Chinese Medicine To Go Global

People across the globe are increasingly turning to traditional Chinese medicine. They use it as an alternative, or to complement Western medical practices. Many Chinese medical practitioners see this as a golden opportunity to modernize the image of Chinese medicine and boost its global appeal.

Practitioners offer a wide array of remedies including countless blends of plants, fungi and animals.

But eastern doctors are looking for ways of modernizing their art of healing to give it an even wider appeal outside of Asia.

Abraham Chan, President M.C.M.I.A. Ltd., said, "What we are doing now is we are making every single herb into soluble granules, just like instant coffee. Now after you have got the prescription, just go to the dispensary, and you will go home having one little sachet, where you can just tear it up, put it in hot water and dissolve it and drink it."

Doctors in Hong Kong use Chinese herbal remedies as a supplement to western medicine. But many hope that one day traditional Chinese methods will be more than that.

John Wu, director at Dr. & Herbs, said, "You cannot replace the Western medicine. But the Chinese medicine can start from the complementary then go to the alternative, then finally maybe after 100 years, Chinese medicine will be parallel with Western medicine."

Modern versions of acupuncture and acu-pressure are being introduced as well as new techniques of Chinese massage. But the transformation takes time for people to accept.

Mrs. Wu, customer at exhibition, said, "I think this modern technology is good for the doctor, but I think it is maybe not good for the patient to take it home, because they don't know about the hand, you know, the points."

Practitioners are hoping that with the correct marketing and proper guidance, patients will be turning more and more to Chinese remedies. After all, they say they are equally effective with few side-effects.

Mr. Donald deKieffer
deKieffer & Horgan
729 15th Street, N.W., Suite 800
Washington, D.C., 20005

Introduction

Mr. Chairman and members of the Subcommittee: I appreciate the opportunity to appear before you. I am Donald deKieffer, attorney at deKieffer & Horgan in Washington D.C. My firm specializes in the practice of international regulatory law. I have over thirty years of experience in trade law and policy development and have worked for more than a decade in tracking and investigating international diverters. Today I will testify regarding the diversion and global counterfeiting of pharmaceutical products. Although many of the clients I represent are pharmaceutical companies, I am neither speaking on their behalf nor on behalf of the pharmaceutical industry in general.

The objective of my testimony is to inform this committee of the existence of an active pharmaceutical diversion trade and to demonstrate how failure to control this practice opens the door for the entry of counterfeit drugs into the United States. I will first present a foundational background on the law regarding drug imports. Secondly, I will discuss the nature of the diversion problem and its influence on criminal activity, the pharmaceutical market, and governmental regulatory agencies, in particular the FDA. Thirdly, I will propose possible avenues to pursue in the development of solutions to these problems.

Overview

Drug Classifications

Controlled substances are classified into five different schedules. The schedules are distinguished from each other based on the potential for drug abuse. Schedule I identifies substances with a high potential for abuse that do not currently have an accepted medical treatment use in the United States, such as heroin and marijuana. Schedules II through V are controlled substances with legitimate medical purposes, such as Ritalin and Valium. Schedules II through V also include “lifestyle drugs.” These substances, such as Viagra, target disorders affecting the quality of life rather than specific diseases. Lifestyle drugs are commonly abused prescription substances. Additional controlled substances, such as OxyContin, which are not lifestyle drugs, are also abused.

Diversion

International diversion is the importation of products originally intended for distribution in another country. Pharmaceutical diversion involves substances classified in schedules II through V. A classic diversion scheme begins when drugs that are produced in the United States are either sold at low prices or are given philanthropically to other countries. Corruption and fraud in the countries of destination permits third parties to obtain large quantities of U.S. produced drugs at low costs. These drugs then make their way back into the U.S. market for resale at going market rates, thus generating large profits for the diverters.

Closely related to diversion is the practice of parallel importing, which is the importation of patented drugs by third parties without the authorization of the patent owner. Drugs produced by U.S. pharmaceutical companies are available for a lower cost in other countries where the foreign governments fix pharmaceutical prices. Diverters purchase these drugs abroad and redistribute them in the U.S. market, thus undercutting the U.S. market price and making a tremendous profit.

