Publications

• Probiotic Efficacy Disputes in Pet Food and Supplements - What Attorneys Need to Know About CFU Counts, Stability, and Label Claims

Veterinary Microbiologist & Feed Additives Expert

Specialties & Experience of this Expert Witness

Additional Information

Dr. Nihan Marun, DVM, PhD Microbiology is a board-eligible veterinary microbiologist and regulatory scientist with 20+ years of hands-on experience in animal health product manufacturing, probiotics/biotics commercialization, and FDA-CVM/AAFCO compliance. She has commercialized 20+ probiotic and microbial products globally across companion animal, livestock, poultry, aquaculture, and agriculture sectors. Areas of Expert Testimony • Pet Food Recall & Feed Contamination Expert Witness: Salmonella, Listeria, E. coli, aflatoxin, heavy metals, Vitamin D toxicity; contamination pathways, manufacturing defects, adulteration, traceability failures. • Veterinary Microbiologist & Probiotic / Microbiome Expert Witness: Probiotic efficacy disputes (CFU counts, strain identification errors, viability loss, shelf-life misrepresentation), microbiome claims, prebiotic/postbiotic/synbiotic substantiation, gut health claims, antimicrobial resistance (AMR). • FDA Warning Letter & Veterinary Regulatory Compliance Expert Witness: FDA-CVM enforcement actions, warning letters, AAFCO labeling, claims substantiation (“natural,” “organic,” “microbiome support”), FSMA, HACCP, CGMP for animal food. • Product Liability & False Advertising Expert Witness: Pet food, supplements, feed additives, and probiotic product liability; mislabeling, false marketing claims, nutritional/regulatory disputes. • Pet Food Safety & Manufacturing Expert Witness: Formulation, ingredient sourcing, improper mixing, mycotoxins, QA/QC failures, preventive controls. Representative Case Types - Pet food and animal feed contamination (Salmonella, Listeria, E. coli, aflatoxin, Vitamin D toxicity, heavy metals) - Probiotic efficacy disputes (CFU counts, strain identification, stability/shelf-life misrepresentation) - FDA enforcement actions, warning letters, and regulatory compliance disputes - False advertising and label claims on pet food, supplements, and probiotic products - Product liability involving animal health products, supplements, and feed additives - Microbiome claims, gut health claims, and biotics (pre-, post-, synbiotic) substantiation - Veterinary malpractice involving infectious disease or microbiome-based treatments - International regulatory disputes involving imported/exported animal health products Unique Expertise Science: DVM + PhD Microbiology | Pathogen identification | Infectious disease | Nutrition & toxicology | Multi-species (companion animal, livestock, poultry, equine, aquaculture) | Zoonoses & public health. Industry: 20+ products commercialized | GMP manufacturing | Formulation & stability testing | Ingredient sourcing | IP & trademarks. Regulatory: FDA-CVM · USDA · AAFCO · EU & APAC frameworks | Labeling & marketing claims | Dossier writing | Compliance audits. Dr. Marun is the founder of SIGMA BioVet Sciences and has completed 150+ consulting projects for Fortune 500 companies and startups. She developed The Responsible Biotics Framework™ for evaluating microbiome-based products from science to market. Published author, peer reviewer (including Frontiers in Microbiology), and university instructor in microbiology, immunology, and zoonoses. Available for plaintiff and defense engagements nationwide and internationally. Contact: nihan.marun@sigmabiovet.com | www.sigmabiovet.com/expert-witness | Florida, USA