FDA In Brief: FDA approves soy leghemoglobin as a color additive

July 31, 2019

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“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. 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,” said Dennis Keefe, Ph.D., director of the Office of Food Additive Safety in the FDA’s Center for Food Safety and Applied Nutrition. “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 analogue products sold directly to consumers, such as in food retail settings.”

Today, the U.S. Food and Drug Administration is amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in uncooked ground beef analogue products (e.g., vegetable burgers). The FDA is taking this action in response to a color additive petition submitted by Impossible Foods Inc. requesting the FDA to issue a regulation listing soy leghemoglobin as a color additive for use in such products.

Impossible Foods previously marketed soy leghemoglobin to optimize flavor in ground beef analogue products intended to be sold to consumers in its cooked form, for example, in a restaurant setting.

Impossible Foods submitted a color additive petition in 2018 because the company intends to sell uncooked, red-colored ground beef analogue products containing soy leghemoglobin directly to consumers. The FDA determined that this 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 analogue.

The FDA reviewed the information and data submitted by the company, as well as other relevant information, and concluded that there is a reasonable certainty of no harm from this use of soy leghemoglobin as a color additive.

Upon publication of the final rule in the Federal Register, the color additive petition process allows for a 30-day period to file objections by any person adversely affected. Should no objections be raised, the direct-to-consumer sale of uncooked, red-colored ground beef analogue products containing soy leghemoglobin will be allowed.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.