Another subcategory of diversion is smuggling. While diverted products re-enter the country under the guise of legal imports, smuggled drugs are routed into the country through illegal means. Smuggling is the preferred means of re-importing diverted drugs. These pharmaceuticals mainly come across customs borders or through the mail system with fraudulent documentation. The sheer volume of diverted drugs entering the country prevents customs officials from detecting or seizing more than a mere fraction of them.

Counterfeiting

Many foreign countries permit the cross border exchange of imitation patented drugs manufactured in countries other than the United States. Counterfeit drugs are a tremendous problem in countries with lax import regulations. Counterfeit pharmaceuticals are often purchased to replenish the dwindling drug supplies that result from diversion. These counterfeits are not subject to any form of production regulation, and once they get mixed into the system they are essentially indistinguishable from the legitimate product. While counterfeit drugs are not yet rampant in the United States, the loosening of import regulations leads to a climate that increases the potential for counterfeit distribution.

Diversion is a Trojan Horse for counterfeits. Drugs are no longer part of a regulatory infrastructure once they leave the control of the originally intended recipient and enter the channels of diversion. Many of these drugs pass through countries where there is rampant corruption and fraud in the drug industry, and counterfeits are in abundance. Because there is no way to monitor where the diverted products have been or how they have been handled, it is highly likely that counterfeits will unknowingly be mixed with diverted drugs. Counterfeit products then enter the U.S. system mixed with legitimately produced U.S. drugs.

Counterfeiting in the U.S. is already existent to a certain extent. For example, between 1991 and 1995 the FDA and U.S. Customs officials seized enough evidence to incriminate Flavine International Inc., a New Jersey based company, in a counterfeit drug scandal. Flavine bought bulk amounts of veterinary antibiotic ingredient base and other human antibiotics from an unapproved source in China for considerably less than the price of the legitimate products. Flavine then resold the material to unsuspecting U.S. drug companies at an inflated rate. The scheme posed a risk to animals and humans because the counterfeit drugs were of unknown potency and quality. Six patients in Denver suffered toxic reactions.

More recently, the FDA has been investigating cases of counterfeit injectable drugs. Instances of counterfeit Serostim, a growth hormone used by AIDS patients, Nutropin, also a growth hormone, and Neupogen, a cancer drug, have been detected in the past month. 1 FDA investigations are ongoing and it is not yet clear whether the drugs were produced in the United States or overseas. At least some of these products ended up in U.S. pharmacies and were actually distributed to customers who experienced adverse reactions. 2

Current Regulations and Laws Regarding Drug Importation

The federal government has jurisdiction to control pharmaceutical importation into the United States. The FDA, DEA and U.S. Customs are the federal agencies primarily responsible for overseeing drug import regulation.

The law effectively prohibits the importation of any drugs, including foreign made versions of U.S. approved drugs, that have not received FDA approval to demonstrate they meet the federal requirements for safety and effectiveness. 3 FDA approved drugs can only re-enter the country if they are being shipped directly back to the manufacturer. When customs officials receive a shipment that contains non-approved pharmaceuticals intended for commercial distribution they notify the local FDA district, and the FDA assumes responsibility for deciding whether or not to seize the goods. FDA personnel are also responsible for monitoring mail importation. Customs officers from the customs mail division will examine a parcel and set it aside if it appears to contain a drug that the FDA has specifically requested be held or an FDA-regulated article that appears to represent a health fraud or an unknown risk to health.

