“As the global supply chain becomes more complex, proper supply chain management is critical,” the group said. “A robust testing program must be balanced with knowledge of the ingredient suppliers’ quality practices. The Working Group’s guidelines emphasize a science- and risk-based approach to supplier qualification and ingredient testing. Those developing the guidelines trust that science- and risk-based principles will also be the foundation for future guidance and rulemaking related to the Food Safety Modernization Act.”
SIDI offered documents it has developed related to guidelines for supplier qualification, including the SIDI Protocol—a voluntary guideline to standardize exchange of relevant and required information between dietary component suppliers and dietary supplement manufacturers—as well as a Certificate of Analysis Guideline for Dietary Supplement Components.
“We feel that the science- and risk-based principles that underpin the Working Group voluntary guidelines should serve as a basis for guidelines and regulations that arise from the FSMA,” the group said. “In addition, given that dietary supplements are addressed in other regulations and legislation, the Working Group encourages FDA to exempt dietary supplements from import certification. We support the agency’s effort to establish accredited third party auditors, which will further the Working Group’s efforts to ensure supply chain integrity.”