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FDA Draws Criticism After U-Turn on Antibiotics in Animal Feed
Environmental groups dismayed after agency drops long-held plan to regulate use of human antibiotics fed to healthy animals
Environmental and consumer groups have condemned the US Food and Drug Administration's move to renege on its long-held policy to regulate the use of human antibiotics in animal feed.
A pig farm in northern Missouri. Critics say the reversal is at odds with its obligations to protect public health. (Photograph: Daniel Pepper/Getty Images) Last week, the agency quietly announced it was withdrawing its plan to limit the use of antibiotics fed to healthy livestock intended for human consumption.
Critics say the U-turn, which comes amid the FDA's own stated concerns over food safety, is at odds with its obligations to protect the public.
The groups also criticized the timing of the announcement, which was made during the holiday season and disclosed only in the federal register.
The use of low doses of antibiotics in agricultural animal feed contributes to drug-resistant superbugs, according to food and health experts.
One leading food policy writer described the policy reversal as "pathetic" and "dismaying."
"It's dismaying, and obviously something they felt sheepish about, otherwise it wouldn't have been released this week," Michael Pollan, author of the Onmivore's Dilemma and Food Rules: An Eater's Manual, told the Guardian.
"When Margaret Hamburg became the head of the FDA, she indicated this was a high priority for them and that she realized how much of a problem the profligate use of antibiotics was. She said she was going to treat this issue as if her hair was on fire. This isn't the way someone acts when their hair is on fire."
Pollan said there was "no question" that meat could be produced without human antibiotics, as the EU has already banned them.
The FDA first acknowledged in 1977 that the overuse of antibiotics in healthy livestock for growth promotion and disease prevention was unsafe and could promote antibiotic resistant bacteria that could infect people. An advisory committee at the time recommended that the FDA immediately withdraw approval for two drugs, penicillin and tetracycline, for subtherapeutic uses of the drugs in livestock.
Last week, in a statement in the Federal Register, the FDA says it plans instead to allow the industry to self-regulate and "focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health".
The problem, said Pollan, boils down to a lack of political will in the face of powerful industry interests. "There's a lot of corporate money in politics these days," he said. "Here you're going up against not just one powerful industry, but two. This administration has had enough trouble going after individual powerful industries. That they would prevail against two of them joined together was too much to hope for."
Livestock consume about 80% of the antibiotics sold in the US.
The FDA's decision comes after a number of high profile meat recalls. In August, 36m lbs of turkey meat were found to have been contaminated with drug-resistant salmonella that caused one death and 76 people to become ill.
When approached by the Guardian, a spokesman for the FDA could not provide anyone for comment.
A statement, taken from the Federal Register, said: "FDA continues to view antimicrobial resistance as a significant public health issue. Today's action should not be interpreted as a sign that FDA no longer has safety concerns about the use of medically important antibiotics in food-producing animals, or that FDA will not consider re-proposing withdrawal proceedings in the future if necessary."
But Avinash Kar, an attorney with the Natural Resources Defense Council (NRDC), described the move as a "step backwards" for the FDA.
Kar believes the move is an attempt to get around a lawsuit filed by the NRDC to force the FDA to withdraw approval for the practice of mixing human antibiotics into animal feed. The lawsuit, filed in May, asked the court to declare that the FDA had violated federal law by failing to withdraw approval of using penicillin and tetracycline in animal feed when animal health is not at stake.
"This action by the FDA is a response to our lawsuit" said Kar. "The findings in 1977 were included in the notice for opportunity for a hearing, and they think they can get around the lawsuit by withdrawing the notices for opportunities for a hearing. But we will not allow the FDA to ignore public health."
In response to the FDA's reliance on voluntary regulations, Kar said: "We don't believe that the industry will voluntarily regulate itself, because for the last 33 years the approach has been voluntary and the use of antibiotics in livestock has not gone down but – based on estimates – has gone up."
"The science has only gotten stronger."
Stephen Roach, of the Food Animals Concern Trust, a group also involved in the lawsuit against the FDA, said he believed the FDA was putting public health at risk.
"It is totally at odds with their mission to protect the public. This month we had a salmonella outbreak in the north-east that was resistant to penicillin and the drug that replaced penicillin, cephalosporin. We are going to continue to have multi-drug resistant salmonella outbreaks and E.coli drug-resistant outbreaks."
Roach said the use of low doses of antibiotics in animals over a long period of time created the ideal conditions for bacteria to develop drug resistance.
A growing number of scientific and medical institutions have urged action on antibiotic resistance. The World Health Organization devoted a WHO day to microbial resistance.
In September, several institutions, including the American Medical Association, the Infectious Diseases Society of America and the Pediatric Infectious Diseases Society, wrote a letter to Congress, calling for them to to reiterate the link between antibiotic resistance and the overuse of antibiotics in food animals. Some of the same health groups took ads out in Politico and The Hill.
