, but activities such as monitoring additives and nutritional labeling is “a very small part of the agency’s day-to-day work.”
“I think increasingly, more and more of its staff and budget has gone towards drugs,” Frohlich said.
Richard Mattes, a distinguished professor of nutrition science at Purdue University in Indiana who consults for the food industry, said that there isn’t enough funding for agencies, like the FDA, to adequately monitor the safety and healthiness of food.
However, he defended the FDA, saying that he believes the agency does “a thorough job of reviewing food ingredients.”
He said that whether a food is safe depends more on how people choose to consume processed foods with added ingredients.
“If we were to moderate our consumption so that we stay within our energy needs and have a balanced diet so we don’t get too much or too little of any particular food constituent, we really wouldn’t have most of the problems that we have now,” Mattes said. “It’s not a matter of a given chemical.”
Pomeranz said she would ideally like to see the FDA get more funding and resources to allow it to review ingredients before they are allowed on the market. She thinks that is partly an area for Congress, adding that at the “very minimum” the FDA should be able to do some premarket review to determine if an ingredient should be labeled GRAS.
“It’s really about safety,” she said. “Safety is something I think all parties can agree on.”
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