FDA cautions plant-based protein producers to bear allergens risk in mind

The US Food and Drug Administration (FDA) has recently issued a letter reminding manufacturers of plant-based proteins to be aware of the legal requirements that apply to their products. This has been intended as a preventative measure for those developers who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens, namely milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame) into new plant varieties used for food.  

At present, there are no food items made from these new varieties of plants available in the US market. Nevertheless, research is underway, prompting the FDA to reach out to developers and producers while such plant varieties are still in early research and development stages.  

As allergens can be hazardous to health, the FDA has urged manufacturers and developers to take into account the potential dangers during the initial stages of development and management of their products. Moreover, the FDA warns that unanticipated and undeclared allergens can have implications beyond the well-being and safety of consumers, such as needing to recall the affected products.    

“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”, stated the agency.  

Starting from 1994, the FDA has been running a voluntary premarket consultation program for food products derived from new plant varieties. The purpose of this program is to safeguard the public by assisting the food industry in verifying that their new plant varieties comply with all the requirements under the Federal Food, Drug, and Cosmetic Act before they are marketed. Therefore, to support developers and manufacturers in their pursuits, the FDA is inviting them to seek guidance from the agency before introducing their products into the market.