STRATEGIC PARTNERS
July 24, 2018
The U.S. FDA has issued what it calls a "No-Questions Letter" to makers of the plant-based Impossible Burger, essentially approving the product as safe to eat, a news release said. The agency had questioned whether the base of the burger, a plant extract called heme, that mimics the flavor of meat, was actually completely safe for human consumption, even though the product is already sold in almost 3,000 international locations, including restaurants, the company said.
The FDA panel unanimously approved heme as safe and takes any questions about its potential dangers out of the equation. Current restaurant brands that have Impossible Burger menu items include White Castle, which sells it at 140 U.S. locations, as well as Fatburger, Umami Burger, Hopdoddy, The Counter and B Spot.
"Getting a no-questions letter goes above and beyond our strict compliance to all federal food-safety regulations," Impossible Foods founder and CEO Patrick O. Brown said in the release. "We have prioritized safety and transparency from day one, and they will always be core elements of our company culture."
The Impossible Burger contains soy leghemoglobin as a key ingredients because the protein carries a naturally occurring iron-containing molecule called heme that the company said is the "magic ingredient" that gives burgers made with the product the taste of real beef derived from cows, without the heavy environmental and animal welfare toll taken by cow-derived meat.
The FDA status "generally recognized as safe" (GRAS) includes a review of the company's research, as well as food safety expert comments on soy leghemoglobin.
"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 said in the release.
In issuing the no-questions letter, the FDA also noted that soy leghemoglobin could be considered a "color additive" in some future applications. The FDA has a separate regulatory process to approve the use of food additives specifically for color, and Impossible Foods is preparing to engage in that process to ensure it has maximum flexibility as its products and business continue to evolve.
