Manufacturing Dietary Supplements: cGMPS

On June 25, 2007, the U.S. Food and Drug Administration (FDA) released the final rule for dietary supplement Current Good Manufacturing Practices (cGMPs). This rule, which establishes uniform standards needed to ensure quality throughout the manufacturing, packaging, labeling, and holding of dietary supplement products, was implemented in 2008 for large companies and allowed for a three-year phase-in for smaller companies. Beginning in June 2010, all companies manufacturing, packaging, labeling, or holding dietary supplements were required to comply. This final rule requires that manufacturers verify the identity, purity, strength, and composition of their dietary supplement products. Dietary supplements containing contaminants or those not containing the dietary ingredient represented on the label would be considered adulterated or misbranded by FDA.

CHPA, in collaboration with two other dietary supplement trade associations (the Council for Responsible Nutrition and the United Natural Products Alliance), participates in the Standardized Information on Dietary Ingredients (SIDI) Work Group, which has released three voluntary guidelines (the SIDI Protocol, the Certificate of Analysis Guideline, and a Dietary Supplement Component Supplier Qualification Guideline) intended to help the dietary supplement industry comply with cGMP regulations. These voluntary guidelines are accessible free of charge following registration at the SIDI website. CHPA has also developed a series of voluntary guidelines for specific dietary ingredients.

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