FDA continues to escalate enforcement for undeclared allergen recalls

As we previously reported, throughout the last several months the FDA sent out several Warning Letters to companies that have had recalls due to undeclared allergens. Now, the agency has taken further action to bring attention to this key area of concern.

The FDA issued a Constituent Update explaining the agency’s significant focus on preventing further undeclared allergen recalls throughout the food industry. The FDA explains that the agency has “begun several initiatives to improve industry’s compliance with allergen labeling requirements and reduce undeclared allergen-related food recalls.” Further, the FDA says: “The food industry can and must do better to prevent exposing consumers to incorrectly labeled packaged food which can cause serious and life-threatening harm. Manufacturers should also ensure they have controls in place to prevent the unintentional addition of allergens during manufacturing processes.”

The Constituent Update also announces that in 2020 FDA sent eight warning letters to companies that manufactured and distributed foods with undeclared allergens. Notably, the Constituent Update also announces that FDA recently, for the first time, sent a Warning Letter to a food retailer alleging that the company “engaged in a pattern of receiving and offering for sale misbranded food products” that contain undeclared allergens over multiple years. 

In a public announcement concerning these developments, William Correll, Jr., Director of the Office of Compliance at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), stated: “The FDA is committed to protecting the health of the American people. It’s important that food packaging, at all points of the supply chain, appropriately lists the presence of all major food allergens so that individuals with food sensitivities can take appropriate steps to avoid products that may cause them serious and life-threatening harm.”

Next steps

We expect undeclared allergens to be a key area of focus and FDA enforcement in 2021. In light of these developments and to help protect allergic consumers, food manufacturers and private label brand owners would be well served to carefully review their (or their contract manufacturer’s) allergen control programs, assess whether there are opportunities for improvement, and reinforce training of personnel involved with these parts of the manufacturing process.

Authored by Maile Hermida and Leigh Barcham.