FDA WARNINGS ON CHINESE PATENT MEDICINESExcerpt from Harvard Law School LEDA article ATTACHMENT A - 08/11/99, ATTACHMENT B - 6/6/00 PROBLEM : New drug without an approved new drug application (DRND) and labeling lacks adequate directions for intended use (DRDW). COUNTRY : HONG KONG (HK, 435) TAIWAN (TW, 281) PEOPLES' REPUBLIC OF CHINA (CN, 280) MANUFACTURER/ SHIPPER : MULTIPLE MANUFACTURER SHIPPER I.D.# : N/A IMPORTER'S I.D.# : N/A CHARGE : When accompanied by drug claims, charge: "The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes (misbranded; 502(f)(1) and it appears to be a new dug without an effective new drug application [unapproved new drug; 505(a)]". When unaccompanied by drug claims, charge: "The article is subject to refusal of admission pursuant to 801(a)(3) in that it appears the labeling fails to bear adequate directions for use for its intended purposes [misbranded; 502(f)(1)]". RECOMMENDING OFFICE : LOS-DO REASON FOR ALERT : Chinese herbal medications have a history, dating back to 1974, of containing strong prescription drugs. In 1974, four cases of agranulocytosis, resulting in the death of one person and extensive hospitalization of three others, were linked to use of these preparations. FDA analysis of pills involved in the illnesses found phenylbutazone and aminopyrine, and analyses of other "herbal medications" found methyl testosterone, prednisolone, diazepam, chlorzoxazone, and acetaminophen. In 1980, several illnesses and another death were linked to use of Chinese herbal medications, particularly chuifong toukuwan. Analysis of chuifong toukuwan from various sources found indomethacin, hydrochlorothiazide, chlordiazepoxide, lead, and cadmium. In 1983, an additional brand of the chuifong toukuwan variety labeled only in Chinese (translated as product number 13 of attachment A below) appeared in the Portland, Oregon area. Trademark is a pair of concentric units surrounding a drag on intertwined about the numeral "7" (Seven Dragon Brand). The pills come 60 to a bag in a white plastic bag with a zip-lock closure. FDA analysis has found phenylbutazone at 10 to 18 milligrams per pill in the product. In 1988, the Food and Drug Branch of the California State Department of Health Services issued a press release announcing an enforcement initiative against dangerous Chinese and other Asian ethnic medicines. Attachment B lists the products involved, the reputed manufacturer, and the hazardous ingredients contained. Currently, herbal pills are being marketed containing a combination of four drugs: diazepam, indomethacin, hydrochlorothiazide, and mefanamic acid. These pills are marketed under a variety of names and in a variety of packagings. They are spherically shaped, approximately 3/8" in diameter, and have a shiny black exterior. When the pills are cracked open, white crystalline material is observed to be imbedded in the brown interior.None of the products list the drug substances as ingredients. Investigation has shown that the pills originate from several sources, and usually enter the country via air mail shipments to health food stores, oriental food stores, novelty shops, and individual consumers. They are occasionally sold door-to- door. These products are listed in attachment A. INSTRUCTIONS : Please inform your local U.S. Customs and Postal Service officials of our interest in these types of products, especially mail entries. FOI : No purging is required. KEYWORDS : Product - Herbal Medicines Chinese Herbal Medicines Toxic Black Pearl Problem - New Drugs DRD Toxic ATTACHMENT A TO IA #66-10 REVISED 08/11/99 ATTACHMENT A: Products found by FDA to contain undeclared drug substances: Product Manufacturer 1. "Long Life Brand Ginseng Nan Lien Pharmaceutical Co., Ltd. Hui sheng Tsaitsaown" Chaiwan, Hong Kong ATTACHMENT A TO IA #66-10 REVISED 08/11/99 PAGE 2 ATTACHMENT A: Products found by FDA to contain undeclared drug substances: Product Manufacturer 16. "China Mong Num" The Peoples Pharmaceutical Factory Jilin, China, PROC 17. Jin Bu Huan Anodyne Tablets Bose Drug