The U.S. Food and Drug Administration is taking its biggest step yet to rein in the indiscriminate use of antibiotics that help food animals grow bigger, faster. The agency said Wednesday it is asking veterinary drug makers to voluntarily phase out medically important drugs from being available over the counter in the hope that the shift will help combat growing antimicrobial resistance.

chicken-factory-350.jpgUnder FDA’s proposal, these antimicrobials will still be allowed in animal agriculture but, if veterinary drug companies agree to change the labels, farmers will be allowed to use the drugs only to prevent, control, or treat diseases and under the supervision of a veterinarian and not for promoting growth or improving feed efficiency.

The agency said it was taking the voluntary action to “preserve the effectiveness of medically important antimicrobials for treating disease in humans.”

According to the most recent estimates, around 80 percent of all antibiotics sold in the United States are given to animals. FDA said it doesn’t know what percentage is used for growth promotion or so-called production uses, which the agency is trying to limit.

The reaction in the public health, veterinary pharmaceutical and animal agriculture community was mixed, but mostly negative.

The Pew Charitable Trusts, which has been lobbying for limiting antibiotic usage in food animal production for years, gave the move a tepid thumbs up.

“This is the most sweeping action the agency has undertaken in this area, as this covers all antibiotics used in meat and poultry production that are important to human health,” said Laura Rogers, director of the Pew’s Campaign on Human Health and Industrial Farming. “There are some gaps in these measures that we will urge FDA to address and, because this is voluntary, we will have to monitor antibiotic usage and resistance rates carefully. If these measures do not bring down antibiotic use and drug-resistant bacteria, then FDA will have to take additional steps.”

The Animal Health Institute, which represents veterinary pharmaceutical companies, also said it supports the FDA’s voluntary stakeholder approach, but has reservations.

“We strongly support responsible use of antibiotic medicines and the involvement of a veterinarian whenever antibiotics are administered to food producing animals,” said AHI. “While we agree with this direction and the collaborative, stakeholder process, there are details that must be addressed to make this approach practical and workable.  We will continue to work with FDA through the comment process to address these details.”

Most consumer and pubic health groups expressed disappointment that the proposal is voluntary and seems toothless.

The Center for Science in the Public Interest called the plan “tragically flawed” because it relies on the industry to voluntarily act in the best interest of consumers, though it did applaud the agency for recognizing the “public health imperative” to address the problem.

The Union of Concerned Scientists, which has been working on the issue for years, was also critical of the voluntary move.

“The approach announced represents a bold, well-intentioned attempt by the FDA to persuade an entire industry to voluntarily abandon claims that allow them to sell a large number of lucrative products,” said Margaret Mellon, the group’s senior scientist. “We have no reason to believe that the veterinary pharmaceutical industry–which, to date, has rarely even acknowledged that antibiotic resistance is a serious public health issue–will cooperate with the agency on a plan that could reduce its profits.”

The National Pork Producers Council blasted the proposal, arguing that it would be burdensome for producers in remote areas who have trouble getting access to veterinary care. NPPC called the plan “problematic” for pork producers, and said it believes the move would not only have a negative effect on animal health, but also increase the cost or producing food.

Congresswoman Louise Slaughter (D-NY) called the announcement “a step in the right direction,” but said she believed “much more must be done.”

“Antibiotic-resistant diseases now kill more Americans than AIDS and this issue needs to be treated with the seriousness it deserves,” said Slaughter, who has introduced legislation on the issue. “Of course if an animal is sick it should be treated, but the misuse of antibiotics in animal feed is destroying the effectiveness of antibiotics and limiting our ability to treat human illnesses.”

“Nonbinding recommendations are not a strong enough antidote to the problem,” added Slaughter.

It is not clear exactly how FDA will measure progress on its voluntary initiative. If drug companies agree to change their labels over the next few months, they are to notify FDA and then they have three years to voluntarily phase in the changes. 

Agency officials were hesitant to say whether the public should expect a significant drop in overall antibiotics usage. Michael Taylor, FDA’s Deputy Commissioner for Foods, said that if progress is not what the agency expected then FDA will look at other regulatory options.

The FDA’s voluntary guidance is independent of a recent court order that directed the agency to revive a 35-year-old proposal to ban three antibiotics from animal feed — penicillin and two types of tetracycline — pending hearings.

