In May 2020, the FDA relaxed food allergen label requirements during the coronavirus pandemic. They called this guidance “minor formulation changes,” which were to “help minimize the impact of supply chain disruptions associated with the current COVID-19 pandemic on product availability.”
One of the changes was to let manufacturers use existing labels when making “minor formula adjustments” due to those disruptions. The guidance also applies to foods sold in vending machines.
The guidance will remain in place as long as the public health emergency is in place. When the emergency is declared over, the FDA will “consider and publicly communicate regarding whether an extension, in whole or in part, is warranted, based on comments received to this guidance and our experience with its implementation.”
Not surprisingly, Consumer Reports has weighed in on this decision. This decision by the FDA troubles people with allergies or special dietary needs. Almost 3000 people have expressed their concern to the government. While Consumer Reports isn’t aware of any adverse events from this guidance, food safety experts are worried. [Editor’s note: I am severely allergic to Yellow #5, not one of the major food allergens.]
There are eight major food allergens peanuts, eggs, milk, finfish, shellfish, tree nuts, wheat, and soybeans. People are allergic to or sensitive to other ingredients, such as sesame, glutamates, and sulfites, but for those ingredients, the FDA lets manufacturers make decisions whether their products pose a health and safety risk to consumers.
FDA guidance states that these temporary rules do “not establish legally enforceable responsibilities,” and “should be viewed only as recommendations.” The FDA did not respond directly to Consumer Reports’ questions, but instead referred them to information on the agency’s website.
To try to mitigate any problems, Food Allergy Research & Education (FARE) met with 30 major food companies about the FDA relaxed food allergen label guidance, and was told that the companies don’t intend to make substitutions. But if they do, FARE and other groups have asked that manufacturers put temporary label stickers on the products or post the changes on their websites. FDA is not requiring the industry to report these product ingredient changes so the possible impact can’t be traced.
Consumer Reports is advising consumers to call the manufacturer about ingredient substitutions if any family members are allergic to a “non major allergen.” You can also register concerns on the FDA’s website. Since there is no set end date for the guidance to be terminated, anyone with allergies and food sensitivities needs to keep up with this story.