Manufactory Kwangsi, China MID# CNBOSDRUKWA 18. Chong Ro Whan Herbal Dong Sung Pharmaceutical Anti-Diarrheal 128 Nong Sung Ri Ki Hung Eup Yong In Kun Kyungki Do Korea MID #KRDONSUN128KIH NOTE: Examination of a sample by FDA Cincinnati District laboratory revealed the presence of Tetrahydropalmatine. This ingredient is not identified in the ingredient statement on the product label. Medical claims listed for uses of the product include in part: " anodyne, sedative, spasm.....insomnia due to pain.....gastric and duodenal ulcer pains, stomach neuralgia, pain in shrunken womb after child birth. Nervous insomnia, spasmodic cough....." 19. Tsang Fook Kee Medicine Co. "Chinese Love Stone" 5 Ko Shing St. "Rock Hard" Hong Kong "Black Stone" MID# HKTSAFOO5UNK "Stud 100" Prod Code: 66[][][][][] 20. Shanghai College of Chinese Medicine Uterine Fibrosis No. 2 Dawn (Shuquang) Hospital Tablets Shanghai, China Ingredients: = Unknown MID #CNSHACOLSHA herbal ingredients ATTACHMENT A TO IA #66-10 REVISED 08/11/99 PAGE 3 21. *Guangzhou Chen Li Ji Pharmaceutical Da Huo Luo Wan Factory 12/5/95 Guangzhou, China FEI# 1000450618 Claims: "...indicated for arthralgia and limited mobility due to rheumatism...paralysis of limbs as a sequeliea [sic] of apoplexy..." 22. *Peking Tung Jen Tang Tsai Tsao Wan Peking, China 12/5/95 FEI# 12697 MID# CNPEKTUNPEK Claims: "...facial paralysis, dysphasia, apoplexy..." 23. *The United Pharmaceutical Manufactory "Chu Kiang" brand Fushan, China Yan Shen Jai Jao Wan FEI# 1000450620 12/5/95 Claims: "For hemiplegia caused by apoplexy...palsy...dysphasia..." *Product codes for the above may include the following: 31K99, 31P99, 54E99, 54F08, 54F99, 54Y99, 66V99. 24. Mei Kang Tang Sleeping Buddha Shanghai, China Happy Buddha FEI #3001374920 Chinese Influ-X 3/6/98 DISTRIBUTOR Treasure Box 4025 E. 2nd Avenue Burnaby, British Columbia, Canada V5C3X1 FEI #3001022004 NOTE: Examination of a sample of Sleeping Buddha, 90 mg capsules by Seattle district found 1.24 mg of undeclared Estazolam. Estalozam is in the prescription drug class of benzodiazepines and is a C-IV schedule drug. If consumed during pregnancy the drug can cause serious adverse effects on the developing fetus, including congenital malformations and depression of the central nervous system. ATTACHMENT A TO IA #66-10 REVISED 08/11/99 PAGE 4 25. United Pharmaceutical Manufactory Pe Min Kan Wan 255 Dong Feng Road W. Tablets (Herbal) Guangzhow 54F--- Peoples Republic of China 8/11/99 FEI# 1000284059 NOTE: FDA examination of two samples of this product revealed the presence of undeclared Chlorpheniramine Maleate. Products were labeled in both Chinese and English, and were labeled and represented as Herbal Products. Revised 6/6/00 Attachment B: Products identified by California Department of Health Services: I. DRUGS THAT CONTAIN TOXIC INGREDIENTS 1. Product name: Butarzol Manufacturer: New York Chemical, Bangkok, Thailand Toxic ingredients: 1,2-Diphenyl 1-3,5-dioxo-4-n-butylpyrazolidine; diazepam Adverse reaction: Death, agranulocytosis, convulsions, seizures, mental confusion. 2. Product name: Chuifong Toukuwan Manufacturer: Nan-Lien Pharmaceutical Co. Hong Kong Shou Sing Pharmaceutical Co., Taiwan and others Toxic Ingredients: Phenylbutazone, aminopyrine, indomethacin, hydrochlorothiazide, chlordiazepoxide, methyltestosterone, prednisone, diazepam, chlorozoxozone, acetaminophen, lead, cadmium. Adverse reactions: Death, agranulocytosis, coma, sedation, increased male sex characteristics. 3. Product name: Cinnabar Sedative Pills Manufacturer: Lanchow Chinese Medicine Works, Lanchow, China Toxic ingredients: Cinnabaris (mercury) Adverse reactions: Death, Kidney disease, liver disease, diarrhea. 4. Product name: Comycin powder or syrup for children Manufacturer: Thai Charoen Bhaeaaj, Thailand Toxic ingredients: Chloramphenicol Adverse reactions: Agranulocytosis, aplastic anemia, cardiovascu1ar collapse, hepatitis, vomiting, diarrhea. 