​FDA did not act after deeming animal feed antibiotics ‘high risk’ to humans - report

Based on the US Food and Drug Administration’s own safety analyses, 30 antibiotic feed additives formerly approved for “nontherapeutic use” on food animals would not meet current agency health standards if submitted for approval today, a new report shows.

Previously undisclosed FDA documents reveal that 30 penicillin and tetracycline antibiotic feed additives reviewed by the agency from 2001 to 2010 would likely fail to meet modern safety requirements for nontherapeutic livestock use if they were proposed as new products, according to a report by the Natural Resources Defense Council (NRDC).

Nontherapeutic use of antibiotics means they are not used to treat diseases, but are rather used for growth promotion in animals or to counteract disease amid crowded or unsanitary conditions for livestock and poultry in industrial farming.

The FDA documents - obtained by the NRDC through a public information request and litigation - show that 18 of the 30 additives were found to be “high risk” for “exposing humans to antibiotic-resistant bacteria through the food supply,” NRDC writes. The other 12 were not supported with enough evidence from the drugs’ manufacturers for the FDA to definitively determine their safety. In fact, 26 of the products did not even meet the FDA’s own safety standards from 1973.

Further, the FDA has not revoked any of the antibiotic additive approvals or required any drug manufacturer to resubmit a product for a new safety assessment following the agency’s reviews, though two were voluntarily withdrawn by their makers.

The NRDC said it is difficult to determine how widespread the use of these antibiotic additives has been, given that the FDA does not offer sales data on specific products.

However, the NRDC found that at least nine of the 30 additives are being marketed today and all of the products - outside of the two already withdrawn - remain FDA-approved despite the agency’s own damning reviews.

The NRDC noted that the reach of the findings goes beyond the 30 antibiotic feed additives surveyed. According to FDA data, the same antibiotics - tetracyclines and penicillins - “together make up nearly half of all the antibiotics used in animal agriculture.”

“Other feed additives with these same antibiotics, including generics, that are approved for similar uses would likely pose a similar risk of promoting antibiotic resistance,” according to the report.

“This risk was recognized by FDA in 1977 when it proposed to withdraw approvals for animal feed additives containing penicillin and most tetracyclines.”

Yet the use of the two antibiotics continues because the FDA never followed through with its own assessment.

Last December, the FDA announced a plan to phase out some antibiotics that promote weight gain, Food Safety News reported. That proposal was criticized because the agency planned on making them “voluntary” – not mandatory.

NRDC microbiologist and co-author of the report, Carmen Cordova, said the FDA’s inaction in regard to the additives’ continued use is “a breach of their responsibility and the public trust.” The NRDC called on the FDA to withdraw the nontherapeutic uses of the two additives.

In response to the report, the FDA issued a statement saying that “based on its review of this and other information, the Agency chose to employ a strategy that would more broadly address the concerns about the production use of medically important antimicrobials in food-producing animals.”

The FDA “is confident that its current strategy to protect the effectiveness of medically important antimicrobials, including penicillins and tetracyclines, is the most efficient and effective way to change the use of these products in animal agriculture,” the statement added, according to Food Safety News.