USA, Redwood City, Cal. Impossible Foods has received a no-questions letter from the US Food and Drug Administration, validating the unanimous conclusion of food-safety experts that its key ingredient is safe to eat.
The Impossible Burger is made through a combination of plant-based ingredients. A key ingredient is “soy leghemoglobin”. Soy leghemoglobin is a protein that carries “heme”, an iron-containing molecule that occurs naturally in every animal and plant. Heme is the ingredient that enables the Impossible Burger to satisfy meat lovers’ cravings.
Before issuing its no-questions letter, the FDA reviewed comprehensive test data about soy leghemoglobin to assess its status as “generally recognized as safe”. That means a food is safe to be consumed under US regulations. As standard process, the FDA posted the full, 1,066-page submission from Impossible Foods on its website for public review. FDA researchers also reviewed the comments of top food safety experts, who unanimously concluded multiple times that soy leghemoglobin is safe to eat and compliant with all federal food-safety regulations.
“We have no questions at this time regarding Impossible Foods’ conclusion that soy leghemoglobin preparation is GRAS under its intended conditions of use to optimize flavor in ground beef analogue products intended to be cooked,” the FDA stated.
In issuing the no-questions letter, the FDA also noted that soy leghemoglobin could be considered a “color additive” in some potential future applications. The FDA has a separate regulatory process to approve the use of color additives, and Impossible Foods is preparing to engage in that process to ensure it has maximum flexibility as its products and business continue to evolve.
Additional testing – including a stringent rat feeding study – provided even more objective, scientific data that the product is safe. A 2016 study examined whether consumption of soy leghemoglobin in amounts orders of magnitude above normal dietary exposure would produce any adverse effects. There were none. And a comprehensive search of allergen databases found that soy leghemoglobin has a very low risk of allergenicity, and it’s shown no adverse effects in exhaustive testing.