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Dietary Supplements

Dietary Supplements

  • Dietary supplements are consumable products such as vitamins, minerals, and herbs that claim to promote wellness. Dietary supplements are classified as food. Firms must obtain a food establishment license to manufacture, hold, pack, label, distribute, or sell dietary supplement products because there is no exemption for dietary supplements in the Michigan Food Law.

    Dietary supplements differ from conventional foods in that they are not typically consumed like conventional foods. They can be tinctures, extracts, capsules, teas, gummies, etc., and may contain dosing instructions or health benefits on their labels.

  • Regulation of dietary supplements is found in 21 CFR 111, also referred to as the Dietary Supplement (DS) Current Good Manufacturing Practice (CGMP) rule, and is adopted by reference in the Michigan Food Law, Act 92 of 2000, as amended, Section 289.7112(1).

  • As of May 1, 2025, individuals and firms that manufacture, hold, pack, label, distribute or sell dietary supplements are required to have a food establishment license from the Michigan Department of Agriculture and Rural Development (MDARD) and must comply with all applicable regulatory requirements. Wholesale and retail firms that do any of the above activities are required to comply with 21 CFR 111.

  • Firms must have designated quality control personnel qualified to perform quality control operations and have supervisory staff qualified to produce dietary supplements to oversee these operations. All firms producing dietary supplements must meet the requirements under 21 CFR 111. It is the responsibility of the firm to comply with the full requirements of 21 CFR 111.

    If a firm is unable to comply with 21 CFR 111, then the firm is not allowed to produce a dietary supplement and the product must conform to the requirements of a conventional food product, including conventional food labeling requirements and comply with applicable regulations.

  • MDARD inspectors will conduct onsite inspections to determine compliance with 21 CFR 111. Each inspection focuses specifically on Plant and Grounds, Equipment and Utensils, and Master Manufacturing Record.

  • The following information must be readily available for the inspector’s review upon request:

    • List of dietary supplements manufactured and/or labeled at the firm.
    • Name and title of the most responsible person and name of the Quality Control Lead.
    • Water supply status (onsite well must provide Local Health Department approval).
    • Wastewater disposal (EGLE permitting may apply).
    • Copies of written procedures: 21 CFR 111 Subparts B, C, D, F, G, J, K, L, M, N, and O.
    • Master Manufacturing Order for anticipated largest volume production product.
    • Batch Record.
    • Copy of the label for the largest quantity produced or most complex dietary supplement for a label review.