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    Regulatory Challenges Persist for Dietary Supplement Stakeholders

    Experts discussed structure-function claims, drug preclusion issues, and more at AHPA’s Regulatory Congress.

    Regulatory Challenges Persist for Dietary Supplement Stakeholders
    By Mike Montemarano, Associate Editor12.20.22
    There are plenty of opinions about potential modifications to the Dietary Supplement Health and Education Act (DSHEA), which amended the Federal Food, Drug, and Cosmetic Act (FDCA) in 1994 to establish a new regulatory framework for dietary supplements.

    For example, some stakeholders have called for changes to how structure-function claims are regulated, the drug preclusion clause, mandatory product listing, and more.

    Information Access

    At the American Herbal Products Association’s (AHPA) virtual Regulatory Congress in November, panelists discussed structural changes to DSHEA and FDCA they would consider to be the most fundamental.

    The intent of DSHEA, when it was proposed, was to avoid limiting access to information and products, said Gretchen DuBeau, executive and legal director at Alliance for Natural Health USA.

    “FDA has p

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