The rules governing personal importation of approved drugs from foreign countries vary slightly. Congress recently stipulated that a United States resident may import up to fifty dosage units of a controlled medication without a valid prescription at an international land border. 4 Medications must be declared on arrival, be for own personal use, and be in their original container. The FDA has the ability to exercise discretion in the enforcement of this law and may permit the entry of unapproved drugs under extenuating circumstances, such as the continued treatment by a foreign doctor. However, this policy does not apply to foreign-made chemical versions of drugs available in the U.S. The FDA cannot assure that such products have been properly manufactured and are effective. Their use would present an unreasonable risk. Additionally, the FDA reserves the right to refuse entry or seize any drug it considers unapproved and, therefore, illegal. 5

The DEA has recently contributed additional regulations designed to help control pharmaceutical imports from foreign markets. According to the DEA, consumers must have valid prescriptions to legally obtain controlled substances. Consumers cannot legally purchase controlled substances from foreign Internet sites and have them shipped to the U.S. unless the consumer is registered with DEA as a controlled substance importer and acts in compliance with DEA requirements. 6

Nature and Consequences of Pharmaceutical Diversion

Promotion of Criminal Conduct

Failure on the part of the U.S. government to control pharmaceutical diversion encourages criminal behavior both domestically and internationally. The ease with which pharmaceutical drugs are smuggled across the border makes diversion enticing as a low-risk criminal activity with high economic returns. Diverters and counterfeiters are able to exploit the American public because of increasing frustration surrounding the high cost of medications and a market that has been traditionally free from unapproved or dangerous products. The proliferation of an American gray market, therefore, invites the theft of American drug products in foreign countries, thus completing the vicious circle of criminal conduct.

The diversion trade also facilitates the abuse of prescription drugs in the U.S. An estimated four million citizens in the United States are addicted to prescription drugs. 7 Many of these products are lifestyle drugs, such as Viagra, weight control products, or tranquilizers. There is also a serious problem with the misuse of other legitimate medications. For example, the pharmacological effects of OxyContin, a central nervous system depressant designed principally as a pain medication for cancer victims, make it a substitute for heroin. 8 OxyContin overdoses have been the cause of over forty deaths on the East Coast in the last year. 9 Much of the illegal OxyContin supply comes from diverted sources. Diversion increases the ability of individuals to receive drugs through improper channels without a prescription, thus fostering the opportunity for misuse of these products.

Destruction of the Pharmaceutical Market

Diverters regularly import undetected pharmaceuticals into the United States. Since 1997, more than 4,600 foreign drug manufacturers have shipped to the United States without being inspected by the FDA. 10 Additionally, Congress has relaxed the regulations on the importation of controlled substances by allowing U.S. citizens to legally import limited amounts of price-controlled drugs from Mexico and Canada for personal consumption. 11 Slackening of import standards increases the likelihood of diverted drugs devastating the U.S. pharmaceutical market.

Diversion, in the form of parallel importing, is a violation of intellectual property rights. Included in most patents is the exclusive right to the use, including importation and exportation, of the patented good. Intellectual property rights are the financial basis of the pharmaceutical industry. The more diverted and counterfeit drugs permitted to enter the country, the less control the patent holders maintain. Taking away the intellectual property rights of the pharmaceutical industry will render patents meaningless and will create major financial set backs for the market. Pharmaceutical companies may have to freeze research and development and may not be able to financially justify pouring resources into the creation of new and improved medications.

Diverted drugs destroy the predictability of supply and demand in the pharmaceutical industry. The U.S. government does not artificially control drug prices. The U.S. pharmaceutical producers have not traditionally competed with international drug distributors, principally for regulatory reasons. The result has been that pharmaceutical companies have freedom to incidentally set prices for the products they develop. Consequently, as happens in many different markets, drug prices are disproportionate to actual production cost. However, inflated prices are necessary to offset the marketing cost of the specific product, to finance research and development of new products, and to subsidize medical assistance to struggling nations. In a regulated system such as this, the pharmaceutical industry bases production on predicted market needs. Diverters destroy the market balance when they enter unknown and unregulated surpluses of any product into the country through the channels of diversion. Companies are unable to maintain any sort of meaningful records regarding the distribution and consumption of drugs and cannot react proportionately to the market need.

