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  • Regulatory NewsRegulatory News

    FSMA and its Impact on Dietary Supplement Companies

    This article discusses FSMA-related regulations and stresses the impact the regulations will have on the dietary supplement industry. Introduction Since the Food Safety Modernization Act (FSMA) was signed into law in January of 2011, regulatory professionals in the food and dietary supplement areas have been barraged. 1 Seldom has one act had as many touch points in food regulation. For dietary supplement companies, FSMA's broad scope and hefty volume have made it a ...
  • Regulatory NewsRegulatory News

    Nutrition, Health and Disease Management, Hot Topics and a Preview of September

    New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management The August collection of feature articles for Regulatory Focus explores the changing healthcare paradigms when food (health) and drug (disease) systems, once separate silos, are now moving closer together. This creates new opportunities, yet also gray zones, making historic pharmaceutical and nutrition "models" prone to be revisited. Leading global experts in their respective fi...
  • Feature ArticlesFeature Articles

    Surviving Your First FSMA Inspection

    This article provides an overview of the new FSMA regulations and suggests some recommended steps to prepare for inspections, including preventive controls, supply chain management and good record keeping practices. Introduction Without question, the US Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) is the most significant food safety law of our generation. The original Federal Food, Drug, and Cosmetic Act of 1938, included a single sentence ...
  • FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements

    The US Food and Drug Administration (FDA) has released a new guidance document intended to clarify elements of a 2002 law passed in the hopes of better allowing the agency to deal with bioterrorism concerns. Background The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPR) of 2002 was passed months after a series of terror attacks hit the US in 2001. While airborne attacks on the World Trade Center buildings and the Pentagon are almost un...
  • New Facility Registration Requirements Come into Effect for Supplement Manufacturers

    A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA) , including for dietary supplement manufacturers. The requirements of FSMA came into effect on 22 October and mandate that all food production facilities-of which supplement manufacturers are by definition a part-register with FDA to mitigate the impact of any potential ...
  • Congress Slams Third-party Food Facility Audits

    A congressional report released on 10 January slammed a third-party auditor for giving a food production facility a "superior" ranking just two months before an outbreak of listeria that originated at the facility killed 30 people . The facility, Jensen Farms, had hired Colorado-based Primus Labs to conduct the facility's audit. Congressional investigators found that the auditors were either ignorant of FDA guidance documents regarding food safety or blatantly ...