The U.S. Food and Drug Administration appears ready to take another look at how it regulates GRAS.
The federal Government Accountability Office’s February report on FDA’s oversight of food ingredients and food contact materials that are considered “Generally Recognized As Safe” (GRAS) revisits some important bedrock concepts about how food is regulated in the United States, and soon may lead to some changes in FDA’s approach.
Conceptually, GRAS status has a certain degree of elegance. It is a state of nature, a status that needs no government confirmation, and the legal basis for the use of many food ingredients and food contact substances. That makes regulatory oversight harder, perhaps, but it doesn’t necessarily lead to safety concerns.
GRAS status is a state of nature in that a particular use of a food ingredient is either GRAS or isn’t GRAS, and it doesn’t matter if anyone has said so, especially the FDA. GRAS status of a use of a food ingredient or food contact material depends on whether relevant experts agree that the use is safe and generally recognized as such among themselves and other similar experts, based on generally accepted and available information (or that it has been safely used in food since before 1958). A company has no obligation to ask FDA’s concurrence or even give FDA notice of its conclusion.
It’s a fascinating concept to build into a legal framework for assuring the safety of the food supply, and perhaps uniquely American in its flavor, because its conceptual core is freedom rather than government regulation.
And it’s probably safe to say that FDA just doesn’t like that. Why? Because FDA is generally uncomfortable with incomplete information, given that Congress expects the agency to be responsible overall for the safety of the food supply.
Remember, though, that the realm of GRAS substances is one of relatively low safety risks. It’s a solid assumption that companies’ GRAS analyses are conducted in good faith, considering the risks of customer and international standards, public relations damage, and even potential civil liability.
So now comes the GAO report, in which it reviewed how FDA keeps tabs on GRAS substances in and on food. GAO made six recommendations to FDA, including figuring out a way to require companies to give FDA notice of their independent GRAS determinations and post them publicly (FDA says that idea might not work, since the public might mistake a listing for an FDA blessing). GAO also recommended that FDA undertake a more systematic approach to post-marketing safety re-evaluations, and FDA agrees that would be a good idea. (GAO gave FDA a look at the report in draft form, then published FDA’s reactions together with the report.)
GAO also wants FDA to take an especially close look at engineered nanomaterials that a manufacturer determines to be GRAS, and FDA agrees, saying it will issue guidance soon to help manufacturers evaluate GRAS status for uses of such materials.
Perhaps the biggest news coming out of FDA’s responses to the report is that FDA says it will finally start making a final rule version of the 1997 proposed rule that explains to companies how to submit GRAS Notices for FDA review. Though since 1997 the rule has been in “proposed” form, ever since its publication, industry and government have been operating under it as if it were final. When it finalizes the rule, FDA says it will address GAO’s recommendation that it offer some parameters for choosing experts to review GRAS status to avoid conflicts of interest.