NIE asked Jeff Crowther, executive director of NPA China, to weigh in on the Chinese market—how GMP certification has gone and what it holds for companies looking to enter:

“China and the US share a unique relationship and position in the global dietary supplement industry. The US is the largest producer and marketer and China is the largest supplier of ingredients. Moreover, China is quickly becoming a market with great potential for the sale of finished products. China is currently ranked fourth behind the US, EU and Japan in terms of supplement sales. It is estimated that the market is worth about $8 billion. Because China is the leading ingredient supplier and a market with great potential for growth, the Natural Products Association (NPA) believed it crucial that the US dietary supplement industry have a voice and position in China, so in 2006 NPA established its China office in Beijing. Since its opening, the office has been working closely with both US and Chinese officials to work toward a more open and transparent system for the sale of dietary supplements and other natural products. The office is also involved in working to educate Chinese suppliers on the importance of quality assurance, GMP standards and US importing regulations. Thus far NPA in conjunction with the US Department of Commerce and US Food and Drug Administration have hosted 10 educational seminars in a variety of cities across China such as Beijing, Shanghai, Guangzhou, Chengdu and Xi’an.

“In order to help Chinese companies meet the standards of the US government, NPA has been offering two programs to suppliers. First is the ingredient-testing program, which is made possible by NPA’s partnership with United States Pharmacopeia (USP). This program allows suppliers to submit a sample of the ingredients they intend to ship to the US to NPA’s China office. The sample is then blinded and shipped to USP’s Shanghai testing facility. After testing is complete, results are given to NPA’s headquarters as well as to the supplier. If the product passes all tests, the certificate of analysis (COA) results will be posted on NPA’s home page for NPA members to view. If the ingredients fail testing, NPA will also release this information as a warning to choose another supplier.

“NPA has also brought its very successful GMP certification program to China. This allows Chinese suppliers to become US FDA compliant and certified by NPA. NPA uses its third-party US auditors to conduct facility inspections. NPA’s GMP certification program has certified 70 companies globally and is seen as a well-known mark and one of the most rigorous programs to pass.

“Both the above programs are active in China. Thus far NPA has tested vitamin C and chondroitin sulfate from the two largest suppliers of these ingredients. On the GMP certification front, NPA has certified two companies. One is Shandong Greentech, a large chondroitin sulfate supplier, and the other is Guangdong Sirio, a large contract manufacturer. There are also three other companies that have paid the fees to schedule their audits. Because NPA’s programs are voluntary, it is a challenging process to convince Chinese suppliers to invest in these programs. NPA and the US industry have to rely on two forces working together to make these programs more successful. One is working with suppliers that understand the perception of Chinese ingredients and want to do all they can to reassure their US partners and potential partners that they are producing quality ingredients and products. The other pressure has to come from US buyers. US companies should be pressuring Chinese suppliers to invest in NPA’s quality assurance programs. This will, in turn, help US buyers with their GMP compliance and vendor qualifications. If Chinese suppliers feel that they could lose business due to lack of US compliance, they will certainly participate in quality assurance programs or lose their business.

“NPA encourages US retailers, manufacturers and ingredient brokers to push this message up the supply chain. Fortunately for US consumers, as of June 2010, all companies manufacturing products and marketing them in the US must be GMP compliant. It is a law and there are stiff consequences for non-compliance. NPA and the industry had been advocating for GMP regulations since DSHEA gave US FDA the right to establish them back in 1994. Although it took a long time, the industry is in a much better position now. Every US company required to be GMP compliant has done so at a cost, but that investment was made to safe guard the industry’s most valuable component … the consumers.”