Safeguarding the Supply Chain
Exploring adulteration in China and how to avoid it.
By Jeff Crowther
The words “safety” and “quality” have been utilized many times to highlight problems, deficiencies and crises with regard to sourcing ingredients and products in China. Just in the last few years, numerous consumers and companies have fallen victim to adulterated products exported from China—e.g., pet food, milk powder, weight loss products, toothpaste. And one only needs look at FDA’s records of refused Chinese imports to see that it consistently ranks in the top three countries not meeting U.S. standards. This certainly paints a grim picture of China and its exporting industries. In order to get a clearer understanding of the reality of the situation, however, it’s important to learn a little about the history and development of China and its raw material industry.
Joining the World Stage
China as we know it today—“People’s Republic of China”—was solidified in 1949, but it remained very much isolated until the late 1970s. In 2001, China was accepted as a member of the World Trade Organization (WTO), allowing it to play a bigger role in global community.
Since joining the world stage, China and its industries have been developing at breakneck speeds. The country’s economic triumphs during the last two decades can be attributed to its low-cost labor force, export oriented policies and devalued currency.
China’s economic advantages quickly won over the world’s dietary supplement companies. Today the country is responsible for supplying upwards of 80% of the raw materials found in supplement formulations. Thomas Tierney, president of California-based Vitatech, elaborated on China’s role in today’s dietary supplement market. “China is moving strategically to control starter materials and commodities, and is now a single-source supplier for many ingredients,” he said.
Due to its abundant resources and super competitive pricing, China has all but cornered the market for many ingredients, including ascorbic acid, chondroitin, glucosamine sulfates, B vitamins, creatine monohydrate and many others.
The U.S. dietary supplement industry has been sourcing from China for quite some time, fortunately with a great record of safety. Although there haven’t been any serious public health events, there is ongoing concern over the potential for contamination and economic adulteration.
Peilin Guo, vice president of functional foods for Jarrow Formulas, Los Angeles, CA, discussed the pros and cons of sourcing in China during the last five years. “It is better [now] in that more [Chinese] manufacturers want to compete in quality and price by introducing advanced technology, modern equipment and strong scientific teams. These manufacturers can be trusted to a great extent for what they supply,” she said, adding, “However, some unethical suppliers constantly improve their adulteration skills, which can be so sophisticated that it is difficult to indentify.”
During the last several years, U.S. manufacturers and ingredient brokers have been pressing China’s suppliers for low pricing. In some cases, this has created unrealistic competitive pricing wars to meet customer demand. This type of behavior can easily prompt unscrupulous suppliers to adulterate ingredients or products in order to capture business from their competition and increase shrinking profits.
Protecting Companies & Consumers from Unsafe Products
As the dietary supplement industry continues to expand globally and raw material price wars continue, the chance of deliberate adulteration for economic gain is very real and must be looked at as an ever-present risk of sourcing in China. Despite this unwanted reality, there are ongoing regulations and programs in place to help protect U.S. companies and consumers from unsafe products.
First, there are government regulations, such as the Food Safety Agreement of 2007, signed by the U.S. Department of Health and Human Services (HHS) and China’s Administration for Quality Supervision Inspection and Quarantine to ensure food and feed products flowing out of China meet U.S. standards. In addition, FDA opened its first foreign office in the Beijing Embassy, with plans to place additional personnel in the Shanghai and Guangzhou Consulates sometime this year.
There are also new U.S. FDA GMP regulations for dietary supplement products, which, although costly to implement, was a necessary step to ensure the dietary supplement industry was doing everything possible to safeguard consumers.
From an industry perspective, the Natural Products Association (NPA), Washington, D.C., is doing its part to protect the supply chain with ongoing GMP certifications and quality assurance education in both the U.S. and China. In fact, in 2006 NPA opened a branch office in Beijing to work on regulatory reforms, protect the supply chain, hold tradeshows, promote its trade mission and enhance online communications.
Protecting the supply chain consists of two parts. The first part includes a 3rd party ingredient testing program, which was recently made possible by a one-of-a-kind partnership between NPA and United States Pharmacopeia (USP), Rockville, MD. The program focuses on testing raw materials prior to their exportation to the U.S. Tests are done at USP’s laboratory, which is located in Shanghai. The second part of the quality assurance program includes NPA’s GMP certification program. This is being offered to Chinese suppliers and manufacturers after passing an audit conducted by U.S.-based auditing firms that are approved by NPA’s quality assurance committee.
For the last few years, NPA has been busy promoting its unique programs in China through educational seminars held in a variety of cities such as Beijing, Shanghai, Guangzhou and Chengdu. In the last two years, NPA-China has hosted eight seminars.
The educational sessions are conducted by NPA’s vice president of scientific and regulatory affairs, Dr. Daniel Fabricant, and are supported by both the U.S. Department of Commerce and China’s Ministry of Commerce: Chamber of Pharmaceuticals and Health Products. With the assistance of NPA’s China partners, the message of quality assurance, 3rd party ingredient testing and GMP standards have reached more than 200 suppliers and manufacturers in China.
For the Future
As more Chinese companies realize the benefits of these quality programs, the U.S. dietary supplement industry will have a greater number of trusted suppliers to choose from. However, for NPA to be successful in safeguarding the supply chain, it needs the support of the U.S. dietary supplement industry. For these and many other reasons, U.S. dietary supplement manufacturers and brokers alike should be strongly encouraging their partners in China to participate in the programs.
Gary Korngold, executive vice president, Nexgen Pharma, discussed some of the benefits of these programs. “If the [Chinese] suppliers commit to GMP certification, it will alleviate some of the concerns regarding purity and safety in Chinese materials.”
Jarrow’s Ms. Guo also added her thoughts. “NPA’s efforts in GMP education and certification, as well as its testing program, not only help U.S. buyers, but also Chinese manufacturers who are serious about their quality and want to protect their reputation.”
Editor’s Note: For more information on these programs and how to support the Natural Products Association’s efforts, please contact Jeff Crowther in Beijing: email@example.com; or Dr. Fabricant at NPA’s headquarters in Washington D.C.: firstname.lastname@example.org.