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    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
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    Enhancing consumer confidence and supplement access through harmonized retail standards

    Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer...
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    Evaluating Science for Health Claims: An Evolving Landscape

    The FDA’s current guidance on evidence-based review for the science needed to support food and dietary supplement health claims was published in 2009. Although this guidance has not changed in the past decade, as demonstrated by two recent agency decisions regarding health claims, the agency’s interpretation of the guidance appears to be changing. The article reviews these two cases—revocation of the soy protein and coronary heart disease health claim and the conclusion t...