U.S. regulators on Wednesday said that 25 out of 26 drugmakers 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 to create beefier cattle, heftier hogs and other outsized animals.
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' labeling, according to the U.S. Food and Drug
The FDA announced the guidelines in December, as part of an ongoing bid to stem a surge in
human resistance to certain antibiotics. Although the guidelines are voluntary, agency officials
have said they expect drugmakers to fully adhere and to narrow their products' use. This labeling
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 The Pew Charitable Trusts,
adding "there's a lot more to do." Critics argue that the guidelines give drugmakers 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, 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 there are currently 26 drug companies and a total
of 283 affected products or applications that fall under the voluntary guidance.
Of the 26, Pharmaq AS was the only company that 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 already is for therapeutic uses only, but is available over the counter,
according to nutritionists.
These companies have agreed to fall under the FDA guidelines
ADM Alliance Nutrition, Inc.
Agri Laboratories, Ltd.
Bayer Healthcare LLC, Animal Health Division
Boehringer Ingelheim Vetmedica, Inc.
Contemporary Products, Inc.
Cross Vetpharm Group Ltd.
Elanco Animal Health, A Division of Eli Lilly & Co.
First Priority, Inc.
G.C. Hanford Manufacturing Co.
Micro Beef Technologies LTD
Novartis Animal Health US, Inc.
Pennfield Oil Co.
Phibro Animal Health Corp.
Quo Vademus, LLC
Ridley USA Inc.
Sparhawk Laboratories, Inc.
Strategic Veterinary Pharmaceuticals, Inc.
Veterinary Services, Inc.
Vetoquinol N.-A., Inc.
Virbac AH, Inc.