“There is a serious gap between public expectations of the FDA’s role in reviewing ingredient safety, and the current industry-run safety determinations that are being made,” the Massachusetts Democrat said in a highly critical letter sent to FDA April 26.
He explains that “the public assumes that the FDA plays a pivotal role in assessing the safety of new food ingredients by ensuring that any ingredient used in foods has been thoroughly vetted and determined to be safe by the agency.”
However, he says, upwards of 1,000 ingredients currently “are used in food and beverages without ever being evaluated by the FDA.”
He explains this is possible because a “loophole” in the regulations allows GRAS substances to be exempt from prior approval by the agency if qualified, scientifically trained experts, often hired by companies, determine there is “common knowledge” about the ingredients’ safety.
While the regulations encourage companies to voluntarily file GRAS notifications with FDA, which the agency would either deny if it found a safety risk or file without objection if it did not, companies are not required to tell FDA if they have self-determined an ingredient to be GRAS prior to use, the senator writes.
As a result, he said, “FDA typically does not know the identity of GRAS substances, the foods in which they are used, and how much they are used,” he said.
Even if FDA is notified of a GRAS determination by one company, if it finds a safety concern it may not be able to guarantee its removal from all products on the market because other companies also could have self-determined the ingredient as safe and not told FDA.
“This system challenges the statutory intent of FDA’s assignment to protect the safety of the food supply, because there is no way to track the degree to which people have been exposed to these types of ingredients,” he argues.
Markey suggests warning labels for GRAS ingredients
One possible solution to bridge the gap between public expectation of FDA’s role in reviewing ingredient safety and the current GRAS self-determination process could be requiring a special label on foods or beverages with ingredients determined to be GRAS without FDA review, the senator suggests in the letter.
“Could the FDA consider the use of a statement similar to the standard disclaimer on dietary supplements, but instead refers to the safety of the product’s ingredient(s),” he asks.
“For example,” he suggests, “The safety of some ingredients in this product has not been evaluated by the Food and Drug Administration.”
Markey also questions FDA’s ability to fulfill a previous suggestion from the Government Accountability Office to develop a system to monitor companies’ GRAS determinations through audits or other means, given the agency does not have full access to all self-determined GRAS substances.
“Does the agency believe it needs additional authority to ensure the safety of GRAS substances?” he asks.
Markey questions authority of impending GRAS guidance
Finally, Markey prods the agency about the whereabouts and potential effectiveness of long-promised guidance to mitigate conflicts of interest among the expert panels that review GRAS self-determinations.
“Conflicts of interest are ubiquitous in GRAS determinations – even those submitted voluntarily to FDA,” as illustrated by the fact that many determinations are made by employees of or experts hired by the companies seeking a positive confirmation, Markey writes.
“Of the 451 GRAS notifications voluntarily made to FDA between 1997 and 2012, 22 percent were made by an employee of an additive manufacturer, 13 percent by an employee of a consulting firm to the manufacturer, and 64 percent by an expert panel selected directly or indirectly by a consulting firm and/or manufacturer,” he writes.
The director of FDA’s Center for Food Safety and Applied Nutrition, Susan Mayne, confirmed last week at the Grocery Manufacturers Association Science Forum that the agency is on track to publish a final rule related to GRAS, after which it will publish two guidances. The first will outline what GRAS means and how FDA interprets GRAS status, and the second will address conflicts of interest on GRAS panels, she said.
While a guidance no doubt would provide companies that want to do the right thing with much needed information on how to do so, Markey says a guidance may not be enough as it would be “nonbinding and completely voluntary.”
With that in mind, he asks FDA if it has sufficient authority to set rules that would reduce conflicts of interest on the expert panels, and if so, when would the agency promulgate the rule.
One reason for the delay on the GRAS final rule and guidances likely is the agency has had its hands full complying with deadlines for new regulations under the Food Safety Modernization Act. However, this may soon no longer be an issue as Mayne also said the agency is on course to publish the last final foundational rule for FSMA by May 2016.
Markey will give the agency through May 17 to respond to his critiques and questions.