GRAS consultants discuss criticisms of GRAS experts.
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FDA’s new final rule for Generally Recognized as Safe (GRAS) regulations devotes many pages of discussion to the topic of GRAS expert panels. GRAS experts are a crucial cog in the wheel of the GRAS process. GRAS regulations permit these experts, who must be “qualified by scientific training and experience,” to review the safety data of an ingredient as it would be used in the food supply. Once experts conclude an ingredient’s intended use in the food supply is safe, companies can consider the ingredient self-affirmed GRAS and can proceed with using the ingredient in the food market.
The majority of firms seeking GRAS conclusions choose to obtain GRAS conclusions via GRAS panels. But the concept of GRAS panels has been criticized over the years.
One criticism is that some GRAS conclusions are rendered by GRAS panels not adequately qualified to perform GRAS reviews. Another concern is that if companies are paying GRAS panels to do GRAS reviews, those GRAS experts may be influenced to deliver positive GRAS findings. For these reasons, critics of the GRAS system, such as the U.S. Government Accountability Office, have in the past urged FDA to provide more regulatory guidance around GRAS panels.
In its GRAS final rule, released on August 12, the agency indicated it plans to do just that. “We intend to issue for public comment a draft guidance to address GRAS panels,” FDA stated in the final rule.
We asked longtime GRAS consultants-those who themselves serve as third-party, paid GRAS experts-whether these criticisms are valid.
Not All GRAS Experts Are Qualified to Perform GRAS Reviews
George Burdock, PhD, founder of regulatory consultancy The Burdock Group (Orlando), which conducts reviews for both GRAS and new dietary ingredient (NDI) notifications, said that he “has no objection to more clarity on expert panels.” According to Burdock, it’s true that not all individuals either creating GRAS dossiers or conducting GRAS reviews are qualified to do so.
“I have seen some GRASes signed by ‘experts’ who could not document their expertise even if their lives depended on it," he said. "There are truly some unvetted people serving as ‘GRAS experts,’ and maybe even more importantly, the inexperienced or biased preparers of GRAS dossiers upon which the GRAS experts base their decision. Some dossiers we have been asked to review were clearly prepared by someone not familiar with the subject matter and who had either cherry-picked the scientific literature or did not know what to look for in the literature and/or were unprepared to interpret the information they found.”
In short, he said, “expertise does not mean two or three people whose first name is ‘doctor.’”
Bob McQuate, PhD, cofounder and senior vice president, sales and business development, for regulatory consultancy GRAS Associates (Bonita Springs, FL), said that even if experts are competent, they may not be knowledgeable enough about the GRAS system to conduct reviews without assistance from those familiar with the system. This fact, he said, “underscores for me the importance of the fact that having someone who is qualified and has been on several expert panels before is an advantage.”
Conflict of Interest for Paid GRAS Panels?
And what if those experts are paid to conduct GRAS reviews? Do they find themselves obligated to deliver news a company will want to hear-a positive GRAS conclusion? Burdock and McQuate disagreed that this is a major problem.
Qualified experts need to be paid, McQuate pointed out. “If you aren’t going to compensate qualified panel members, who are you going to get to do those evaluations?” he asks. “Are you going to get people who are unqualified but who would be willing to do it gratis because they’re trying to cultivate a name and a visibility for themselves? You’ve got to compensate people.”
McQuate also maintained that not all GRAS panels deliver positive opinions just because they’re getting paid. “The fact that you’re getting compensated doesn’t mean your opinion can be bought. There are a lot of panels that convene and they decline to confer GRAS status because the criteria have not been met. We do that. Not everybody that asks for engagement gets the results they want.”
According to Burdock, “the conflict of interest…issue is a canard, a red herring, a distraction from the real issue.”
“The people who clamor most about [conflict of interest] are those wanting to be paid for working as GRAS experts but whose primary credential is that they know nothing practical about the subject or GRAS process,” he explained. “Yes, they are not conflicted because they have never been involved to any extent in food ingredient safety…”
One area where there may be a conflict of interest is if a GRAS expert is not a third-party paid consultant but rather an employee of the firm seeking the GRAS conclusion, McQuate said. This is one area “where I do agree with some of the critics and the consumer activists with regard to members of expert panels,” he said.
“If you’re an employee of a company, and even if you have excellent scientific credentials and familiarity with the regulatory process, you can’t expect that employee to be truly independent,” he continued. “If they are being paid by the company, can they disagree with something that would be disadvantageous to the company? And it can be argued that they can’t truly be independent.”
“I would say that aspect is one of the things that can legitimately be aired and discussed in terms of preserving the integrity of an expert panel,” McQuate concluded. “If a company that’s the sponsor of a GRAS determination wants to have an independent panel, they should not include their employees as scientists. They can be on the expert panel, they can be engaged as scientific advisors to make sure that good, rigorous science is involved, but they should not be involved in a decision-making capacity as a member of an expert panel.”
GRAS Expert Criticizes GRAS Rule's "Granular" Details
Looking beyond GRAS panels and to the totality of the document, Burdock said that the final GRAS rule may in a way be a hindrance to firms who want to generate high-quality GRAS conclusions. In short, he said, the level of detail FDA goes into are “granular requirements, needless micromanagement, and potential ‘gotchas'" that Congress did not intend when establishing the GRAS framework.
Of the GRAS final rule, he said, “In retrospect, the framework will either be seen as GRAS DIY instructions (inviting more poorly done GRASes), or so complex and filled with potential ‘gotchas’ as to go the way of the NDI guidance, with the bar for a successful notification raised too high [and] resulting in fewer notifications and increased risk to public safety,” Burdock said. “When historians start looking for causation, they will conclude that such detailed instructions were totally antithetical to the concept of generally recognized as safe.”
He said that this was not Congress’s intent when establishing the GRAS process. The law, he said, welcomed the concept of "bona fide experts having knowledge of the universe of food ingredient safety, such that they can make judgments not just on a particular isolated case but also how that ingredient compares to other ingredients used in food,” he said. “Broad-based experts, with practical knowledge in this field, is what Congress had in mind when debating the 1958 amendment and creating the concept of GRAS.
"Congress knew that FDA could possibly be flooded with hundreds of food-additive petitions (FAP) if all ingredients in food were required to undergo the FAP process. Congress chose to enlist the help of experts who could make a judgment on safety for ingredients that may have been in use for hundreds of years (such as spices) or whose outward characteristics did not reflect any known toxic effect through ‘scientific procedures,'" he said. Instead, the final rule ultimately may be a hindrance, not help, to the GRAS process.
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