The U.S. Food and Drug Administration has pushed back the deadline of a safety review of Impossible Foods Inc.’s “magic” ingredient that makes its veggie burgers taste like meat, delaying a regulatory blessing the company has long sought.
The FDA extended its review by 90 days, according to an email the agency sent to the company’s outside counsel and obtained through the Freedom of Information Act. The agency was previously slated to respond by April 24. No reason was given for the change.
The agency said in some instances it needs more time to finish reviews. In the case of Impossible Foods, the FDA said in a statement it intends to complete the process within the new time frame.
The 90-day extension is part of routine administrative protocol, Rachel Konrad, a spokeswoman for Impossible Foods, said by email. The company expects a positive response from the agency, she said. Meanwhile, the Impossible Burger is “totally safe to eat, and millions of people have enjoyed it,” she said.
The Redwood City, California-based company has said it’s asking the FDA to review its product’s safety in the interest of transparency, though the ingredient is already in compliance with existing regulations.
The company’s signature product, the Impossible Burger, contains an ingredient called heme (pronounced HEEM), a molecule that abounds in the blood and muscle of animals. It also exists in smaller amounts in plants, and Impossible Foods harvests it from soybean roots. The company uses a genetically modified yeast to mass-produce the substance. Impossible Foods Chief Executive Officer Patrick O. Brown calls heme a “magic ingredient” that makes the company’s veggie burger taste, feel and look like beef.
This is Impossible Foods’s second round of filings with the agency. In a previous effort, the FDA said the company had to establish the safety of the food by providing direct evidence.
In most developed nations, companies usually have to get government approval before they can market novel food ingredients. By contrast, the U.S. has a rule called “generally recognized as safe,” or GRAS, which allows the sale of foods containing new ingredients without FDA approval as long as experts say the additives are safe. Impossible Foods convened a panel in 2014 and has been GRAS-certified since.
The regulatory process has angered Brown, who has said he’s certain of the science behind the product. For the new filing, which exceeds 1,000 pages, Impossible Foods included data from tests where rats were fed large amounts of its heme ingredient for 28 days. But Brown has said that was needless.
“We did it only because we felt that we had to, not that we would learn anything from it,” he said in a February interview.
Some food safety and environmentalist groups have taken issue with Impossible Foods’s heme ingredient, saying it shouldn’t be on the market before the FDA gives its thumbs-up. Others hail the Impossible Burger as a way to wean people from eating beef, which degrades the environment.
Heme is also involved in another controversy. A March survey of studies from the World Health Organization’s International Agency for Research on Cancer reported there’s “strong evidence” that eating it can contribute to the formation of carcinogens in the gut. Impossible Foods disagreed with the finding, citing “the scientific and logical flaws in each of the studies.”
Plant-based products like the Impossible Burger are on the rise. Chicago-based analysts at L.E.K. Consulting have estimated that the market grew 8 percent to $5 billion last year from 2016. The Impossible Burger has expanded to more menus, even to fast-food joints like White Castle. It also recently made its debut in Hong Kong.
According to the FDA’s website, a response to Impossible Foods’s notification is still pending. GRAS rules state that the agency commits to responding to notifications in 180 days, but can extend by 90 days if needed.
(Adds FDA comment in third paragraph.)
–With assistance from Anna Edney.©2018 Bloomberg L.P.
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