Dietary supplements and prescription drugs are pouring in from China, but U.S. regulators are not ensuring their quality, safety or proper labeling.
Federal regulators have inspected only a fraction of the hundreds of Chinese factories making prescription drugs for the U.S. market, a new report from the Government Accountability Office says.
Consumers can’t tell where imported drugs and dietary supplements are made because country-of-origin labeling laws are not being enforced.
Chinese officials and businesses defend the quality of their products and say their defect rates have been decreasing. But problems with Chinese products keep cropping up — such as a recent case of Viagra contaminated with a drywall ingredient.
The Food and Drug Administration says it does not have sufficient staff to monitor the overseas plants, which produce nearly 80 percent of the pharmaceutical ingredients and nearly 40 percent of the finished prescription drugs consumed in the U.S.
About half of those imports, the FDA says, come from China and India.
“The sheer number of foreign facilities, the complexity of the drug supply chain and the rapidly changing use of suppliers all pose formidable obstacles,” the FDA said, responding to the GAO report.
The Kansas City Star, in a recent article, examined China’s rising role in the dietary supplements industry by sifting through import records for fish oil capsules, the third-most-popular supplement in the U.S.
The Star found that China in just the past few years had captured 20 percent of the U.S. fish oil market, and that those capsules were not labeled as coming from China.
Further interviews and the FDA response make it clear that Chinese manufacturers also have captured a big share of the market for prescription drugs, and for vitamins and other dietary supplements.
Leo Hepner, an international consultant on food and dietary supplement ingredients, said U.S. consumers did not realize that China now supplied most of the world’s vitamin C and antibiotics, along with substantial amounts of other drugs and supplements.
Foreign drug and supplement plants producing for the U.S. market are supposed to meet FDA standards. But the GAO report, released in late October, said the FDA over the past few years had checked only 12 percent of the hundreds of Chinese plants producing pharmaceutical ingredients or finished products for the U.S. market.
The FDA did get to 52 of the plants in 2009, the report said, but that meant it had yet to visit 811 of the 920 Chinese facilities it is supposed to oversee. At the current inspection rate, it will take the FDA more than 15 years to get to the rest of China’s plants.
In contrast, the FDA inspected 1,015 facilities in the U.S. in 2009, a pace that will allow it to cover all U.S. plants in 2½ years.
In addition, the FDA’s overseas inspections covered only pharmaceuticals. The agency has yet to inspect any Chinese operations devoted to vitamins, fish oil or other dietary supplements.
One consequence of the lack of regulation has been a rising number of counterfeit drugs, said Peter Pitts, a former associate commissioner of the FDA.
One case, he said, involved counterfeit influenza medicine from China that was supposed to be Tamiflu, but contained none of its active ingredients.
Another involved counterfeit Viagra, the erectile dysfunction drug that contained a drywall ingredient. En Wang, the owner of a Houston company, was convicted in that case of conspiring with others in China to import the counterfeit Viagra.
“It’s a nascent public health crisis and we shouldn’t wait until we have bodies in the street,” said Pitts, president of the Center for Medicine in the Public Interest, a New York nonprofit group that promotes drug and food safety.
Besides the counterfeiting, there have been cases of drug contamination. In 2008, a contaminated ingredient from China showed up in heparin, a blood-thinning medicine that was linked to 149 deaths.
In a product quality case in another industry, China was not cooperating with U.S. officials who were in the country investigating tainted drywall believed to have contaminated thousands of U.S. homes, the nonprofit news organization ProPublica reported last month. At one point, a Chinese official tried to pry a piece of drywall from the hands of a U.S. investigator.
Chinese companies’ awareness of such concerns was on display last month at a dietary supplement trade show in Las Vegas.
The SupplySide West 2010 show billed itself as the largest of its type in the world, filling an exhibition hall the size of four football fields. Chinese companies, selling supplements and drug ingredients to wholesalers and retailers, dominated the aisles.
Lower prices were their main selling point, but their marketing literature often emphasized safety and quality.
Huaitai Bipharma, for example, said it had state-of-the-art facilities and a “top class” laboratory to ensure quality control.
Jiangsu Kanion Pharmaceutical’s materials said its mission was to “help people enjoy healthy lives with superior and pure natural products” by bringing together high-quality processes and materials.
At the trade show, a Jiangsu salesman, Steven Zhao, noted the variety of the company’s offerings. He passed his hand under a glass shelf filled with varieties of fish oil and said, “We can make all of these.”
Rongcheng Baihe Biology Technological Co., able to produce 20 million dietary supplements a day, offered more than 100 products, including fish oil, multivitamins and gingko.
Another company said it could provide dozens of ingredients and be the “Chinese connection” for the purchasing departments of other companies.
Aoxing Biotechnology said it made more than 150 products, including over-the-counter medications such as aspirin and benzyl benzoate, which is used to treat lice.
Some of the Chinese companies at the supplements show also made prescription drugs.
North China Pharmaceutical Group Corp. claims to be the second-largest producer of penicillin in the world. It says the Chinese government has made it a “top priority” that it become one of the top 500 companies in the world selling antibiotics, veterinary medications, pesticides and vitamins.
China’s growing share of drug and supplement manufacturing has yet to gain wide notice or regulation. But that could change.
Two dietary supplement trade groups are considering a push for labeling that tells consumers where fish oil capsules come from — an effort that could eventually extend to other supplements. Legislation was proposed in Congress to do the same for prescription drugs.
A bill also has been offered in Congress that could help the FDA be able to inspect more plants in China. The proposal, backed by a group spawned by The Pew Charitable Trusts to promote drug safety, would bolster the FDA’s ability and authority to regulate overseas factories making prescription drugs and ingredients.
“This is unfinished business that needs to get done,” said Allan Coukell, a pharmacist and executive director of the Pew Prescription Project.
