Building Supply Chain Excellence in China

As has been widely reported, China has emerged as a leading supplier for commodity ingredients (i.e. vitamins, minerals, amino acids, etc.) for the dietary supplement industry. China’s technical savvy and infrastructure have made it a sought-after partner for sourcing supplement ingredients at a favorable price.

Competition is fiercer than ever in the raw materials and ingredient supply segment of the dietary supplement and nutrition industry. Product quality, reliability, consistency of supply and efficacy remain key problems for most overseas buyers of Chinese products, as the quality of these ingredients sometimes does not meet purchasers’ specifications. Rejected lots are nearly impossible to return to the Chinese supplier, and recent media coverage of contaminated food products exported to the United States from China has raised the level of concern to an all-time high—whether justified or not.

While some suppliers are familiar with these problems and go to extraordinary lengths to validate the quality and consistency of products, a gap remains in quality and communicating transparency. With that in mind, the Natural Products Association (NPA) and U.S. Pharmacopeia (USP) sat down over a year ago, on the cusp of each organization opening its office in China, to discuss plans and goals. While other factors influenced both organizations’ decision to open offices in China, during our discussion it became apparent that sourcing ingredients and, more importantly, identifying quality ingredients and quality sources in China, were of great interest to both USP and NPA. Our focus was on both the value of the industry and the consumers the industry serves. From that point we started to imagine how our aligned views and organizational strengths could work together to provide added value to the industry and consumers.

The end result is an agreement under which NPA will be able to independently test dietary supplement ingredients originating from China and bound for finished products in the United States and elsewhere using USP’s state-of-the-art facility in China. The program will officially launch in September of 2007, when Chinese suppliers can begin contracting with NPA to have their ingredients tested.

The program will work as follows:

• The Natural Products Association and program user will contract for service;

• Natural Products Association China receives testing specifications and sample(s).

• Natural Products Association China blinds the sample and submits samples to USP-China for testing work following receipt of appropriate documents from the user.

• USP-China has fulfilled the contract when the test report NPA. If additional testing or re-testing is required by the supplier, there is an additional fee.

To ensure the sample tested matches the lot/batch received by the manufacturer, NPA will collect samples from U.S. manufacturers following their receipt of lots/batches that have been tested through the program. NPA will build dossiers on raw ingredient manufacturers to track their performance, enabling U.S. firms to build better business partnerships with their suppliers. This data will be available on the Web for NPA members. Non-members will also have access to the data for a fee.

With the GMP (good manufacturing practice) regulation from FDA now official, more U.S. firms manufacturing finished supplement products will want verification that the ingredients they source meet their intended specification. At a minimum, many U.S. firms are interested in testing data on Chinese raw materials for: potency, microbacterial counts, heavy metals, identification (botanicals), and physical characteristics (particle size, etc.). The new NPA-USP program will enable U.S. firms to “plug-in” an ingredient supplier that meets their specifications. With the appropriate documentation in hand to satisfy regulatory compliance, the goals of both GMP compliance and basic testing can be met. Initially, while we anticipate only testing those ingredients for which compendial or validated analytical procedures are in place, USP-China will allow for the most up-to-date technological testing specifications to match what is used in the United States, such as ICP-MS (inductively coupled plasma mass spectroscopy) for heavy metal/elemental analysis. This means when a need arises in the industry to test a particular ingredient, we will have the flexibility and technology to meet that need. USP provides the technology and knowledge that are currently unavailable in third-party/independent Chinese labs.

The NPA-USP initiative helps to meet a fundamental health policy goal of both organizations—to protect and enhance the public by safeguarding and providing safe and high-quality products to consumers.

Daniel S. Fabricant, Ph.D., is the vice president of scientific and regulatory affairs for the NPA (NaturalProductsAssoc.org). Vijayaraghavan “Srini” Srinivasan, Ph.D., is the vice president, Dietary Supplement Verification Program, USP.