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  • Feature ArticlesFeature Articles

    Regulatory Focus, June issue: Nutrition in health and disease management

    This month marks the fifth anniversary of the annual series on nutrition in health and disease management, initiated in 2016 by Manfred Ruthsatz , PhD, RAC, FRAPS (executive director, Nutrition+HealthCARE, Switzerland). Ruthsatz has led all five series to date, this year, together with co-lead, Andrea Wong , PhD (SVP, scientific and regulatory affairs, Council for Responsible Nutrition, Washington DC). They have coordinated authors and reviewers who are global leaders in...
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    Sarcopenia: Potential interventions for a newly recognized disease

    This article discusses sarcopenia, a newly recognized skeletal muscle disease. The authors review the disease, its diagnosis, the role of malnutrition in muscle deterioration, nutritional interventions, and EU regulatory considerations. They conclude that good nutritional health, physical activity, and pharmacologic options are the most effective early interventions. The most promising nutritional interventions are high-quality, protein-enriched supplements and multivitami...
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    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
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    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...
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    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...
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    Latin America market opportunities for food supplements: Navigating regulatory complexities

    This article discusses the growth opportunities in Latin America for food supplement businesses. It provides guidance for companies eager to interpret current regulation, predict future direction, and plan successful commercial strategies. The author addresses the commercial advantages going along with increased regional and global harmonization and how to navigate current regulatory complexities to realize commercial opportunities and meeting the challenges and opportunit...
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    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

    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...
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    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...
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    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...
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    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 ...
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    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 ...