U.S. Human Food and Animal Feed Law- Issues Related to Food Safety, Formulation, Ingredients, Manufacturing, Labeling, Exporting and the Sale of Products in the United States
Karl M. Nobert, Food and Drug Regulatory Attorney, The Nobert Group LLC
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The U.S. Food and Drug Administration (“FDA”) and a variety of other governmental agencies (U.S. Department of Agriculture, U.S. Department of Commerce, and U.S. Environmental Protection Agency) regulate the marketing and sale of human food and animal feed in the United States.
This food safety compliance seminar will examine the federal laws and regulations that govern ingredient food safety, manufacturing, labeling, marketing, packaging, adverse event report and exporting. Participants who attend this seminar will have the opportunity to learn the history of federal food laws and enforcement and will discuss case studies highlighting current issues in the news, e.g., salmonella contamination, recall of “defective” foods, regulation of biotechnology use in foods, melamine poisoning of pet food, food import detentions and the science underlying food regulation and food production.
Significant emphasis will also be focused on the adopted and currently evolving Food Safety Modernization Act (“FSMA”) signed into law by President Obama on January 4, 2011. The FSMA has changed the FDA’s and USDA’s position on global food imports from a reactionary to a proactive approach and this has resulted in a much larger number of foreign inspections and enforcement actions.
Attendees will also learn about the U.S. import and export regulations. Compliance with U.S. import and export Customs’ laws requires an understanding of the Customs & Border Patrol’s (“CBP”) regulatory framework and how goods clear CBP into the commerce of the United States. This part of the course summarizes a vast array of customs law topics and focuses on some of the primary Customs compliance requirements.
Specific topics to be covered include:
- How food and beverage products are regulated
- The role of the FDA
- The role of the U.S. Department of Agriculture (“USDA”)
- Facility registration
- Food and ingredient safety; and Generally Recognized As Safe (“GRAS”)
- Current Good Manufacturing Practices (“cGMPs”) – What are they?
- The labeling, marketing and advertising of food and beverage products
- The regulation of energy drinks and sports beverages
- Exporting food & beverage products to the U.S.
- Preparing for an FDA inspection
- FDA enforcement activity in the UAE and the Middle East generally
Upon completing this course on U.S. regulation of food participants will:
- Gain a basic understanding of FDA’s regulation of human food and animal feed products
- Understand the purposes and importance of the Generally Recognized As Safe or “GRAS” standard for food and feed ingredients
- Become knowledgeable of the federal and state regulations governing the marketing and sale of food and feed products in the U.S.
- Learn and develop an understanding for FDA and USDA’s various rules covering food safety, formulation, manufacturing, quality control, packaging, transport and retail sale
- Develop a comprehensive understanding of the rules governing the product label and labelling; and what can and cannot appear on each.
- Be able to navigate the U.S. food export and import programs
- Learn strategies for mitigating potential FDA risk and reducing the possibility of product detentions
- Gain strategic recommendations for preparing for an FDA facility inspection including how to get ready and then undergo a successful facility inspection.
- Understand what to do if your company has a bad inspection and how to respond to FDA observed facility violations.
- Learn how to avoid FDA enforcement action when labelling and advertising a food or feed product.
- Be able to distinguish between the different types of enforcement action.
- Learn the process for successfully exporting food and feeds to the U.S.; and how to comply with CBP’s rules.
- Understand the importance and relevant requirements of the Food Safety and Modernization Act or “FSMA”
- Be able to identify and discuss similarities and differences between U.S. Food Law and the newly adopted UAE Food Law
Who will Benefit:
This course is designed for people tasked with developing a regulatory and business strategy for the marketing, export and sale of human food, animal feed and ingredients in the United States. This includes individuals who are responsible for ensuring that their company’s products comply with FDA’s regulatory requirements, satisfy the relevant U.S. laws and regulations; and those tasked with the shipping and exporting food and feed products to the U.S. The following personnel will benefit from the course:
- The Human Food Manufacturing Industry
- The Animal Feed Manufacturing Industry
- The Food and Feed Ingredient Manufacturing Industry
- Manufacturers and Producers
- Senior Regulatory Professionals
- Compliance Professionals
- Food Technologists and Consultants
- Food Safety Consultants
- Corporate Legal Departments
- Food and Feed Exporters & Importers
- Regulatory Consultants
- Research Analysts
- Production Supervisors
- Product Labelers
- Those Interested in the FSMA
- Quality Control Personnel
- Regulatory Auditors
- Customs Brokers
- Product Labelers and Contract Labelers
- Contract Manufacturers
- Governmental Officials
- Investment Analysts
- Venture Capitalists
- M&A Professionals
- Middle Eastern Food Safety Officials
- Professors and Students
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Introduction to the United States Food and Drug Administration (“FDA””) and the United State Department of Agriculture (“USDA”)
- The Role of FDA in Human Food Regulation
- The Federal Food, Drug & Cosmetic Act (“FDCA”) – Statutory and Regulatory Requirements
- The Role of the U.S. Department of Agriculture (“USDA”)
- USDA’s Relevant Laws, Regulations and Directives
- How Human Food and Beverage Products are Regulated in the United States
- The Growing Importance of the Food Safety Modernization Act or FSMA
- Facility Registration
- Food and Ingredient Safety; and Generally Recognized As Safe (“GRAS”)
- Current Good Manufacturing Practices (“cGMPs”) – What are they?
- Relevant Case Studies to Confirm Understand of Day 2 Material
- The Labeling, Marketing and Advertising of Food and Beverage Products
- Exporting Food & Beverage Products to the U.S.
- Preparing for an FDA Inspection
- Similarities and Differences between U.S. Food Law and U.A.E. Food Law and Middle Eastern Food Law Generally
- The Regulation of Animal Feed Products in the United States
- The Manufacturing, Labeling, Distribution and Sale of Animal Feed
- The Animal Feed GRAS Notification Process
- Introduction and Explanation of the Association of American Feed Control Officials or “AAFCO”
- Exporting Animal Feed and Veterinary Drug Products to the United States
- A Comparison of U.S., U.A.E. and Middle Eastern Feed Laws Generally
- Animal Feed Case Studies
- FDA Enforcement Procedures
FDA’s Regulations of Import & Exports
- The Concepts of “Adulteration” and “Misbranding”
- Warning Letters
- Civil and Criminal Penalties
- “The Park Doctrine”
General Case Studies Applicable to both Human Food and Animal Feed
- Import Regulations
- Legal Authority
- Prior Notice Requirements
- Import Alerts
- Import Detentions
- Export Regulations
- Certificates of Free Sale
- Product Specific Issues
- Human Food Products
- Animal Feed Products
- U.S. Customs and Border Protections (“CBP”)
- Importer’s Liability
- Tariff Classification and Product Duties
- Country of Origin and Marking
- Customs Entry Process
- Import Licenses and Tariffs
- Strategic Recommendations for FDA Compliance and Successful Imports / Exports
Meet Your Instructor
||Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC
Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.
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