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  • Feature ArticlesFeature Articles

    A mandatory dietary supplement registry: Transparency as ‘disinfectant’

    The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...
  • Feature ArticlesFeature Articles

    Integrating master files in the NDI notification process to facilitate innovation in dietary supplements

    This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.   Introduction Innovation grows industries, and it is no different for the dietary supplement industry...
  • Regulatory NewsRegulatory News

    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
  • Regulatory NewsRegulatory News

    Study Finds Stimulants in Supplements After FDA Action

    A study published in JAMA Internal Medicine on Monday raises questions about the effectiveness of the US Food and Drug Administration’s (FDA) actions to address stimulants found in dietary supplements.   While FDA often issues public notices or takes enforcement action aimed at specific companies or products, from 2013-2016 the agency issued public notices warning consumers about four sympathomimetic stimulants found in dietary supplements.   None of the stimulan...
  • 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

    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
  • Regulatory NewsRegulatory News

    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
  • 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...