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Particulars of GRAS process leave it open to criticism, expert says

By Hank Schultz

11-Jul-2014
Last updated on 14-Jul-2014 at 17:46 GMT2014-07-14T17:46:40Z

Claire Kruger PhD

Claire Kruger PhD

The GRAS process as it stands in the United States is vulnerable to criticism based on possible conflicts of interest and low-quality safety work, said Claire Kruger, PhD, president of Spherix Consulting, a division of ChromaDex.

In a video shot with NutraIngredients-USA at the recent Institute of Food Technologist’s show in New Orleans, Kruger said the way the process is put together from a regulatory perspective lends it some unique elements that differentiate it from almost any other market around the world in the freedom it affords manufacturers to quickly bring ingredients to market.

Unique process

“The GRAS process is actually quite old. It started back in 1958. It has three pivotal elements. The first is documenting the safety of the ingredient. The next two are actually unique to the GRAS process: The second is the pivotal information on which you rely must be publicly available. And the third thing is that you have to show that there is a consensus of expert opinion. Those last two elements differentiate it from the food additive process, which is a premarket approval process,” Kruger said.

But while the process makes for a freewheeling market, it opens the door for critics.  For example, a study published last year in JAMA Internal Medicine alleged that conflicts of interest are ubiquitous in GRAS determinations and a in a significant minority of cases, manufacturers are effectively judging their own work. The study has been challenged by food safety experts, but nevertheless found traction in the mainstream media.

Using conflict of interest criteria developed by the Institute of Medicine, Tom Neltner and colleagues from the Pew Health Group analyzed 451 GRAS notifications voluntarily submitted to the Food and Drug Administration (FDA) between 1997 and 2012.

They found that 22.4% of the GRAS assessments in question were conducted by an employee of the manufacturer of the ingredient being scrutinized, 13.3% were conducted by an employee of a consultancy selected by the manufacturer and 64.3% by an expert panel selected by a consultancy or the ingredient manufacturer.

Question of quality

“There is no requirement that a company notify FDA that they have made this determination of safety. So the questions of who is doing it and how are they doing it and whether there are conflicts of interest in those who are going that process, is that something that is worth discussion?  Certainly it always worthwhile to go back and question old paradigms,” Kruger said.

Kruger said that one frequent observation is that many experts appear on many GRAS panels and do so over a period of years, leading to a inference of cronyism. She countered that many of these experts have impeccable credentials, and their experience is big plus.

“If you had a car that was broken and you could take it to someone who had worked on your kind of car or to someone who had never seen your kind of car, who do you think would be better qualified to fix it?” she asked.

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