Dear Mr. Cohen:

Prior to commercial distribution of any new animal drug for use in food-producing animals, a sponsor must prove its product is safe and effective when used as described in the proposed labeling of the drug. Effectiveness simply means that the product does what the labeling claims. Safety routinely covers the safety of the food products to humans, and safety to the target animals. In addition to these requirements, the sponsor must prove that they can consistently manufacture the drug to a specific purity, potency and quality.