Advocacy in action

Concerns with the use of unapproved products

I wanted to take this opportunity to discuss the issue of the use of “unapproved” products in swine production. These products are marketed in both the animal and human health arenas for a variety of indications. They have not, in most cases, ever been submitted to the US Food and Drug Administration (FDA) for consideration or approval. Some have been on the market for many years and FDA considers them a “low regulatory priority.” The Center for Veterinary Medicine (CVM) at FDA stresses, however, that the use of unapproved products in food-producing animals is illegal. Concern has also been raised regarding possible consumer perception of the use of these products.

The FDA-CVM estimates that there are approximately 1700 approved products on the market and two to three times as many unapproved products sold over the counter in pharmacies, feed stores, and farm-supply catalogs. How can you tell if a product you are considering using is FDA approved? It’s not as easy as you might think. Approved products have been assigned a New Animal Drug Application (NADA) number by the FDA. Unfortunately, there is no requirement that this number, or any other statement attesting to the fact that the product has been approved, appear on the product label. Therefore, it is left up to the end-user to verify the product’s approval status by accessing the FDA animal-drug database, which contains a listing of all approved products. The searchable database is available online at http://www.accessdata.fda.gov/scripts/animaldrugsatfda/

The AASV has been in contact with the FDA regarding this issue. While acknowledging that veterinarians are at times faced with the challenge of having to treat conditions for which there are no approved products for swine, the agency reminds veterinarians that the use of unapproved products in food-producing animals is illegal. The FDA has the authority to come onto a farm and inspect the supply of drugs on-hand and all pertinent treatment records.

The FDA has expressed an interest in trying to find a way to evaluate the marketing and use of these products, particularly those that have been on the market and in use for many years. This could potentially be achieved through some mechanism that would evaluate the safety of the product and result in either its removal from the market or its designation as safe and legal for use. Similar mechanisms have been used to designate unapproved feed ingredients as Generally Recognized as Safe (GRAS). Some unapproved human products have been deemed safe following the publication of a monograph in which scientific experts evaluate products and attest to their safety.

In the absence of an approved product, FDA recommends that veterinarians resort to the extra-label use of approved products as defined within the Animal Medicinal Drug Use Clarification Act (AMDUCA). This act allows veterinarians to prescribe approved products for use in an extra-label manner. Thus, products approved to treat a condition in other species, including human products, could be used in food-producing animals for which there is no approved product.

Many products approved for use in non-food-producing species carry a statement on the label implying that the product should not be used in food animals (eg, “Not intended for use in food animals,” or “Not approved for use in animals intended for human consumption”). Officials at the FDA-CVM clarified this statement to mean that the product has not been submitted for approval in food-producing animals, but it is not prohibited for use in an extra-label manner under AMDUCA. The provisions of AMDUCA are applicable to any product that carries an FDA approval for any species. Therefore, all FDA-approved products may be prescribed by a licensed veterinarian for extra-label use in food-producing animals EXCEPT for the list of products expressly prohibited by the FDA. A list of those products is available on the FDA Web site at http://www.fda.gov/cvm/Documents/530_41.pdf. The only products currently banned for extra-label use in food-producing animals include:

1. Chloramphenicol
2. Clenbuterol
3. Diethylstilbestrol
4. Dimetridazole
5. Ipronidazole
6. Other nitroimidazoles
7. Furazolidone
8. Nitrofurazone
9. Sulfonamide drugs in lactating dairy cattle (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
10. Fluoroquinolones
11. Glycopeptides
12. Phenylbutazone in female dairy cattle 20 months of age or older

In conclusion, veterinarians and producers should examine their pharmacies to determine if they contain unapproved products. Recognize that the use of unapproved products in food-producing animals is illegal and may be of concern to packers and consumers. For those indications for which we do not have an approved product, consider using a product approved for another species, or a human-label product, in an extra-label manner as allowed under AMDUCA.

-- Harry Snelson, DVM