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Dietary Supplement Adulteration: Laboratory Approaches to Risk Mitigation.

Cuiying Ma, Maria Monagas, Leah Bronstein

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    Dietary supplement (DS) manufacturers face continuous adulteration risks, heightened by supply chain issues. Compliance with Good Manufacturing Practices (GMP) and utilizing third-party testing are crucial for ensuring product safety and quality.

    Keywords:
    GMP implementationdietary supplement adulterationdietary supplement quality controlquality control testingrisk to consumer healthtools for industry to mitigate DS risk

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    Area of Science:

    • Food Science
    • Analytical Chemistry
    • Regulatory Affairs

    Background:

    • Adulteration poses a persistent challenge for dietary supplement (DS) manufacturers.
    • Recent supply chain disruptions have exacerbated the risk of product adulteration.
    • Manufacturers in the U.S. must adhere to Good Manufacturing Practices (GMP) for quality control.

    Purpose of the Study:

    • To highlight the ongoing problem of adulteration in the dietary supplement industry.
    • To discuss the impact of supply chain disruptions on product integrity.
    • To outline strategies for mitigating adulteration risks.

    Main Methods:

    • Review of current adulteration issues and regulatory requirements.
    • Analysis of the role of Good Manufacturing Practices (GMP) in quality control.
    • Identification of risk mitigation tools for DS manufacturers.

    Main Results:

    • Adulteration remains a significant concern for dietary supplement quality.
    • Supply chain vulnerabilities increase the likelihood of adulterated products.
    • GMP compliance is essential for ensuring product identity, purity, strength, composition, and contaminant limits.

    Conclusions:

    • Dietary supplement manufacturers must prioritize robust quality control measures.
    • Implementing DS certification, quality agreements, and third-party testing can significantly reduce adulteration risks.
    • Adherence to regulatory standards like GMP is fundamental to consumer safety.