FDA Announces Plan to Help Curb Unapproved Animal Drugs

The Food and Drug Administration (FDA) has announced an initiative to address “the prevalence of animal drug products marketed in the United States without approval or other legal marketing status.” Unapproved animal drugs on the market include injectable vitamins, shampoos, liniments, and electrolyte and glucose solutions.

FDA is concerned that the safety and effectiveness of these drugs has not been demonstrated and is open “to using both the agency’s existing authority and new approaches to make more drugs legally available to veterinarians, animal producers and pet owners,” according to a December 20, 2010, press release. The agency requests comments by February 18, 2011, on ways to increase the availability of legally marketed animal drugs and has launched a web page detailing problems involving the use of unapproved products. See Federal Register, FDA Press Release, December 20, 2010.