The U.S. Food and Drug Administration’s Regulation of Pet Food: Complying with FDA’s Rules for the Marketing and Sale of Dog and Cat Food

Why Should You Attend:

This webinar will focus on FDA rules governing product development and formulation, manufacturing, facility inspections and recalls. It will also cover the various rules governing the use of labeling and promotional claims such as “maintains urinary tract health,” “low magnesium,” “tartar control,” “hairball control,” and “improved digestibility.” In terms of labeling, the presenter will include a 2011 Year End Wrap-Up discussing enforcement action taken by the Agency over the past couple of years and during 2011 specifically highlighting particular enforcement trends and areas of potential risk. Considerable attention will also be devoted to a discussion of the recently enacted Food Safety Modernization Act (“FSMA”) and where FDA is in the process of implementing its requirements and publishing related guidance documents.

This webinar will also provide an overview of recent regulatory trends and potential enforcement risks in the market today. This will include an introduction to several safety issues impacting the industry that have come up over the last few years including problems with Chicken Jerky Treats and the widespread contamination of pet food with melamine.

Another major focus of the webinar is on the FDA’s regulation of food and food additives including the pre-marketing clearance requirement, the food additive petition process and the process for showing that an ingredient is Generally Recognized as Safe (“GRAS”). On a related note, the webinar will also provide an introduction to the function and responsibilities of the Association of American Feed Control Officials (AAFCO).

The presenter will also provide a brief introduction to the regulation of veterinary dietary supplements / nutraceuticals, the use of health claims in marketing and promotion, the feeding of raw foods to their pets and past FDA enforcement action in the area.

Learning Objectives:

• Obtain a basic understanding of FDA's regulation of pet food in the United States.
• Learn what FDA requires to appear on the label of a pet food product.
• Identify potential risks involved with the marketing and promotion of pet food products.
• Become familiar with the process by which a new ingredient is approved or accepted for use in pet food in the U.S.
• Understand the role of the Association of American Feed Control Officials (AAFCO) in the development, formulation and labeling of pet food and feed products.
• Understand how FDA regulates those products marketed as veterinary dietary supplements or nutraceuticals in the U.S.
• Obtains a basic introduction to the veterinary drug approval process.

Areas Covered in the Webinar:

• FDA's regulation of pet food products including the rules covering product formulation, manufacturing, labeling and promotion.
• The various components of a pet food label.
• The process for introducing a new ingredient or feed additive to the market.
• The differences between the Pre-Market Clearance Process, the Food Additive Petition Process and the process for having an ingredient deemed Generally Recognized As Safe (“GRAS”).
• Update on the status of the Proposed GRAS Self-Affirmation Notification Program.
• A summary of FDA's recent enforcement activity in the area and recent trends and areas of particular enforcement risks.
• What are a veterinary dietary supplement / nutraceutical and how they are regulated by FDA.
• A brief introduction to the animal drug approval process.

Who Will Benefit:

• Pet Food Industry Representatives
• Regulatory Affairs Professionals
• Consultants
• Scientists
• Research Analysts
• State Department of Agriculture Officials
• Investment Analysts and Venture Capitalists
• Pet Food Formulators, Manufacturers, Labeler and Retailers
• Foreign Manufacturers
• Importers / Exporters
• Ingredient Producers
• Financial analysts and investors focusing on the pet, pet food, animal health and companion animal markets

Karl M. Nobert
President, ReCellerate, Inc.

Karl Nobert, is a Food & Drug Regulatory Attorney and a Principal with The Nobert Group which focuses on FDA and USDA legal issues. He provides regulatory advice and counseling to both domestic and international food and feed companies. Among others, his clients include ingredient manufacturers, formulators, labelers, distributors and exporters of various animal health products. He also has considerable experience related to the regulation of veterinary biologics including veterinary cellular and genetic therapies.

Topic Background:

Pet food is regulated by the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug, and Cosmetic Act (“FDCA”) which defines food as "articles used for food or drink for man or other animals, chewing gum, and articles used for components of any such article." Thus, pet food squarely falls under FDA’s regulatory jurisdiction. In addition to FDA, pet food is also regulated by the various individual states to some extent.

At the end of June 2014, FDA published consumer advice warning pet owners about their pets’ risk for contracting Salmonella or Listeria monocytogenes from raw food. Commenting on the practice, FDA Veterinary Medical Officer William J. Burkholder stated “Feeding raw foods to pets increases the risk that both the pet and the people around the pet will encounter bacteria that cause foodborne illness, particularly if the products are not carefully handled and fed.”

With regards to Chicken Jerky Treats, the FDA has received approximately 4,800 reports of pet illnesses, which may be related to consumption of the jerky treats. These include about 1,800 reports received since FDA’s last update in October 2013. The reports involve more than 5,600 dogs, 24 cats, three humans, and include more than 1,000 canine deaths.

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