Environmental, public health groups sue FDA to pull ractopamine approvals

CHICAGO (Reuters) - A group of environmental and public health groups sued the U.S. Food and Drug Administration in federal court on Thursday, seeking to have the court set aside the agency's approvals for various ractopamine products – feed additives used to boost the weight of cattle and pigs.

Used for more than a decade in the U.S. agriculture industry to build lean muscle instead of fat, the beta-agonist additive 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 two separate but related lawsuits filed in the U.S. district court of 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 sole 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, 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 law requires federal agencies to consider and report on environmental impacts of their actions, such as how use of a livestock drug might affect the environment or human health.

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.

The FDA could not immediately be reached for comment Thursday. The FDA first approved ractopamine for use in commercially raised swine in 1999. The agency has previously told Reuters it stands by that decision, and the drugs' safety has been corroborated four times. Industry analysts estimate that more than half of all U.S. hogs currently raised for meat are fed ractopamine.

Eli Lily & Co's Elanco Animal Health unit, the leading producer of ractopamine-based livestock drugs, could not immediately be reached for comment. Zoetis Inc, which recently rolled out two generic ractopamine products, also could not be reached for comment.

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 the Humane Society, Farm Workers and Animal Legal Defense Fund.

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

The cases are Humane Society of the United States (HSUS) et al v. Margaret A. Hamburg, in her official capacity, Commissioner, and U.S. Food and Drug Administration, U.S. District Court, Northern District of California, No. 3:14-cv-04933; and Center for Food Safety et al v. Hamburg et al, No. 3:14-cv-04932.