Diverters exploit the price disparities between U.S and foreign pharmaceutical prices. Pharmaceutical companies provide drugs to other countries either philanthropically or at much lower prices than they are sold domestically. Diverters capitalize on this price differential by obtaining low priced drugs in other countries. They are then able to undercut the market price when re-selling drugs back in the U.S. This practice generates a surplus in the American market and prevents pharmaceutical companies from meeting their projected sales quotas. Ironically, customers are not the ones financially benefiting from diverted drug sales. Diverted drug products often barely undercut the normal retail prices. However, because diverters obtain the drugs at a fraction of U.S. resale prices, the diverters assume a tremendous profit while the customers reap only a fractional benefit.

The entrance of diverted drugs and counterfeit products into the market creates a financial liability for the pharmaceutical industry. Prescription drugs carry a strict liability for the producers. Strict liability means that drug companies are completely accountable for their products and must bear the cost of lawsuits and fines, regardless of any question of negligence. Counterfeit drugs may easily be mixed with diverted products. Counterfeit drugs are dangerous because they are entirely foreign substances masquerading as the genuine product, and they may not even consist of the same ingredients that they profess to contain. There is a high likelihood that customers who unsuspectingly ingest these products may be adversely affected. It is difficult, even for a professional, to distinguish between counterfeited and legitimate drugs. Since these counterfeit products are difficult to distinguish, companies may find themselves liable for situations that were not of their own causing. The potential financial hit that the pharmaceutical industry will bear, as a result of liability, will adversely affect the financial stability of U.S. drug companies.

Diversion also affects world pharmaceutical markets and finances criminal conspiracies. Many countries, such as South Africa, Israel, Russia and the Philippines have open borders with respect to the importation and exportation of pharmaceutical products. Open border countries have lost strict regulatory control of their drug markets. For example, in South Africa over fifty percent of the medication supplied to the government ends up stolen. Open border countries have also experienced a corresponding surge in counterfeit medicine entering under the guise of parallel imports. Frequently, the counterfeits enter the country as a means of replenishing the drug supply depleted due to the diversion of the legitimate drugs to more lucrative markets in Europe and America. Consequently, the medicines intended for a particular population are not getting to the people that need them; in their place, false and dangerous counterfeits are being provided, and criminals reap the financial benefit.

Undermining the FDA

The American public is currently frustrated with high priced pharmaceuticals. There is an outcry for access to pharmaceutical products that are cheap, readily available, efficacious, and safe. However, permitting diversion and parallel imports is not a viable solution. Safe and efficacious products come at a cost. The entrance of diverted and counterfeit drugs into the U.S. will destroy drug control regimes currently in place and the FDA will lose its ability to monitor and control drug production and distribution in this country.

Increased diversion traffic through inefficient monitoring at the border will prevent the FDA from controlling drug entry and distribution. Unchecked pharmaceuticals currently enter the country through the mail system and across the Mexican border. Due to the sheer volume, this influx of drugs basically goes unmonitored by federal regulatory groups such as the FDA. As a result, drugs in this country are being distributed and sold without proper authorization. This diminishes the ability of the FDA to control the distribution of drugs. Citizens are able to access “lifestyle” drugs and potentially addictive substances without prescriptions or the direction of a physician. Consequently, the FDA is losing its ability to manage prescription drug use.

Counterfeit drugs present a danger to citizens because the FDA is unable to monitor the products for quality and safety. Counterfeit drugs, principally produced in countries such as India, are imitations of U.S. made products. However, it is impossible to know for certain what these medications contain, how they were produced, where they were stored, or the potential side effects of ingestion. By allowing the diversion trade to persist, the likelihood of distribution of these potentially lethal medications increases, and the FDA loses the ability to regulate the quality and safety of products being distributed to the unsuspecting U.S. public.

Diverted drugs that leave the control of the original distributor place consumers in jeopardy because the means of shipment and storage are unregulated. Diverted drugs enter and exit the hands of multiple unknown parties before they eventually reach a consumer. These drugs are commonly stolen in bulk from government agencies in foreign countries and are routed through countries such as Mexico before they reach consumers in the United States. Most drug products have specific instructions regarding storage temperature and expiration date. With diverted drugs, there is no guarantee that the products were properly handled during shipping and storage. The FDA has always exerted strict controls on the production and distribution of drugs in the United States. Consumers have learned to expect pharmacies and drug distributors to provide safe medications. Allowing diverted drugs into the country will destroy the FDA’s ability to guarantee safety and will increase the danger to consumers who may unknowingly purchase and ingest these products.

