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Stronger FDA Action Needed Now on Antibiotics

By: Cameron Harsh, Senior Manager for Organic and Animal Policy

January 11, 2017
Center for Food Safety
Center for Food Safety

Rules Restricting Antibiotics Meant for Food Animals Are Now in Effect. They Won’t Be Enough.

For most animals raised for food in the United States, life is characterized by confinement in crowded, filthy conditions. This environment puts their health and immunity at extreme risk. In order to help them survive, they are given a slew of drugs to fight off disease and spur rapid weight gain. For decades, antibiotics have been used for both purposes, through daily feed and water rations or even by injection for groups of young animals as a protective boost before entering intensive facilities.

As of January 1, though, the U.S. Food and Drug Administration’s (FDA) voluntary plan to reduce unnecessary use of antibiotics in animals raised for food is in effect. But what exactly does this government strategy accomplish? And how far will it go towards eliminating routine use of antibiotics and improving the lives of animals? The answer to both is: not enough. And here are four reasons why:

1. The label changes on antibiotics are not mandatory.

Guidance 213 is meant to reduce the growing threat of antibiotic resistant bacteria by changing the labeling requirements for antibiotic drugs that are considered medically important and used in food animals. The guidance set out a plan for drug companies to voluntarily remove growth promotion uses from their labels within a three-year timeline, which ended as of January 1. Producers are not allowed to use a drug in a manner that is not indicated on the label. But, because these new label requirements were issued through guidance, they are not binding federal law. Drug companies, therefore, ultimately decide whether or not to remove all "growth promotion" indications from their product labels. While most have complied so far, growth indications for virginiamycin, for example, are still on the label.

2.   The rule only impacts growth-promotion doses.

Using antibiotics to promote weight gain is only one of the major uses that boost productivity rather than treat sick animals. The other is called disease prevention—routinely giving healthy animals drugs to keep them from getting sick. This sounds positive, but in reality it is often used as a cheap and easy substitute for actually improving the heinous living conditions that harbor infections. Disease prevention doses are allowed to continue under the rule. Further, the growth promotion dose level for some drugs, like the combination of tylosin and sulfamethazine in feed, has been removed, but replaced with a similar dose that has been renamed as “reduction in severity of specific diseases”. These claims allow producers to continue giving drugs and growth promotion levels under the guise of reducing disease. The lines between growth promotion and disease prevention are not clearly defined. As they are both focused on productivity rather than animal wellbeing, both must be eliminated.

3.   The rule is specific to medically important antibiotics.

This is significant for two main reasons. First, there are a number of antibiotics that are used in animals and are not currently considered medically important. These will continue to be allowed for routine use to promote rapid weight gain, and the impacts of their routine use are not fully understood. Second, FDA's list of medically important antibiotics is less extensive than the international community's. Two antibiotics considered medically important by the World Health Organization, bacitracin and tiamulin, are not impacted by this rule and FDA will continue to allow them for growth promotion uses.

4.   Sales of medically important antibiotics continue to increase.

Despite the industry claiming for years that it was taking steps to eliminate growth promotion uses of medically important antibiotics in anticipation of the voluntary rules, sales of antibiotics meant for food animals continue to rise. New data released by FDA show that sales of medically important antibiotics increased by two percent from 2014-2015, adding slightly to an overall trend in which sales increased 26 percent from 2009-2015. In fact, sales of medically important antibiotics had greater increases than all antibiotics. This trend stands in contrast to promises that the industry has been working to address routine, unnecessary use of medically important antibiotics.

It will take time to fully see and understand the impacts of the new rule, particularly whether the removal of growth promotion indications will lead to measurable reductions in antibiotic use in food animals. One problem, though, is that we only have sales data available, and we lack necessary information to see the full picture of on-farm usage of antibiotics. In addition, producers that are no longer able to use most antibiotics to promote growth may turn to other animal drugs to boost weight gain, such as ractopamine, that may pose substantial health, environmental, or animal welfare concerns.

To protect public health, the environment and our food system, we need extensive, mandatory restrictions on the use and abuse of antibiotics in the agricultural sector.

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