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Hawai'i CFS

New FDA Rule on Food Additives Fails to Protect Consumers

August 15, 2016
Center for Food Safety

WASHINGTON— On August 17, the Food and Drug Administration (FDA) will issue a final rule defining when chemicals added to or used to make food can be considered “Generally Recognized as Safe” (GRAS).

The final rule comes in response to a 2014 lawsuit brought by Center for Food Safety charging that the agency was operating under an interim process illegally. Unfortunately, under the new rule FDA is continuing to fail in its duty under the Federal Food, Drug, and Cosmetic Act to protect the food supply from unsafe substances.

FDA itself has acknowledged it cannot keep up with GRAS notifications, and that in hundreds of cases, the FDA isn’t even aware of new additives. “We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, former FDA deputy commissioner for food.

FDA missed a golden opportunity to close a dangerous loophole that allows chemicals to be approved for use in food with no required FDA notification, and no meaningful independent review by FDA to determine whether a food additive is safe for use. In essence, FDA is allowing companies to completely avoid FDA’s safety review process and regulate themselves, resulting in a public more at risk from dangerous food additives and unable to make informed decisions about their food choices.

The new GRAS rule:

  • Allows the use of chemicals in food without FDA’s knowledge or approval
  • Leaves in place a completely voluntary “notification” system, where manufacturers simply tell FDA they are using a substance that they believe is safe, without any safety review by FDA
  • Weakens the standard for when a substance can be considered GRAS
  • Doesn’t address conflicts of interest issues, and allows the industry to regulate itself
  • Doesn’t require public access to documents, continuing the secret nature of this system
  • Provides for a longer timeframe for FDA to respond to notifications (180 days instead of 90), and does not specify what action FDA takes in response

The following is a statement from Cristina Stella, Center for Food Safety Staff Attorney:

“FDA’s new rule results in a public more at risk from dangerous food additives, as well as a public unable to be fully informed on the food it is consuming. FDA has now codified its practice of letting the fox guard the henhouse, and we are disappointed that FDA has thrown away a golden opportunity to bring meaningful reform to this sector of the food industry.”


In 1958, Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act in response to public concern about the increased use of chemicals in foods and food processing. The Amendment required FDA to initiate a formal pre-market review process when a manufacturer petitioned FDA to approve a new food additive. The Amendment was intended to save the time and resources of both food manufacturers and FDA by exempting GRAS substances from the burdensome food additive approval process. However, numerous substances have been classified as GRAS despite the fact that their safety had not been adequately established at the time or was later shown to be unsafe. For example, cyclamate salts, a class of artificial sweeteners, were removed from the GRAS list because they were connected to cancer.

In April of 1997, FDA proposed to streamline the GRAS process. Under the proposed rule, any person could notify FDA that a use of a substance is GRAS, and could then use the substance in food without formal approval or review by FDA. FDA would no longer conduct its own detailed analysis to evaluate the data. In fact, FDA would no longer affirm whether or not a substance’s use is safe at all—it would merely issue an opinion on a manufacturer’s independent determination that it is. The manufacturer would not even submit back-up information. And, there would not be any easily accessible collection of data made available to the public. This puts the burden on the public and other public interest groups to independently gather this data to monitor food safety. The proposal drew extensive criticism from former FDA staff, the Government Accountability Office, and public interest groups. Over the past decade, almost all new chemicals added directly to food have gone through this streamlined GRAS process rather than the formal approval process intended by Congress.

With its final rule, FDA has made this practice into law.



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