Counterfeit drugs that enter under the guise of parallel imports likely come from unapproved locations. Both counterfeit drugs and diverted drugs are huge risks to the citizens of this country. The FDA has traditionally been able to approve the production location of drugs and foreign products. When drugs are smuggled into the country, there is no way of knowing where they have traveled. Additionally, counterfeit drugs entering the country through diversion may have been produced anywhere. The FDA is, therefore, losing its ability to control and monitor the production sites for pharmaceuticals being imported into this country.

Diverted drugs may contain incorrect informational material and directions or may be mislabeled entirely. Medications are, of course, dangerous when misused and req uire specific instructions as per their usage. Divergence from these requirements may prove extremely harmful and potentially lethal. Diverted goods are often taken from their original packaging and distributed to many different importers. The potential is high that drugs may be mislabeled or put into packages that lack the appropriate informational material. As the diversion trade increases, the FDA will in turn lose control over the packaging and instructions accompanying large quantities of drugs in this country.

Additionally, the diversion trade destroys systems of record keeping for the U.S. drug industry. With products being illegally mailed into the country and smuggled across the borders, it is impossible for the FDA or the drug industry to keep track of what is currently on the market. This makes it easier for people to obtain drugs illegally and promotes the abuse of prescription products.

Potential Solutions

There needs to be better cooperation between the government agencies in charge of enforcing laws relating to diversion and counterfeit trade. According to a report issued by the U.S. General Accounting Office, the efforts of the FDA, DOJ, DEA and Customs do not always support each other. 12 For example, sometimes the FDA releases packages of drugs detained by Customs in an effort to conserve resources. These kinds of actions are counterproductive, undermine the law, and send mixed signals to the individuals involved. 13 Laws have been put in place to control diversion; however, it needs to be clear who is in charge of enforcement. Efficacious systems of detection and seizure as well as substantial penalties for abusers must be implemented and enforced.

Foreign Internet pharmacies dealing in illegal imports need to be eliminated. An abundance of Internet pharmacies situated in foreign countries advertise prescription drugs. These sites do not require individuals to have a prescription from their doctor in order to obtain drugs. Although DEA regulations and the Controlled Substances Act allow individuals to bring limited quantities of controlled substances into the U.S for personal use, these regulations do not apply to shipments into the U.S. from foreign Internet pharmacies. It is illegal to purchase drugs from such sites. These pharmacies are aware that they are engaging in illegal activity. Many sites explicitly justify their practice and include instructions on how to avoid having the packages seized by U.S. Customs. This problem needs to be attacked at the source. There must be a crack down on foreign Internet pharmacies dealing in illegal importation.

The government should look for solutions to help support/subsidize providing affordable prescription drugs for the elderly and others who are unable to afford necessary medications. The diversion trade seems to be supported in part by frustrated Americans seeking cheaper drugs. It is contended that many of these individuals are seniors who are on tight budgets and cannot afford the medications they require. The government should consider providing a means-tested subsidization for U.S. citizens unable to afford the medications they require. Providing medication to those who are feeding the diversion market will reduce the demand for smuggled drugs.

Penalties for prescription drug abuse must be increased. It is currently very difficult to detect prescription drug abuse, and many people fail to even recognize it as a crime. Harsher penalties may decrease the demand for diverted pharmaceuticals and naturally cause that market need to decrease.

Finally, there needs to be cooperation between government agencies and the pharmaceutical industry in creating better systems for overseeing philanthropic drug distribution in other countries. Much of the aid that is sent to struggling countries is well intended. However, it has been proven time and time again that these countries lack the infrastructure and integrity to properly distribute the products to the intended recipients. It is counterproductive to provide mass quantities of free or low-priced medication to countries that cannot properly handle or distribute it. Until a more reasonable infrastructure can be put in place, bulk deliveries of U.S. pharmaceuticals to underprivileged countries should be severely restricted.

