by Marion Nestle
Apr 12 2012

The FDA takes action on animal antibiotics, at long last

Yesterday, the FDA proposed long-awaited action against use of antibiotics for non-therapeutic purposes in animal agriculture.

From the outside, this might look more like inaction.  The agency is asking drug companies to voluntarily cut back on producing antibiotics for non-therapeutic purposes and to require veterinary oversight of use of these drugs.

The announcement comes in the form of three documents in the Federal Register.

  • Final Guidance for Industry: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.
  • Draft Guidance for Industry aimed at assisting drug companies in voluntarily removing from FDA-approved product labels uses of antibiotics for production rather than therapy, and voluntarily changing the marketing status to include veterinary oversight.  This is open for public comment.
  • A draft of a proposed Veterinary Feed Directive regulation,  also open for public comment, outlining how veterinarians can authorize the use of antibiotics in animal feed.

In an FAQ on the announcement, the FDA answers some obvious questions:

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary;

Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation.

FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use (my emphasis).

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry.

In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA.

Translation: this has been in the works for a long time and is the result of extensive discussions with the relevant industries.

As Food Safety News explains, the reaction of just about everyone to this announcement has been tepid.

  • Food safety advocates object to voluntary, because it never works.
  •  The meat industry insists that non-therapeutic antibiotics are essential for producing cheap meat under crowded conditions.

For example, the National Pork Producers make the usual industry arguments:

Harm to small farmers: The guidance could eliminate antibiotics uses that are extremely important to the health of animals…And the requirement for VFDs [veterinary oversight] could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.

Voluntary equals regulation: The guidance, which does not have the force of law but may be treated as such by FDA, is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.

The science is “junk”: But numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics use in food-animal production.

My interpretation:

The FDA’s position on non-therapeutic use of antibiotics in animal agriculture is quite clear.  The agency recognizes that based on the science, the use of antibiotics as growth promoters in animals poses a serious risk to human health.

I’m guessing this is the best the FDA can do in an election year.

This move looks to me like a direct challenge to drug companies and meat producers to clean up their acts and take some responsibility for the effects of their misuse of animal antibiotics on public health.

It’s also a challenge to food safety advocates to make sure that the FDA monitors the effects of its voluntary guidance and, if the industries don’t cooperate, that the FDA gets busy on real regulations.

Addition: The account in today’s New York Times explains why the FDA is starting with voluntary efforts:

The reason for the reliance on voluntary efforts is that the F.D.A.’s process for revoking approved drug uses is lengthy and cumbersome, officials said. The last time the F.D.A. banned an agricultural use of a medically important antibiotic against the wishes of its maker, legal appeals took five years. In this case, hundreds of drugs are involved, each with myriad approved uses in various animals.

“You and I and our children would be long dead before F.D.A. could restrict all of these uses on its own,” Ms. Rogers [of the Pew Foundation]said.

  • Re: The FDA’s position on non-therapeutic use of antibiotics in animal agriculture is quite clear. The agency recognizes that based on the science, the use of antibiotics as growth promoters in animals poses a serious risk to human health.

    It would be nice to know what the serious risks are. Without disclosing that information, the Internet will be abuzz with all types of risk analysis.

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  • FarmerJane

    The impact of this is not yet clear to me. In the end, it may depend on the region of the country one is in and the availability of vets who practice “Food Supply Veterinary Medicine”. Regional disparities are astounding. The AVMA website at has a dandy map showing the ratio of food supply veterinarians to animal population served. The ratios in American counties range from one veterinarian to 750,000 animals to one veterinarian for a few hundred animals.
    Additionally, remember that the mega-farms often have their own in-house veterinarian. With less than 10,000 large animal veterinarians in the country, smaller farmers are sometimes left to fend for themselves, doing almost all their work on their own. Vet students do not want to go into large animal medicine with the big profits to be found in pet care. Larger farms are catered to, while there are plenty of small farms who can’t get a regular veterinarian. The large farms’ vets will be free to decide what is “judicious”. Very common here in the Northeast for smaller farmers to have NO large animal veterinarian available. And, if you can get one, you better have a good credit card available to pay for a large animal vet to drive to your farm, dispense advice and a prescription if needed.

