US Dietary Supplement Industry Releases Draft Document to Support GMP Compliance

The SIDI Work Group is requesting comments on the draft voluntary guideline from industry stakeholders, regulators, and other interested parties within a 60-day period, ending June 18. The SIDI Work Group will consider comments it receives as it finalizes the guideline.

18 April 2012 --- The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, has announced the release of its new draft voluntary guideline, the Dietary Supplement Component Supplier Qualification Guideline. The SIDI Work Group, formerly known as the Joint SIDI (Standardized Information on Dietary Ingredients) Working Group, is made up of three of the supplement industry’s trade associations the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) and dietary supplement ingredient suppliers and finished product manufacturers with an interest in strengthening the industry’s self-regulatory practices.

Under Good Manufacturing Practices (GMPs), manufacturers are responsible for qualifying their suppliers and this draft guideline offers recommendations as to how companies can ensure they are compliant in this regard. The SIDI Work Group is requesting comments on the draft voluntary guideline from industry stakeholders, regulators, and other interested parties within a 60-day period, ending June 18. The SIDI Work Group will consider comments it receives as it finalizes the guideline.

The voluntary supplier qualification draft guideline outlines the process a dietary supplement manufacturer might use when qualifying an ingredient supplier. This draft guideline will mark the third voluntary guideline developed by the SIDI Work Group, and is a companion piece to the earlier guidelines the SIDI Protocol and the CoA Guideline (Certificate of Analysis Guideline).

“The SIDI Work Group intends for the supplier qualification guideline to be flexible so that it can be applied across the industry, and so that large, medium and small companies will find it a useful tool to support the development of individual company supplier qualification programs,” said Duffy MacKay, N.D., chair of the executive committee, SIDI Work Group, and vice president, scientific and regulatory affairs, CRN. “A practical aspect of the guideline is the stratification of supplier and component risk, which allows companies to better allocate limited resources during the supplier qualification process.”