FDA revokes ban on antimicrobial

By staff reporter

- Last updated on GMT

Related tags Antibiotic resistance Food and drug administration

The Food and Drug Administration (FDA) said it has revoked the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals.

The revision comes despite the US regulator’s assessment in July that the use of cephalosporin in this way was a public-health risk.

According to the FDA, it received many substantive comments on the order of prohibition regarding cephalosporin, which was published on the US Federal Register on 3 July, and, it said that in order for the agency to fully consider that feedback, it was required to revoke the order.

The US regulator’s plan to ban many uses of cephalosporin drugs in cows, pigs, and poultry was challenged by industry, with agriculture groups and animal-drug companies saying that the antibiotics prevent many infectious diseases in animals.

The term ‘extralabel use’​ refers to use of an approved drug in an animal in a manner that does not follow the approved labelling. The FDA said its position was that extralabel drug use should only occur in circumstances when an animal’s health is threatened, or suffering or death may occur if treatment is not administered.


Resistance to antibacterials in animals is rising, meaning that the risk of animal-based food becoming contaminated is higher. At the same time, antimicrobials are also becoming less effective in fighting human infections.

The European Food Safety Authority’s (EFSA) panel on biological hazards (BIOHAZ) claims that more needs to be done to ensure that the food we eat does not become a ‘carrier’​ for antimicrobial resistant agents which could leave the body open to health risks.

The regulator adopted a redrafted opinion in October which claims that the growing use of antimicrobial agents in food could be damaging human resistance to bacteria.

Risk management

EFSA said that there is a need to keep a close eye on this issue to ensure all potential entry points into the food chain for such resistant bacteria are controlled.

The agency urged all stakeholders, including the national food safety authorities, to apply effective risk management in this area.

The Biohaz panel said that controls operated at the pre-harvest phase and those aimed at limiting antimicrobial usage are potentially the most effective and as such are capable of playing a major role in reducing the occurrence of AMR bacteria in food.

Related topics Regulation

Related news

Follow us


View more