Founder -- Contract In-House Counsel and Consultants, LLC
Marc’s firm focuses on FDA, U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS)/Animal and Plant Health Inspection Service (APHIS)/Agricultural Marketing Service (AMS), and the Federal Trade Commission (FTC),), as well as other federal, state, and international consumer protection agencies governing rules and regulations related to drugs, foods, dietary supplements, homeopathic remedies, medical devices, medical foods and cosmetics.
Marc works extensively in the areas of food and dietary supplement safety, labeling and advertising claims. He drafts opinion letters regarding the status of food ingredients in the United States and assisted in the preparation of food additive petitions, Generally Recognized as Safe (GRAS) notifications, and new dietary ingredient notifications. He also assists companies in developing self-determined GRAS positions for food ingredients. His practice also specializes in international compliance and distribution agreements.
Marc advises clients on issues related to FDA and FSIS’s labeling requirements as well as on organic products and genetically modified organisms. He has assisted companies on important FDA, FSIS, APHIS compliance issues, including Hazard Analysis And Critical Control Point (HACCP), good manufacturing practice, product recalls vs. market withdrawals, inspections, warning letters, complying with FDA’s and FSIS’s standards of identities, importing meat and poultry products into the United States, warning letters, and record keeping.
Marc has also been involved extensively on issues related to the marketing of foods and dietary supplements, including health claims, qualified health claims, structure/function claims, and nutrient content claims. He has developed strategies for companies to communicate information about their products without running afoul of FDA, FSIS and FTC regulatory requirements.