Since 2001, FDA has issued at least 28 warning letters notifying dairy farmers, veterinarians, and firms marketing veterinary products of violations including the use or sale of new animal drugs without the approvals required by federal law. Some of these violations also resulted in illegal drug residues, which can be prevented, as previously described.
- Whether used in animal feed, applied topically, or injected, FDA regulates the use of drugs in animals.
- Veterinary products marketed for use in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or function of animals, are considered drugs.
- If not generally recognized by relevant experts to be safe and efficacious under the conditions prescribed, recommended, or suggested by the labeling (on the product label, the website, catalog, or other advertising materials), these products are also considered new animal drugs.
- All new animal drugs must be approved by the FDA prior to sale.
- Interstate marketing and sales of these products before such approval has been obtained is prohibited and the products are considered unsafe and adulterated.
- Marketing of these products for use in food animals raises the level of concern, because of the potential health concerns to humans.
To addition to selling products only after all approvals have been obtained, avoid the use of the following terms and any statements suggesting the unapproved products may be useful for the prevention or treatment of the following conditions (a more comprehensive list is maintained by FDA).
- wound care;
- disease prevention;
- defend against diseases;
- aids to overcome conditions or diseases;
- alleviate certain conditions;
- maintain healthy bodily functions or systems;
- promote normal bodily functions;
- strengthen the immune system.