Self-affirmed GRAS under fire again as PEW highlights ‘loophole that appears to have swallowed the law'

By Elaine Watson

- Last updated on GMT

Neltner: 'How can the FDA ensure the safety of chemicals added to food if it has no information on one in 10 of the chemicals in question?'
Neltner: 'How can the FDA ensure the safety of chemicals added to food if it has no information on one in 10 of the chemicals in question?'
There are serious weaknesses in a system that allows firms to self-affirm the safety of food ingredients without the approval or knowledge of regulators, according to researchers conducting a probe into the nation’s food additives law.

Tom Neltner is in charge of a comprehensive, three-year investigation into food additive regulations conducted by the Pew Health Group, which is part of The Pew Charitable Trusts.

Speaking to this publication about the progress of the project two years in, Neltner said firms opting for self-affirmed GRAS (Generally Recognized as Safe) status for their ingredients are not legally required to notify the Food and Drug Administration (FDA), which means the agency cannot ensure the sufficiency of all new GRAS determinations because it only reviews the ones that are sent to it.

How can the FDA ensure the safety of chemicals added to food if it has no data on one in 10 of them?

He added: “Of the 10,000 chemicals added to food we looked at, we believe more than 3,000 have never gone through an FDA review and for at least 1,000 of these, the FDA has received no notification at all​.

“The other 2,000 are flavors and at least there are records of these from the Flavor and Extract Manufacturers Association (FEMA), but for the 1,000 other substances, the FDA is completely in the dark.  We think this is the first time that anyone has tried to calculate just how big this number might be.

“There is a loophole here that appears to have swallowed the law. How can the FDA ensure the safety of chemicals added to food if it has no information on one in 10 of the chemicals in question?"

FDA in the dark about self-affirmed GRAS substances

The safety standards to which firms going through the GRAS process must adhere are just as high if not higher than those required for firms making a food additive petition, he said.

However, firms choosing to go down the self-affirmed GRAS route are not legally required to notify the FDA that they have done so, said Neltner, who plans to publish his group’s findings and policy recommendations over the next 6-9 months in a series of articles in peer-reviewed journals.

Thus the FDA has no central record of the estimated 1,000+ self-affirmed GRAS determinations made where companies have not notified the agency, and therefore no means of checking the quality of the evidence submitted or the credentials of the experts reviewing that evidence, said Neltner.

“Who is on these panels? How many people sit on them? Are they independent? Or are companies judging their own work?”​.

Companies can withdraw from the FDA notification process voluntarily

He added: “Another problem is that if you do decide that you will submit the findings of your panel of experts to the FDA, they may and often do come back and ask questions. And if it looks as if you could receive a letter saying there is insufficient evidence to support the GRAS status of your ingredient, you can withdraw your notification voluntarily.

“This happens in a significant number of cases. And in some of these, if a company does not resubmit the GRAS determination to the FDA, it may market the products ​[anyway]."

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

Many of Neltner’s concerns reflect those 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’.

In its list of recommendations (also supported by the American Heart Association - which has petitioned the FDA to reassess the GRAS status of salt), the GAO said 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 also urged the FDA to develop a strategy to reconsider the safety of GRAS substances that were ‘grandfathered in’ decades ago (such as salt) “in a more systematic manner”​.

AIBMR: GRAS system is working pretty well

However, Seattle-based AIBMR Life Sciences, which has helped several firms prepare GRAS self-affirmation determinations for FDA review, argued the system was actually working pretty well in a recent interview with this publication.

John R. Endres, ND, chief scientific officer, said: “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: “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​.”

Meanwhile, manufacturers “generally don’t do their own GRAS determinations​”, he claimed. “They normally contract 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."

Spherix: The more transparency the better

However, Dr Claire Kruger, chief executive, and Dr Nancy Booth, science consultant, at consultancy Spherix Health Sciences, said more transparency would be helpful: “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.”



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GRAS Self-affirmation principles

Posted by Roy Upton,

The regulatory nature of the food and supplement supply requires for ingredients to be safe for their intended use.If this criteria is not met, FDA retains the authority to remove those ingredients from the market. There is a good reason self-affirmation of GRAS exists; if it did not, 99% of the common foods we eat from carrots, to broccoli to kiwi fruits, none of which were ever subjected to formal safety reviews could remain on the market. The majority of herbal and nutritional ingredients have similarly been in the public domain for decades or centuries. Conversely, the same level of safety cannot be presumed for new synthetic ingredients that are introduced and so for such substances a formal process should be required.

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Posted by Harry Rice,

While some companies may use the self-affirmation process as a way to decrease their due diligence, I believe the majority of companies are compiling their GRAS Determinations the way FDA intended. Ingredient buyers need to do their due diligence and ask for the proper documentation. It's well within a buyer's rights to ask for a copy of a supplier's Self Affirmation. Refusal by the supplier should raise a red flag.

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GRAS is not always greener

Posted by James J. Gormley,

To give Mr. Neltner and the PEW Health Group a little perspective, it took the FDA nearly 20 years (1950 to 1969) to remove cyclamates from the market by pulling it off the GRAS list and that was mainldy due to tremendous pressure from consumers.

In December 1958 the FDA compiled a tentative list of 189 substances that it believed could be GRAS, and the agency sent the list to 900 scientists, only 350 of whom replied, and of that number only 194 "concurred with the list or made no comment."

Based on these replies, an updated list, which only deleted 6 of the original substances, became official in November 1959.

Once an item is on the GRAS list, it remains there, not reviewed, until questions are brought up about its safety. Since 1959, there has been no systematic review of any items on the GRAS list.

I place much more trust in a properly conducted self-affirmed GRAS determination than in the haphazard and casual approach the FDA has used.

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