Why the 'Bloody' Impossible Burger Faces Another FDA Hurdle [View all]

Source: Bloomberg

Why the ‘Bloody’ Impossible Burger Faces Another FDA Hurdle

The regulator wants more information before raw versions appear in your local supermarket. The agency’s approval process is being questioned, too.

By Lydia Mulvany and Deena Shanker
December 26, 2018, 4:00 AM EST

The famous “bloody,” plant-based Impossible Burger is now available at almost 5,000 restaurants in all 50 states. But the very appearance of bloodiness may have presented another regulatory hurdle for the company that makes it, 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 that gives the Impossible Burger its essential meat-like flavor, the company said. 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 the burger looks that’s now 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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Read more: https://www.bloomberg.com/news/articles/2018-12-26/why-the-bloody-impossible-burger-faces-another-fda-hurdle