The United States Pharmacopeia (USP), the official standards-setting authority for prescription and over-the-counter medicines, as well as dietary supplements and other healthcare products manufactured and sold in the United States, opened its third international facility in September of 2007, which is located in Shanghai, China.1
The new 10,500 square-foot, state-of-the-art facility will provide local manufacturers with better access to USP’s publications and reference standards, as well as other USP services. USP’s reference standards are used to help assure product quality during testing by showing whether a tested ingredient conforms to the published standards in the USP’s official publications, the US Pharmacopeia and the National Formulary. USP standards are recognized and used in more than 130 countries.
“This new site demonstrates USP’s commitment to ensuring the quality and safety of pharmaceuticals, dietary supplements, and food ingredients for everyone, regardless of geographic, economic, or political borders,” said Roger L. Williams, executive vice president and CEO of USP in a recent press release.1 “As the world continues to focus on these issues, it is even more important for standards-setting bodies and governments to collaborate. This office and laboratory facility will help USP work with Chinese regulators and manufacturers to move toward that goal.”
The new USP-China facility will also implement a new program of the Natural Products Association (NPA) for testing Chinese raw materials for conformity to their specifications, including identity, purity, and composition.2 Under the new NPA program, raw materials used in the most common dietary supplements will be tested in the new USP laboratory, and NPA officials will provide test results to member companies and subscribers. NPA will further create a database on these raw material suppliers, which will be made available to American manufacturers to assist them in making contracting and supply-chain decisions. According to the NPA, Chinese suppliers who submit ingredients for testing should be able to gain access to new customers and build reputations as reliable business partners through participation in the program.
“Dietary supplements are safe today, and this will help make them even safer,” said NPA Executive Director and CEO David Seckman in an NPA press release.2 “This program is an innovative response to a growing challenge in the global food supply chain to make sure what reaches the shelf is safe, high-quality, and what it claims to be. By testing raw materials in China, we’re adding another layer of consumer protection to a process that has delivered good health products to Americans for generations.”
China has come under increased scrutiny lately by regulators and US consumers due to repeated occurrences of contaminated products and product recalls originating from China. The September 2007 issue of the International Trade Centre’s Market News Service for Medicinal Plants and Extracts (MNS) contained 2 editorials regarding herbal ingredients from China and concerns over their quality.3,4 The first editorial, by Roy Upton, executive director of the American Herbal Pharmacopoeia, noted that China has been a prolific supplier of herbal ingredients. According to Upton, China has some of the highest quality herbs available in the world. Moreover, American companies have access to Chinese suppliers knowledgeable about quality and to herbal ingredients grown under specific, clean conditions.3 He wrote, “With a little bit of knowledge, quality control personnel can get exactly what they desire, balancing quality and price with product expectation, and without undue contamination.” Upton added that buyers primarily need to know the right questions to ask their Chinese suppliers to ensure that they are purchasing ingredients of the proper quality.
In the second editorial, Josef Brinckmann, vice president of research and development at Traditional Medicinals and editor of the MNS newsletter, wrote that the purchasing practices of some American companies have undoubtedly contributed to some of the consumer backlash recently directed at China.4 He argued that, although there are many quality-focused herbal companies in the United States, there are also many that demand low prices and use the least stringent ingredient and product specification requirements. According to Brinckmann, many natural ingredient suppliers worldwide typically export their highest quality raw materials and extracts to European buyers, while the materials rejected by Europeans on the basis of quality are often earmarked for export to the American market due to its often lower standards and because fewer questions are asked by buyers. He added that, even if natural ingredients from China were boycotted on the basis of quality concerns, the trade flow of low quality and adulterated or contaminated ingredients and products would likely continue unabated so long as American buyers and consumers continue to demand products with the lowest costs.
Some North American companies have recently expanded their presence in, and relationships with, China. For instance, BI Nutraceuticals of Long Beach, California, a leading importer and distributor of botanical and related ingredients, opened a new facility in Suzhou, China, in June of 2007. This 75,000 square-foot facility provides the company with enhanced manufacturing capacity. It also contains a full-service quality assurance lab to test all extracts and ingredients purchased in the region to ensure that they are free of contaminants prior to being shipped to the United States.5 A. M. Todd Botanical Therapeutics of Logan, Utah, a leading manufacturer and supplier of botanical extracts and dietary supplements, announced in September of 2007 that it has become the exclusive North American distributor for the Chinese company Ningbo Green-Health Pharmaceutical Co., Ltd., a major manufacturer of chondroitin, bilberry (Vaccinium myrtillus, Ericaceae), and ginkgo (Ginkgo biloba, Ginkgoaceae) extracts.6
References
- US Pharmacopeia inaugurates new facility in Shanghai [press release]. Shanghai, China: US Pharmacopeia; September 6, 2007.
- Natural Products Association launches new program to verify purity of Chinese raw materials [press release]. Washington DC: Natural Products Association; July 21, 2007.
- Upton R. Editorial: quality control of herbs from China—the good, the bad, and the ugly! Market News Service for Medicinal Plants and Extracts. September 2007;24:26-27.
- Brinckmann J. Editorial: consumer backlash against Chinese ingredients and products continues. Market News Service for Medicinal Plants and Extracts. September 2007;24:28-30.
- BI Nutraceuticals continues to raise industry standards for ingredient quality control in Asia Pacific region [press release]. Long Beach, CA: BI Nutraceuticals; June 11, 2007.
- A. M. Todd Botanical Therapeutics announces distribution agreement with Ningbo Green-Health Pharmaceutical Co., Ltd [press release]. Logan, UT: A. M. Todd Botanical Therapeutics; September 8, 2007.