There likewise needs to be a better system of tracking drugs destined for distressed markets where there is a possibility of corruption or diversion. There are FDA approved means of marking both drugs and packaging that would allow customs officials to quickly and efficiently monitor what crosses the border. Such a system would help catch diverted products before they entered the market.

Conclusion

In summary, drug diversion is a crime. Its occurrence is increasing. By permitting this practice to continue, the government will open the way for counterfeit drugs to enter the U.S., foster criminal conduct both internationally and domestically, harm the pharmaceutical market, and undermine the regulatory structure of the FDA. Measures should be taken to recognize and address these issues.

http://home.caregroup.org/clinical/altmed/interactions/Herb_Groups/Adulteration_an.htm

Please note the particular manufacturer of a contaminated product. Other factories may use the same or similar English name for a contaminated product listed below, when in fact they may be pure.

• An Gong Jiang Ya Wan, Beijing Tung Jen Tang, Beijing. Application: High blood pressure. Contaminants: Arsenic 192 ppm.

• An Kung Niu Huang Wan, Beijing Tung Jen Tang, Beijing. Application: High fever. Contaminants: Lead 184 ppm, Arsenic 46,400 ppm, Mercury 1450 ppm
Comment: An extremely toxic level of arsenic.

• Ansenpunaw, Chung Lien Drug Works, Hangzhou. Application: Insomnia, palpitation. Contaminants: Arsenic 60 ppm, Mercury 3590 ppm. Comment: A very toxic level of mercury.

• Chin Koo Tieh Shang Wan, Tianjin Lerentang Pharmaceutical Factory, Tianjin. Application: Trauma. Contaminants: Lead 11 ppm, Arsenic 35 ppm. Comment: These are low levels of contamination, but they may cause a problem if taken over a period of time. Plum Flower offers a non-contaminated version.

• Ching Chun Bao: Recovery Of Youth Tablets, Hangzhou Chinese Medicine Factory. Application: Geriatric tonic. Contaminants: Arsenic 20 ppm. Comment: This is a low level of contamination. As a tonic, however, long term usage can cause an accumulative affect.

• Compound Prescribed Water Melon Frost, Guilin Chinese Medicines Pharmaceutical Factory, Guilin. Application: Sore throat. Contaminants: Arsenic 1360 ppm, Mercury 1230 ppm. Comment: Arsenic and mercury levels are high. Please note that the following versions are uncontaminated: Compound Watermelon Frost, Guilin Chinese Medicine Factory; Water Melon Frost, Fei Shan United Manufactory.

• Ding Xin Wan, Min-Kang Drug Manufactory, Yichang. Application: Insomnia, palpitation. Contaminants: Lead 77 ppm, Mercury 1750 ppm. Comment: This is a high level of mercury.

• Du Huo Jisheng Wan, Min-Kang Drug Manufactory,Yichang. Application: Lower back pain. Contaminants: acetominophen* Comment: Plum Flower offers the same product in a non-contaminated version.

• Fargelin For Piles, United Pharmaceutical Manufactury, Guangzhou. Application: Hemorrhoids. Contaminants: Arsenic 20,200 ppm. Comment: This is a very toxic level of arsenic. It should not be confused with High Strength Fargelin For Piles, United Pharmaceutical Manufactury; Guangzhou.

• Gan Mao Qing Capsules, Bai Yun Pharmaceutical Factory, Guangzhou. Application: Common cold or flu. Contaminants: Acetaminophen, chlorpheniramine*. Comment: There are many similar formulas without western pharmaceuticals.

• Ganmao Pien, Tianjin Drug Manufactory, Tianjin. Application: Common cold or flu. Contaminants: Lead 241 ppm. Comment: This is a moderately toxic level of lead. Also, there are many similar formulas without heavy metals.

