On Food Additive Safety, FDA Just Watches the GRAS Grow

by Matthew Madia, 3/5/2010

A February Government Accountability Office report released today chides the Food and Drug Administration for failing to ensure the safety of common food additives. By law, manufacturers may assign additives a "generally recognized as safe," or GRAS, designation, a process that the FDA neither monitors nor verifies in most cases, according to the GAO.

MSGCompanies are supposed to make GRAS determinations based on the latest and greatest scientific evidence. Later, if new information turns up or if citizen petitions are filed with the FDA, additives can potentially be stripped of their GRAS designation.

One would expect that the FDA would keep tabs on GRAS substances. One would be wrong. Perversely, companies are not required to tell the FDA they have made a GRAS determination. (Many do notify the FDA voluntarily.) This makes it kind of difficult for the FDA to ensure food safety, according to GAO:

Once a GRAS substance has entered the marketplace, FDA would find it difficult to identify that substance as the potential source of a food safety problem, especially if FDA is unaware that the substance has been determined to be GRAS. Food products may contain numerous ingredients, including GRAS substances, making it difficult, if not impossible, for public health authorities to attribute a food safety problem to a specific GRAS substance. [Emphasis added.]

The report has many other specific criticisms of the FDA. It seems as though there are two overarching problems. First, regardless of whether the agency is aware that a GRAS determination has been made, the FDA tends to sit back and wait for new information to come to it. Second, when risk information does find its way to the FDA, the agency is slow to respond.

The report also delves into the issue of nanomaterials – tiny devices and products constructed of materials 100,000 times smaller than the width of a human hair. Although the FDA acknowledges that much remains unknown about nanomaterials (FDA has said it is not even comfortable defining nanotechnology), and even though some fear nanomaterials may have adverse effects on public health and the environment, manufacturers may designate nanomaterials as GRAS food additives. “Nevertheless, the decision to notify FDA of a GRAS substance, even one that contains engineered nanomaterials, is still voluntary,” the report says.

The GRAS problem is typical of the U.S.’s shoot-first-ask-questions-later approach to regulating. Safety is presumed, and regulation can only occur after evidence to the contrary reaches a critical mass.

GAO concluded the report by recommending several ways the FDA can sharpen oversight of GRAS determinations, including mandatory notification. “FDA generally agreed with the report’s findings and recommendations,” GAO said.

Image by Flickr user PunkJr, used under a Creative Commons license.

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