Ingesting Risk — The FDA and New Food Ingredients

Authors: Pieter A. Cohen, M.D., and Emily M. Broad Leib, J.D.

Published originally in The New England Journal of Medicine on Sept. 7, 2024

On June 22, 2022, Food and Drug Administration (FDA) officials arrived at Stone Gate Foods in Minnesota to investigate the production of a new ground-beef substitute.¹ Consumers of the product had reported abdominal pain, nausea, vomiting, fever, and fatigue, and clinicians had found elevated liver enzyme levels in some patients, with multiple biopsies suggesting drug-induced liver injury. Several patients had recurrent symptoms after consuming the meat substitute a second time.

FDA inspectors at the facility uncovered no manufacturing problems or contamination with adulterants, pesticides, mycotoxins, bacterial pathogens, or heavy metals. The ground-beef replacement contained only what was listed on the label. After nearly 400 consumers in 39 states fell ill, including more than 130 people who were hospitalized, investigators determined that a new ingredient listed on the product’s label — tara flour — was found to be the most likely cause of the liver injuries.¹ Nearly 2 years later, in May 2024, the FDA completed an independent safety evaluation of tara flour, finding that it was not “generally recognized as safe” (GRAS) and, therefore, is an unapproved food additive.

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