Reading The Research Regarding Supplements

By Mary Cissy Majebe, OMD

Each month I receive a newspaper entitled, Family Practice News. It refers to itself as “The Leading Independent Newspaper for the Family Physician.” I look through it as a way of keeping myself up to date with Western medicine, as well as with what the Western medical press may be reporting about alternative or complementary medicine. During the week of December 1, 2008, on page 32, the headline at the top of the page read:

“Prescribed Drugs, Supplements Tied To Liver Injury”

It went on to state: "Single prescription medication was the likely cause of the liver injury in 73% of cases. Multiple prescription medications or a combination of prescription medicine and dietary supplements were the cause in 18%. Single or multiple dietary supplements were the cause in the remaining 9%.”

Needless to say, I was distressed, so I sought out the research citation: “Causes, Clinical Features, and Outcomes From a Prospective Study of Drug-Induced Liver Injury in the United States.” Gastroenterology 2008: 136: 1924-1934. After reading this article, I had a much different picture.

The article’s headline listed both pharmaceuticals and supplements. However, of the total 300 patients in this study, 270 of these liver injuries were linked to either one or multiple pharmaceuticals. Only 30 of these liver injuries were linked to a supplement, and 2 of these 30 were linked to a pharmaceutical and a supplement. In other words, 90% of the liver injuries in this study are associated with pharmaceuticals and 10% to supplement usage. Of the 10% with liver injuries due to supplement usage, 65% of these were using supplements for weight loss and muscle building.

Furthermore, 73% (217 patients) of the liver injuries were due to pharmaceuticals, while 18% (55 patients) were linked to multiple pharmaceutical and supplement usage. Of these 55 patients, 2 of them used a supplement that was also listed as a probable causative agent, including Cell Tech, which is a muscle-building agent for body builders, and a Source of Life multivitamin supplement. For 53% of the 55 patients, they were using multiple pharmaceuticals. For 9% (28 patients), they were linked to supplements. Of these 28 patients, 19 were using supplements geared towards body building or weight loss.

All of the liver injuries that resulted in death (11% or 18 patients) were attributed to pharmaceuticals. No liver injuries in these 18 patients were attributed to supplements. Eight of the patients who were in this study received a transplant. One of these was attributed to an over-the-counter weight loss supplement, CVS Spectravite.

My concern with this type of reporting is that often, I, like many other health care professionals, only read the titles and highlights. Of the total 30 patients who were taking supplements, there were also no indications whether they had been prescribed to them by a Licensed Health Care Practitioner or a Trained and Educated Health Care Practitioner.

I find the article in Family Practice News to be reflective of the bias in the media and in allopathic research, which often highlights aspects of wholistic medicine, rather than focusing on the consequences of an over-medicated society. A point of interest is that all liver injuries due to Acetamenaphin were excluded from this study. I wonder how much smaller would the percentage have been for supplements, if all Liver injuries were included in this report.

Ensuring the Safety of Chinese Herbs

By Mary Cissy Majebe, L.Ac.

Due to the arrival of toxic toys and foods from China into the United States, I would like to address the safety of Chinese herbal medicines for our patients. I will share information with you about how herb producers and manufacturers in the United States have been working to ensure the safety of Chinese herbal products.

First of all, for more than ten years, herbal manufacturers and Chinese medicine practitioners have taken steps towards ensuring a safe supply of Chinese herbal products. Aware of potential issues, Licensed Acupuncturists and herbal companies in the U.S. had already begun instituting procedures to ensure that herbal medicines were safe. This was done well before the recent crisis involving toys and foods from China, and the FDA’s new regulations for dietary ingredients, nutritional supplements and herbal medications.

Secondly, herbal companies in the U.S. carry product liability, which means they must have Certificates of Analysis for each herb product they offer for purchase. This verifies the identity of the herbs in order to prevent misidentification. This process also involves testing to assess any heavy metal toxicity or bacterial contamination.

