SUBSCRIBE

Breaking News on Food & Beverage Development - North AmericaEU edition | Asian edition

News > Regulation

Loading...

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

Post a comment

By Hank Schultz

11-Jul-2014
Last updated on 14-Jul-2014 at 17:46 GMT

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.

Subscribe to our FREE newsletter

Get FREE access to authoritative breaking news, videos, podcasts, webinars and white papers. SUBSCRIBE

Post a comment

Comment title *
Your comment *
Your name *
Your email *

We will not publish your email on the site

I agree to Terms and Conditions

These comments have not been moderated. You are encouraged to participate with comments that are relevant to our news stories. You should not post comments that are abusive, threatening, defamatory, misleading or invasive of privacy. For the full terms and conditions for commenting see clause 7 of our Terms and Conditions ‘Participating in Online Communities’. These terms may be updated from time to time, so please read them before posting a comment. Any comment that violates these terms may be removed in its entirety as we do not edit comments. If you wish to complain about a comment please use the "REPORT ABUSE" button or contact the editors.

Consumers say it’s natural if it comes from a plant: PureCircle

Consumers say it’s natural if it comes from a plant: PureCircle

Faith Son

vice president of global marketing and innovation, PureCircle

Cargill rides publicity wave with Trehalose functional ingredient

Cargill rides publicity wave with Trehalose functional ingredient

Cargill has weathered a potential media storm concerning its functional ingredient Trehalose.  The ingredient,...

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

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

The GRAS process as it stands in the United States is vulnerable to criticism...

Global ID: 'Demand for Non-GMO-Project verification doubled after Whole Foods put its GMO cards on the table...'

Global ID: 'Demand for Non-GMO-Project verification doubled after Whole Foods put its GMO cards on the table...'

The growth of the Non-GMO Project verification scheme has been nothing short of explosive...

Bread in terminal decline? 'We’re actually very positive about the future of grain-based foods,' says Ardent Mills

Bread in terminal decline? 'We’re actually very positive about the future of grain-based foods,' says Ardent Mills

Lackluster sales of packaged bread & ready-to-eat cereals might suggest that years of carb-bashing...

'It's business as usual': Davisco Foods on Agropur takeover

'It's business as usual': Davisco Foods on Agropur takeover

Polly Olson

Vice President of Business Development, Davisco Foods International

Snack trends 2014: Euromonitor says popcorn and thins

Euromonitor: Popcorn and thins epitomize ‘indulgence without the guilt’

Popcorn has exploded and thins have sliced into action in snacking – both riding...

InHarvest: Legumes, pulses steal spotlight from animal protein

At the 2014 Research Chefs Association Conference & Culinology Expo, FoodNavigator-USA caught up with...

SFA head: ‘A little term called class action suits’ is prompting GMO removal

SFA head: ‘A little term called class action suits’ is prompting GMO removal

Genetically modified organisms are safe and there is a need and place for them...

Could oats be the next gluten-free star?

Could oats be the next gluten-free star?

Oats, when the supply chain ensures no cross-contamination, are a gluten-free cereal grain. So...

Fed up: Probiotic research veteran issues global call to action

Fed up: Probiotic research veteran issues global call to action

Veteran probiotic researcher professor Gregor Reid is not a happy man. It’s time the...

GMO-free Cheerios: Did General Mills buckle to consumer pressure? Will the move backfire?

GMO-free Cheerios: Did General Mills buckle to consumer pressure? Will the move backfire?

General Mills’ move to go GMO-free on its flagship Cheerios brand has caused quite...

Irish firm offers (cheaper) heat resistant probiotics for infant formula

Irish firm offers (cheaper) heat resistant probiotics for infant formula

Sinéad Doherty, PhD

Founder, AnaBio Technologies

Conservative North American dairy more 'open to innovation': Chr Hansen

Conservative North American dairy more 'open to innovation': Chr Hansen

Roy Riley

Marketing Director Cultures and Enzymes, Chr Hansen