FDA Withdraws Arsenic-Based Animal Drug Approvals


At the request of two drug companies, the Food and Drug Administration (FDA) has announced that it will withdraw approvals for three of four arsenic-based drugs currently approved for use in food animal production. A fourth arsenic-based drug used to make turkeys and chickens grow faster, among other purposes, will remain on the market.

 Center for a Livable Future Science Director Discusses Roxarsone at Press Conference

  Center for a Livable Future Science Director Keeve Nachman issues statement on the hazards of roxarsone, an arsenic-containing antimicrobial drug that is widely used in poultry production and to a lesser extent in swine production to make food animals grow faster, improve their pigmentation, and to combat intestinal parasites. Statement is from a Nov. 23, 2009 press conference with U. S. Representative Steve Israel to announce the bill (HR 3624), known as the Poison-Free Poultry Act of 2009. Posted November 24, 2009


At the request of two drug companies, the Food and Drug Administration (FDA) has announced that it will withdraw approvals for three of four arsenic-based drugs currently approved for use in food animal production. A fourth arsenic-based drug used to make turkeys and chickens grow faster, among other purposes, will remain on the market.

On October 1, 2013, The New York Times reported,  “The companies, Zoetis and Fleming Labs, already had largely withdrawn the three drugs from the market after recent studies showed levels of arsenic in chicken that exceeded amounts that occur naturally.

“The compounds — roxarsone, carbarsone and arsanilic acid — have been used in 101 drugs added to feed for chickens, turkeys and pigs to prevent disease, increase feed efficiency and promote growth, according to the Center for Food Safety, which together with several other advocacy groups filed a petition almost four years ago seeking to ban the drugs in animal feeds.”


Food and Drug Administration Animal and Veterinary Product Safety Information


3-Nitro (Roxarsone) and Chicken

Arsenic is in the environment as a naturally occurring substance or as a contaminant and is found in water, air, soil, and food. Published scientific reports have indicated that organic arsenic, a less toxic form of arsenic and the form present in 3-Nitro® (roxarsone), an approved animal drug, could transform into inorganic arsenic. In response, scientists from the FDA’s Center for Veterinary Medicine and the Center for Food Safety and Applied Nutrition developed an analytical method capable of detecting very low levels of inorganic arsenic in edible tissue.

Using the new method, FDA scientists found that the levels of inorganic arsenic in the livers of chickens treated with 3-Nitro® were increased relative to levels in the livers of the untreated control chickens.  

Alpharma, a subsidiary of Pfizer, Inc., decided to voluntarily suspend sale of 3-Nitro® and to facilitate an orderly process for suspending use of the product in the United States. Alpharma’s plan provides for continued sales of 3-Nitro® for 30 days from June 8, 2011. The company stated that allowing sales for this period will provide time for animal producers to transition to other treatment strategies and will help ensure that animal health and welfare needs are met. FDA officials stress that the levels of inorganic arsenic detected were very low and that continuing to eat chicken as 3-Nitro® is suspended from the market does not pose a health risk.


The Johns Hopkins Center for a Livable Future (CLF) reported that the FDA’s move follows a study led by CLF and published in May 2013 that found clear evidence that using these drugs in chicken production increased levels of inorganic arsenic, a known carcinogen, in chicken breast meat.

The study, “Roxarsone, Inorganic Arsenic, and Other Arsenic Species in Chicken: A U.S.-Based Market Basket Sample,” by Keeve E. NachmanPatrick A. Baron, Georg Raber, Kevin A. Francesconi, Ana Navas-Acien, and David C. Love, was published in the journal Environmental Health Perspectives in May 2013.  It is available here:

Keeve Nachman, PhD, MHS, a member of the faculty of the Bloomberg School of Public Health issued the following statement:  “Our research found clear evidence that using arsenic-based drugs in poultry production increased people’s exposure to a potent carcinogen. The findings made it clear that continuing to use these drugs would increase the risk of cancer and possibly other diseases, too.

“We are glad that FDA and drug companies have bowed to public health concerns about using arsenic to produce chickens and turkeys, but the agency still has work to do. FDA must withdraw the approvals for nitarsone so that arsenic is no longer used to make food that people eat.” 


Out to Pasture: The Future of Farming?


The Johns Hopkins Center for a Livable Future (CLF) teamed up with the Video and Film Arts Department at the Maryland Institute College of Art (MICA) to produce this film about sustainable food animal production entitled Out to Pasture: The Future of Farming? (34 minutes). CLF’s Leo Horrigan plays a producer and Allen Moore, a MICA professor and independent filmmaker, plays a director. Out to Pasture contrasts industrial-style confined animal production with farms that raise food animals outdoors in diversified operations, striving to be sustainable.  Several of these pasture-based farmers are profiled. They tell their own stories, discussing how they got started in farming (three transitioned from confinement operations), what’s important about their farming methods, how their conventional-farm neighbors view them, how to keep young people on the farm, the future of the food system, and other compelling topics. The film also features Dr. Robert Lawrence, director of CLF; and John Ikerd, a leading thinker on sustainable agriculture issues.

Related link: Poultry Drug Increases Levels of Toxic Arsenic in Chicken Meat). 


