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GRAS Concerns are Back in the Media Spotlight

Quorn is getting some press coverage again after a Sunday Washington Post article laid out the Food and Drug Administration’s lack of oversight concerning the safety of food additives.

Mycoprotein is a fungus-based meat substitute that is used in Quorn brand foods, and consumer advocates have compiled lists of the dangerous allergic reactions it can cause. The Center for Science in the Public Interest cites anaphylactic reactions, nausea, cramps, diarrhea, vomiting so forceful it could break blood vessels in the eyes, and even two deaths.

The concern that CSPI and others have is that FDA has not adequately investigated the safety of Quorn because it is used under the category that it is “Generally Recognized as Safe” (GRAS).

In February, the Center for Food Safety (CFS) filed a lawsuit against FDA in an attempt to vacate the agency’s 1997 proposed rule replacing the traditional petitioning process for a manufacturer seeking GRAS status for an additive with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS.”

As a 2010 Government Accountability Office report put it, “companies may determine a substance is GRAS without FDA’s approval or knowledge.”

In their complaint, CFS cited Quorn as one of the potentially hazardous additives that the GRAS notification process has allowed to enter the food supply.

A statement from Quorn’s manufacturers says that the studies critics cite are “not only outdated but misleading. Quorn products have been tested in numerous medical studies, and through decades of testing and statistics, all have proven that Quorn products are safe and much less likely to cause a reaction than soy, nuts or dairy. Quorn’s main ingredient — mycoprotein — is not classified as an allergen in the U.S. or the fourteen other countries where it is currently sold.”

In May, FDA filed a motion to dismiss the suit, arguing that CFS has not identified any member of the organization “who has actually suffered this clearly speculative injury” and that “the proposed rule does not cause the alleged injuries from consumption of food substances.”

The litigation has since been stayed until late September to give the parties an opportunity to reach a negotiated settlement.

“We simply do not have the information to vouch for the safety of many of these chemicals,” Michael Taylor, FDA’s deputy commissioner for foods and veterinary medicine, told the Washington Post.

The Natural Resources Defense Council (NRDC) has previously estimated that about 1,000 of the 10,000 additives in our food are being used based on undisclosed GRAS safety determinations. The group’s April 2014 report identified 275 chemicals from 56 companies that appear to be marketed for use in food based on undisclosed GRAS safety determinations.

NRDC also found that between 1998 and February 2014, FDA rejected 17 out of 466 notices submitted to the agency. About 30 are still pending, and another 80 notices were withdrawn by the companies.

These withdrawals don’t prevent a company from using an additive in food. The report detailed four chemicals with withdrawn GRAS notices that are used in food products despite safety concerns. One is epigallocatechin-3-gallate (EGCG). The Washington Post article states that before its withdrawal, FDA asked the maker to address findings that the chemical has the potential to cause “toxicity in the liver, kidneys and intestine” and “defects in the brain and heart,” and may even “contribute to infant leukemia.”

A different company later began marketing EGCG as GRAS in its green tea powder, telling the newspaper it did not participate in FDA’s voluntary GRAS determination process because it wanted to protect proprietary information.

The NRDC report concluded that, “A chemical additive cannot be ‘generally recognized as safe’ if its identity, chemical composition, and safety determination are not publicly disclosed.”

“We aren’t saying we have a public health crisis,” Taylor told The Washington Post. “But we do have questions about whether we can do what people expect of us.”

© Food Safety News
  • Oginikwe

    Never heard of “Quorn.” Sounds disgusting.
    “The mycoprotein used to produce Quorn is extracted from the fungus Fusarium venenatum. The product was developed by Rank Hovis McDougall and Imperial Chemical Industries, and launched commercially as the Quorn brand as a joint venture of the two companies under the operating name of Marlow Foods.”

    http://en.wikipedia.org/wiki/Quorn

    It is later identified as mold. Sounds like soylent green.

    • FoodSci

      Sounds more like tempeh.

    • Tess Bagley

      Wow, I used to love quorn but a few years ago they changed the recipe and the taste and consistency were not to my liking. Guess it was a blessing in disguise!

  • oldcowvet

    How can an unknown substance be generally recognized if no one knows what it is? Seems somewhat through the looking glass.

  • FoodSci

    I hope we all know that the “chemical” epigallocatechin-3-gallate is a naturally occuring antioxidant in tea, particularly green tea. Not that natural absolves anything from toxicity, but you just know the general public is thinking it’s some man-made toxic chemical “Big Food” is trying to sneak into the food supply, especially since no explanation is given. Just a scary sounding word Michael Pollan and his grannie can’t pronounce.