Generally recognized as controversial

May, 2013

Eric F. Greenberg | Attorney-at-Law

General recognition of safety is a bedrock concept underlying food safety and regulation. But it's widely misunderstood. Lately, organizations in and out of government have expressed discomfort because the law is set up to allow companies to use substances in food on the basis of an independent determination that the use is both safe and generally recognized as such, without having to get FDA approval or even let them know.

The record of GRAS substances, though, appears to be largely safe, so it's not clear any new procedures or laws are warranted. Those who call for more action appear to be surprised to learn that companies, not regulators, always bear the primary responsibility to assure that what they put into food is safe.

GRAS, or Generally Recognized As Safe, is the highest status a use of a substance in food can achieve, reflecting not only that it's safe when used that way, but that its safety is publicly known and not particularly controversial, that is, that the safety of the use is "generally recognized" by relevant scientists. If a substance was used in food since before 1958, it might also achieve GRAS status that way.

It's a big deal if a use of a substance in food is GRAS because, by legal definition, it is not a food additive, which would require FDA clearance of one kind or another. (Exceptions from this are for substances such as pesticide residues, new animal drugs and a few other substances that get into food but that are the subject of other specialized clearance processes.)

GRAS status of a particular use of a particular substance exists if it exists, doesn't if it doesn't, and you don't need FDA to tell you so for it to be so. Strictly speaking, you don't even legally need to evaluate a use and conclude it's GRAS for it to be GRAS, if it is in fact GRAS. But you'd be, to use the formal legal term, a huge idiot to use it but not evaluate it.

FDA used to be in the business of publishing in regulations the uses of substances that they had found or affirmed to be GRAS, but stopped doing that in the mid-90's. Since then, though, they have made themselves available to look over a company's conclusion that a use is GRAS and let the company know if they have any serious questions about that conclusion. The agency's conclusions on these so-called GRAS Notifications are published by FDA on its web site.

Companies have no obligation at all to send FDA such notices of their conclusions. FDA is probably uncomfortable that they are not fully aware of all the uses of all substances in food, and it's hard not to sympathize with these regulators for feeling left out. This is especially so when Congress or the public expect them to magically know everything and blames them for anything that goes wrong in the nation's food supply.

The alternatives, such as changing the law to make GRAS uses have to be the subject to prior approval by FDA, sound like a laborious mess of new bureaucracy that is especially out of proportion given that we are dealing with probably safe and not controversial substances. Even FDA seemed to acknowledge that the realm of GRAS substances was probably mostly safe back when they decided to switch from issuing GRAS affirmations to receiving GRAS Notifications. Another alternative would be to have companies just notify FDA when they use a substance on the basis of their own determination that the use is GRAS, and have FDA make the notices public.

That's one of the changes in the system that the Government Accountability Office recommended back in 2010, but even that is likely to be a big bureaucratic mess. If there are really many thousands of such uses, as estimated, that's a lot of filings for companies to take the time to make, and for FDA to manage. Seems like a lot of work to try to catch or anticipate a potential safety problem. Right now, new information about substances or other reasons to question a use's safety can inspire citizen's petitions or action by FDA, and companies always retain the obligation to keep track of whether their earlier GRAS decision remains valid.

GAO's recommendations also included the idea that procedures be made or recommended to avoid conflicts of interest on the part of experts asked to opine on GRAS status (though it's not clear that has been a significant problem); conduct random audits of company GRAS decisions; have FDA be more systematic in reconsidering product safety; and have FDA pay special attention to emerging nanoscale materials used in food. FDA has said it agrees with some of the recommended changes, some of which the agency can implement itself, some of which would require changes in the law by Congress.

Separately, the private Pew Health Group's 2012 report raised concern about the fact that FDA isn't aware of many uses of substances in food and so can't assure their safety; that companies aren't required to notify FDA of their uses of substances on the basis of GRAS conclusions; and that FDA doesn't have the resources to manage the safety issues relating to GRAS substances.

The GAO and PEW studies appear just generally uncomfortable with FDA's lack of knowledge and the fact that companies can make their own decisions. But as FDA (and I) never tire of telling companies subject to FDA's requirements, the primary obligation for assuring a product is in compliance with FDA requirements is the company's, from when you first place it into commerce and on an ongoing basis after that.

So it really shouldn't be a surprise that these GRAS decisions are left to companies in the first instance. And if there is some discomfort with the present system, such that one might suggest a pre-approval or even a notice system for GRAS uses, the correct question would seem to be whether there is a critical mass of safety concerns to warrant such a new burden. At present, it doesn't appear that the balance tips that way. PW

Eric Greenberg can be reached at, and visit his firm's Web site at

This article is informational only and is not intended as, and should not be considered to be, legal advice.

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