REDWOOD CITY, Calif. – Impossible Foods has received a no-questions letter from the US Food and Drug Administration (FDA) in which the agency accepts the unanimous conclusion of a third-party panel of experts that a key ingredient in the Impossible Burger is safe to eat.

Organizations such as the ETC Group and Friends of the Earth last year argued that Impossible Foods should pull its burger off the market until the FDA agreed all its ingredients were safe. The FDA in the no-questions letter said it had no questions about the Generally Recognized As Safe (GRAS) status of soy leghemoglobin/heme.

“Getting a no-questions letter goes above and beyond our strict compliance to all federal food safety regulations,” said Patrick O. Brown, MD, Ph.D., CEO and founder of Impossible Foods. “We have prioritized safety and transparency from day one, and they will always be core elements of our company’s culture.”

Redwood City-based Impossible Foods makes patties designed to duplicate the look and taste of animal-based meat, directly from plants. The plant-based product contains soy leghemoglobin, a protein that carries heme, which is an iron-containing molecule that occurs naturally in every animal and plant. Heme enables the Impossible Burger to satisfy meat lovers’ cravings, according to Impossible Foods.

The Impossible Burger is found in nearly 3,000 locations in the United States and Hong Kong. Impossible Foods genetically engineers and ferments yeast to produce the heme protein called soy leghemoglobin. The heme in the Impossible Burger is identical to the essential heme that humans have consumed for hundreds of thousands of years, but producing the Impossible Burger uses about 75 percent less water, generates about 87 percent less greenhouse gasses and requires about 95 percent less land than conventional ground beef from cows, according to Impossible Foods.

The company began to seek validation for the safety of soy leghemoglobin in 2014, or before it began selling its plant-based burgers to restaurants. A panel of food safety experts gave the opinion that the soy leghemoglobin in the Impossible Burger was GRAS. A 2016 study examined whether consuming soy leghemoglobin in amounts above normal dietary exposure would produce any adverse effects. None were found. A search of allergen databases found soy leghemoglobin had a “very low risk” of allergenicity.

Impossible Foods filed its GRAS findings with the FDA in August 2017. The FDA posted the 1,066-page document from Impossible Foods for public review on its website. The document may be found here.

The FDA in the no-questions letter also noted soy leghemoglobin could be considered a color additive in some potential future applications. The FDA approves the use of food additives specifically for color through a separate regulatory process. Impossible Foods plans to engage in the process.

Read more about Impossible Foods in MEAT+POULTRY’s report.