• Guanxin Suhe Jiaonang, Jing Xi Tang Pharmacy, Guangzhou. Application: Coronary heart disease, angina. Contaminants: Arsenic 74 ppm. Comment: This is a moderately toxic level of arsenic.

• Hong She Pills, Chung Lien Drug Works, Wuchang (Hubei). Application: Bi syndrome, arthritis, rhuematism. Contaminants: Mercury 181 ppm, strychnine, ephedrine. Comment: This has a moderate level of mercury. Strychnine is found in the Chinese herb Strychnos Ma Qian Zi, and ephedrine is found in Ephedra (Ma Huang).

• Huang Lien Shang Ching Pien, Tientsin Drug Manufactory, Tianjin.
Application: Bacteriaol infections of the throat, gums or eyes.
Contaminants: Pugelone, phenacetin*. Comment: Plum Flower offers the same product in a non-contaminated version.

• Hui Chun Dan, Kwong Tong Fushan Pharmaceutical Manufactory, Fushan. Application: Pediatric fever. Contaminants: Lead 56 ppm, Arsenic 32 ppm, Mercury 50 ppm. Comment: Not commonly available.

• Kai Yeung Pill: Trisnake Itch-Removing Pill, Wuzhou People's Pharmacy, Guangxi. Application: Skin itching. Contaminants: Lead 5 ppm, Arsenic 51 ppm. Comment: Safer versions are available from Hanyang Pharmaceutical Works; Hubei, and from Plum Flower.

• Kang Gu Zeng Sheng Pian, United Pharmaceutical Manufactory, Foshan. Application: Vertebral calcification. Contaminants: Arsenic 21 ppm, Mercury 35 ppm. Comment: These are low but significant levels of contamination.

• Lu-Shen-Wan, Shanghai Chinese Medicine Works, Shanghai. Application: Sore throat. Contaminants: Lead 40 ppm, Arsenic 82,000 ppm, Mercury 3850 ppm, resibufogenin. Comment: Very toxic level of arsenic and mercury.

• Nan Bao, Tianjin Li Sheng Pharmacy, Tianjin. Application: Male impotence or poor sexual function. Contaminants: Lead 68 ppm. Comment: This is a moderate level of lead contamination.

• Niu Huang Chieh Tu Pien-Bezoar Antipyretic Pills, Peking Tung Jen Tang. Application: High fever. Contaminants: Arsenic 59 ppm. Comment: Taiwan also found this product contaminated with mercury, as well as a product by the same name manufacturered by Tientsin Drug Manufactory, Tianjin.

• Niu Huang Ching Hsin Wan, Tientsin Drug Manufactory, Tianjin. Application: High fever. Contaminants: Arsenic 4520 ppm, Mercury 2080 ppm. Comment: These are very toxic levels of arsenic and mercury.

• Pe Min Kan Wan, United Pharmaceutical Manufactory, Fushan. Application: Sinus congestion. Contaminants: Chlorpheniramine*. Comment: There are many clean versions of this product by other manufacturers, including Fo Shan Herbal and Yu Lam Medicine Factory. Plum Flower also offers it in a non-contaminated version.

• Ren Shen Zai Zao Wan, Kwong Tong Fushan Pharmaceutical Manufactory, Foshan. Application: Wei syndromes, post-stroke, trembling of limbs. Contaminants: Mercury 827 ppm. Comment: This is a toxic level of mercury.

• San She Dan Chuan Bei Powder, United Pharmaceutical Manufactory, Guangzhou. Application: Cough. Contaminants: Arsenic 148 ppm. Comment: This is a significant level of arsenic contamination. Do not confuse it with the glass vial liquid, San She Dan Chuan Bei Ye.

• Shu Kan Wan: Hepatico-Tonic Pills, Lanchow Chinese Medicine Works, Lanzhou. Application: Liver-stomach dysharmony. Contaminants: Arsenic 49 ppm. Comment: Plum Flower offers the same product in a non-contaminated version.

• Tao Chih Pien (For Babies), Tientsin Drug Manufactory, Tianjin. Application: Pediatric fever. Contaminants: Arsenic 26 ppm.

