The Food and Drug Administration is reminding manufacturers of plant-based proteins to be aware of the legal requirements of such products.

The reminder is a pre-emptive strike for developers and manufacturers of new plant varieties who intent to transfer genes for proteins that are food allergens into new plant varieties used for food.

“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,” says the FDA reminder. 

“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 federal government’s list of major food allergens includes the nine following foods: milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.

Because of the safety risks posed by these allergens, the FDA has asked manufacturers and developers to consider dangers during the early development and management processes. The FDA warned producers and developers that food safety risks from unlabeled allergens could have consequences other than the health and welfare of consumers.

“. . . 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 warned. “The FDA is reminding the industry of the relevant legal requirements and potential food safety concerns related to producing, processing, packaging, and holding these types of plant varieties and the 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 the 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.”

To support developers and manufacturers in their pursuits, the FDA is inviting them to consult with the agency prior to marketing their products. The FDA has offered such consultation since 1994 for foods from new plant varieties.

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