In late July, the U.S. Food and Drug Administration released an updated guidance document for producers of certain animal feed medications that includes regulations for the content and format of product labels. While this move will likely have a small impact on animal feed manufacturers, it may cause some disruption for drug companies that develop new medications. But to understand what's changed, it's useful to recap current industry practices and requirements.
What is "Blue Bird" labeling?
According to the FDA, "Blue Bird" labeling "function[s] as a guide to manufacturers of medicated animal feeds in the preparation of final printed feed labels." Since many animal feed producers do not have the infrastructure or knowledge to create their own medications, they typically obtain health-related additives from pharmaceutical companies. This partnership has allowed for continued innovation and improvement in animal feed manufacturing, but it's also created some confusion about how certain products should be labeled. Under current regulations, the FDA recognizes three different types of medicated products that have separate labeling rules, including:
- Type A refers to the raw medications produced by pharmaceutical companies used in the production of Type B and Type C animal feeds. Developers of Type A "medical articles" are required to create Blue Bird labels that provide important information for their affiliates.
- Type B refers to medicated feed that contains extremely high levels of beneficial additives and must be diluted before it can be fed to livestock. In most cases, these products are used in the production of Type C medicated feeds or mixed into animals' standard fare.
- Type C refers to medicated feed that is safe for livestock to consume with little or no dilution. These products are typically purchased wholesale by farmers and used in conjunction with other (non-medicated) animal feed.
What's different about the FDA's updated guidance?
The purpose of the FDA's new guidance document is to compel developers and sponsors of Type A medicated articles to supply manufacturers with clearer recommendations for labeling Type B and Type C medicated feeds that contain their new animal drug. This includes detailing the intended use of their products in the creation of Type B and Type C animal feeds. Under the new guidelines, all Blue Bird labels should include information such as:
- Product name
- Active drug ingredients
- Feeding directions
- Caution/warning statements
- Guaranteed analysis