Experts in helping firms navigate the GRAS (generally recognized as safe) process say the American Heart Association (AHA) made some valid points in its recent attack on GRAS, but argue the system is actually working pretty well.
The AHA, which claims there are serious weaknesses in a system that allows firms to self-affirm the safety of ingredients without the approval or even the knowledge of the FDA, outlined its concerns in a recent submission to the government’s Food Safety and Inspection Service (FSIS).
Is the GRAS process flawed?
Its biggest gripe was that manufacturers choosing to go down the self-affirmed GRAS route are not legally required to notify the Food and Drug Administration (FDA) that they have done so.
“If manufacturers choose not to submit notifications to the Agency, the FDA will, in general, have no information about those GRAS determinations. Thus, the FDA cannot ensure the sufficiency of all new GRAS determinations because it only reviews the ones that are sent to it.”
Another weakness in the GRAS process is that there is “no mechanism for systematically ensuring the independence and sufficiency” of the expert determinations companies rely on for GRAS affirmations, said the AHA.
AIBMR Life Sciences: The current GRAS system is working well
John R. Endres is chief scientific officer at Seattle-based AIBMR Life Sciences, which has helped several firms prepare GRAS self-affirmation determinations for FDA review.
He told NutraIngredients-USA: “We agree that it would be prudent to have system in place where companies that attain GRAS self-affirmations at least have to let the FDA know this so they are aware of new ingredients being added to food.
“It goes without saying that if companies don't follow the guidelines and don't use a proper expert panel with proper qualifications, an ingredient could claim to be GRAS, when in fact it isn't. [But] we don't feel this is happening for the vast majority of GRAS self-affirmations.”
He added: “I believe that the vast majority of companies are ethical and are following proper methods for achieving GRAS status.
“We feel the current GRAS system is working well. The FDA was getting so far behind on GRAS reviews that the proposed rule in 1997 [which replaced a voluntary petition process with a voluntary notification system] was good for innovation and the US economy by providing a mechanism where ingredients could be evaluated for safety and then if safe could make it to the market much more quickly.”
Self-affirmed GRAS is not ‘GRAS-lite’
The implication in the AHA’s submission to the FSIS that self-affirmed GRAS was ‘GRAS-lite’ was also misleading, added Endres.
“Qualitatively and quantitatively there should be no difference between a safety assessment for either a GRAS self-determination or an FDA GRAS notification as they are both subject to the same criteria.
“Manufacturers generally don’t do their own GRAS determinations. A manufacturer or ingredient supplier normally contracts a firm such as AIBMR Life Sciences with years of experience with a highly-regarded expert panel to prepare a safety assessment of the ingredient."
Big food manufacturers expect GRAS ingredients that are checked by the FDA
However, he acknowledged that most major food manufacturers viewed self-affirmed GRAS as only the first step in the process, adding: “It should also be pointed out that many of our clients achieve a critical growth level that sparks the interest of the large multi-national companies.
“These companies require a no objection letter from the FDA on a GRAS notification before they will add the ingredient to their foods. Therefore, the ingredients that result in the greatest exposure to the US population have most likely been reviewed for safety by the FDA.”
He also challenged the AHA’s contention that there is no clear guidance for companies seeking to self-affirm their wares as GRAS, adding: “FDA does have guidance for many aspects of GRAS notifications.”
FDA is constantly listening for signals to establish of GRAS determinations need revisiting
As for the AHA’s claim that there is no mechanism in place to monitor GRAS substances on an ongoing basis, the FDA uses a system dubbed ‘signal strength’ to determine if the GRAS status of a substance needs revisiting, he said.
“They are constantly listening for signals regarding harm to the US population. When a signal gets strong enough, they quickly move into action."
Spherix: Mandatory notification to FDA would boost transparency of GRAS process
Dr Claire Kruger, chief executive, and Dr Nancy Booth, science consultant, at consultancy Spherix Health Sciences, also agreed that when carried out with due diligence, the GRAS process "is a robust, comprehensive, and transparent safety evaluation process".
But the AHA had raised some legitimate concerns, they added: “The FDA has not officially opined on a definition of ‘expert’, leaving it to companies to identify and recruit appropriate scientific experts to serve on GRAS panels.
“Nor has it issued guidance regarding the definition of conflicts of interest for those who serve on expert panels convened by companies to self-determine the GRAS status of an ingredient."
The AHA's key point regarding transparency was also a fair one, they noted: “A criticism that can be lodged against GRAS is that the FDA is less informed about the nation’s food supply than it could be because notification of GRAS determinations to the FDA is not mandatory.
“One approach to further strengthen the GRAS process would be for the FDA to seek authority from Congress to require all companies to notify the FDA of their GRAS determinations. Requiring Notification would further enhance transparency of the GRAS process by allowing easier public scrutiny of the scientific information compiled in support of an ingredient’s safety.”
As for salt, they noted that the Institute of Medicine’s recommendation to impose upper limits for salt content in various foods did not amount to “a revocation of the GRAS status of salt but a process of re-defining the upper threshold of use under which GRAS status no longer applies.”
They added: “FDA has addressed the goal of reducing sodium intake through labeling approaches rather than ingredient regulation to encourage lower sodium intakes.”
Click here to read the AHA's comments on the GRAS process, contained in its comments to the government's Food Safety and Inspection Service (FSIS), which is conducting a probe into sodium reduction strategies.