FDA Issues Guidance on Dietary Supplement cGMP Regulations

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In its recent guidance on the Dietary Supplement Current Good Manufacturing Practice Rule ("the DS cGMP"), the U.S. Food and Drug Administration (FDA) has provided a detailed road map of the requirements set forth in the regulations at 21 C.F.R. § 111.

Who must comply with the DS cGMP?

Entities or individuals who manufacture, package, label or hold a dietary supplement are subject to the DS cGMP. However, there are some exceptions, highlighted below.

- Retail establishments that sell directly to consumers are exempted from complying with the DS cGMP. However, a warehouse or other storage facility that is holding a dietary supplement for a retailer does not fall within the exception. Moreover, a dietary supplement manufacturer that sells directly to consumers must comply with the DS cGMP.

- Contractors may also be exempt from the rule if the primary control of the dietary supplement remains with the manufacturing firm. Under this rationale, a contractor who receives a dietary supplement for packaging from the manufacturer and then returns it to the manufacturer for future sale is not required to comply with the DS cGMP. The FDA views the dietary supplement as remaining within the control of the manufacturer. Broadly, the guidance appears to indicate that the FDA will determine which regulations apply to a contractor based on the contractor’s role in the manufacturing process....

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