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Covington’s animal food and drug practice dates back to the 1960s, and our most senior lawyer specializing in this area holds a Doctorate of Veterinary Medicine (DVM). Ours is the preeminent regulatory practice relating to veterinary pharmaceuticals and biological products, animal feed, and pet food, and we act as food and drug regulatory counsel to most major animal health companies, as well as to manufacturers of animal feeds or feed ingredients.
Our lawyers advise both large and small clients on all aspects of veterinary pharmaceutical and biologics regulation, manufacture, approval, marketing, importation and exportation. We routinely advise feed and feed ingredient manufacturers on the complex, state-centric regulation of animal feeds, supplements, and pet food in the United States, and our colleagues in our London and Brussels offices advise clients on the corresponding areas in Europe. We also routinely defend companies in enforcement actions brought by FDA, USDA, and the states.
Our lawyers advise clients, including human pharmaceutical companies, on FDA and USDA import and export issues for animal-based products and ingredients, and we have advised clients for a number of years on compliance with the Animal Welfare Act and its regulations governing animal research.
Assist client in designing, planning, and establishing a significant new animal health business.
Working with pet food and animal feed companies on preparing and filing GRAS notifications, food additive petitions and AAFCO feed ingredient definition applications for animal feed and pet food ingredients.
Advising veterinary pharma companies on issues relating to abbreviated paths to drug approval and issues related to the Center for Veterinary Medicine’s new positioning on growth promotion claims for antibiotics used in human medicine.
Assist animal health companies successfully respond to FDA enforcement actions, including Warning Letters and Form 483 observations.
Defense of administrative compliance actions and investigations brought by the USDA under the Animal Welfare Act and assistance with conducting internal investigations related to such actions.
Representation of animal food and drug clients in connection with FDA and USDA import detentions, import refusals, re-exportations and destructions of refused imports, and successful petitions for removal from FDA Import Alerts.
October 2016, Digital Health Legal
September 21, 2016, Covington Alert
On September 21, 2016, the Court of Justice of the EU (CJEU) delivered its judgment in Case C-592/14 European Federation for Cosmetic Ingredients v UK Secretary of State for Business. The Court has ruled that animal tests performed outside the European Union (EU) to comply with non-EU rules should not be used for the product safety assessment to gain access to ...
August 26, 2016, Covington Alert
Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry #235, “Current Good Manufacturing Practice Requirements for Food for Animals,” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance contains information designed to help ...
Earlier this week, the Center for Veterinary Medicine (CVM) of the Food and Drug Administration (FDA) published Draft Guidance for Industry No. 239, “Human Food By-Products for Use as Animal Food” as part of the agency’s implementation of the Food Safety Modernization Act (FSMA). The draft guidance describes the regulatory requirements — including the ...
August 18, 2016, Covington Alert
Nineteen years after first publishing its proposal, FDA published in yesterday’s Federal Register its final rule on substances generally recognized as safe (GRAS) for their intended use in human and animal food. This Alert addresses the final rule as it applies to food for animals. For an analysis of how the final rule will affect human food, see our Alert “FDA ...
July 18, 2016, Covington Alert
On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA ...
April 7, 2016, Covington Alert
Yesterday, FDA published in the Federal Register its final rule establishing sanitary transportation requirements for both human and animal food. The rule is intended to ensure that food transportation practices do not create food safety risks. FDA provides a flexible, risk-based approach that largely aims to allow the transportation industry to continue to use ...
March 31, 2016, Update
November 17, 2015, Covington Alert
6/18/2015, Covington Alert
June 3, 2015, Covington Alert
February 21, 2014, Covington E-Alert
February 5, 2014, Covington E-Alert
January 22, 2014, Covington E-Alert
October 31, 2013, Covington E-Alert
December 7, 2012, Covington E-Alert
February 23, 2009, Covington E-Alert
January 26, 2009, Covington E-Alert
January 16, 2009, Covington E-Alert
December 15, 2008, Covington E-Alert
October 28, 2008, Covington E-Alert
July 29, 2008, Covington E-Alert
November 6, 2007, Covington E-Alert
September 21, 2007, Covington E-Alert
January 19, 2007, Covington E-Alert
October 13, 2006, Covington E-Alert
September 27, 2006, Covington E-Alert