"Hundreds of scientific studies conducted over four decades have shown that feeding low doses of antibiotics to healthy food animals leads to drug-resistant infections in people," they wrote in the ad. "In fact, America's leading medical, scientific and public health organizations have been warning of the danger for years."
Politicians also expressed dismay at the FDA's move.
In a statement on her website, Democratic congresswoman Louise Slaughter, the author of the Preservation of Antibiotics for Medical Treatment Act (PAMTA), a legislative framework aimed at tackling antibiotic resistance, said: "Every year, 100,000 Americans die from bacterial infections acquired in the hospital and this is just the tip of the iceberg. Seventy percent of these infections are resistant to drugs commonly used to treat them. I wonder how many lives could have been saved if these proposals were adopted in 1977 as they should have been.
"We need to get our head out of the sand and start taking public health advice from scientists rather than industry lobbyists."
57 Comments so far
Show AllI brought this article up amongst a number of my co-workers (professional engineers) and not one had ever heard of the Guardian.
About as many USAns have head of the Guardian as have heard of "Democracy Now".
Yeah they aren't, but they are clearly trying, for example they have started covering (poorly, I must say) US sports like, MLB, NFL, NBA. They have several reporters covering / writing on America, they have a Comments is Free (their online discussion section) section specifically for America.
If you hang out on the Guardian's website, you will notice some (UK) posters complaining pretty regularly about the "obsession" that the Guardian has with the US, and why the Guardian pays so much attention to the US, instead of say, China, or Germany.
FBI, FDA, and the IRS Raid Natural Medicine Cabinet
http://www.naturalfoodlist.com/5854/fbi-fda-and-the-irs-raid-natural-med...
And there are plenty more "unexpected" raids just like them. In fact, unlike most nations in Europe that ban dangerous Big Pharma chemicals, the FDA takes until eternity to even consider any action against them. And if not the FDA, the DEA is there to enforce all the gags against as many natural medicine products as possible.
another issue is that natural / herbal companies can claim that their products contain a substance, without any evidence that the product actually does contain that substance. There is minimal regulation of this.
the natural / herbal medicine industry is also capitalist, people involved in the industry are also in it for profit. In some cases big pharma actually owns some natural / hdrbal medicine companies.
as for Europe, in some western eu countries, supplements, herbal or not, are regulated far far more tightly than they are in the us. Supplement that can be easily bought at a health food store or just at a supermarket, in the us, cannot be bought so easily in some western eu countries. America actually adopts a pretty laissez faire approach to the regulation of supplements.
don't get me wrong, i don't like the fda, in my opinion the fda is hugely problematic and flawed, but for the most part the natural /herbal medicine industry is barely regulated. You're
My wife is an addict to this quackery and it is consuming all our income and driving us to the poorhouse! I try to tell her it is nonsense, but all that results is a violent argument. My $70,000 a year income is going down the drain feeding it.
However, Jennifer does have a point. In the US, government regulatory compliance does fall unfairly hard on small businesses compared to large corporations who can afford the consultants and lawyers needed to get the permits. Thus regulation ends up having the effect of increasing the already considerable advantage that big businesses have over small ones. This is not be an argument against regulation, just that enforcement need to be done in fairer way. Europe seems to have a healthier small business environment, yet tougher regulations. How are they doing things differently than the US?
Honest response pjd412 !!
My compliments - luck to all of us.
Mike
====First, as to the article, this comes as no surprise as politics is merely an arm of the corporate state. It has been so practically from the inception of this nation. Done and done.
Secondly, as to the supplement industry - we have to be careful about the double-edge of regulation. While there is a good amount of puffery and snake-oil-sales, quite a bit of it is perfectly valid and useful. Humans (as well as other animals) have used herbs and other treatments for millennia and there is a useful application for them still. When we invite the government into our medicine cabinets and kitchens (along with the pharma industry) we are giving over control over what we consume. Not good! That's like having the USDA poke its nose into the organics industry. While regulation is necessary, the government/industry typically want more. They want control. A very slippery slope and we have to be vigilant.
pjd412, I feel for you. While I do take supplements, I know that a lot of money is mis-spent on them. But then, a lot of money is mis-spent on needless pharmaceuticals and other medical interventions. If all of this were being done purely on the basis of good health, there would be much less quackery. Unfortunately, money trumps most things and it matters little whether those making the big bucks are wearing vitamin logos or white lab coats. As always, caveat emptor...and let the people decide.
Despite my response to Jennifer, I actually generally favour the laissez faire attitude to how supplements are regulated, not because I am against regulation in principle, but because I have absolutely no confidence that the FDA will not make things even worse. The FDA is pretty much irredeemably corrupt.