A commercial meat chicken production house in Florida, USA: Photograph by USDA courtesy of WikipediaA commercial meat chicken production house in Florida, USA: Photograph by USDA courtesy of Wikipedia 

Nicolas D. Kristof’s New York Times column today, “Are Chicks Brighter Than Babies?” addresses the question of avoiding eating chicken in the aftermath of the salmonella outbreak. As he writes about avoiding poultry because of this outbreak, so too can his words apply to concerns about other potential contaminants in poultry. He writes, “But there is another reason to avoid poultry, and that’s the inhumane way birds are raised…just as we try to protect dogs and cats from undue suffering, without necessarily considering them our equals, it makes sense to minimize suffering more broadly when we can. So even when there are no salmonella outbreaks, there are good reasons to keep away from wretched birds raised in factory farms.” 


Consumer Reports Findings on Arsenic:

Consumer Reports magazine of November 2012, presented its findings on “Arsenic in your food,” in which they state, “Our findings show a real need for federal standards for this toxin.” The article, available at, says, “the foods we checked are popular staples, eaten by adults and children alike. See the chart summarizing results of our tests for arsenic in rice or rice products. Though rice isn’t the only dietary source of arsenic—some vegetables, fruits, and even water can harbor it—the Environmental Protection Agency assumes there is actually no “safe” level of exposure to inorganic arsenic. No federal limit exists for arsenic in most foods, but the standard for drinking water is 10 parts per billion (ppb). Keep in mind: That level is twice the 5 ppb that the EPA originally proposed and that New Jersey actually established. Using the 5-ppb standard in our study, we found that a single serving of some rice could give an average adult almost one and a half times the inorganic arsenic he or she would get from a whole day’s consumption of water, about 1 liter.

“We also discovered that some infant rice cereals, which are often a baby’s first solid food, had levels of inorganic arsenic at least five times more than has been found in alternatives such as oatmeal. Given our findings, we suggest limiting the consumption of rice products. Use our recommendations.”


The European Food Safety Authority (EFSA) Risk Assessment of Arsenic in Food

The European Food Safety Authority (EFSA) which describes itself as “the keystone of European Union (EU) risk assessment regarding food and feed safety, Panel on Contaminants in the Food Chain (CONTAM), published a Scientific Opinion on Arsenic in Food updated 27 September 2010. That Article is available at The panel “assessed the risks to human health related to the presence of arsenic in food. More than 100,000 occurrence data on arsenic in food were considered with approximately 98 % reported as total arsenic.”

Science protecting consumers from field to fork

Millions of Europeans make choices about food every day. EFSA provides independent scientific advice to decision-makers who regulate food safety in Europe. This short film published on Nov 30, 2012, provides a concise overview of EFSA's food safety role. From among the many areas of EFSA's work, this video highlights three important examples: food-borne diseases, pesticides and health claims.


World Health Organization, International Programme on Chemical Safety: Arsenic

The WHO addresses concerns about arsenic and provides guidance available at

Here are excerpts:

“Soluble inorganic arsenic is acutely toxic. Intake of inorganic arsenic over a long period can lead to chronic arsenic poisoning (arsenicosis). Effects, which can take years to develop depending on the exposure level, include skin lesions, peripheral neuropathy, diabetes, cardiovascular diseases, and cancer.

“Human exposure to elevated levels of inorganic arsenic occurs mainly through the consumption of groundwater containing naturally high levels of inorganic arsenic, food prepared with this water, and food crops irrigated with high arsenic water sources.


WHO short information documents for decision makers

Tools for action

Norms and guidance values

 Fact sheet  Arsenic

About the Johns Hopkins Center for a Livable Future

The Johns Hopkins Center for a Livable Future promotes research and develops and communicates information about the complex interrelationships among water, diet, food production, environment and human health while advancing an ecological perspective in reducing threats to the health of the public and promotes policies that protect health, the global environment and the ability to sustain life for future generations.

About the European Food Safety Authority (EFSA)

European Food Safety Authority (EFSA) was set up in January 2002, following a series of food crises in the late 1990s, as an independent source of scientific advice and communication on risks associated with the food chain.  EFSA was created as part of a comprehensive programme to improve EU food safety, ensure a high level of consumer protection and restore and maintain confidence in the EU food supply.

“Food is essential to life. We are committed to ensuring food safety in Europe.”

“In an ever-changing environment EFSA's work helps to ensure that our food is safe. In the European food safety system, risk assessment is done independently from risk management. As the risk assessor, EFSA produces scientific opinions and advice to provide a sound foundation for European policies and legislation and to support the European Commission, European Parliament and EU Member States in taking effective and timely risk management decisions.

“EFSA’s remit covers food and feed safety, nutrition, animal health and welfare, plant protection and plant health. In carrying out its work, EFSA also considers the possible impact of the food chain on the biodiversity of plant and animal habitats. The Authority performs environmental risk assessments of genetically modified crops, pesticides, feed additives, and plant pests. In all these fields, EFSA’s most critical commitment is to provide objective and independent science-based advice and clear communication grounded in the most up-to-date scientific information and knowledge.

“EFSA’s independent scientific advice underpins the European food safety system. Thanks to this system, European consumers are among the best protected and best informed in the world as regards risks in the food chain.




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