Natural Products Insider

MAR-APR 2019

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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58 INSIDER March/April 2019 Ensuring Supply Chain Integrity Before Beginning Supplement Operations by Mark A. LeDoux In this remarkable age of international supply chains, instant transmissions of electronic information and voice communications, and the varied impositions of tariffs by different governments, the need for supply "country of origin" transparency has never been greater. Recent statements from FDA Commissioner Scott Gottlieb, M.D., showed the agency believes it needs to step up its enforcement of the abuses of the dietary supplement industry that have been exposed in recent years. Concerns associated with imported goods remain, including the undisclosed presence of active pharmaceutical ingredients or their analogs, which have been identifi ed by agency laboratories. The agency realizes to safeguard consumers, it needs to step up enforcement of quality checks for imported materi als. One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notifi cation acceptance and better managing import alerts to customs and border offi cials to prevent adulteration, misbranding and potential harm to the consumer. This mandates transparency in the supply chain and honesty in disclosure documents. Supply chain integrity rests squarely with the fi nished brand. This elevation of responsibility was defi ned in statute with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent imposition of the cGMP (current good manufacturing practice) requirements. What remains a mystery is why almost half of the cGMP inspections conducted annually by FDA still result in either offi cial or voluntary actions being taken by the fi rms inspected to correct defi ciencies in some of the most basic components of a cGMP system, according to information obtained in a Freedom of Information Act (FOIA) request. Supply chain transparency, or lack thereof, can contribute to signifi cant problems with the agency and the products intended for commerce. Executives in the supplement industry should adopt a checklist when identifying the responsibilities mandated under statute, and the best practices for achieving those in preparation for sourcing, compounding, manufacturing, labeling and releasing products into commerce. A brand should: Know the material it is buying. The supplement executives must determine • 410-754-8141 • Please visit us at SupplySide East Booth# B125 Fulfillment Service Inc. SISK Scan for more details & contact us today. • • NSF cGMP COMPLIANCE • TEMPERATURE & HUMIDITY CONTROL • RETURNS MANAGEMENT • HIGH VOLUME ORDER CAPACITY • SAME DAY ORDER FULFILLMENT • LOT # AND EXPIRATION DATE CONTROL Contract Manufacturing: Supply Chain Transparency

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