According to a safety review conducted by the U.S. Food and Drug Administration, penicillin and tetracycline antibiotic feed additives approved for “nontherapeutic use” do not meet the agency’s current safety standards.
In a Natural Resources Defense Council (NRDC) report released today, previously undisclosed FDA documents reveal that none of the 30 products reviewed between 2001 and 2010 “would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines.”
What’s more, 18 of the additives were regarded as “high risk” for exposing humans to foodborne antibiotic-resistant bacteria. For the other 12, the drug manufacturers failed to provide enough evidence for FDA to determine their level of risk.
At least 26 fail to satisfy FDA’s safety standards from 1973.
Apart from the two antibiotic feed additives withdrawn by the drug manufacturer, the rest included in the internal review continue to be used with FDA approval.
Carmen Cordova, NRDC microbiologist and lead author of the new NRDC analysis, called FDA’s allowance of these drugs in animal feed “a breach of their responsibility and the public trust.” And, given FDA’s history with antibiotics, she said the discovery “is disturbing but not surprising.”
In 1977, the agency concluded that using penicillin and tetracylines in animal feed was not safe and proposed withdrawing approval for those uses, but that never happened.
In December 2013, FDA released a plan to phase out the use of certain antibiotics to promote weight gain, but drew criticism from many safety advocates for not making the plan mandatory.
“Unfortunately, the FDA’s failure to act on its own findings about the 30 reviewed antibiotic feed additives is part of a larger pattern of delay and inaction in tackling livestock drug use that goes back four decades,” read the report.
NRDC concluded its analysis of the documents it obtained through a Freedom of Information Act (FOIA) request and subsequent litigation by calling on FDA to withdraw approval of penicillin and tetracyclines in animal feed for nontherapeutic uses and to do the same for other classes of medically important antibiotics that are not shown to be safe.
If the agency fails to act, NRDC calls on Congress to pass the Preventing Antibiotic Resistance Act and the Preservation of Antibiotics for Medical Treatment Act requiring that nontherapeutic uses be phased out.
FDA issued a statement concerning the report: “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.”
It went on to state that the agency “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.”© Food Safety News