‘Generally Recognized As Secret’
If there is, it’s almost impossible for the FDA to police it.
Under today’s system, manufacturers that establish that an ingredient is safe for a specific use can either submit their safety evaluation to the FDA for a cursory review or keep their determination private. The FDA encourages companies to choose the former option, but companies more often choose the latter.
The NRDC estimates that about 1,000 ingredients have been added to food without FDA review since 1958. They dubbed the process “generally recognized as secret.”
Two industry consultants told Center for Public Integrity reporters that two-thirds of their safety reviews are never sent to regulators. An international food company told the GAO that it introduces five new ingredients yearly without telling the FDA.
The 2010 GAO report said the FDA should require companies to submit basic information from safety evaluations, including a substance’s identity and use.
But the FDA says requiring this information is beyond its power. “If we tried to make it mandatory,” said Dennis Keefe, director of the FDA's Office of Food Additive Safety, “we would be sued.”
Leaving regulators and the public in the dark means it’s nearly impossible to track how much exposure people have to some ingredients, NRDC researchers say.
Safety evaluations must legally “consider the cumulative effect from all probable sources,” said Tom Neltner, an attorney and chemical engineer who has co-authored many reports about the GRAS system for Pew and the NRDC. “And if you don’t know something’s there in food, how are you going to do an assessment?”
Consider how this could play out at a family’s breakfast table.
A company might privately conclude an ingredient is safe at a specific level in cereal. Another might do the same for its use in muffins. Ditto for a third company adding it to juices.
A family sitting down to a breakfast of all three foods could end up consuming much more of the ingredient than each company had anticipated.
“How can FDA fulfill its responsibility for protecting public health and safety of the food supply if they don’t even know all the chemicals that are being used in the food supply?” asked Lisa Lefferts, senior scientist at the Center for Science in the Public Interest.
In response to such concerns, the Grocery Manufacturers Association, a powerful food industry trade group, announced last year that it is working to increase transparency in the GRAS system by creating a database of safety determinations made by industry and making it available to the FDA.
The GMA, which also announced the establishment of the Center for Research on Ingredient Safety at Michigan State University, stated in an email response to reporters’ questions that industry is “committed to providing regulators and consumers with the important information they need about our products.”
Caffeinated jelly beans
Few ingredients demonstrate the FDA’s challenges in policing the GRAS system like caffeine.
While the FDA has long recognized the safety of caffeine at a certain level in cola-type beverages, companies have expanded that use to other products by making GRAS determinations on their own. In 2013, an FDA consumer update stated that “existing rules never anticipated the current proliferation of caffeinated products.”
In recent years, companies have added caffeine to jelly beans, sunflower seeds and energy drinks. The FDA noted in its consumer update that energy drinks are “aggressively marketed” to young people, despite links to deaths and other adverse reactions.
The latest concerns about caffeine-infused products follows one of the GRAS system’s most high-profile controversies: alcoholic energy drinks, which the FDA banned in 2010 after public outcry.
In September 2010, Bo Rupp, a 15-year-old high school sophomore from Centreville, Virginia, drank two 23.5 oz. cans of Four Loko, a popular alcoholic energy drink.
During a concert that night, Rupp went “completely, intoxicatedly manic and wired,” said his family’s attorney Jeffrey Simon. Event staff had to call the boy’s parents to pick him up.
Rupp acted paranoid, according to his mother, Karla, who drove home with one hand on the wheel and the other arm holding back her son from jumping out of the moving car.
When they arrived home, Rupp ran out of the car to a busy highway where he reportedly sat down in the road. He was struck by a vehicle and airlifted to a nearby hospital. He died the next day.
Three months before he died, a panel of experts convened by industry-consultant Burdock’s firm concluded the alcoholic energy drink was safe. The manufacturer, Phusion Projects, had notified the FDA of their conclusion less than a year after 18 attorneys general told regulators that they were concerned that caffeine-infused energy drinks like Four Loko were unsafe.
Some states like New York, Utah, Oklahoma, Michigan and Washington banned the sale of the beverages before the FDA acted. Two months after Rupp’s death, federal regulators told Phusion and three other companies that their products were unsafe, essentially banning them.
"While Phusion Projects does not comment on specific legal matters," the company said in a statement to the Center about the Rupp family's lawsuit, "it is important to remember that just because a lawsuit is filed does not mean it has merit."
Burdock declined to answer questions about caffeinated alcoholic drinks, stating in an email that he “can’t discuss client business.”
The story of caffeinated alcoholic beverages highlights the FDA’s limited ability to monitor many food additives. Because industry isn’t required to seek pre-market approval from the agency, the FDA is often left to police ingredients after they’ve already hit the market.
“Having pre-market authority, having people come to us and review what they plan to apply to the food supply is much more efficient for us,” the FDA’s Keefe said, adding that post-market reviews are resource intensive. “We strongly encourage them to come to us.”