Business

Impossible Burger faces FDA hurdle

Additive that gives the product the flavor of blood must be approved

Bloomberg

Sandwiches made with Beyond Meat breakfast sausage.
Bloomberg Sandwiches made with Beyond Meat breakfast sausage.
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The famous “bloody,” plant-based Impossible Burger is now available at almost 5,000 restaurants in all 50 states.

But that very appearance of bloodiness may have presented another regulatory hurdle for the company and its effort to get the product into supermarkets.

Impossible Foods, the Silicon Valley-based maker of the eponymous burger, uses genetically modified yeast to mass produce its central ingredient, soy leghemoglobin, or “heme.” It’s heme, the company said, that gives the Impossible Burger its essential meat-like flavor.

The substance was ready to break out this summer after the U.S. Food and Drug Administration, following years of back-and-forth, declined to challenge findings voluntarily presented by the company that the cooked product is “generally recognized as safe,” or GRAS.

Such a “no questions” letter means the FDA found the information provided to be sufficient.

Heme is “responsible for the flavor of blood,” Impossible Foods CEO Patrick Brown said in an interview earlier this year. “It catalyzes reactions in your mouth that generate these very potent odor molecules that smell bloody and metallic.”

It’s how it looks that’s at issue, though. An FDA spokesman said heme, which is red in hue, needs to be formally approved as a color additive before individual consumers can purchase the uncooked product.

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“If the firm wishes to sell the uncooked, red-colored ground beef analogue to consumers, pre-market approval of the soy leghemoglobin as a color additive is required,” FDA spokesman Peter Cassell told Bloomberg in a Dec. 17 email.

Impossible Foods filed a petition Nov. 5 seeking heme’s formal approval as a color additive, the FDA said.

The agency has 90 days to respond, and the timeline can be extended.

Impossible Foods says heme isn’t a color additive as currently used in cooked Impossible Burgers sold in restaurants. However, other future uses might qualify as a color additive, company spokeswoman Rachel Konrad said in an email.

The company submitted the FDA petition to retain “maximum flexibility as our products and business continue to evolve.” Konrad declined to say whether uncooked heme-containing products to be sold in supermarkets were one of those contemplated future uses.

“Impossible Foods is in full compliance with all federal food-safety regulations and has been since 2014, well before we launched a product at restaurants in 2016,” she said.

The color additive FDA filing won’t affect the continued sale of cooked Impossible Burgers in restaurants, and approval by the regulator of the color-additive petition could come in time for the company to roll out the raw product next year, as planned.

The demand for it definitely exists. Once just the province of animal welfare advocates and the health conscious, the meat-alternative market has turned white-hot, given the massive role industrial meat production plays in global warming.

Impossible’s biggest competitor, Beyond Meat, is backed by food giant Tyson Foods Inc. Its pea-based, beet juice-colored Beyond Burger already sells in supermarkets and has seen 70 percent annual growth.

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The company has even filed for an initial public offering. Both Impossible and Beyond count Microsoft Corp. founder Bill Gates as a backer — he helped raise $450 million for Impossible.

Other meat giants, such as Cargill, which has facilities in Cedar Rapids, are investing in the rapidly growing sector, too.

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