Concern Over Quality Control Of Chinese Herbs

Dear D.,

We appreciate your concern about possible contamination of herbal products imported from China. Your question is not unusual, of course, as we are asked the same thing 2-3 times per day by new customers evaluating OsteoPhase and our other products. All of our formulas are produced as concentrated powders at certified GMP (Good Manufacturing Practices) factories in China, and after clearing customs and being released by the FDA are encapsulated, bottled and labeled at GMP facilities in California.

The issue of formula purity as related to recent news regarding products from China is also not new. When I began my acupuncture practice over 20 years ago quality control of herbal products was already an important issue in the acupuncture community, especially since licensed acupuncturists are allowed to prescribe herbal formulations to patients, and all of us practicing the medicine wish to ensure that we are working with clean products.

The majority of Chinese herbs and herbal formulations imported into the United States come in through California ports, and are regulated, in part, by the California Department of Health Services as dietary supplement products. For the last 16 years the California Department of Health Services, under the direction of Dr. Richard Ko, has worked closely with the FDA to establish standards for evaluating herbal imports and detecting contaminated products,

Dr. Richard Ko:

Dr. Ko received his undergraduate degree in biochemistry from the University of California, Berkeley, and his Doctor of Pharmacy and Doctor of Philosophy from the University of Southern California, Los Angeles. His doctoral dissertation was on pharmacokinetic drug interactions.

As a Research Scientist (Food and Drug Scientist) at the California Department of Health Services, Food and Drug Branch, Dr. Ko was actively involved in regulating dietary supplements and investigating herbal products related to injury and death.

Dr. Ko has published numerous peer review articles, including “Adulterants in Asian Patent Medicines” (New England Journal of Medicine, Sept. 17, 1998, Vol. 339:847, Num. 12), and most recently co-authored “Safety of Green Tea Extracts: A Systematic Review by the US Pharmacopeia,” in Drug Safety, a premier international journal covering the disciplines of pharmaco-vigilance, pharmaco-epidemiology, benefit-risk assessment and risk management.

Under the direction of Dr. Richard Ko, the California Department of Health Services evaluated and identified products with contaminants as well as the factories where they were produced. He has also located factories producing safe products. The work of his office has enabled Tango to identify sources for products with standards of purity that exceed USP (United States Pharmacopeia) standards.

Product purity was foremost in our minds when we launched Tango five years ago to import advanced herbal formulas from leading Chinese doctors, hospitals and research institutes. Prior to beginning our lengthy clinical evaluation programs all potential formulas were submitted to Dr. Ko’s lab at the California Department of Health Services for initial testing for some 300 potential contaminants (drugs, heavy metals, pesticides, etc.). Additionally we submitted samples of each formula to independent testing labs for further verification before allowing the powders to be released for production. This process has guaranteed that all of our products exceeded the exacting standards for safety and purity as set by Dr. Ko and the USP, including OsteoPhase.

Dr. Ko is now a consultant to Tango Advanced Nutrition, assisting in our quality control programs and overseeing product evaluation and testing processes, most recently for ArthriPhase. Our quality control program is especially important, since China is at least 20 years ahead of the rest of the world in developing breakthrough herbal medicine formulations for every conceivable disorder. These breakthroughs are based on the following:

1. Due to its large size and variety of climates from deserts to tropical areas and mountains to seashores, the base of natural medicinal ingredients is the largest of any country.

2. Thousands of years of traditional empirical development have improved current herbal medicine formulations. Formulas are preferred for both efficacy and safety over individual herbs.

3. Over the past 50 years scientific advancement at hospitals and research institutes in every major Chinese city have focused on developing treatments for specific disorders. This research effort is currently the equivalent of three or more US Apollo programs to put a man on the moon. It is doubtful that the rest of the world combined will match this ongoing research any time this century.

Our task at Tango is to identify, evaluate and introduce such important products as OsteoPhase. OsteoPhase, in particular, is a product of modern scientific research and biotech production. Manufacture of the powder involves a skilled extraction of protein peptides from the inner lining of the oyster shell that act as directing agents for biological processes. In this case, these protein peptides regulate how calcium is used and stored in the body, including regulation and enhancement in the bone building process.

French scientists also identified these protein peptides and concluded that they would be able to reduce osteoporosis, but they were unable to come up with a commercial extraction process that would enable use as a dietary supplement.

I realize this is a long answer to your question, but I wanted to provide a summation of our efforts in making OsteoPhase available.

John Steinke, L.Ac.
VP of Product Development