The US Food and Drug Administration (FDA) has approved soy leghemoglobin as a color additive in uncooked ground beef analog products. This follows meat-alternative company Impossible Foods’ 2018 petition to have the ingredient accepted as a color additive. Soy leghemoglobin imparts a reddish-brown color but has already been used by Impossible Foods as the “magic ingredient” to give an optimized beefy flavor. This ruling will allow the company to now sell raw Impossible Burgers directly to consumers, instead of cooked via restaurants.

“We are in the midst of a revolution in food technology that in the next ten 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,” says 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, 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,” he continues. 

The FDA has reviewed all the information and data submitted by Impossible foods, in addition to other outside information. The regulatory body concluded that there is a reasonable level of certainty that no harm will come from this use of soy leghemoglobin as a color additive. There is now a 30-day window for any person adversely affected to file an objection. If no objections are raised, the direct-to-consumer sale of uncooked, red-colored ground beef analog products containing soy leghemoglobin will be allowed.

The “magic” ingredient
Soy leghemoglobin is a form of heme – an iron-containing compound found in every living organism. Heme is naturally found in animal blood or in the case of soy, in the roots. Impossible foods use a genetically engineered yeast to harvest leghemoglobin at an industrial scale. The company says that this ingredient is what gives the burgers a specifically meaty flavor.

In July 2018, Impossible Foods received a no-questions letter from the FDA validating the unanimous conclusion of food-safety experts that its key ingredient soy leghemoglobin generally recognized as safe (GRAS). As part of the message, the FDA also noted that the ingredient could be considered to be a color additive in some potential future applications. This is because the color is key to marketing the appearance of the food as ground beef analog in direct-to-consumer settings. 

This summer, the company is partnering with Burger King to roll out the Impossible Whopper throughout the US. This comes after a successful trial run in 59 St Louis stores in April, and the company aims to have the Impossible Whopper be available nationwide by the end of the year if the reception looks promising. 

However, European meat-alternatives are facing nomenclature obstacles, with the EU proposing a ban on phrases such as “vegan sausage” and “veggie burger.” Ten animal protection, consumer, environment and food NGOs have united in an open letter in opposition of the ban, with petitions already gathering around 80,000 signatures.