Pork Industry Voices Concern Over FDA's Proposed Action on Carbadox

( National Pork Board and the Pork Checkoff )

NPPC submitted comment on the U.S. Food and Drug Administration’s (FDA) proposed action to revoke the approved method for assessing residues of carbadox, an animal drug used in swine for production and therapeutic purposes. 

“Carbadox has been effectively used by most pork producers for decades to support animal health, while adhering to the 42-day withdrawal period. Since carbadox is mainly used pigs at the nursery stage, the 42-day withdrawal period is likely extended to 60 days or more, resulting in an additional safety buffer against residues. Pork producers prioritize the avoidance of violative residues of all animal health products,” NPPC explained in a letter to FDA Commissioner Stephen Hahn on Sept. 17.

Removing carbadox from the marketplace would increase the use of other antibiotics and increase the chances of antimicrobial resistance in important bacterial pathogen, NPPC wrote. 

“We believe this to be in direct conflict with the objectives of FDA’s Guidance for Industry 213 and the goals outlined in FDA’s 2018 five-year plan, including aligning antimicrobial drug product use with the principles of antimicrobial stewardship and fostering stewardship of antimicrobials in veterinary settings,” NPPC wrote in the letter. 

In a 2016 survey, U.S. swine veterinarians expressed concern that removal of carbadox from the U.S. market would increase disease prevalence and disease severity in pigs. In 2020, this survey was repeated, NPPC explained. 

Responding veterinarians who participated in the health decisions of more than 94 million pigs said removing carbadox from the market would have “disastrous” impact on the health of the U.S. swine herd, including a significant increase in enteric disease issues. Veterinarians estimate that removal of carbadox would result each year in up to 53.5 million otherwise healthy pigs becoming ill.

“If FDA has concerns about the method it uses to test carbadox residue, NPPC believes the agency should work with the sponsor to develop and approve a new regulatory method rather than remove this very effective, non-medically important antibiotic,” NPPC wrote in the letter. 

Read the full letter here.

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