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Package Design Q&A

  • Asked August 22nd, 2012

    The dietary supplement and nutraceutical market has been affected by the FDA’s Dietary Supplement Current Good Manufacturing Practices (cGMPs) “Final Rule” (21 CFR Part 111). The Final Rule adopts all of the requirements specified in 21 CFR 210 and 211, which affect pharmaceutical manufacturers. These cGMPs apply to all companies that manufacture, package, label, or hold dietary supplements and nutraceuticals. Dietary supplements and nutraceuticals imported from outside the United States are also subject to the Final Rule.

    The Food and Drug Administration has significant authority to regulate the dietary supplement industry, including (but not limited to) the authority to:

    • Stop a company from selling any dietary supplement that is unsanitary or unsafe.
    • Stop the sale of any dietary supplement that makes false or non-substantiated claims on its labeling.
    • Stop the sale of any nutritional supplement that poses “a significant or unreasonable risk of illness or injury.”

    The Federal Trade Commission has the authority to regulate the advertising of the supplement industry, including (but not limited to) the authority to:

    • Challenge and stop advertising that is not sufficiently substantiated.
    • Negotiate a consent order for a company to change or fix its promotional marketing or advertising practices.
    • Seek substantial civil penalties for violations of trade regulation rules or violations of cease and desist orders.

    Having a thorough understanding of the cGMPs is critical for success.

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