FDA issues letter to industry on the food safety risks of transferring genes for proteins that are food Allergens to new plant varieties used for food
On 13 April 2023, the U.S. Food and Drug Administration issued a letter reminding 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 of the relevant legal requirements for these products.
The FDA is not aware of any foods currently in the U.S. market from these types of new plant varieties, but is aware of research and development in this area. Because adverse reactions to food allergens can be severe and life-threatening, including when the allergen is present at low levels, FDA thinks it is important to reach out to developers and manufacturers now, while such plant varieties are still in early research and development stages.
The FDA is asking developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks. In addition to the food safety risks, if unexpected and unlabeled allergens enter the food supply, this could have other consequences for food producers, such as needing to recall the affected products.