  • Alex

    Is it feasible to allow smaller doses of antibiotics without a vet on hand for dispensing? Doses too small to be used in feeding numerous animals regularly, but large enough to treat animals that need it for real health issues? It seems to me that is a reasonable allowance and solution for smaller producers.

    I do not have enough personal knowledge to know if vet drugs are separated into restricted and OTC. But it seems that it would be reasonable to allow small doses to be bought OTC in order to care for animals that need it for medicinal purposes. Restrict purchasing amounts much like pharmacies do for ephedrine sorts of drugs to prevent abuse of those.

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  • FarmerJane

    Alex, yes, I hope there will be some accommodation for smaller farmers. Currently, there are several basic antibitoics such as penicillan that are available at farm stores or via internet that one can get without a prescription. However, there are many more that you can get only from a veterinarian. Some of these antibiotics that you can get only from veterinarians are the newest state of the art antibiotics that target specific problems for dairy animals. I can only hope that all the stakeholders including farmers of all sizes are engaged and that the issue is not decided in the media by people who have never actually farmed or worked to keep a herd of animals healthy.
    I also wanted to mention that there is a good deal of misinformation out there. When it comes to dairy cattle, it is unlawful to just feed your cows antibiotics. This is simply not done. Testing is very rigorous, every load, every day, every time. A farmer who shipped milk by accident that contained any trace of antibiotic would be severely penalized financially with fines of several thousand. Basically, you pay for the entire 1/2 milk trailer load that is ruined (compartments of milk inside the big tankers you see on the road). If it happens again, you are kicked out of your coop.
    Over the past several years, there have been tremendous advancements that the public has no info about when it comes to dairy. First, the heros of the day are the dairy scientists who have developed on-farm lab testing that is very easy where a farmer can test milk for antibiotics. This is the Delvo test developed in Holland. Every farm I know has this lab potential or availability nearby.
    Also, educational materials for farmers have been widely distributed and more and more are available. Webinars on proper antibiotics handling and withholding times have been literally booked solid. Veterinarians are also more conscious now in terms of actually talking with the farmers to thoroughly inform on withholding times. (Cow-side chat).
    With all of this coming into play, the results have been spectacular. With some 3.2 million milk tankers tested last year, only about 621 were tested postiive and dumped nationwide.
    Farmers are professionals who constantly educate themselves on this topic. I have seen first hand the miracle of antibiotics save a calf dying of pneumonia or a cow burning with fever. I want to keep using them and I want them effective. I am all for utilization of state of the art, modern medicine for my cows just as for myself or my pet cats. I am also for preservation of antibiotics only for sick animals for all the same reasons as any other person.

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  • melissa

    While FDA’s action declaring a voluntary cut back on using antibiotics on animals for non-therapeutic purposes is a step in the right direction, it is not strong enough to make any change. The FDA’s emphasis allowing antibiotics for “judicious” uses is vague and many corporate farmers could argue that their practices are judicious. This regulation does not give enough incentive for industrial meat farmers to actually change their practices when their ultimate goal is to increase profits.

    I believe that while these strides are important for the FDA there needs to be more push from federal agencies addressing food safety and illnesses arising from meat consumption. FDA needs to collaborate with the USDA in order to create permanent and mandatory standards for use of therapeutic drugs on healthy animals.

    There also needs to be a stronger push from the consumer side- environmentally concerned eaters, vegetarians, those who advocate for food safety, to dominate the supply of food for the country. If consumers want safe and uncontaminated meat they need to make a stand for it so that the next regulation the FDA makes is to ban the use of antibiotics for animal production permanently.