The World Health Organization (WHO) has published its first global report on antimicrobial resistance, warning that the threat has spread to every region in the world and is attributable, in part, to inappropriate use of antibiotics in animal husbandry. Among the report’s key findings are (i) “standard treatments no longer work”; (ii) “infections are harder or impossible to control”; (iii) “the risk of the spread of infection to others is increased”; (iv) “illness and hospital stays are prolonged, with added economic and social costs”; and (v) “the risk of death is greater—in some cases, twice that of patients who have infections caused by non-resistant bacteria.” According to the report, even “last resort” antibiotics have become ineffective in certain populations. The report also discusses information gaps, noting that surveillance of antimicrobial resistance “is neither coordinated nor harmonized.” To address the issues identified, WHO is developing a global action plan that will…
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The U.S. Food and Drug Administration (FDA) has secured the participation of all but one animal drug company in the agency’s plan to phase out the use of medically important antimicrobials in food animals for food production purposes, such as artificial weight gain. Each company has “committed in writing to seek withdrawal of approvals for any production uses of affected drug applications and change the remaining therapeutic uses of their products from over-the-counter (OTC) to use by Veterinary Feed Directive (VFD) or prescription.” See FDA News Release, March 26, 2014.
According to news sources, several U.S. beekeeping companies have filed lawsuits under the federal Racketeer Influenced and Corrupt Organizations Act (RICO), alleging that the defendant companies illegally imported honey from China thus evading millions of dollars in anti-dumping duties and depressing the price for domestic honey. Moore v. Groeb, No. 13-2905 (N.D. Ill., filed April 17, 2013); Adee Honey Farms v. Groeb Farms, Inc., No. 13-2922 (N.D. Ill., filed April 18, 2013). Among other things, the complaint alleges that some of the imported honey contained adulterated antibiotics, was not actually honey and was falsely represented to government authorities as honey from countries other than China. The plaintiffs reportedly cite a February 2013 agreement between defendant Groeb Farms and the federal government indicating that the company’s “unlawful actions ‘caused losses to the United States of no less than $78,866,216’ in the form of unpaid antidumping duties” during a four-year period. As part…
According to an Environmental Working Group (EWG) analysis, more than one-half of meat and poultry samples tested in 2011 contained antibiotic-resistant bacteria. Using findings from the federal government’s National Antimicrobial Resistance Monitoring System, the report asserts that “store-bought meat tested in 2011 contained antibiotic-resistant bacteria in 81 percent of raw ground turkey, 69 percent of raw pork chops, 55 percent of raw ground beef and 39 percent of raw chicken parts.” “Consumers should be very concerned that antibiotic-resistant bacteria are now common in the meat aisles of most American supermarkets,” said EWG nutritionist Dawn Undurraga. “These organisms can cause foodborne illnesses and other infections. Worse, they spread antibiotic-resistance, which threatens to bring on a post-antibiotic era where important medicines critical to treating people could become ineffective.” See EWG News Release, April 15, 2013.
Two agricultural organizations have filed a citizen petition with the Food and Drug Administration (FDA) seeking to ban the use of antibiotics in ethanol production so that the leftover mash, known as “distillers grains with solubles (DGS),” which is fed to livestock, does not add to the levels of antibiotics used in the production of poultry and meat in the United States and thus contribute to the development of “superbugs,” that is, bacteria resistant to multiple antibiotics. In re Ctr. for Food Safety, No. __, (FDA, filed March 15, 2013). In the alternative, the petitioners request that FDA adopt regulations that deem antibiotics sold to ethanol producers for DGS production as new animal drugs, require drug sponsors to seek FDA approval for their use and ban the sale of antibiotics that have not been approved as new animal drugs. According to the Center for Food Safety and Institute for Agriculture…
A U.S. attorney in Illinois has announced charges filed against two companies and five individuals in a five-year investigation of imports that allegedly circumvented $180 million in anti-dumping duties on honey from China and involved purportedly “adulterated” honey containing the antibiotics chloramphenicol and tetracycline. Groeb Farms, Inc., described as the largest industrial honey supplier in the United States, knowingly avoided more than $78.8 million in antidumping duties by buying mislabeled honey imported from China and has agreed to pay a $2 million fine and “to dispose of any illegally-entered Chinese-origin honey in its possession.” It will also institute a corporate compliance program to ensure supply chain integrity and conduct “reasonable inquiries to safeguard against any illegal activity.” Jun Yang, Urbain Tran and Hung Yi Lin were all charged with brokering or transporting illegal Chinese-origin honey in the United States. Yang will plead guilty and has agreed to a fine of $250,000…
Public Employees for Environmental Responsibility (PEER) has posted to its website documents relating to the use of antimicrobial drugs in livestock feed received from the Food and Drug Administration (FDA) under a Freedom of Information Act request. According to PEER, internal memos show that FDA is not, as the agency has claimed, working successfully with industry to phase out this use of antimicrobials, estimated at 30 million pounds in feed troughs annually. PEER claims that “70,000 Americans die each year from drug-resistant infections” and that the “rise of drug-resistant ‘super diseases’ is driven by overuse and misuse of antimicrobial drugs in livestock feed primarily to promote livestock growth.” In litigation, FDA defended its failure to timely follow through on proceedings to withdraw from use two antimicrobials by claiming that it had abandoned formal rulemaking in favor of more effective voluntary measures. Details about a court order requiring that FDA initiate…
The Food and Drug Administration (FDA) has extended the comment period for an advanced notice of proposed rulemaking (ANPR) that announced potential changes to regulations governing new antimicrobial animal drug reporting. The ANPR proposed altering these regulations to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). FDA has requested public comments “on how best to compile and present the summary information as directed by ADUFA 105, and on alternative methods available to the Agency for obtaining additional data and information about the extent of antimicrobial drug use in food-producing animals.” FDA has extended the comment period at the request of responders until November 26, 2012. See Federal Register, September 26, 2012.
New York University researchers using the Avon Longitudinal Study of Parents and Children with data on more than 11,000 children have purportedly found a consistent association between antibiotic exposure in the first six months of life with “elevations in body mass index with overweight and obesity from ages 10 to 38 months.” L. Trasande, et al., “Infant antibiotic exposures and early-life body mass,” International Journal of Obesity, August 21, 2012 (online). The researchers suggest that the administration of antibiotics during early life, “a critical period for gut colonization,” may disrupt “ancient patterns of intestinal colonization.” U.S. farmers since the late 1940s have apparently given low-dose antibiotics to domesticated mammalian and avian species to hasten weight gain with the understanding that “alterations in the microbiota change ‘feed efficiency.’” Thus, the researchers explored the possibility of similar effects in human children. According to lead researcher Leonardo Trasande, “Microbes in our intestines may…
A federal magistrate judge in New York has determined that the Food and Drug Administration (FDA) must begin proceedings to withdraw its approval of the use of certain antibiotics in livestock for non-therapeutic purposes on the agency’s timeline, thus denying FDA’s request for a stay while the matter is pending on appeal before the Second Circuit. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided August 8, 2012). In June, the court determined that FDA arbitrarily denied petitions filed by advocacy organizations in 1999 and 2005 requesting the initiation of these proceedings. More information about the case appears in Issue 442 of this Update. The magistrate first ruled on the Natural Resource Defense Council’s (NRDC’s) motion to strike a document from the record; it was an Animal Health Institute statement “expressing general support for the FDA’s plans to reduce the non-therapeutic use of medically-important antibiotics in animal feed through a voluntary guidance…
