Key Impossible Burger ingredient finally approved by FDA for direct-to-consumer sales
After overcoming a number of regulatory hurdles it looks like Impossible Foods' plant-based meat alternative will finally be hitting grocery stores in the United States. The U.S. Food and Drug Administration (FDA) has approved the additive soy leghemoglobin in uncooked foods for sale directly to consumers, allowing Impossible Foods to move from only selling its products in restaurants and into supermarkets across the country.
Although Impossible Foods has been selling its plant-based burger products in restaurants across the United States for several years, it only really received full, clear FDA approval in the middle of 2018. And even then, the approval was significantly limited to, "ground beef analogue products intended to be cooked," meaning the uncooked product could still not be sold directly to consumers.
The big hurdle that slowed down the roll out related to a key compound that made Impossible Foods' product unique – soy leghemoglobin. Heme is a molecule found in almost every living thing on the planet, and it is this molecule that Impossible Foods suggests creates the distinct red, bloody texture and taste of meat. It can be conveniently harvested from the roots of soy plants in the form of soy leghemoglobin. But even more efficiently, Impossible Foods developed a method allowing soy hemoglobin to be produced by a specially engineered form of yeast.
In the 2018 FDA approval, the regulatory agency classified soy leghemoglobin as a color additive, meaning it needed extra pre-market approval before it could be sold directly to consumers. Now, pending a 30-day period evaluating any objections from the public, the FDA has finally approved soy leghemoglobin.
"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, director of the FDA's Office of Food Additive Safety. "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."
The FDA announcement comes at a good time for Impossible Foods, ahead of an enormous deal to roll out the Impossible Whopper in Burger Kings across the US from August 8th. While legally the company will most likely be able to move its product into grocery stores from early September, it is unclear how quickly supplies will be able to meet the dramatically increased demand.
Throughout much of 2019 the company has struggled to scale up production to match the growing popularity of its plant-based burgers. New funding, and increased manufacturing capacity, promises to expand supply to at least consistently deliver burgers to restaurants already serving the product, but it may take some time before Impossible Foods can get its burgers into supermarkets and grocery stores across the country. Impossible Foods claims it will launch "in select retail outlets in September."