The Food and Drug Administration allowed 30 potentially harmful antibiotics, including 18 rated as “high risk,” to remain on the market as additives in farm animal feed and water, according to records obtained by the Natural Resources Defense Council.
The data, released on Jan. 28, show the use of the drugs in livestock likely exposes humans to antibiotic resistant bacteria through the food supply, the NRDC said. The FDA’s reviews of the antibiotics occurred between 2001 and 2010, yet the drugs remain approved and, in many cases, on the market for use in industrial animal agriculture operations.
“Drugmakers never proved safety. And FDA continues to knowingly allow the use of drugs in animal feed that likely pose a ‘high risk’ to human health,” said Carmen Cordova, NRDC microbiologist and lead author of the new NRDC analysis. “That’s a breach of their responsibility and the public trust.”
Cordova added, “This discovery is disturbing but not surprising given FDA’s poor track record on dealing with this issue. It’s just more overwhelming evidence that FDA — in the face of a mounting antibiotic resistance health crisis — is turning a blind eye to industry’s misuse of these miracle drugs.”
The NRDC report, “Playing Chicken with Antibiotics,” shows safety reviews of various drugs in the penicillin and tetracycline drug classes — antibiotics considered important to human medicine, which together comprise nearly half of all antibiotics used in animal agriculture in the United States.
NRDC, in the report, said FDA papers obtained through freedom of information requests, show:
• None of the 30 antibiotics would likely be approved as new additives for livestock use if submitted under current FDA guidelines, because drugmakers have not submitted sufficient information to establish their safety.
• 18 of the 30 antibiotic feed additives reviewed were deemed to pose a “high risk” of exposing humans to antibiotic resistant bacteria through the food supply and of adversely affecting human health.
• Drug manufacturers never submitted sufficient information for the remaining 12 products to establish safety, meaning there is no proof of their safety for humans when used in animal feed and the products could not be approved today.
• 29 of the reviewed additives fail to satisfy FDA’s first iteration of safety requirements from 1973.
A large body of scientific work on bacterial cross- and co-resistance has established that the misuse of one antibiotic can lead to bacterial resistance to other antibiotics.
According to the NRDC, the 30 penicillin- and tetracycline-based animal feed additives could reduce the effectiveness of a range of other medically important antibiotics that are solely used to treat people.
FDA first recognized the risks from the use of antibiotics in animal feed in 1977 when it proposed to withdraw approvals for animal feed containing penicillin and most tetracyclines. NRDC won a lawsuit against the FDA for failing to follow through and address the threat posed by the misuse of penicillin and tetracyclines in the livestock industry.
The FDA appealed, and a decision is pending in the U.S. Court of Appeals for the Second Circuit, in New York.