I take supplements too, and have been following the supplement industry closely for a number of years. It is why I do not have an idealistic romaticised view of it. As you say, it is about money. People involved in alternative medicine are not saints.
"People involved in alternative medicine are not saints."
Agreed. Who is?
I agree with you and Jennifer about how regulation is often structured to crush small businesess, with very high costs for complying with that regulation. I made a similar point about a week ago, in an argument in the thread about the farmer who was in trouble for selling surplus milk from his one cow. I was arguing that applying the same regulation to him as that applied on some industrialised dairy farm with thousands of cows kept in dirty cramped conditions, pumped full of antibiotics and hormones, is ridiculous.
As to the quackery, it is somewhat complicated. Some of the stuff is clearly quackery. Chiro is pretty much quackery. OTOH, people turn to chiro because most (conventional) doctors are completely, utterly useless at treating (low) back pain. The default is some pain killing medication + bed rest. For an acute, one time minor back injury, that will work, the body heals itself. But, for a chronic back problem that does not work. And then what happens is that the doctor doubts the patient, if a basic MRI / x ray does not immediately reveal a problem: the doctor stars assuming that the patient is malingering (ie faking the pain to get off work) or that the pain is psychosomatic (ie, it is all in your mind). There are doctors who are capable of treating back injuries, typically those with sports medicine backgrounds, or some kind of athletic background of their own, but there aren't many of such doctors. So, unsurprisingly, people who are in unpleasant pain, turn to whatever alternative that they can find
Most chiros are definitely lying quacks, but there are a few that will admit the flaws and weaknesses of chiro, and try to look at the back problem systematically, and not immediately fall into the default position of trying to "adjust" the sufferer's spine. But, generally chiros are quacks.
But. That doesn't necessarily mean that all / most "alternative" "medicine" is necessarily quackery. Take massage. Popular and much used worldwide, throughout most of human history, used in many cultures. The scientific evidence, ie scientific studies, on massage, whether for pain reduction, relaxation, promotion of physical recovery (after sports / athletic activity) is divided. There are some studies that show benefits (ie, the benefit of massage intervention compared to no treatment is statistically significant), there are some studies that show no benefits (ie, no benefit at all, or whatever benefit is not statistically significant). Yet, people all over the world use it. More, athletes, high level athletes, WR holders, and their coaches, use massage. So is it quackery? The science evidence from scientific studies is unsure, whereas many people swear by it. Why? It could possibly that whether a massage intervention works depends on the skill of the practitioner, and also the receptivity of the patient. For example, I personally am (very) sensitive to touch, especially on some parts of my body. A level of pressure that is comfortable, even relaxing, on massage, for most people, causes me pain, or at the least discomfort, makes me grit my teeth, grab the massage bed, and struggle not to jump off the bed in pain. A skilled / experienced practitioner will notice this immediately, a less skilled /experience one, won't, especially since a less skilled one will assume that someone lean / muscular like me will be "tough" and be able to handle a high level of pressure on massage. Stuff like this is difficult to control for in a clinical trial. There are also a whole bunch of other complications that are difficult to test in a standard clinical trial. There is some Russian research that show WHEN the massage was conducted, affects its efficacy, ie immediately after athletic activity, 3 hours after, 6 hours after, etc.
As for acupuncture, the general consensus seems to be that while the (traditional) explanation of how it works is, basically wrong, it might, might have effects for other reasons. There was a recent study that showed that it lowers a stress protein, in, note RATS, not humans:
Acupuncture at ST36 prevents chronic stress-induced increases in neuropeptide Y in rat
http://ebm.rsmjournals.com/content/early/2011/12/06/ebm.2011.011224.abst...
http://www.georgetown.edu/news/acupuncture-stress-reduction-study.html
http://nhs.georgetown.edu/259986.html
As for quackery in general, personally, I favour the more laissez faire attitude used. As long as the quackery isn't causing active harm, for example, by promising the ability to cure cancer / aids, or by promising immunity aids, I personally don't agree with banning. If the patient gets satisfaction, even if only via the placebo effect, then so be it. Some people like me spend money on music and books. Some people spend it on quackery..
Regarding fraud, yes, there are laws obviously, but it isn't easy for your average person to prove so. Let's say you buy a supplement, a powder or a pill, that CLAIMS to have herb A, extract B, and ingredient C; but in truth, it is only is made of maltodextrin, or sugar, or some similar filler. Would you have the capability of taking the supplement to a lab to get it tested? How many people have such a capability? So, the result is asshole fly by night companies lying, not just about what their supplements can do, but what they actually contain.
The situation with some EU countries vis supplements isn't necessarily better. In some cases, they are too tightly regulated, even things like vitamins are regulated. That is overkill, that is way to far in the other direction.
I suggestion is that you don't argue with your wife, but get her to read up / look up the scientific evidence.
