The Food and Drug Administration published a new rule last week to clarify how it regulates ingredients that are added to processed food that are generally recognized as safe.
"Experience has shown that our regulations need further clarification to help stakeholders understand when a substance is eligible for classification as GRAS in human food or animal food under the conditions of its intended use," the rule states. "Experience also has shown that streamlining our evaluation of conclusions of GRAS status will enable us to evaluate more, and higher priority, substances."
But some say the 329-page rule on these additive ingredients — known by the acronym GRAS, which include items like vinegar, oils, spices and preservatives — brings more obfuscation than understanding. The rule adds more detail to how a report needs to be made, but does not fundamentally change the hands-off process the agency has used to approve these ingredients since 1997.
Consumer groups say that the rule allows manufacturers to continue to hide their actions and secretly add things that may be unsafe to food.
"I'm not sure that this changes much," Laura MacCleery, vice president for consumer policy and mobilization at the Consumers Union, which publishes Consumer Reports, told Food Dive. "It sanctifies a problematic policy."
Manufacturers, however, say that it is a large step forward in terms of transparency.
"This rule has done a number of things to benefit the industry and consumer," Dr. Leon Bruner, chief science officer for the Grocery Manufacturers Association told Food Dive.
The Consumers Union and other advocacy groups said they are examining the options available to continue the debate and get a clear policy with more regulation in place.
"This really was a missed opportunity," Cristina Stella, staff attorney at the Center for Food Safety, told Food Dive.
How did we get here?
Under a proposed rule in 1997, an ingredient could receive the GRAS designation as long as it met basic guidelines for food additives and members of the scientific community could show a reasonable certainty that it wouldn’t cause harm. But food manufacturers are under no obligation to report an ingredient they think should receive the designation to the FDA.
In 2004, the Center for Food Safety filed a lawsuit against the FDA, claiming the agency was not following federal law by allowing the manufacturers to make safety determinations on ingredients. The lawsuit demanded that the FDA finalize the GRAS rule. In the filing, the CFS mentioned ingredients that received a GRAS designation—including volatile oil of mustard, Olestra and mycoprotein (also known by the brand name Quorn)— but are potentially hazardous.
In 2010, the U.S. Government Accountability Office weighed in. "FDA's oversight process does not help ensure the safety of all new GRAS determinations," a report directing the agency to strengthen its authority on the issue says.
With manufacturers providing the scientific basis for ingredients to receive a GRAS designation, a 2013 study by the Pew Charitable Trusts found many conflicts of interest. In a review of 451 GRAS notifications between 1997 and 2012, 22.4% of the assessments came from employees of additive manufacturers, 13.3% from employees of consulting firms chosen by the manufacturers, and 64.3% by expert panels chosen by either consulting firms or manufacturers. In an editorial written about the study for JAMA Internal Medicine, food studies professor and author Marion Nestle wrote this made up “an astonishing 100 percent” of the members on expert panels.
The final rule published last week does not change the process where manufacturers can choose to report that ingredients are GRAS. The Consumers Union estimates that around 1,000 items have gotten into the food supply without notice to the FDA through this process, and thousands more have had only minimal oversight.
Stella said this codifies a "huge loophole" that manufacturers were taking advantage of, and that the agency has taken a step backward in its mandate to keep consumers safe.
"That was the whole reason we brought the lawsuit," she said. "It was our opportunity to end this proposal for food companies to operate with no accountability."
What about manufacturers?
The ruling, consumer advocates said, favors food manufacturers and lets them keep adding whatever they want to food. Stella said it could embolden some manufacturers who are "bad actors."
Bruner said that the industry doesn't want to hide anything.
"Food safety and transparency is as important to us as it is to anyone else," he said. "There is no drive, no interest whatsoever in putting unsafe ingredients in food products. ... The industry applauds all efforts to improve safety in this area."
The new rule does a great deal to improve safety, he said. It clarifies definitions and rules, and codifies the type of safety data that needs to be submitted to the FDA. It calls for this data to be in the public domain, adding to the transparency process. And he said it requires manufacturers to wait for the FDA to review their GRAS notification before they can put products with those ingredients into production. Bruner said the FDA will be much more engaged in GRAS designations under the new rule.
And, Bruner pointed out, all food products have every ingredient on their labels, so nothing can be secretly added.
Since 2014, the GMA has been working on an initiative to improve transparency in GRAS assessments. This includes developing a publicly available standard for GRAS determinations, a database with all GRAS assessments, education and training for scientists who assess ingredients, and a communications outreach program.
MacCleery said that the rule does no favors for those in the industry who are trying to increase transparency and cut back on additives or questionable ingredients.
"In the absence of regulations, the food industry can talk until it's blue in the face. With this rule, it lacks credibility," she said. "And this is not a problem the food industry can fix on its own."
MacCleery said that action on the issue is not over.
"The FDA cannot set meaningful priorities when it does not know what is in the food supply. Period. It’s that simple,” she said.
In April, Sen. Ed Markey (D-MA) wrote a letter asking FDA Commissioner Dr. Robert Califf to respond to several key consumer concerns about the GRAS rules. In response to the new rules, he said in a written statement that he will explore a legislative remedy to the issue.
"The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn't even have to hand in," he wrote. "The FDA missed an opportunity to strengthen the GRAS process by requiring mandatory reporting of GRAS substances."
Bruner said there is no need to revisit the rule.
"There is no self grading," he said. "There are specific requirements now. There is a specific dossier that needs to be sent to the FDA."