• Regulatory NewsRegulatory News

    Study Raises Questions Over FDA’s Handling of Adulterated Supplements

    A new study published in JAMA Network Open on Friday raises questions about the US Food and Drug Administration’s (FDA) oversight of adulterated dietary supplements.   The study, which analyzed data from FDA’s Tainted Products Marketed as Dietary Supplements database, found more than 776 instances of supplements containing hidden pharmaceutical ingredients from 2007-2016.   However, only 360 of the 776 adulterated supplements were subject to a voluntary recall, w...
  • Regulatory NewsRegulatory News

    Surveillance of Adverse Events for Dietary Supplements

    This article discusses past and present congressional legislation and FDA regulations pertaining to reporting dietary supplement adverse events. It also focuses on the value of post-market surveillance to protect consumers and defines and clarifies the regulatory professional's role in communicating product safety as technology continues to expand data access. Introduction Current laws regarding Dietary Supplement (DS) regulation by the US Food and Drug Administration...
  • Regulatory NewsRegulatory News

    The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative

    This article discusses the role industry self-regulation plays in fostering trust from regulators, lawmakers, and consumers. It introduces an important self-regulatory initiative for the dietary supplement industry - the Supplement Online Wellness Library (OWL) - laying out its history and how it will serve regulatory audiences, retailers, and ultimately, consumers. Introduction When the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 industry ...
  • 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

    NDI Guidance: The Waiting Game

    This article discusses FDA's publication of its revised draft of Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry (2016 Draft Guidance) and the implications regarding the lack of finalization in the year following its publication. The authors make suggestions regarding what companies may begin doing prior to and in anticipation of eventual finalization. Introduction Regarding how dietary supplements should be regulate...
  • Regulatory NewsRegulatory News

    Preparing for Dietary Supplement Label Changes Under the Final Rule for Nutrition and Supplements Facts Labels

    This article summarizes several key provisions introduced by FDA's new Nutrition and Supplement Facts Labels rule with a specific focus on their effect on the development and marketing of dietary supplements. Potential implications of the new requirements and changes are presented and suggestions are provided for managing various aspects of the new rule. Introduction On 27 May 2016, the US Food and Drug Administration (FDA) published in the Federal Register its final...
  • Regulatory NewsRegulatory News

    Guest Editorial: Does Nutrition Have a Role in Disease Management?

    This editorial is meant to encourage discussion and thinking about the value of diet and nutrition in the management of disease and a regulatory framework that would be useful in the US to protect public health and provide benefit to individuals who live with chronic disease or an increased risk of such diseases. Introduction The current regulatory approach, with respect to food and nutrition, tends to categorize individuals as consumers or patients and yet these stat...
  • 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

    The US Regulatory Environment for Promoting Nutritional and Healthful Aspects of Food

    This article presents FDA's regulatory framework for food for human consumption and how the various legislation regarding information about nutritional content and health-related aspects of food should be presented on food labels. Regulatory Categories Food and Drugs Products marketed in the US, other than tobacco products and alcoholic beverages, and intended for ingestion, are regulated either as foods or drugs. This regulatory scheme has been in place since the pa...
  • Feature ArticlesFeature Articles

    Regulation, Substantiation Requirements and Enforcement of US Dietary Supplement Claims

    This article discusses claim categories for dietary supplements and recent related regulatory development and enforcement activity to help those who market dietary supplements understand the evolving regulatory climate, legalities and substantiation requirements. Introduction A recent survey reveals 68 percent of American adults take dietary supplements. 1 Users of dietary supplements report taking such products for overall health and wellness, as well as for specifi...
  • Regulatory NewsRegulatory News

    Capsule Supplier Changes: FDA Offers an Updated Policy

    Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday. Prior Approval Supplement When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change. Depending on the seriousness of...
  • Regulatory NewsRegulatory News

    FDA Unveils New Office of Dietary Supplement Programs

    As part efforts to elevate the regulation of dietary supplements, the US Food and Drug Administration announced on Monday the creation of the new Office of Dietary Supplement Programs (ODSP). The new office, which previously worked as a division under the Office of Nutrition Labeling and Dietary Supplements, comes as the supplement industry has more than quadrupled in the 20 years since the establishment of that first division – from about $6 billion to more than $35 bil...