• Ta Huo Lo Tan, Beijing Tung Jen Tang; Beijing. Application: Bi and Wei syndromes, arthritis. Contaminants: Arsenic 30,900 ppm. Comment: This is an very toxic level of arsenic.

• Tian Wang Bu Xin Wan, Min-Kang Drug Manufactory, Yichang. Application: Insomnia, Shen disturbance. Contaminants: Lead 5 ppm, Mercury 1580 ppm Comment: This is a high level of mercury contamination. Plum Flower offers the same product in a non-contaminated version.

• Tien Wang Pu Hsin Tan, Lanchow Chinese Medicine Works, Lanzhou. Application: Insomnia, Shen disturbance. Contaminants: Mercury 2290 ppm. Comment: A high level of mercury contamination. This is a confusing entry, because an identical looking package, Tien Wang Pu Hsin Tan, Lanzhou Foci Pharmaceutical Factory; Lanzhou, had no contaminants. This product (above) may in fact be a countefeit. Plum Flower offers the same product in a non-contaminated version.

• Tin Tzat To Chung Pills, Shan Sai Hang Lam Medicinal Manufactory. Application: Bi syndrome, arthritis and rheumatism. Contaminants: Lead 62 ppm. Comment: This is a moderate level of lead contamination.

• Tsai Tsao Wan, Tientsin Drug Manufactory, Tianjin. Application: Wei syndromes, flaccid paralysis, trembling of limbs. Contaminants: Mercury 204 ppm.

• Tung Shueh Pills (Cow's Head Brand), Ta Ang Pharm Co; Kaohsiang, Taiwan. Application: Bi syndrome, arthritis and rheumatism. Contaminants: Diazapam, chlorzoxanone, caffeine, chlormezanone*.

• Yen Shun Zai Zao Wan, Fushan United Med. Fact. Guangzhou Application: Wei syndromes, post-stroke, trembling of limbs. Contaminants: Lead 51 ppm, Mercury 1500 ppm. Comment: These are high levels of lead and mercury contamination.

• Zhong Gan Ling, Meizhou City Pharmaceutical; Guangdong Application: Viral cold or flu. Contaminants: Mercury 22 ppm; chlorpheniramine, dipyrone*. Comment: This formula is available in a non-contaminated version by Golden Flower.

In addition to the material published in The Compendium, the American-based Chinese herbal product manufacturer and distributor, Mayway USA sent patent medicines out for laboratory analysis, and reports the following contaminants. Parts per million (ppm) of heavy metals, or amounts of other additives, were not reported. The information however, is important to practitioners and again, caution is advised in using the following medicines.

• Bi Tong Pian, Guangzhou Medicine and Health. Application: Sinus congestion. Contaminants: Chlorpheniramine*

• Bi Yan Pian, Chung Lien Pharmaceutical Works. Application: Sinus congestion. Contaminants: Acetaminophen*. Comment: Plum Flower offers the same product in a non-contaminated version.

• Farfunpeiminkam Wan, Foshan United Pharmaceutical Co., Foshan. Application: Sinus congestion. Contaminants: Chlorpheniramine*.

• Gan Mao Ling, United Pharmaceutical, Guangzhou. Application: Cold, flu, respiratory viral infection. Contaminants: Acetaminophen, caffeine*. Comment: Plum Flower offers the same product in a non-contaminated version.

• High Strength Yin Chiao, United Pharmaceutical, Guangzhou. Application: Cold, flu, respiratory viral infection. Contaminants: Acetaminophen, pulegone*.

• Margarite Acne Pills, Foshan United Pharmaceutical Manufactory. Application: Asthma. Contaminants: Sophoridane*. Comment: Plum Flower offers the same product in a non-contaminated version.

• Niu Huang Chiang Ya Wan, Tianjin Pharmaceutical Manufactory. Application: High blood pressure. Contaminants: Mercury, Lead.

• Niu Huang Chiang Ya Wan, Peking Tung Jen Tang, Beijing. Application: High blood pressure. Contaminants: Mercury, Lead.

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