3 YEAR PHASE-OUT A WIN FOR CONSUMERS, FOOD SAFETY ADVOCATES, AND MEDICAL COMMUNITY; CONTINUED OVERSIGHT NEEDED

The Center for Food Safety (CFS) applauds the U.S. Food and Drug Administration (FDA) today for issuing industry guidance limiting the use of antibiotics in food-producing animals.  Antibiotics are essential tools in both human and animal medicine but mounting evidence has linked persistent use of these drugs in animal production to the development and spread of antibiotic-resistant organisms.

“This is an important step in protecting the public from the proliferation of antibiotic-resistant bacteria,” said Paige Tomaselli, Attorney for the Center for Food Safety. “But it’s high time that FDA takes drastic measures to eliminate all non-therapeutic uses of all antibiotics in food animal production.”

FDA said its actions today would result in a “sea change” from decades of widespread antibiotic use.  The FDA’s plan includes encouraging industry to voluntarily eliminate non-therapeutic antibiotic use within three years, to include veterinary oversight or consultation for administration of antibiotics to food-producing animals, and to implement “judicial use” principles.  FDA’s action today included issuing a Final Guidance for Industry (#209), issuing a proposed Guidance for Industry (#213) with specific recommendations on how to align animal drug applications with Final Guidance #209, and a proposed rule linking the FDA’s Veterinary Feed Directive with the industry guidances. When FDA releases the proposed rule, the public will then have 90 days to comment.

In human medicine, antibiotic use is generally confined to treatment of illness.  Yet, on many industrial livestock farms in the U.S., antibiotics and other antimicrobials (drugs that kill microorganisms like bacteria) are routinely administered to healthy animals. In fact, 80 percent of all antibiotics produced in the U.S. are given to animals, not humans.  One result of this unregulated overuse has been a significant increase in antibiotic-resistant “superbugs” which can dangerously jeopardize the use and effectiveness of medically important antibiotics for humans.

In August 2010, more than 180,000 citizens sent letters to the FDA responding to the agency’s request for comments on rules governing the judicious use of antibiotics on industrial farms.  Those letters joined dozens of scientific experts and public interest organizations calling on FDA to tighten oversight and curtail misuse and overuse of antibiotics on industrial farms. In 2011 and 2012, FDA’s actions took inconsistent turns as the agency refused to withdraw approval for tetracycline and penicillin, yet it limited certain uses of cephalosporins.

“Today’s action by the FDA puts forth a plan that demonstrates the agency’s commitment to public health, added Tomaselli. “The Center for Food Safety will keep pressure on the FDA to ensure it stays the course to implement the guidances and the proposed rule.”