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Hawai'i CFS

Generally Recognized as Safe (Because Industry Says So)

By - Cristina Stella, Center for Food Safety Staff Attorney

May 22, 2017
Center for Food Safety

Epigallocatechin"‘3-gallate. Gamma"‘amino butyric acid. Theobromine. Nano-scale titanium dioxide.

Most consumers expect the foods they purchase and feed their families to be free of chemicals like these—chemicals that they can barely pronounce and the effects of which may be completely unknown and untested. Yet over the past decade, ingredients like these and an estimated 3000 others have been added to our food supply without U.S. Food & Drug Administration (FDA) review, approval, or even knowledge.[1]

We know that consumers expect more from FDA, and the law does too. The Federal Food, Drug, and Cosmetic Act sets the standards for the safety of our food supply. It requires FDA to ensure that potential food additives are safe—including lab-created chemical substances that have never been used before. FDA is required to take into account consumers’ entire diet and all exposures to a chemical and similar chemicals before allowing a new chemical to be used in food. The only exception is for substances that are “generally recognized as safe” or “GRAS.” Substances such as oils and vinegar that are considered “GRAS” can be used in food without going through the pre"‘market review and approval process that is required for food additives.

And yet, despite what the law requires, it has been just over twenty years to the day since FDA handed over its legal authority to ensure food is safe to the very industry it is required to regulate. This has caused many potentially harmful food additives and chemical substances to enter the food supply, unchecked.  

In May 1997, FDA proposed a practice of allowing food and chemical manufacturers to decide for themselves that their own chemicals are safe, and to simply keep FDA and the public in the dark about those decisions. Under the proposal, FDA would not independently determine whether food additives or purported GRAS substances were safe. Instead, it would take industry’s word. And—because the proposal made it completely optional for manufacturers to even ask FDA for permission to market a chemical—if FDA raised any concerns about a chemical, the manufacturer would still have the option of simply marketing the ingredient without telling FDA.

FDA operated under this proposal for 17 years, until in 2014 CFS took FDA to court to challenge it—and won. As a result of our lawsuit FDA was forced to finalize the proposal, and in so doing, was forced to explain its rationale for adopting such a misguided and disastrous approach. Now that FDA has adopted the practice into law, CFS is back in court to challenge it.

By now, we may come to expect the president and his administration to easily sacrifice the public good for private industry interests. Yet when the federal government is required by law to regulate an industry, it is unconstitutional for it to turn its power over to that industry.

The secrecy of the GRAS system deprives the public from vital information about what is in their food and how it is produced. It also makes it impossible for manufacturers to ensure their chemicals are safe for consumers who may already be consuming other similar chemicals. The fact that GRAS determinations can be kept secret from FDA—so neither FDA nor manufacturers can assess the cumulative impact of chemicals being added to food—means that neither FDA nor manufacturers can truly determine if new uses of these ingredients are safe. Because FDA does not require manufacturers to keep records of their self-determinations, FDA cannot even enforce this law against manufacturers who have, in fact, never assessed whether their products are safe.

The GRAS loophole is unconstitutional, illegal, and not what Congress intended. And the public is suffering as a result.

Today, on the twenty-year anniversary of this absurd scheme, CFS has decided that enough is enough. The government may be willing to put consumers at risk by handing over its power to chemical manufacturers, but CFS is not. That’s why we and the environmental law firm Earthjustice are representing CFS, Breast Cancer Prevention Partners, Center for Science in the Public Interest, Environmental Defense Fund and Environmental Working Group in a lawsuit against FDA for unconstitutionally and illegally delegating its legal authority to self-interested food and chemical manufacturers.

We will continue to fight on behalf of food safety for all Americans. Click here to find out more about how you can join us in that fight.


[1] Pew Charitable Trusts, “Fixing the Oversight of Chemicals Added to Our Food” (2013),

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