- Impossible Foods needs pre-market approval from the U.S. Food and Drug Administration to sell uncooked Impossible Burgers directly to consumers, according to an agency statement reported by Bloomberg. Previously only sold in restaurants, Impossible Foods announced last month it would begin selling its plant-based burger in retail outlets next year.
- The FDA said because the soy leghemoglobin in the products provides a red color important to their appearance, the ingredient will need the agency's sign off as a color additive. Impossible Foods has filed a petition to that effect, which the FDA has 90 days to consider and another 90 days after that if needed.
- Company spokeswoman Rachel Konrad told Bloomberg that there are "many ways Impossible Foods could enter retail, and there is ambiguity about which, if any of them, might raise color additive issues. We filed a Color Additive Petition so that we could ensure maximum flexibility as we move forward with new commercial applications, including new products and business models."
Depending on what Impossible Foods decides to do next, this regulatory hurdle could be a problem since the company hoped to debut its products in retail stores sometime in 2019.
Since first being introduced in 2016, the plant-based "burger that bleeds" has only been available in restaurants — a strategy that may have enhanced the hype over the product. But it hasn't been quite as visible as its competitor, Beyond Burger, which has been sold in refrigerated retail meat cases since 2016 and is now in 10,000 grocery stores and more than 10,000 food service locations.
Still, choosing to introduce the Impossible Burger through restaurants helped the company scale up production while ramping up marketing outreach. Since July 2016, the company has sold 13 million burgers via restaurant partnerships. And when the California-based company opened a production plant in Oakland in September 2017 capable of turning out 500,000 pounds of the product each month, speculation also ramped up that retail availability couldn't be far behind.
Besides grappling with the product distribution issue, Impossible Foods has previously tussled with federal regulators over the soy leghemoglobin. The FDA and some environmental and consumer groups expressed concern last year that the ingredient had never been consumed by humans before and might not be safe, but the agency ended up determining this past summer that soy leghemoglobin was labeled Generally Recognized As Safe. At the time, the FDA "also noted soy leghemoglobin could be considered a color additive in some potential future applications," according to Meat + Poultry.
The Color Additive Petition approval process might not take too long since the FDA has already given soy leghemoglobin GRAS status, but it could hold up retail distribution of the Impossible Burger longer than the company planned. Any delay isn't likely to dampen consumer enthusiasm for plant-based meat alternatives, and it may even whet the public's appetite for the Impossible Burger.
Data from Nielsen and the Plant-Based Foods Association show sales of plant-based meat alternatives were up during the past year by 24% to $670 million, while sales of animal-based meat only rose 2% during that same period. Having to get the FDA's approval for a color additive isn't likely to adversely impact Impossible Foods' popularity nor that of plant-based products in general as long as the company is transparent about the process and maintains flexibility about the next steps it might take.