- Impossible Foods wants the Food and Drug Administration to confirm that its secret ingredient — soy leghemoglobin, a substance found in nature in the roots of soybean plants that the company makes in its laboratory — is safe to eat, according to The New York Times. But the agency has raised concern that it has never been consumed by humans and may be an allergen.
- Since the FDA’s approval is not required for new ingredients, Impossible Foods is still able to sell its alternative meat burgers. The VC-backed food startup intends to resubmit its petition to the FDA.
- The FDA first wants Impossible Foods to also establish the safety of more than 40 other proteins in its genetically manufactured soy leghemoglobin because the company’s original assessment did not supply enough information to determine the ingredient’s potential as an allergen.
Impossible Foods may have inadvertently hurt itself by trying to get approval for its “secret ingredient” — something it didn’t exactly need in the first place. The company rushed to get FDA approval back in 2015 and got stonewalled by regulatory hurdles, and now the startup is discovering how its fast-growing, VC-backed business can be hampered by government red tape.
Impossible Foods isn’t the only innovative venture capital upstart to encounter problems with the FDA. Hampton Creek also faced issues in 2015 over its use of the word “mayo” on its Just Mayo products. The FDA warned the company it could not use the term “mayonnaise” or the image of an egg for its vegan-friendly products because they do not contain eggs. According to the FDA definition, mayo requires egg as an ingredient.
While Impossible Burgers can remain on the market without FDA approval, there are risks that come with being denied agency approval. It's possible that shoppers could shun the plant-based burgers over safety concerns, hurting sales. Foodservice customers also could drop its products if word of the burger’s regulatory setback spreads.
Transparency is important to today's food shoppers. Consumers expect companies to be forthcoming about product ingredients, food sources, processing standards, sustainability and corporate responsibility, among other issues. Getting safety approval from the FDA is a key way for food manufacturers to prove to consumers they have nothing to hide.
“We respect the role the FDA plays in ensuring the safety of our food supply, and we believe the public wants and deserves transparency and access to any information they need to decide for themselves whether any food they might eat is safe and wholesome,” a spokesperson for Impossible Foods wrote in an email to The New York Times.
The FDA 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' desire to gain FDA approval could indeed open up a wider consumer audience for the plant-based protein startup. A lack of approval, however — and any related publicity issues — could perhaps temper the company’s outlook.