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The human gastrointestinal tract contains over 1,000 different types of bacteria. The role of the gut bacteria (microbiota) on health and disease is a subject of extensive research in recent years. As a result, our knowledge and understanding of their impact is rapidly growing. The articles “Role of the gut microbiota in health and chronic gastrointestinal disease: understanding a hidden metabolic organ” and “Rapidly expanding knowledge on the role of the gut microbiome in health and disease” discuss the impact of gut microbiota on Irritable bowel syndrome, inflammatory bowel disease, colorectal cancer, obesity and type 2 diabetes. Prebiotics (nutritional compounds used to...

FSMA represents the most sweeping change to U.S. food regulations in over 70 years. It represents a radical change for food safety in US and its suppliers abroad, bringing a new focus on prevention. It is a fundamental change in food regulations affecting the entire food supply chain.Now, all seven rules of FSMA (Food safety Modernization Act)  are now final and implementation for the large companies starts now. Below is a quick overview of the new rules provided by the FDA. The final rules are: Preventive control for human food Preventive control for animal food Accredited third-party certification Foreign supplier verification programs for...

Food Allergies on the Rise According to FARE (Food Allergy Research & Education) there are an estimated 15 million Americans with food allergies.  More that 17 million Europeans have food allergies.  In a study released in by the CDC in 2013, food allergies among children increased by 50% between 1997 1nd 2011. The eight foods (the “big 8”) that cause 90% of all food allergies are milk, eggs, peanuts, tree nuts, soy, wheat, fish and shellfish. In 2004 the FDA enacted  the Food Allergen Labeling and Consumer Protection Act (FALCPA), requiring that foods are labeled to identify the 8 major allergens. Recalls on the Rise...

CORRECTIVE ACTION & PREVENTIVE ACTION What are Corrective Action and Preventive Action? Corrective action is an action taken to prevent the re-occurrence, Whereas Preventive action is an action to prevent the occurrence. FDA investigators focus on CAPA during inspections because it is a roadmap to identify potential and existing problems at a company. CAPA documentation provides FDA investigators, auditors, and executive management a means to review problems. Therefore, effective management of the CAPA system is critical to compliance. By following five essential steps, companies can be CAPA compliant and ensure a successful audit or inspection. The failure to either have a CAPA process,...