Playing Chicken with Antibiotics: Previously Undisclosed FDA Documents Show Antibiotic Feed Additives Don't Meet the Agency's Own Safety Standards

Between 2001 and 2010, the United States Food and Drug Administration (FDA) quietly reviewed the safety of 30 penicillin and tetracycline antibiotic feed additives approved for "nontherapeutic use". Nontherapeutic use refers to using antibiotics for growth promotion or to prevent disease in typically crowded, often unsanitary conditions in livestock and poultry. NRDC obtained the previously undisclosed review documents from the FDA as a result of a Freedom of Information Act (FOIA) request to the agency and subsequent litigation made necessary by FDA's failure to provide any of the requested documents.

FDA's scientific reviewers' findings show that none of these products would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines. Eighteen of the 30 reviewed feed additives were deemed to pose a "high risk" of exposing humans to antibiotic-resistant bacteria through the food supply, based on the information available. The remainder lacked adequate data for the reviewers to make any determination and their safety remains unproven. In addition, FDA concluded in their review that at least 26 of the reviewed feed additives do not satisfy even the safety standards set by FDA in 1973.

To our knowledge, FDA has taken no action since the reviews to revoke approvals for any of these antibiotic feed additives (although two were voluntarily withdrawn by the drug manufacturer). The FDA does not disclose sales of specific animal drug products, and we have no information about the quantities of these specific antibiotic additives that were sold for livestock use or administered to food animals. However, we found evidence suggesting that at least nine of these additives are being marketed today, and all but the two voluntarily withdrawn additives remain approved for use today.

FOIA Documents (PDF, 308 MB)