Senator slams FDA final rule on GRAS: ‘a self-graded take home exam that industry doesn’t even have to hand in’

By Elaine Watson

- Last updated on GMT

Picture credit: Istockphoto, Liudmyla Supynska
Picture credit: Istockphoto, Liudmyla Supynska

Related tags Gras Fda

New FDA rules clarifying the process by which ingredients are deemed generally recognized as safe (GRAS) have been welcomed by some stakeholders, but harshly criticized by others, who say any system allowing firms to self-determine the safety of their own products without the knowledge – never mind approval - of regulators is fundamentally flawed.

Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same strict safety standards as approved food additives, said the FDA, which noted that the GRAS process was designed to cover ingredients that were either widely and safely consumed before 1958 or are considered safe by qualified experts based on data that is “generally available and accepted​.”

In its final rule ​– which formalizes the voluntary GRAS notification procedure (changing from a petition to a notification process - which has been in place since the late 1990s) and clarifies what kind of science is required to determine if an ingredient is GRAS – the FDA “strongly encourages​” companies to notify the agency of their GRAS determinations, but does not mandate it.

Under the rule, FDA must respond to a GRAS notice within 180 days after filing, with an option to extend the timeframe by an additional 90 days as needed.   

The FDA has also committed to issuing guidance outlining how to avoid potential conflicts of interest on GRAS panels, in order to address concerns ​that in a significant minority of cases, manufacturers are effectively judging their own work.

FDA: GRAS is not a means of circumventing food additive process 

According to the FDA, which stressed that the food industry has been “actively submitting GRAS notices​” on a voluntary basis for years, “mandating submission of GRAS notices would need to be done in a separate rulemaking to ensure adequate notice and comment.”

Meanwhile, forcing companies to maintain active registrations for GRAS substances in a public database - something consumer advocacy groups would like to see - was not within its legal remit, it argued: “This… is suggesting a process not within our regulatory framework … We note, however, that the final rule provides a framework for making the GRAS notices, and our responses to these notices, available to the public​.”

Finally, to those arguing that the food industry is using the GRAS process to circumvent the food additive petition process, the FDA said it would tell companies if a food additive petition was more appropriate for their ingredients: “We will, when appropriate, issue an ‘insufficient basis letter’ or a ‘cease to evaluate letter’ signaling that a petition to obtain a regulation is more appropriate than a GRAS notice.”

Sen. Markey: Legislative remedy may be needed

However, Senator Ed Markey (D-Mass), said the above point was clearly moot if the FDA was not notified about the GRAS determination in question in the first place, adding: “The health and well-being of the American people depend on a meaningful food safety regulatory policy, not a self-graded take home exam that industry doesn’t even have to hand in.

“The FDA missed an opportunity to strengthen the GRAS process by requiring mandatory reporting of GRAS substances. I plan to explore whether a legislative remedy is needed to ensure the safety of our food supply.”

His comments were echoed by Jessica Almy, deputy director of nutrition policy, at the Washington DC-based consumer advocacy group the Center for Science in the Public Interest (CSPI), who said she was “sorely disappointed​” by the final rule.

The fundamental problem - whch this rule fails to address - argued Tom Neltner, chemicals policy director at non-profit organization the Environmental Defense Fund (click HERE​), is that without forcing companies to notify the FDA of their GRAS determinations, the agency has no means of checking the quality of the evidence reviewed or the credentials of the experts reviewing it.

"If the agency is unaware of what chemicals are being added to food, it cannot efficiently ensure that these additives – and the food that contains them – are safe."

Toxicologists: No evidence that scores of dangerous ingredients have 'slipped through the net'

However, while toxicologists contacted by FoodNavigator-USA told us that the GRAS system is not perfect and that there are always going to be some unscrupulous companies that do not do things the right way, critics have not provided any evidence that the GRAS system is putting the public at risk or that scores of dangerous ingredients have 'slipped through the net,' they argued.

Meanwhile, if there if there are signals from the market that a substance in the food supply may not be safe, the FDA can take action, as it recently has with partially hydrogenated oils (PHOs)​, Bob McQuate, PhD, chief regulatory officer and co-founder at consultancy GRAS Associates, told FoodNavigator-USA.

For example, in 2010, the FDA sent letters to companies asking if they had determined that adding caffeine to alcoholic beverages was GRAS following reports of adverse effects. In 2011 it found a GRAS submission to this effect to be insufficient and issued warning letters directing firms to end the practice, he said.

Congressional intervention needed to require that GRAS determinations be provided to FDA

Asked about Senator Markey et al's concerns about the voluntary nature of the notification process, Dr McQuate said: "Congressional intervention would seem to be the only avenue available to REQUIRE that GRAS determinations be provided to FDA. Senator Markey and other legislators have the authority to take the initiative to require a direct role by FDA with future GRAS determinations, but FDA does not presently have the authority on its own​ to circumvent self-determined GRAS evaluations at this time."

He added: "While the present system with GRAS operations is truly working well insofar as protection of the public health is concerned, improvements could be made by ensuring that at least a minimum safety standard has been met as determined by an independent reviewing entity such as FDA or a qualified, validated independent third party."

As for the composition of GRAS panels of experts convened to determine an ingredient's safety, he said: "Having company employees serving on expert panels would seem to trigger questions and concerns even when such individuals are highly competent and qualified to function on expert panels, since actual employees may not be able to truly function in an 'independent' capacity."​ 

However, the FDA is going to issue guidance on how to avoid potential conflicts of interest, he added.

'The GRAS process is a living, breathing organism'

Dr Claire Kruger, chief executive Spherix Consulting, a division of Chromadex, welcomed the final rule: "The safety standard for GRAS ingredients is the same as that for food additives, 'reasonable certainty of no harm.' In addition, however, it must rely on information that is generally available to and accepted by qualified experts.  This adds a layer of robustness and transparency to the criteria for GRAS that strengthens this process as one which can adequately protect the safety of our food supply.

"One of the most important aspects of the GRAS system is that it is a dynamic process, one that can incorporate new methodologies, and superior strategies.  One of the key updates to the final rule is the statement that, 'General recognition of safety through scientific procedures must be based upon the application of generally available and accepted scientific data​, information​, or methods.

"The acknowledgment that new processes as well as data can change and improve our scientific risk assessment indicates that all relevant tools not only should be but will​ be used in protecting our food supply.  The GRAS process is a living, breathing organism that can react and adapt more quickly than other approval processes to new advancements in science."

Click HERE​ to read the final rule.  

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