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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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    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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    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
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    FDA Withdraws Proposed Rule on Generic Label Changes

    The US Food and Drug Administration (FDA) on Thursday withdrew a proposed rule on label changes for generic drugs after concerns were raised by commenters and FDA resources were considered. The proposed rule from 2013 would have allowed abbreviated new drug application (ANDA) holders for generic drugs to independently update and promptly distribute revised product labeling to reflect newly acquired safety-related information, even if the revised labeling may temporarily...
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    Stage Set for Merck’s SCOTUS Case Over Warnings in Labels

    With the acting solicitor general set to participate in oral arguments before the Supreme Court on 7 January, the high court will be deciding a contentious case centered on who has the final say in warning labels on pharmaceuticals. The case, known as Merck v. Albrecht , presents the question of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempting to change the warning label and having FDA reject its...
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    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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    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...
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    FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

    The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday. "Because of the potential side effects associated with long-term aspirin therapy...