Asia Natural is the primary company that supplies the Chinese Acupuncture Clinic with the herbs used for making teas. We have worked with this company for more than 20 years, and I have personally visited them in Berkley, California, where I was given a tour of their facilities. I left the factory reassured that the company was doing an excellent job supervising the growing of the herbs in China and following the testing guidelines for herbal products.

In June of 2007, the FDA published its final regulations. Called FDA cGMP, these standards require that each herb importer and manufacturer have documentation attesting to the identity and purity of the herbs it has imported into the U.S. from China. All raw herbs entering the U.S. must meet specifications, which include testing for active ingredients, heavy metals and bacterial contamination. These regulations are to be implemented June 25, 2009 or June 25, 2010.

Likewise, regulations have been published in China requiring cultivators to follow certain practices that minimize pesticide use and residues. In July 2001, China adopted the "Green Trade Standards of Importing and Exporting Medicinal Plants and Preparations." These standards provide for testing of organochloride pesticides, as well as heavy metals, bacteria and aflatoxin. Although pesticides of various types are used in growing some portion of Chinese herbs, detectable levels of pesticide contamination cannot be found.

In conclusion, thanks to a safety net of regulations from the U.S. and China, as well as the conscientious oversight and testing of American herbal companies, I feel comfortable trusting the herbal products available to our patients at the Chinese Acupuncture Clinic.

Understanding GMP and Quality Control of Chinese Herbs

By Ann Wolman, L.Ac., & Joshua Herr, L.Ac.

Many people are aware that China has made headlines in the last several years for allowing unsafe products to be placed in the marketplace. This has led several patients of the Chinese Acupuncture Clinic to ask about quality control of the herbs that we use.

The Chinese Acupuncture Clinic Dispensary would like to address this concern by informing you about where our Chinese Herbal Products come from and explaining about the quality control of the products we are using. As you know, we have numerous brands of pills, whole herbs, granules, tinctures and essential oils.

Our tinctures and essential oils are the two items we dispense that are not manufactured in China. A company in New Mexico produces the tinctures. Our manufacturers of essential oils are located primarily in Europe. We have concentrated on obtaining the highest quality, internal grade essential oil collection. These essential oils are extracted without the use of solvents, which creates a product that is more potent and suitable for multiple forms of use.

Our manufacturers of pills, whole herbs and granules have been internationally as well as China GMP certified. GMP stands for current Good Manufacturing Practice. This international term is recognized worldwide and is used for the control and management of manufacturing and quality control testing of foods, pharmaceuticals and medical devices. It first appeared in the U.S. as part of the 1938 Food, Drug and Cosmetic Act.

GMP certification means that the facility and methods used in the production of products has been subject to a thorough quality control investigation and is certified to be in compliance. This covers all aspects of manufacturing, including inspection of the building and grounds, the air and water purification systems, the handling and processing of raw herbs, the product manufacturing process, the operation and cleaning of equipment, the training of personnel as well as quality control testing and documentation.

By June of 2010 the manufacture of all dietary supplements in the United States will be subject to national GMP requirements.

The companies that import the herbs we use are responsible for ensuring that manufacturers are adhering to GMP standards. Testing includes moisture content and amounts of heavy metals and mold found in sample batches. An example of how Lanzhou Foci Herb factory reports to Mayway, the company that imports herbs for sale at the Chinese Acupuncture Clinic can be found on the web at www.mayway.com.

Each herbal product manufactured in China is licensed, as drugs are in the U.S., and is produced according to stringent Chinese Pharmacopoeia guidelines and government sanctioned references. This assures that the products are sourced, formulated, extracted and tested according to laboratory and clinical parameters. The high standard for quality control insures consumer safety. Additionally, the FDA monitors the safety of herbal products coming into the country. Chinese herbs are routinely held and inspected, often causing backorders and delays.

The Chinese Acupuncture Clinic Dispensary is dedicated to providing the safest and most effective herbs and herbal products available. We are updated on a regular basis by our distributors and professional organizations regarding herbal medicine safety issues and changes to FDA rules and regulations. We put our patients first when making decisions regarding our herb supply. If you have any questions regarding our products do not hesitate to call the clinic at 828-258-9016.