With more than 40 years of direct industry experience in the manufacturing and distribution of food, dietary supplements, cosmetics, and related products, David has been actively involved in the evolution of the U.S. natural health products industry. His experience spans the implementation and ongoing development of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the Food Safety Modernization Act (FSMA) in 2011, and the Modernization of Cosmetics Regulation Act (MoCRA) in 2022. This extensive experience provides David with a comprehensive understanding of the U.S. regulatory landscape from both business and regulatory compliance perspectives.
Throughout his career, David has directly led and participated in numerous regulatory inspections conducted by the U.S. Food and Drug Administration (FDA), Texas Department of State Health Services (TDSHS), and U.S. Department of Agriculture (USDA). He has also managed annual certification and compliance audits involving SQF, NSF, EU Dairy, Health Canada, Gluten-Free, USDA Organic, Kosher, and Halal standards. These experiences have provided him with a strong foundation in FDA regulatory compliance, quality systems, preventive controls, Good Manufacturing Practices (GMPs), and risk management associated with the manufacture and distribution of regulated products.
David has maintained FDA registrations for facilities manufacturing food, cosmetics, and over-the-counter (OTC) drug products, as well as registrations with the Texas Department of State Health Services for food, drug, and consumable hemp products. He was directly responsible for implementing dietary supplement cGMP requirements under 21 CFR Part 111 beginning in 2009 and food cGMP and preventive control requirements under 21 CFR Part 117 beginning in 2015. His responsibilities included translating regulatory requirements into practical manufacturing procedures, quality systems, documentation, employee training, and day-to-day operational execution.
David can assist clients with a broad range of regulatory and compliance initiatives, including the development, review, and implementation of Standard Operating Procedures (SOPs); ensuring the effective execution of SOPs and maintaining documentation to demonstrate regulatory compliance; preparation for FDA, state, and third-party certification inspections and audits; development and implementation of corrective and preventive actions (CAPA); regulatory gap assessments and risk management; and review of product labeling, claims, advertising, and marketing materials for regulatory compliance.
His approach combines extensive hands-on manufacturing experience with a practical understanding of regulatory requirements, allowing him to help organizations not only understand what the regulations require, but also effectively implement and document the systems necessary to achieve and maintain compliance.