- Impossible Foods has received a no-questions letter from the Food and Drug Administration accepting the unanimous conclusion of a panel of food-safety experts that its key ingredient, soy leghemoglobin, is safe to eat, according to CNBC.
- The soy leghemoglobin is a protein that carries heme, which is an iron-containing molecule that occurs naturally in every animal and plant. For the Impossible Burger, however, it is created in a lab. Heme, which makes the Impossible Burger "bleed" and appear pink in the middle, is the "magic ingredient" that enables the product to satisfy meat lovers’ cravings, according to Impossible Foods.
- In issuing the no-questions letter, the FDA also noted that soy leghemoglobin could be considered a “color additive” in some potential future applications, which would require Impossible Foods to go through a separate regulatory process if they wished to use it in this manner.
At the same time Beyond Meat received its non-GMO designation, Impossible Burger’s “secret ingredient” was given the seal of approval by the FDA.
Although neither company was technically required to get these labels, in an effort to attract customers — including meat eaters and abstainers — both VC-backed startups pursued the transparency route to assure consumers their ingredients are safe beyond a doubt. For Beyond Meat, this means none of its ingredients are genetically modified. For the Impossible Burger, this means its never-before-seen genetically engineered heme is safe to eat.
Transparency is important to today's food shoppers. Consumers expect companies to be forthcoming about issues including product ingredients, food sources, processing standards, sustainability and corporate responsibility. Getting safety approval from the FDA is a key way for food manufacturers to prove they have nothing to hide.
FDA's seal of approval holds a lot of weight with American shoppers. According to the Food Marketing Institute's U.S. Grocery Shopper Trends study, 54% of consumers rely heavily on the FDA to ensure food safety. So it stands to reason that Impossible Foods' unequivocal FDA approval could indeed open up a wider consumer audience for the plant-based protein startup.
This is Impossible Foods’ second attempt at seeking this designation. In 2015, the company rushed to get FDA approval and got stonewalled by regulatory hurdles. In its second effort, the company also conducted two rat studies and various in vitro tests to see whether soy leghemoglobin would cause chromosome damage or mutagenicity before they resubmitted their now-approved application for generally recognized as safe status.
Although this soy-based heme, a substance found naturally in the roots of soybean plants, had never before been consumed by humans in large quantities, it is an identical replica of animal heme, which is what gives the burgers their meatiness. It is also used to make the burger patties "bloody."
This finding may also prove to be a boon for other plant-based meat substitutes that are looking to attract a portion of a flexitarian market hungry for realistic alternatives to meat. At the same time, this designation opens the door for other startups to confidently engineer their own plant-based heme, since they will not have to contend with the "what-ifs" of customers who are unsure about the safety of lab-created ingredients. In the end, this FDA approval may have inadvertently created more competition for Impossible Burger.