FDA Will Pull Vet Drug Used in Pork Industry Over Cancer Concerns for Humans
WEDNESDAY, Nov. 8, 2023 (Healthday News) -- The U.S. Food and Drug Administration said Tuesday that it plans to pull a veterinary drug used commonly in the pork industry because it might pose a cancer risk to humans who eat pig products.
The antimicrobial, carbadox (Mecadox), is typically added to pig feed to fight infections and fatten up the animals.
But pork contaminated with "carcinogenic residues" from the drug could wind up in foods like hot dogs and cold cuts, though the agency stressed in its notice that it isn't telling people to change their food choices at the moment.
The FDA's concerns with carbadox date back decades: When it was first approved in 1998, the agency's worries were abated by a strategy that involved testing edible parts of pigs that had been given carbadox. According to the agency, data now shows that those testing methods do not adequately measure the cancer risk posed by pork produced while using the drug.
After issuing its first warning about pulling the drug in 2016, it isn't clear why the agency didn't move sooner to actually do so, CBS News reported.
"This action itself arrived long overdue. The European Union and Canada prohibited use of carbadox in 1999 and 2006, respectively, due to concerns about residues and the safety of workers handling the drug," advocacy groups wrote in a 2022 letter to the agency.
"Because the FDA first made public its concern regarding the adequacy of the 1998-approved [testing] method with regard to carbadox in 2016, the swine industry has had the opportunity to consider and mitigate potential impacts of this action for several years," the agency said in a post about the drug.
Drug maker Phibro Animal Health Corp. said Tuesday it was "extremely disappointed" by the FDA's latest move.
"While Phibro has continuously offered to meet with FDA to discuss the regulatory method and has offered viable alternative methods currently being used in other countries, it is clear that, instead, the FDA is ignoring the long history of safety that Phibro has established and reaffirmed through its most recent studies," the company said in a news release.
Pulling carbadox from the market could also result in millions of lost pigs, the National Pork Producers Council claimed.
"It is a vital product to treat gastrointestinal disease [swine dysentery] in young pigs, improving their health and welfare. With few interventions available, carbadox is essential," the council told CBS News.
Phibro could have one more chance to persuade the FDA not to pull its carbadox approvals.
The drugmaker could submit a request for a hearing to the agency raising "a genuine and substantial issue of fact." The deadline for such a request is Dec. 7, the FDA's notice said.
"Phibro will take appropriate action and next steps to continue to defend swine producers' ability to use Mecadox to protect the health and welfare of their animals," the company said.
Visit the FDA for more on carbadox.
SOURCE: CBS News