Since its beginning in the 1950s, the poultry industry has relied on science and technology to enhance its ability to produce a safe, economical and wholesome source of protein for the world’s population. One tool that has made this goal possible is the inclusion of arsenicals in poultry diets. For more than sixty years, arsenicals have been used to control the parasitic coccidia, especially Eimeria tenella, to enhance the health of the chicken’s intestinal tract.

Although the benefits realized from the use of this product are numerous, the Food and Drug Administration apparently requested the drug’s manufacturer, Alpharma, a subsidiary of Pfizer, to withdraw it from the market after completing a study that assessed arsenic levels in birds fed Roxarsone. While research is the mainstay of the poultry industry’s efficacy, the research performed by the FDA lacks the scrutiny necessary to justify FDA's rushed judgment concerning the use of Roxarsone in poultry feed diets.

Questionable rationale and research  

FDA’s rationale for requesting suspension of the sale of Roxarsone was based on an FDA in-house study performed on 100 birds, about half of which were fed rations with Roxarsone. Although the study showed varying levels of arsenic in the liver, FDA reported that “total arsenic analysis for both liver and muscle indicated the mean of measured levels were below the established tolerance values of 2000 ppb and 500 ppb.”

To be more precise, the level of total arsenic in tissue was an order of magnitude below the allowable tolerances. In addition, the study involved newly developed analytical techniques, included extremely long sample freezer storage periods, and utilized a feed formulation atypical of commercial poultry feed, all issues that would likely be pointed out had the study gone through a proper peer review process.


Different standard than for approvals  

Beyond the concerns over the technical issues regarding the study, what is more disconcerting is the manner in which the decision was reached. After six decades of usage by billions of chickens with no evidence of any adverse health effect, a non-peer reviewed study of 100 chickens has resulted in the almost immediate loss of a valuable tool in maintaining poultry health. Just as FDA never would consider basing a product approval decision on a study with parameters like those listed above, such a study should not have formed the basis for the agency to urge suspension of sales of this product.

Reflection on the actions by FDA should be sobering for anyone interested in maintaining U.S. agricultural competitiveness and for our ability to produce safe, healthy, affordable food products for the world. While the poultry industry would support the removal of Roxarsone from the market should a complete and accurate pool of research warrant that decision, the current body of data collected from this research project does not meet that benchmark.