WASHINGTON — The Food and Drug Administration (FDA) is amending its color additive regulations to allow for the use of soy leghemoglobin. The approval is in response to a petition filed by Impossible Foods, Redwood City, California. Soy leghemoglobin is an ingredient that gives Impossible Foods’ plant-based burger, the Impossible Burger, its juicy, bleeding attribute.

Impossible Foods previously marketed soy leghemoglobin to optimize flavor in ground beef analogs intended to be sold to consumers in its cooked form, for example, in restaurants, according to the FDA Impossible Foods submitted a color additive petition in 2018 because the company planned to sell uncooked, red-colored ground beef analogs containing soy leghemoglobin directly to consumers.

The FDA said it determined that the direct-to-consumer use of soy leghemoglobin required pre-market approval as a color additive, because the reddish-brown coloring is important to the appearance and marketability of the food as ground beef analog.

“We are in the midst of a revolution in food technology that in the next 10 years will likely lead to more innovations in food and ingredient production than there have been in the past half century,” said Dennis Keefe, director of the Office of Food Additive Safety in the FDA’s Center for Food Safety and Applied Nutrition. “As these new products and ingredient sources come to the market, the FDA has a responsibility to provide the appropriate regulatory oversight to protect public health by ensuring that these new foods and food ingredients are safe.

“As part of these efforts, today the FDA has approved Impossible Foods’ color additive petition for the use of soy leghemoglobin in alternative, non-animal protein sources, like vegetable burgers. After a thorough review of available scientific information, the FDA has concluded that this use is safe. This action will allow the use of soy leghemoglobin in uncooked beef analog products sold directly to consumers, such as in food retail settings.”

Leghemoglobin is a protein found in plants that carries heme, an iron-containing molecule. In July 2018, the FDA sent a no-questions letter to Impossible Foods giving soy leghemoglobin Generally Recognized As Safe (GRAS) status.