In 1977, FDA determined these three antibiotics were likely contributing to drug-resistant bacteria strains in humans and should be reserved for only therapeutic uses. But the agency never held the drug company hearings required to put this proposal into place, and in December of 2011 it revoked these approval withdrawals altogether. In March 2012, a federal court ruled that FDA had to revisit the issue.


  • Madeline

    Of all farm groups, the “small farm” lobby should be screaming their heads off to stop this. When they doctor their own animals without veterinary supervision they will now be breaking the law. Some will say they are organic so they don’t treat sick animals, only let them suffer and die and there should be a law against that special sort of inhumane treatment. Professional livestock producers already benefit from veterinary supervision so this law is superfluous to them.

  • John Simms

    It doesn’t go far enough.

  • JC

    Don’t expect the biggest users of antibiotics — the Confined Animal Feeding Operations (CAFOs) — to curtail antibiotic use — even a little bit….
    For the majority of massive amounts of antibiotics being used to treat livestock — it’s the sub-therepuetic doses the poultry , hogs, cattle — raised in CAFOs — that are receiving standard doses of antibiotics on a daily basis IN THEIR FEED that mounts up the most.
    However, the Factory Farm CAFO farmers aren’t the ones adding the antibiotics — the CAFO corporations supply the Medicated Feed with their own formulations that contain antibiotics and other drugs — that’s how the banned CIPRO got into the chickens which became revealed by the recent study of feather meal.
    Requiring a prescription here is meaningless as “Madeline” has already put a finger on:
    “Professional livestock producers already benefit from veterinary supervision so this law is superfluous to them.”
    Yes, the CAFOs have plenty of vets on staff with their prescription pads always at the ready…

  • Michael Bulger

    Small, organic farms treat livestock without the use of these antibiotics. If an animal is given a prohibited substance, than it is removed from the herd and can be sold into the conventional supply chain.

  • Eyes Opened

    These damned organic farmers are being recognized as a menace to society. Just this week we learn they use conventional chicken manure contaminated with drugs and lie about testing it, smear it over vegetable cropland and overcharge us for it. Now we learn from Michael Bulger they pump damaged and unwanted organic livestock full of drugs and dump them into the conventional market! These reckless organic farmers should be reined in before they poison us just like the organic farmer in Germany who killed 50 and poisoned thousands.

  • JT

    Jaundiced eyes, really — from the reckless Muddddite who makes totally unsubstantiated claims about Organic on one day — and then refers to them as “proof” the next. Repeat it often enough and maybe Somebody will believe it — Not!
    And Madeline Muddd -There will be no screaming from the “organic lobby” over this FDA ruling about the use of antibiotics, as tepid and toothless as it is.
    Michael Bulger has it right: Organic standards completely PROHIBIT the use of antibiotics, hormones and other drugs in the raising of livestock and poultry. And unlike the unhealthy and injurious conditions in Confined Animal Feeding Operations (CAFOs) factory farms, organic requires humane treatment — including sizable space requirements and freedom of movement as well as regular access to the outdoors, sunlight and pasture.
    Further, all feed must be raised organically, water tested, etc. Organic practices therefore avoid the abuse of antibiotics that have proven negative consequences for treatment of disease in humans, including the well-documented dangers of antibiotic-resistant bacteria.
    The bottom line is CAFOs cannot exist without antibiotics keeping poultry and animals alive in such deplorable conditions. Antibiotic use is masking and allowing for injurious industrialized livestock practices with major effects on animal — and human health.
    Without the crutch of using antibiotics, organic producers focus on health maintenance and disease prevention by emphasizing proper nutrition and sanitation, and reducing animal stress — and they have a wide range of holistic and preventive care practices to rely on including selecting genetically diverse breeding stock (which are naturally less susceptible to disease), quarantining incoming stock, and maintaining an appropriate environment for each particular animal species.
    There are also numerous treatments available to treat sick animals and specialized organic vets have a high success record. Further, unlike the dismal existence in CAFOs — animal suffering is not allowed. If an antibiotic is needed as a remedy to restore an animal to health, that animal cannot be used for organic production or be sold, labeled or represented as organic. The conventional markets readily accepts them — as they are already full of medicated animals…

  • Now We Know

    So, to cut to the chase…organic enthusiasts aim to BS us into thinking animals kept unconventionally never get sick but, when they do an organic farmer first farts around with homeopathic remedies or other ineffective mystical nonsense. Then when it is too late the organic farmer pumps the poor sick animal full of conventional drugs and finally dumps it into the conventional market. Appropriately on-topic disclosure for an article concerning antibiotic abuse. Good to know.