FDA clarifies term for 'non-lactating' cattle


FDA clarifies term for 'non-lactating' cattle

Apr 01, 2012

ROCKVILLE, MD. — The U.S. Food and Drug Administration issued a statement clarifying that dry dairy cows should not be included in the definition of non-lactating dairy cattle. The agency fears the term could mistakenly be interpreted when drugs are dispensed.

FDA says it was concerned that the term would be confused to mean that drugs approved for use in non-lactating dairy cattle are safe when used in cows between two lactations.

The terms non-lactating dairy cattle includes replacement dairy heifers, replacement dairy bulls and dairy calves, according to current animal-industry standards and a long-standing FDA practice. These classes of dairy cattle have not yet, or would never, produce milk for human consumption, FDA says. The agency explains that dry dairy cows have previously produced milk for human consumption and will again in the future. Therefore, the clarification is an important food-safety step. In order for these drugs to be approved for use in dry dairy cows, FDA says residue-depletion studies would be necessary.

FDA says it is working with sponsors of products approved for use in non-lactating dairy cattle to revise product labeling to better define non-lactating dairy cattle.