• FDA regulates human and animal food from plants, including plants produced through genetic engineering (GE), under the Federal, Food, Drug, and Cosmetic Act (FD&C Act).  Foods derived from new plant varieties, both GE plants as well as varieties from traditional plant breeding, must meet the same FDA regulatory requirements that apply to all foods.  FDA has established a voluntary Plant Biotechnology Consultation Program whereby companies may submit notices, which FDA reviews and responds to with respect to whether food derived from a new plant variety presents safety and regulatory issues.  One of the factors that FDA considers is whether a protein expressed by a new plant variety may cause an allergic reaction because adverse reactions to food allergens can be severe and life-threatening, including when the allergen is present at low levels. 

• In an April 13, 2023 Constituent Update, FDA announced that a letter was sent to manufacturers and developers 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.  FDA cautions these developers to consider the food safety risks posed by such allergens and plan early in development to manage the risks.  Although meat is not a major allergen, plant-based proteins made by adding a gene for an allergenic animal protein to a new plant variety are called out in FDA’s letter as an example of GE that could result in the presence of an unexpected allergen in another food made with a new plant variety as an ingredient.  The only other cautionary example provided in FDA’s letter is the historical case of a Brazil nut gene that was transferred into a soy variety to improve its nutritional profile for animal feed, in which case development was voluntarily discontinued based on the developers’ concerns that they could not ensure the modified soybean would not inadvertently get into human food.  In this regard, FDA’s letter reminds developers to consider 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 and how their products need to be properly labeled when intentionally part of the food supply.  FDA’s letter also cautions that 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.

• FDA’s letter does not explain how the presence of an allergen is likely to be “unexpected and unlabeled” in the case of proteins from new plant varieties that are being developed as plant-based substitutes for animal proteins, such as collagen, myoglobin, ovalbumin or casein that are used in currently marketed foods containing these proteins.  The larger issue would seem to be unintended spread of a gene for an allergenic protein to non-GE crops.  For example, we have discussed how genetic material from two new GE varieties of canola seed was found in specific lots of non-GE canola seed and a small number of non-GE canola fields before voluntary premarket consultations with FDA for the GE canola were completed.  In this case, new proteins expressed in the canola were found unlikely to be allergenic and the issue of preventing unintended spread to non-GE crops (which is in the jurisdiction of USDA’s Animal and Plant Health Inspection Service (APHIS)), was not addressed in FDA’s favorable response letters on the GE canola.

Lauren Haas, Frederick Stearns, and Emily Thomas also contributed to this article.