FDA Warns Industry on Food Safety Risks of Transferring Genes for Proteins that are Food Allergens

No Comments
May 1, 2023


• Categories: Compliance, Food Labs, RC - Compliance Management, RC - Regulatory & Lab Efficiency

The FDA has issued a letter to developers and manufacturers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food. The purpose of the letter is to remind them of the relevant legal requirements for these products, which may include adding a gene for an allergenic animal protein to a new plant variety to provide a non-animal source of the protein for use as an ingredient in another food.

While the agency noted that it is not aware of any foods currently in the U.S. market derived from these types of new plant varieties, it is aware of research and development in this area.

The FDA is asking developers to consider the food safety risks posed by such allergens and plan early in development to manage those risks, including the potential for recalls due to undeclared allergens.

“We are specifically reminding those developers who are now exploring development of these types of plant varieties of their responsibility for food safety. In particular, we are reminding them to consider the allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply,” the FDA stated. “We are also reminding them that they need to be properly labeled when intentionally part of the food supply.”

To reduce risk to consumers as well as the risk of recalls, the FDA is encouraging developers of new plant varieties to consult with the agency through its voluntary premarket consultation program for foods from new plant varieties prior to marketing.