Self-affirmed GRAS under fire as AHA steps up sodium reduction campaign

By Elaine Watson

- Last updated on GMT

Related tags Food and drug administration Government accountability office Food

GAO: Any company that conducts a GRAS determination should have to provide FDA with at least some basic information, such as the substance's identity and intended uses
GAO: Any company that conducts a GRAS determination should have to provide FDA with at least some basic information, such as the substance's identity and intended uses
There are serious weaknesses in the system that allows firms to self-affirm the safety of foods without the approval or knowledge of the Food and Drug Administration (FDA), according to the American Heart Association (AHA).

The AHA, which has called on the FDA to modify the GRAS (generally recognized as safe) status of salt, says it has major concerns about the GRAS process.

In its submission ​to the Food Safety and Inspection Service (FSIS) probe into sodium reduction, AHA president Dr Gordon F. Tomaselli said:

The current process relinquishes too much of the Agency’s authority to food manufacturers and does not do enough to ensure the safety of substances that are added to foods.

“We believe the FDA should have greater involvement in GRAS determinations, should increase its level of enforcement, and should implement a process to periodically review the science supporting a GRAS claim.”

FDA in the dark about self-affirmed GRAS substances

The AHA was particularly alarmed by the lack of accountability in the self-affirmed GRAS process, he said.

“AHA is concerned that the current process allows food manufacturers to make their own GRAS determinations.

“If a manufacturer determines that a use of a substance is GRAS as set forth in the FDA regulations, it does not need to seek premarket approval from the FDA to use the substance in that way.

But far more worrying was the fact that firms choosing to go down the self-affirmed GRAS route are not required to notify the FDA that they have done so, he said.

“We are further concerned that manufacturers may choose – but are not required – to notify the FDA of their GRAS determination. 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.”

No mechanism for ensuring independence and quality of expert determinations in GRAS affirmations

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 determinations, said Tomaselli.

For example, in about half of the GRAS determination notices, the FDA receives expert panel reports, “most of which have not been published in peer-reviewed journals”, ​he said.

“However, the FDA has not issued any guidance about conflicts of interest for these experts, nor does it require companies to provide information or assurances about the independence or potential conflicts of interest of these expert panelists.”

And if firms opt for self-affirmed GRAS and do not notify the FDA that they have done so, “there is no way to ensure independent review of such GRAS determinations”, ​he said.

GAO 2010 report: Firms doing self-affirmed GRAS should have to notify the FDA

Many of the AHA’s concerns about the GRAS process were also raised by the Government Accountability Office (GAO) which published a report in 2010 entitled: ‘Food Safety: FDA Should Strengthen its Oversight of Food Ingredients Determined to be Generally Recognized as Safe’.

According to the GAO, the FDA “has not issued guidance to companies on how to document their GRAS determinations or monitored companies to ensure that they have conducted GRAS determinations appropriately”.

Moreover, the FDA is “not systematically ensuring the continued safety of current GRAS substances​” and has “largely not responded to concerns about GRAS substances” ​raised by advocacy groups, ​claimed the GAO.

Meanwhile, FDA does not know to what extent, or even whether, companies track evolving scientific information about their GRAS substances, it pointed out.

It its list of recommendations, the GAO said the Commissioner of FDA should “monitor the appropriateness of companies' GRAS determinations through random audits or some other means, including issuing guidance on how to document GRAS determinations”.

And any company that conducts a GRAS determination should have to provide FDA with at least some basic information, such as the substance's identity and intended uses, it added.

Finally, the FDA should develop a strategy to reconsider the safety of GRAS substances “in a more systematic manner”, ​it concluded.

Why should salt’s GRAS status be modified?

And salt is a prime example of a GRAS substance that warrants reconsideration, according to the AHA.

Said Tomaselli: “We request that the FDA act now and modify salt’s GRAS status. To be considered GRAS, salt must be ‘generally recognized’ by scientific experts or scientific procedures to be safe under the conditions of its intended use. Salt does not meet the FDA’s definition for a general recognition of safety.

“In fact, the general consensus among the scientific community – including the experts appointed to the 2010 Dietary Guidelines Advisory Committee – is that sodium is not safe and has negative health consequences.

“Thus, salt also does not meet the ‘safe’ requirement.”

The FDA should now consider how much salt is used and in what foods and the relation of its probable human intake to the level at which adverse effects are observed in toxicological studies, he said.

“The FDA must consider not only the amount of salt in a particular food product, but an individual’s likely cumulative intake, which… far exceeds the recommended daily amounts.”

The FDA was unavailable for comment as this article went to press.

Click here ​to read more about the AHA's position on sodium reduction.

Click here​ to read more about concerns surrounding the self-affirmed GRAS process.

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