REDWOOD CITY, Calif.--(BUSINESS WIRE)--Impossible Foods received approval today from the US Food and Drug Administration for use of a key ingredient as a color additive, clearing the way for new uses in future plant-based foods.
Impossible Foods makes meat from plants -- with a tiny fraction of the environmental footprint of meat from animals. The food technology startup combines scientific innovation with ingredients from nature to create wholesome and nutritious food, restore natural ecosystems and feed a growing population sustainably.
The company’s first product, the Impossible Burger, debuted in 2016 and is now on menus in about 10,000 restaurants in the United States, Hong Kong, Singapore and Macau.
Impossible Foods plans to launch the award-winning Impossible Burger in select retail outlets in September. Additional details about this highly anticipated retail debut we be announced as the launch approaches. Stay tuned.
Above and beyond strict compliance
In July 2018, Impossible Foods received a no-questions letter from the FDA, which agreed with the unanimous conclusion of a panel of food-safety experts that its key ingredient -- soy leghemoglobin -- is safe to eat.
Soy leghemoglobin is a protein that carries “heme,” an iron-containing molecule essential for life that occurs naturally in every animal and plant. Impossible Foods’ scientists discovered that heme is the “magic ingredient” that makes meat taste like meat, and enables the Impossible Burger to satisfy meat lovers’ cravings.
Before issuing its July 2018 no-questions letter, the FDA reviewed comprehensive test data about soy leghemoglobin to assess its status as “generally recognized as safe,” or GRAS. As a standard process, the FDA posted Impossible Foods’ full 1,066-page report of evidence for its safety on its website for public review. FDA researchers also reviewed the evaluations 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.
In issuing the no-questions letter last year, the FDA noted that soy leghemoglobin could be considered a “color additive” in some potential future applications. Federal regulations require color additive approval on all ingredients, with limited exceptions, used to impart color to food -- from synthetic substances to fruit extracts.
Even though the FDA had already reviewed and concurred with the evidence for the safety of soy leghemoglobin, federal regulations require a specific regulatory process, separate from its GRAS process, to approve the use of an ingredient as a color additive. Impossible Foods submitted a color additive petition to FDA to ensure maximum flexibility as its products and business continue to evolve. The FDA accepted that submission in early November 2018.
“We’ve been engaging with the FDA for half a decade to ensure that we are completely compliant with all food-safety regulations—for the Impossible Burger and for future products and sales channels,” said Impossible Foods Chief Legal Officer Dana Wagner. “We have deep respect for the FDA as champion of US food safety, and we’ve always gone above and beyond to comply with every food-safety regulation and to provide maximum transparency about our ingredients so that our customers can have 100% confidence in our product.”
About Impossible Foods:
Based in California’s Silicon Valley, Impossible Foods makes delicious, nutritious meat and dairy products from plants — with a much smaller environmental footprint than meat from animals. The privately held company was founded in 2011 by Patrick O. Brown, M.D., Ph.D., Professor Emeritus of Biochemistry at Stanford University and a former Howard Hughes Medical Institute investigator. Investors include Khosla Ventures, Bill Gates, Google Ventures, Horizons Ventures, UBS, Viking Global Investors, Temasek, Sailing Capital, and Open Philanthropy Project.