Why the ‘bloody’ Impossible Burger faces another FDA hurdle

John Makhou, owner of Papa Mak's Burgers, with the Impossible Burger on Friday, Aug. 3, 2018, in San Francisco, Calif. The burger spot is located at 3755 Noriega St. John Makhou, owner of Papa Mak's Burgers, with the Impossible Burger on Friday, Aug. 3, 2018, in San Francisco, Calif. The burger spot is located at 3755 Noriega St. Photo: Santiago Mejia, The Chronicle Buy photo Photo: Santiago Mejia, The Chronicle Image 1 of / 3 Caption Close Why the ‘bloody’ Impossible Burger faces another FDA hurdle 1 / 3 Back to Gallery

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 Redwood City 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 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 people can purchase the uncooked product.

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“If the firm wishes to sell the uncooked, red-colored ground beef analogue to consumers, premarket 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.”

“Impossible Foods is in full compliance with all federal food-safety regulations and has been since 2014,” she said, well before the product was introduced at restaurants in 2016. 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 release 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 massive role industrial meat production plays in global warming.

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 or ask for more safety tests. (Impossible Foods and the FDA declined to share the petition.)

“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 United States 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’ filing.

The agency did offer a caveat, however. “In Impossible Foods’ notice, soy leghemoglobin preparation is described as red/brown,” the FDA wrote. “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.”

A key issue for regulators, legal experts said, is whether an ingredient’s inclusion is intended to add color, and whether it’s advertised as such.

In a July 2016 announcement, Impossible Foods said its burgers would be available at the New York restaurant Momofuku Nishi. In the release, the company said the burger “looks, cooks, smells, sizzles, and tastes like conventional ground beef.” According to an Aug. 24, 2017, version of the frequently asked questions section of the Impossible Foods website, accessed through the nonprofit Internet archive Wayback Machine, “Heme contributes to the characteristic color and taste of meat.”

Photos of the burger, in media and on the company website at that time, also show a red, bloody- looking medium-rare burger.

Konrad said heme was not added for its appearance. “It would be ridiculous to use heme for color,” she said, adding that there are cheaper and easier options, such as beet juice. “Because the importance of heme stems from its impact on taste and smell, we do not emphasize its color in our marketing materials.”

Senior said that, regardless of questions of intent, the new FDA review is unlikely to keep raw Impossible Burgers out of supermarkets. While the color additive review process is more stringent than the one for the designation “generally regarded as safe,” he said, rejection of heme as a color additive after it has already gone through the other review process is “very unlikely.”

Food safety advocates say the entire episode is emblematic of larger questions about the burgeoning meat-alternatives segment, and more broadly, the FDA approval process itself.

Michael Hansen, a scientist at Consumers Union, the research arm of Consumer Reports, said the heme used in Impossible Burgers should be considered a color additive even in its cooked form, and shouldn’t be on the market until it gets approval as such. Some additional, longer-term tests would have given consumers a better picture of the product’s safety, said Lisa Lefferts, a senior scientist at the Center for Science in the Public Interest.

“If people are are going to be eating this, it should be tested for its long-term effects,” she said.

Lydia Mulvany and Deena Shanker are Bloomberg writers. Email: lmulvany2@bloomberg.net, dshanker@bloomberg.net