The U.S. Food and Drug Administration (FDA) has issued new guidelines for protein analog producers in order to support the fast-growing sector.
The guidance most pertinent to the alt-protein industry is around how to label plant-based analogs of foods that are traditionally animal-derived, like alt-seafood. The FDA shared a draft guidance document on this topic, allowing citizens to submit comments on the language until 7 May 2025.
The guideline’s key recommendations include that producers accurately and prominently label their products with both their main ingredients and by the “common or usual name of the food, if there is such a name.”
This means that a plant-based product meant to provide an alternative to crab, for instance, should be labeled as “cashew-derived crab alternative.”
“Consumers should be able to readily observe this information when reading the label,” the FDA said. “Statements of identity that contain a limited amount of information may not sufficiently describe the basic nature of the food or its characterizing properties or ingredients. For example, names such as ‘Plant-Based Burger,’ ‘Meatless Meatballs,’ or ‘Vegetarian ChickN Sausage’ may signal to consumers that the food is a meat alternative, but they do not identify the plant source comprising the food.”
The FDA also issued new draft guidance around how to safely treat low-moisture, ready-to-eat foods and how to respond to pathogen contamination events.
For the latter events, the FDA advised that producers should establish a routine sanitation and environmental monitoring program, conduct root cause investigations (RCIs) following pathogen contamination events, apply sanitizing treatments when responding to pathogen contamination events, take steps to identify affected food, and be wary of relying solely on product testing as verification of pathogen contamination elimination.
Though an update was also added to the FDA’s guidelines on food allergen labeling, the changes were editorial, not substantive. The last major change to the FDA’s allergen guidelines came in 2021, when sesame was added to the section which describes major food allergens.
The Food Allergen Labeling and Consumer Protection Act (FALCPA), itself an update of a 1938 law, dates back to 2004, when the organization began requiring companies to list substances that are major food allergens in plain language on their ingredients list. The current list includes milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybean, and sesame.
The update also included new language on how producers should treat allergens that do not fall into the nine major categories listed above. This new guidance is primarily directed at FDA staff who evaluate citizen petitions for inclusion in the major allergen list and for citizens seeking to understand the process of submitting a petition.
FDA guidelines are unenforceable recommendations which the organization provides in order to give businesses and the public access to its most current thinking on an issue of public health concern.