Voluntary approach Twenty-five companies will comply with American regulator’s request to remove growth promotion from product labels
CHICAGO, Ill. (Reuters) — Twenty-five out of 26 drug makers in the United States that sell antibiotics used in livestock feed for growth enhancement have agreed to follow new guidelines that will make it illegal to use their products for that purpose.
The companies, which include Eli Lilly & Co.’s Elanco Animal Health unit, Bayer Healthcare LLC’s animal health division and Zoetis Inc., have agreed to start the process of removing any growth promotion claims on their products’ labelling, according to the U.S. Food and Drug Administration.
The FDA announced the guidelines in December as part of an ongoing bid to stem a surge in human resistance to certain antibiotics.
The guidelines are voluntary, but agency officials have said they expect drug makers to fully adhere and to narrow their products’ use.
The labelling shift will ultimately mean that while farmers, ranchers and other agriculture groups can continue to use such drugs to treat sick animals, they will be banned from using them for promoting growth in livestock, according to regulators.
“The FDA and drug makers appear to have passed the first big test of the agency’s voluntary approach,” said Laura Rogers, director of human health and industrial farming for Pew Charitable Trusts.
“There’s a lot more to do.”
Critics argue that the guidelines give drug makers too much discretion in policing their own use of antibiotics and provide no mechanism for enforcement.
“This plan is likely to lead to label changes, not a reduction in use,” said Avinash Kar, a health attorney with the Natural Resources Defense Council.
Public health experts have become worried in recent years about the emergence of new strains of bacteria that cannot be controlled by a wide range of current antibiotics.
Some suspect that these “superbugs” have developed as a result of livestock being fed low levels of antibiotics throughout much of their lives, creating an environment for bacteria to mutate and develop resistance to drugs that are key to human health.
The companies have also agreed to require such antibiotics, which are typically added to animals’ food or water, to be made available only through a veterinary prescription or via a veterinary feed directive status instead of being available for sale over-the-counter at feed stores and other retail outlets, according to regulators.
The agency said 26 drug companies and 283 affected products or applications fall under the voluntary guidance.
Only Pharmaq AS declined to follow the voluntary guidelines. Pharmaq makes an antimicrobial powder used to treat certain conditions in salmon, trout and catfish. The Norwegian company’s product is already for therapeutic uses only, but is available over the counter, according to nutritionists.