Are You Aware there are Unapproved Animal Health Products on the Market?

It has come to our attention that there are a number of products available over-the-counter (OTC) for the topical treatment of wounds in livestock that have not been subjected to the FDA approval process. Use of these products in food-producing animals is illegal for producers and veterinarians even under the Animal Medicinal Drug Use Clarification Act (AMDUCA) which only allows for the extra-label use of APPROVED products.

According to the FDA, there are many animal and human health products available for sale OTC that have not received agency approval. FDA officials admit these products should not be available for purchase but many have been marketed for years with no apparent adverse effects. The challenge is to determine which products have received FDA approval and which have not. All FDA-approved products are assigned a New Animal Drug Application (NADA) number. According to officials, however, there is no requirement that the NADA number appear on the label or that the label contain any information indicating that the product is FDA approved. Therefore, you cannot look at a product label and determine for sure that it is, in fact, approved for use in animals or humans unless it happens to display an NADA number.

The only way to know for sure that the products you purchase are FDA approved is to look for an NADA number on the label or verify that the product is listed on the FDA's database of approved animal drugs. This database, entitled Animal Drugs@FDA, is available online and can be searched by NADA number, ingredient, common name, species, route of administration, dose form or manufacturer. If a product is not on this list it is not approved for use, even in an extra-label manner, in food-producing animals.

Unfortunately, there are no FDA-approved products for the topical treatment of wounds specifically in swine. So, what options are available for swine producers and veterinarians to address the welfare and animal health concerns associated with wound treatment in pigs? Upon review of the FDA database, approximately 20 products are approved for use in animals as a topical would treatment. Of these products, 5 are available OTC. Two of these, Trypzyme® Aerosol and Granulex Aerosol Spray, do not list a particular species but rather just state for use "in animals". According to communications with FDA officials, veterinarians and producers could use either of these 2 products legally in swine as per label instructions. The other 3 OTC products, Nolvasan® Antiseptic Ointment, Kopertox® and Horseshoer's Secret Thrush Treatment Aid (formerly Thrush-XX), all indicate for use in species other than food animals and thus their use in swine would be considered extra-label. They could, however, be prescribed for use in swine by a licensed veterinarian under the guidelines of AMDUCA if the 2 approved products were found to be ineffective.

Many of the prescription products on the approved list of topicals have established tolerances for tissue residues in food animal species although they are not approved for use in those species. These tolerances can be found in the FDA database and may provide some guidance when determining withdrawal periods if prescribed for use under AMDUCA. You will also notice that many of the product labels contain the statement "not for use in animals intended for food" or something to that effect. According to FDA officials, this statement does not preclude the use of these products in food animals it simply means the product has not been evaluated for use in animals intended for human consumption. Therefore, as approved products, they could be prescribed by a veterinarian for use in swine in an extra-label manner under the conditions set forth in AMDUCA.

You can find a spreadsheet on the AASV website, entitled FDA Approved Topicals, listing the 20 approved topical products for wound treatment in animals. Take note, however, that of the 20 products, only the 2 trypsin-based products can be used in food-producing animals without veterinary prescription. The other products on the list could be prescribed by a licensed veterinarian on an extra-label basis assuming the criteria set forth under AMDUCA are met.