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U.S. groups suing FDA over ractopamine approvals

Chicago | Reuters –– A group of environmental and public health groups sued the U.S. Food and Drug Administration on Thursday, seeking to set aside the agency’s approvals for feed additives containing ractopamine that are used to boost the weight of cattle and pigs.

The groups, in two related lawsuits filed in federal court, claim that the FDA failed to adequately assess environmental and health issues related to ractopamine.

Used for more than a decade in the U.S. agriculture industry to build lean muscle instead of fat, ractopamine, a beta-agonist, has been barred by some major meat importers around the globe, including China. China last year began requiring third-party verification that U.S. pork products were ractopamine-free. Beta-agonists boost an animal’s ability to convert calories to marketable meat.

In the two lawsuits filed in U.S. District Court for Northern California, the groups challenged the FDA’s approvals from 2008 through 2014 of 11 new animal drug applications. The approvals allow use of ractopamine as the active ingredient, as well as paired with antibiotics, some of which fall into the same class of drugs deemed critical for human health.

In the lawsuits, the Humane Society of the United States (HSUS), United Farm Workers of America and the Center for Food Safety and other groups say the FDA failed to fully follow the federal National Environmental Policy Act (NEPA) when it approved these drugs.

The agency did not adequately assess the impact of ractopamine on food safety, the environment, animal welfare and farm workers, the complaints allege. The suits ask the court to set aside FDA’s approvals of ractopamine-based animal drugs since 2008 and comply with NEPA before approving ractopamine-based products in the future.

“While its manufacturer admits that Ractopamine is toxic to plants and aquatic invertebrates, the drug is used in at least 23 states that are known to provide habitat for threatened and endangered plants and aquatic invertebrates,” according to one of the lawsuits, filed by HSUS. “Ractopamine exposure has also been linked to adverse health events in humans and animals.”

The complaints also allege that hogs fed ractopamine can exhibit increased concentrations of stress hormones, which research has found to increase the presence of bacteria that can lead to food-borne illness, including E.coli and Salmonella.

The FDA told Reuters it does not comment on pending litigation.

The FDA first approved ractopamine for use in commercially raised swine in 1999. Industry analysts estimate that more than half of all U.S. hogs currently raised for meat are fed ractopamine.

Eli Lilly’s Elanco Animal Health unit, the leading producer of ractopamine-based livestock drugs, said in a statement to Reuters it remains confident in its products’ safety and the FDA’s approval process.

“Its safe use has been affirmed by 30 regulatory authorities globally using their stringent safety criteria for approval,” Elanco said. “Since its introduction in 1999, there have been no confirmed human health reports related to the consumption of meat products from animals fed ractopamine.”

Zoetis said in a statement it stands by “the safety and efficacy of our generic ractopamine products and believe they deliver value to our customers.”

The lawsuits cite FDA documents known as adverse event reports that detail examples of ractopamine-fed pigs becoming sick, suffering from hoof disorders, and dying prior to slaughter.

“Pigs in a research barn squeal when they take steps, as if in pain,” according to one lawsuit, brought by HSUS.

The complaints do not name what pharmaceutical company produced the drugs involved in the incidents.

— P.J. Huffstutter reports on agriculture and agribusiness for Reuters from Chicago.

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