Fake ‘burger’ pursues OK for bloody tint

‘Heme’ for meatlike color faces U.S. regulatory hurdle

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 stands to present another regulatory hurdle for the company and its effort to get the product into supermarkets.

Impossible Foods, the Silicon Valley 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 meatlike flavor. The substance was ready to break out this summer after the U.S. Food and Drug Administration, after years of back-and-forth, declined to challenge findings voluntarily presented by the company that the cooked product is “Generally Recognized as Safe.” 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 chief executive Patrick Brown said 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 consumers can purchase the uncooked product.

“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 an email this month. 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 spokesman 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 hemecontaining 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 is definitely there. Once just the province of animal-welfare advocates and the health conscious, the meat alternative market has turned white-hot, given the huge 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. 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 Inc., are investing in the rapidly growing sector, too. According to Neal Fortin, director of the Institute for Food Laws & Regulations at Michigan State University, Impossible Foods’ color additive petition probably includes evidence of heme’s safety. He said the regulator will evaluate the submission, take public comment and issue a final rule. While the safety standard for food additives and safety-recognized substances is the same, there’s arguably more on the line with this evaluation: The FDA will be making a more substantive safety determination than under the safety process, and the comment period opens the door to critics. The agency could also ask for more safety tests. (Impossible Foods and the FDA declined to share the petition with Bloomberg.)

“If you slow the process down, and there’s public comment and groups sign in and

scientists have to affirmatively say it’s safe, it makes a tremendous difference,” Fortin said.

Heme is a naturally occurring, iron-containing molecule that’s abundant in the blood and muscle of animals. It also exists in smaller amounts in plants such as soybeans, specifically nodules on their roots, which Impossible Foods harvests for use in its burgers. The company has pointed to heme’s natural occurrence in animal flesh as the reason it tastes so much like meat.

But the company has also promoted its Impossible Burger by saying it looks like meat.

Except in certain categories, a company can start selling novel ingredients in the U.S. as food whenever and wherever it wants, as long as a panel of third-party experts review it and deem it safe. If it wants the government’s blessing — a way to win consumer confidence — the company can present its results to the FDA. The regulator can either raise questions or accept the conclusions and issue a “no questions” letter. The safety standard applied by the FDA is, as Cassell stated in his email, “reasonable certainty of no harm under the conditions of the intended use.”

Impossible Foods convened such an expert panel to evaluate heme’s safety in 2014. When it first showed the FDA its evidence, the regulator said the company had yet to prove that heme was safe. The company followed up with a 1,000-page filing. It included studies on everything from allergens to identifying proteins to rats made to eat heme for 28 days, all to show that it should be “Generally Recognized as Safe.” In July 2018, the FDA issued a “no questions” letter in response to Impossible Foods’ safety filing.

The agency did offer a caveat, however. “There is no [Generally Recognized as Safe] provision for color additives,” the FDA wrote. “In Impossible Foods’ notice, soy leghemoglobin preparation is described as red/brown. As such, the use of soy leghemoglobin preparation in food products (other than ground beef analogue products intended to be cooked) may constitute a color additive use.” “Part of the potential consumer appeal of the uncooked product is that it also looks like ground beef,” Cassell, the FDA spokesman, wrote Bloomberg. “The soy leghemoglobin imparts a red color that is important to the appearance of the food (i.e., makes it look like uncooked ground beef). Therefore, 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.”

Konrad, the company spokesman, said the FDA has already fully evaluated and accepted the safety of heme. She declined to say whether the company will delay the rollout of raw Impossible Burgers to consumers until the FDA makes a ruling on its petition. “It’s absurd to suggest that the mere fact that leghemoglobin, an intrinsically safe ingredient, has a visible color should raise any new safety concerns,” she said.

Substances used to color food have long faced stricter federal safety requirements. The higher level of scrutiny stems from a long history of U.S. food and cosmetics companies using dangerous chemicals to color products. The Federal Food, Drug, and Cosmetic Act of 1938 included new regulations around color, specifically those derived from coal-tars. In the fall of 1950, a number of American children were sickened by Halloween candy that was discovered to have been made with a toxic orange dye containing benzene. A subsequent FDA investigation showed it was a widely and heavily used substance. In 1960, the law was amended to require more federal oversight and pre-market approval.