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Originally published March 2 2014

FDA deliberately allows animal drugs to stay legal even when they threaten humans with superbugs

by David Gutierrez, staff writer

(NaturalNews) The FDA allowed 18 separate animal antibiotics to remain on the market even after concluding that they posed a "high risk" of leading to antibiotic resistance in bacteria that cause disease in humans, according to a new study by the Natural Resources Defense Council (NRDC).

Microbiologist and lead author Carmen Cordova called the FDA's inaction in the face of its own findings "a breach of their responsibility and the public trust."

The study is the latest contribution to an ongoing debate over the prolific use of antibiotics as growth-promoting agents in the meat industry. Scientists and health professionals have been warning for years that this practice promotes the evolution of antibiotic resistance in bacteria, including among many species that can infect human beings.

Antibiotic-resistant infections are responsible for 23,000 deaths per year in the United States alone.

No evidence of safety

In order to evaluate the agency's regulation of antibiotics in agriculture, the NRDC reviewed more than 3,000 pages of internal FDA documents acquired as the result of a Freedom of Information Act request. The documents focused on 30 penicillin- and tetracycline-based drugs that the FDA had approved for use as feed additives. All 30 drugs were approved for "subtherapeutic" or "nontherapeutic" uses, meaning that they could be used for goals such as growth promotion even in the absence of a bacterial infection.

In a review conducted between 2001 and 2010, the FDA classified 18 of the antibiotics as posing a "high risk" of contributing to health problems in humans. The other 12 were not classified as safe, but escaped being labeled "high risk" simply because there was not enough data to make any definitive statements about their safety at all.

The NRDC says that 26 of the drugs studied had actually been approved by the FDA even though their manufacturers had never met the requirement (under a 1973 FDA policy) of submitting scientific studies proving their safety.

In spite of these findings, the FDA took no action to remove a single one of the 30 drugs from the market, the NRDC report says. Although some of the drugs have since been pulled from the market by their manufacturers, nine of the drugs classified as "high risk" are still being regularly used.

"Pattern of delay and inaction"

Just last year, the FDA announced new voluntary guidelines intended to lead to a phasing out of antibiotics as growth enhancers in livestock.

According to Deputy FDA Commissioner Michael Taylor, once a company has voluntarily removed farm-production uses from a drug's label, it becomes illegal to use that drug for such goals. Taylor said that the FDA will take action against agribusinesses that violate the new usage rules.

But NRDC attorney and study co-author Avinash Kar questioned whether the FDA can be trusted to enforce these rules.

A case in point is the drug Penicillin G Procaine 50/100, which Zoetis Inc. makes as a poultry growth promoter. The NRDC says that it has contacted the FDA on two separate occasions to draw attention to the fact that the drug was approved without meeting the FDA's own safety guidelines. Yet the drug is still on the market, although the company (a Pfizer subsidiary) says it has plans to phase it out as a growth promoter.

"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," Kar said.

"They are not meeting their responsibility to protect public health. They need to be doing better."

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