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NRDC Analysis of FDA Documents Finds Livestock Antibiotics ‘High Risk’ to Humans

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Apart from the two antibiotic feed additives withdrawn by the drug manufacturer, the rest included in the internal review continue to be used with FDA approval.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
  • Peter Mundy

    Who to trust? The likes of the World Health Organization, the U.S.
    Centers for Disease Control and Prevention, the American Medical
    Association (I could go on and on), or the intensive livestock industry
    lobby, the drug companies, and their long list of paid-up cronies? Golly, it’s a tough
    one……….

    • http://www.beaksandnoses.net/ ibnevrywhre

      trust nobody when it comes to pharmaceutical company’s ! i think that they are all in it together for the $$ they care nothing about the citizens of this country

    • doc raymond

      I am glad you mentioned the CDC. Now go read their 100+ page report released in Sept 2013 and get educated. Michael, I was just at a very large conference attended by thousands. I asked the MDs in the room when the last time was they had prescribed oxy- or chlortetracycline. They all shrugged. So I asked them to raise their hands if they had prescribed either one in this century. No hands went up.

      • Michael Bulger

        Great anecdotal story. Thanks for that. Why don’t you email CDC, FDA, WHO, and the major medical organizations that are calling for livestock agriculture to end nontherapeutic antibiotic use? I’m sure they’d be thrilled with your amazing new data.

        You didn’t link to the CDC report, so I will: http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf

        Just a few my favorite quotes from CDC:

        “Antibiotics are also commonly used in food animals to prevent, control, and treat disease, and to promote the growth of food-producing animals . The use of antibiotics for promoting growth is not necessary, and the practice should be phased out.”

        “… with increasing resistance to other drug classes, tetracyclines are considered as a treatment option.”

        “… much of antibiotic use in animals is unnecessary and inappropriate and makes everyone less safe.”

        They also have a great visual of how livestock ag is clearly contributes to antibiotic-resistant infections in humans.

        So, yeah. Thanks for directing me to a report that reinforces and supports my assertions. Richard, you’re one in a million.

        • doc raymond

          3 pages in the CDC report out of over 100 talk about antibiotic use in animals. Why did you not include the quote about 50% of all antibiotics prescribed in human medicine are unnecessary and inappropriate? Your first quote is spot on, and most everyone agrees with the CDC position on this, which is much different from your statement that CDC, WHO, etc are calling for “livestock agriculture to end nontherapeutic antibiotic use”.

          • Michael Bulger

            1. The section on healthcare settings is only 2 pages. What point do you really think you’re making with such an assinine comment? As if the number of pages denotes the level of significance..

            2. I limited my quote to the relevant subject matter. This is FOOD Safety News. Not Hospital Safety News or General Practitioner Safety News.

            3. Another choice quote from the CDC report: “Because of the link between antibiotic use in food-producing animals and the occurrence of antibiotic-resistant infections in humans, antibiotics should be used in food-producing animals only under veterinary oversight and only to manage and treat infectious diseases…”

            If it is prescribed and used to treat disease, it is therapetuic. If you use low, resistance-promoting levels for growth promotion, it is nontherapeutic. CDC, WHO, etc. are calling for livestock agriculture to end growth promotion through antibiotics > CDC, WHO, etc are calling for livestock agriculture to end nontherapeutic antibiotic use.

            It would be a half-baked arguement to make (though, you likely will attempt it anyways) that you are “managing” disease by continuing to feed groups of healthy individuals nontherapeutic and resistance-promoting levels of antibiotics. There’s a reason why we don’t “manage” disease like this in human medicine. It’s crude and counterproductive.