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  1. CFSAN Constituent Updates

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

Constituent Update

April 13, 2023

Today, 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 we are 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, we think 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.

The 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.  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. We are also reminding them that they need to be properly labeled when intentionally part of the food supply.

The FDA encourages developers of new plant varieties to consult with us prior to marketing.  Since 1994, the FDA has operated a voluntary premarket consultation program for foods from new plant varieties.  This program is intended to protect the public by helping the food industry ensure that foods from their new plant varieties meet all relevant requirements under the Federal Food, Drug, and Cosmetic Act before marketing.

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