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 identified by agency laboratories. The agency realizes to safeguard the consumers, it needs to step up enforcement of quality checks for imported materials.
One mechanism of this guardianship is the policing of new dietary ingredient (NDI) submissions by issuing timely acknowledgements of notification acceptance and better managing import alerts to customs and border officials 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 finished brand, which is tasked with the selection, handling, testing and processing of ingredients and components, as well as the composition, dose and shelf life of the finished product, whether it be a powder, liquid, tablet or capsule or in confectionery form. This elevation of responsibility was defined 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 official or voluntary actions being taken by the firms inspected to correct deficiencies 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 significant problems with the agency and the products intended for commerce. Either producers of products in our industry are naïve, or they are willfully ignorant of their responsibilities. In certain circumstances, importers are willfully ignorant of what is in their products. Those that engage in such deception should be met with the full force of federal law, and the offending products should be subject to immediate seizure, no matter where or how the products are being sold in the United States.
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