The U.S. Food and Drug Administration (FDA) has issued a letter reminding developers and manufacturers of new plant varieties used for food intending to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into such new plant varieties of the relevant legal requirements for such products.

Foods derived from new plant varieties developed using genetic engineering or genome editing are often referred to as Genetically Modified Organisms (GMOs) or as “bioengineered.” An example of gene transfer of allergen proteins into novel plants would be adding the gene for an allergenic animal protein to a new plant variety to provide a non-animal source of the protein to use as an ingredient in another food.

FDA is not aware of any foods currently in the U.S. market from these types of new plant varieties, but the agency is aware of research and development in the area. Because adverse reactions to food allergens can be severe and life-threatening, including when the allergen is present at low levels, FDA found it appropriate to reach out to developers and manufacturers while such plant varieties are still in early research and development stages.

Since FDA published its 1992 policy on food from new plant varieties, the agency is aware of only one case in which a company transferred a gene from a major food allergen into a crop plant—a gene for a Brazil nut protein into a soy variety to improve its nutritional profile for animal feed. Upon discovery that the transferred Brazil nut protein was an allergen, the developers voluntarily discontinued development of the new variety because of the food safety risk to individuals allergic to Brazil nuts.

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.

Additionally, FDA is reminding industry of the relevant legal requirements and potential food safety concerns related to producing, processing, packaging, and holding these types of plant varieties and industry’s responsibility to ensure that they do not become unintended or unexpected allergens in final food products. In particular, the agency is reminding developers 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. FDA is also reminding developers that products need to be properly labeled when intentionally part of the food supply.

FDA encourages developers of new plant varieties to consult with the agency prior to marketing through its voluntary premarket consultation program for foods from new plant varieties.