Nutraceutical/Dietary Supplements

Safety evaluation for a direct food additive or color additive used in food involves assigning the additive to a Concern level is FDA requirement. Raw materials, finished nutraceuticals and dietary supplements, feed, novel food, food additives, food enzymes and flavorings are assessed for its toxicology profile following (EFSA) and GRAS (Redbook 2000, FDA) guidelines.

Key Pointers

• Genetic toxicity tests
• Short-term toxicity tests with rodents
• Sub chronic toxicity studies with rodents & non-rodents
• Chronic toxicity or combined chronic toxicity/carcinogenicity studies with rodents
• Carcinogenicity studies with rodents
• Reproduction & developmental toxicity studies
• One-year toxicity studies with non-rodents
• Immunotoxicology
• Neurotoxicity
• Active ingredient method development and analysis
• Heavy metal detection
• Microbial detection