December 14, 2018

FDA Update on Guidance #213

Last year, the FDA announced a new voluntary guidance plan to help “phrase out” the use of medically important antibiotics in factory farm animals for purposes of growth promotion. The government asked the animal pharmaceutical industry to withdraw animal drug approvals used for production and to transfer the remaining uses of the drugs to prescription-only.

AntibioticsNow the FDA says that out of 26 affected sponsors, 25 have confirmed in writing their intent to “engage with FDA as defined in Guidance #213” and have given the agency consent to list their names. Those corporations hold 99.6% of the appliances affected by Guidance #213, and represent 99.95% of the total sales of products affected by Guidance #213.

Those corporations include Bayer Healthcare LLC Animal Health Division, G.C. Hanford Manufacturing Company, Novartis Animal Health US, Inc., Sparhawk Laboratories, Inc., Sstrategic Veterinary Pharmaceuticals, Inc., Virbac AH, Inc., and Zoetis Inc.

Food Poisoning Bulletin has been reporting on the problem of antibiotic use in food animals for purposes of growth and disease prevention for years. Many agencies, including WHO and say that these sub therapeutic uses of the drugs are creating antibiotic-resistant bacteria and are threatening human health.

The agency is encouraged by the positive responses. But it will take time to see if this voluntary document actually makes a difference. Agencies that want to see the government make these directives mandatory, and not voluntary, include Food & Water Watch, Center for Food Safety, Johns Hopkins Center for a Livable Future, and many others. And those agencies say that 63% of the drugs in question can still be given to animals to prevent disease at sub therapeutic levels, which does not solve the problem.

Comments

  1. About time. This has been an ongoing no-brainer battle forever.

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