Finally, someone is talking about this, and trying to do something about this. The rise of superbugs isn't so much due to the much blamed (wrongly) overprescription of antibiotics to human patients. Compared to the use of antibiotics in industralised farming, that is a minor problem. But, too many people, including doctors and scientists, don't have the courage to talk about the issue publicly, to address the problems of industrialised farming of animals.
But then again, I do have first hand experience of how one particular person at There was a local organic sprout producer near where i lived - "Mung Dynasty" who grew sprouts for local small grocers and retails sale from an operation in a part of the old Duquesne Brewery. But then there was that 2006 e-coli outbreak in spinach, and the FDA imposed new, needed regulations. (This is a serious ongoing issue. Earlier this year, 50 Germans died eating e-coli tainted sprouts.) Shortly after, Mung Dynasty closed up shop. The shop owner claimed that he would have had to have had to hire a full-time microbiologist to comply with the new regulations. Whether this is hyperbole or not I don't know.
But, having written the above, as someone who works in government regulation, I do often find that small business people can be hard-headed about learning what is actually required to meet regulations by actually reading the regulations, and often greatly inflate the paperwork burden in their heads. Contrary to what people think, (with the exception of the IRS), the language in the code of Federal Regulations is usually in pretty plain language - and the internet allows one to look up a regulation in minutes.
Also, other big red flag is that 80% of antibiotic is being consumed ultimately by population, those eating meat. These antibiotic is being consumed by those eating meat without even being prescribed to them !!
***
The FDA has not been "obligated" to protect the public for years now. Any more than POTUS and other federal elected officials are obligated to "protect and defend the Constitution of the United States".
Other than a few ailments (and a couple of chronic life-long ones that may actually be contributed to by still consuming wheat and gluten) I have been healthier and freer of 'bugs', 'viruses', and the dreaded 'flu' (if you don't count the two adverse reactions to the only two flu shots I've ever gotten) the entire time I have been meat free.
I don't have the facts and figures right in front of me, but my past research indicated that a sizable percentage of ALL stomach flues, the classic 12 to 24 hour bugs that almost everyone gets, and several other intestinal ailments are directly caused by some degree of food poisoning...usually from meat. Although, very poor food handling practices seem to be giving us an inordinate number of food poisoning outbreaks from vegetables now, as well...but that is another whole issue.
I'm no longer on my "everyone with any sense would be a vegetarian" soapbox, but I do still like to point out that if one consumes ANY factory farmed meats, poultry or vegetables they are surely running a considerably higher risk of contracting food-born illnesses than those who eat a plant-based diet...all organic if possible. Otherwise all advantages will likely be nullified by the chemicals, pesticides and herbicides used or built into the seeds to produce the picture-perfect, unblemished, nutrient deficient GMO vegetables produced by farmers owned or controlled by Monsanto and friends.
If you just have to eat meat, do your very best to get it from local organic farmers...same as produce. I don't know about other areas, but where I live there are quite a few organic farms and coops that make getting fresh organic produce and meat very easy...at typically higher cost, though much bartering goes on. And consume your meat in moderation, as a side-dish. To do otherwise IS pretty much guaranteed to adversely effect your health and well-being...not to mention the torture Mother earth is subjected to...the depletion of water, clear-cutting of forests and resulting loss or displacement of all creatures inhabiting them, along with the decimation of fertile soil by factory-farming methods.
Two of the very worst Industrial Age creations we are plagued with is the modern factory farm....and packaged processed pretend food. That so many foods consumed in the US are nothing more than spiced and seasoned lab concoctions should be something everyone would actively work to change or at least bring to the level of nationwide public debate.
However, based upon what I have seen of the eating public during my years as a vegetarian, I don't hold out much hope that enough people will give up their burgers, steaks or fast food to send the kind of message to our so called food producers that will alter the way so many of them are doing business.
On another note, if anyone with knowledge or information would like to engage in a side discussion about the fact that soy lecithin is added to almost everything (I noticed just this morning that it is in most all of the varieties of tea that are in my cabinet...why oh why????), I would be most interested.
Thanks, bon appetit!
I have believed for a long time that the presence of unpronounceable, seemingly unnecessary 'additives' in packaged and processed food has a much more sinister explanation than the industries who foist them on us will ever willingly admit to.
There is another reason - the antibiotics are used in a short term effort to keep food animals alive in horrible conditions of crowding, poor food, lack of exercise, sunshine and fresh air. Here we have an example of how mistreatment of the natural world comes back to bite humans. We are all interconnected.
We need to talk to our neighbors and local stores about how our food is raised and appeal either to their self-interest or their concern about animals. We also need to either cut out eating meat, even chickens, or demand organic meats raised in decent conditions. The food industry fights tooth and claw against labeling requirements, so it is not always easy to find such goods.