The Center for Food Safety (CFS) has called on FDA to recall the uncooked Impossible Burgers being sold at grocery stores. In a letter to the agency, the consumer advocacy group states that there is no regulation in effect to allow such sales as required under federal law.
Impossible Foods uses soy leghemoglobin or "heme,” which is synthetically extracted from the roots of soy plants and inserted into a genetically engineered yeast, to give the product its meaty appearance and color. It is the use of this as a color additive that required Impossible Foods to seek FDA approval before it could sell uncooked product in grocery stores.
In August, FDA approved Impossible Foods' petition to list heme as a color additive. But CFS filed objections to that approval in September, which legally prevent the regulation from going into effect and prohibit sales of the product until those objections are resolved.
"Without valid FDA approval in place, it is unlawful to sell uncooked Impossible Burgers at retail stores," said CFS Staff Attorney Ryan Talbott. "The law is clear that when FDA receives an objection to a proposed color additive, FDA must hold approval of its use while it reviews the objection, in order to ensure that it is safe for human consumption. FDA should issue a recall telling retailers to remove uncooked Impossible Burgers from their shelves immediately."
The objections filed by CFS raised several issues about FDA's safety review of the heme, including that to be approved as a color additive, there must be "convincing evidence that establishes with reasonable certainty that no harm will result from the intended use." CFS' objection states that through the synthetic biology (synbio) extraction process, new compounds, including proteins, may be created, so the impact in humans is unknown.
"This is the first time that people have consumed synbio heme," said CFS Policy Director Jaydee Hanson. "FDA should have required additional testing to make sure that this new substance does not cause allergic reactions in people, but the agency failed to do so."