Impossible Foods was the subject of a misleading article today in Bloomberg, which insinuated that a key ingredient in the Impossible Burger is somehow unsafe or embroiled in a “controversy” when none exists. Impossible Foods has requested a correction and clarification of the deceptive article and is waiting for a response.
Some versions of the article misleadingly implied that the FDA’s requested 90-day extension is an unusual step that should be cause for concern. In fact, a 2016 FDA regulation specifically provides for such 90-day extensions of the the review timeline, and the agency frequently extends its review period in this manner before granting no-questions letters.
This extension is a normal and expected part of the protocol, and a significant percentage of the no-questions letters issued recently have required more than 180 days.
Importantly, the article also omits the relevant fact that the FDA has not come back with any questions or requests for additional scientific data or testing regarding the Impossible Burger or its key ingredient, soy leghemoglobin. The Bloomberg article also tried to suggest that heme might have a role in the link between consumption of red meat and colon cancer.
In fact, the 2018 report (opens in a new tab)cited by the article, from the International Agency for Research on Cancer (part of the World Health Organization), concluded, “There is inadequate evidence in experimental animals for the carcinogenicity of haem iron” — precisely the opposite of what the misleading article implies. (Similarly, a 2017 study by the American Institute for Cancer Research(opens in a new tab) reviewed all of the available evidence and concluded that there is “no significant associations were observed between haem iron and colorectal, colon or rectal cancer.”)
Read this blog post(opens in a new tab) for more details and studies about the extraordinary safety record of heme.