Final Rule for Dietary Supplement GMPs

On June 25, the FDA issued the long-awaited good manufacturing practice (GMP) requirements for dietary supplements. The final regulation applies to all firms that manufacture, package, label, or hold dietary supplements, unless specifically excluded (e.g., retail establishments). Manufacturers of dietary ingredients and other components are not subject to the final rule.

In the preamble to the final regulation, the FDA states that the intent of the GMP requirements is to ensure that dietary supplements meet their established product specifications and are not contaminated during manufacturing operations. To ensure that product specifications are met, one of the most significant requirements will be that supplement manufacturers confirm the identity of each dietary ingredient prior to use by testing or examination. Under the final rule, reliance on a certificate of analysis, or even test data, from the supplier will not be considered sufficient to confirm dietary ingredient identity. The FDA acknowledges, however, that 100% identity testing for dietary ingredients may not always be necessary, and has issued an interim final rule setting forth procedures by which a supplement manufacturer may apply for an exemption from the 100% testing requirement. Under the interim rule, a supplement manufacturer would submit a petition (under the citizen petition process ) to the FDA for an exemption, including a scientific rationale and data to support the conclusion that an alternative testing scheme is sufficient to ensure the correct identity of dietary ingredients. The FDA is soliciting comments on the proposed petition process, and has requested that comments be submitted by September 24, 2007.

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