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.
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 who the actual producer is to ensure it’s not a supplier that is neutralizing documents or selling others’ goods as their own. If the material is an herb or extract thereof, brands should make sure it has adequate standards to confirm identification. If it is a protein product, brands should check to ensure it has not been illegally spiked with individual amino acids or derivatives to spike the nitrogen content in order to fool a high-performance liquid chromatography (HPLC) or other instrument.
- Implement a rejection policy that destroys counterfeit or adulterated materials and implement it when called for.
- Decide how to qualify raw material suppliers, preferably with a quality team visit and audit. At the minimum, brand executives should learn how to conduct paper audits.
- Know the financial condition of the supplier. Companies with high amounts of leverage are more susceptible to fall prey to the temptation of economically driven adulteration to improve their profitability.
- Seek and obtain appropriate valid documentation from the supplier.
- Ask for compliance documents from the supplier, e.g., inspection reports, third-party inspection reports, documentation concerning product recalls, etc. Brands should check these against public files available online from the agencies in question.
- Establish who is responsible for the purity and potency of raw materials. Much of this is covered by regulatory framework, but brands must ensure legal responsibility is documented, and they should set up guard rails for handling “out-of-specification” ingredients.
- Receive appropriate assurances of country of origin.
- Develop clear standards for the procedures of qualification, identification verification, shelf life validation, microbiological standards, positive release or rejection, etc.
Given the significant expense associated with installing a quality system, it may behoove producers in the dietary supplement industry to adopt benchmarking created by the retailer-driven Supplement Safety Compliance Initiative (SSCI, ssciglobal.org), which is in advanced stages of releasing protocols and recommendations for auditing, procurement and identification testing. The objective of the SSCI is to enhance consumer confidence in products made to these standards. A critical component of this endeavor is to provide maximum transparency in the supply chain.
Without question, now is the time for transparency in documentation, sourcing and legal liability. The days of taking certificates of analysis (CoAs) at face value have been over for a decade or more, and those that want to skirt the issue are doing so at their own regulatory peril.
Mark A. LeDoux is founder, chairman and chief executive officer of Natural Alternatives International Inc. (NAI) an organization established in 1980 with facilities in the United States and Switzerland engaged in the research, design and manufacture of nutritional supplement programs and products for multinational clients. LeDoux has been a proud member since 1980 of the Natural Products Association (NPA) based in Washington, currently serving as chairman of its Board of Directors.