The U.S. Food and Drug Administration’s Regulation of Pet Food

Recorded Webinar | Karl Nobert | From: Jan 15, 2021 - To: Dec 31, 2021

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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

This webinar will provide an introduction to FDA rules governing manufacturing, testing, labeling, and marketing of pet food in the U.S. In addition to facility inspections and product recalls, the webinar will summarize and assess FDA’s enforcement activity in the U.S. pet food market paying particular attention to enforcement trends and risks.

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 the 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 the FDA's recent enforcement activity in the area and recent trends and areas of particular enforcement risks.
  • What are veterinary dietary supplements/nutraceuticals and how they are regulated by the FDA?
  • A brief introduction to the animal drug approval process.

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 the FDA’s regulatory jurisdiction. In addition to the FDA, pet food is also regulated by 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.

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 the 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.

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 Nobert

Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics vitamins and dietary supplements; and veterinary products. He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.