5. Product name: Koong Yick Hung Far Oil aka Red Flower Oil Manufacturer: Koong Yick & Co. Ltd., Singapore Toxic ingredients: 70% Methyl salicylate, Methyl phthalate Adverse reactions: Death, coma convulsions, vomiting, headache. 6. Product name: Niu Huang Chieh Tu Pien Manufacturer: Peking Tung Jen Tang, Peking, China Toxic ingredients: Borneo Camphor Adverse reactions: Death, convulsions, tremors, nausea, vomiting, headache 7. Product name: Niu Huang Xiao Yan Wan aka Bezoar Antiphlogistic Pills Manufacturer: Suzhou Lei Yung Shang, Chinese Medicine Works, Jiangau, China Toxic ingredients: Realqar 19.23% (Arsenic Disulfide) Adverse reactions: Exfoliation and pigmentation of skin, altered formation, degeneration of liver an d kidneys. 8. Product name : Noxa Capsules Manufacturer : Krungdheb Pharmacy Ltd. Part., Bukkalo, Dhonburi Toxic ingredients: Phenylbutazone, chlordiazepoxide Adverse reactions: Death, agranulocytosis, convulsions, seizures, mental confusion, tiredness, weakness. 9. Product name: Po Ying Tan Baby Protector Manufacturer: Po Che Tong Poon Mo Um Co., Hong Kong Toxic ingredients: 20% camphor Adverse reactions: Death, convulsions, tremors, nausea, vomiting, headache. 10. Product Name: Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules Tongyi Tang Diabetes Pearl Hypoglycemic Capsules Diabetes Hypoglucose Capsules Pearl Hypoglycemic Capsules Zhen Qi Capsules Raw Materials: Zhenqi (Zhen Qi) Powder Shentong Powder Shippers: Harbin Dong Fang International Trading Corp. No. 68 Dong Feng St. Dist. Harbin Aphin, China FEI# 3002158294 China Hua Yang Technology & Trade Corp. No. 13, South Xin Hua St, He Ping Men Beijing, 10052, China FEI# 1000280039 Toxic Ingredient: Glyburide and Phenformin Adverse reaction: Fatigue, excessive hunger, profuse sweating, numbness of extremities 11. Product name : Tse Koo Choy Manufacturer : WangHing Co., Ltd., Hong Kong Toxic ingredients: Mercurous chloride, santonin Adverse reactions: Mental and sensory disturbances, mental deterioration, pink to red coloring of extremities, tremor, nausea, vomiting, diarrhea, headache. 12. Product name : Wong Lop Kong Oil Manufacturer : Wong Lap Kwong Medicine Co. Ltd., Hong Kong Toxic ingredients: 20% camphor Adverse reacitons: Death, convulsions, tremors, nausea, vomiting, headache. 13. Product Name : Zhong Gan Ling Manufacturer : Meizhou City Pharmaceutical Manufactory Guangdong, China FEI# 3000148401 Toxic Chemicals : Aminopyrine Dipyrone Chlorpheniramine Adverse Reactions: Blood dyscrasia Agranulocytosis Product codes for the above may include the following: 31K99, 31P99, 54E99, 54F08, 54F99, 54Y99, 66V99. 14. Product Name: Dianolyn Capsules Dimelstat Capsules Raw Materials: Dianolyn Powder (bulk) Shippers: HeilongJiang Provincial Hechang Import & Export Ltd. Co. Ltd. Harbin, China FEI# 3002799803 Manufacturer: Harbin Zhongshan Diabetes Research Institute Harbin, China FEI# 3003028087 Toxic Ingredient: Glyburide Adverse reaction: Fatigue, excessive hunger, profuse sweating, numbness of extremities II. DRUGS THAT CONTAIN SPECIALLY REGULATED INGREDIENTS 1. Product name: Madame Pearl's Cough Syrup Manufacturer: The Luxembourg Medicine Co. Ltd. Hong Kong *This drug contains an ingredient, codeine, specially regulated because of its abuse potential. 2. Product name: Leung Pui Kee Cough Pills Manufacturer: Leung Pui Kee Medical Factory, Hong Kong *This drug contains Dover's Powder-ipecac and opium powder, specially regulated because of its abuse potential. 3. Product name: Fructus Persica Compound Pills Manufacturer: Lanzhou Fo Ci Pharmaceutical Factory, Lanzhou, China *This drug contains an ingredient, Cannabis indica seed, specially regulated because of its abuse potential. III DRUGS THAT MAKE UNPROVEN TREATMENT CLAIMS FOR SERIOUS MEDICAL CONDITIONS. DRUGS WHICH MAKE THESE CLAIMS MAY NOT BE SOLD WITHOUT A DOCTOR'S PRESCRIPTION. 1. Product name: Chih Pai Pa Wei Wan Manufacturer: Lanchow Chinese Medicine Works, Lanchow, China 2. Product name: Chinese Chufeng Toukwwan Manufacturer: China National Chemical Import and Export Branch. Kwangtung Branch 3. Product name: Dendrobium Moniliforme Night Sight Pills Manufacturer: Tientsin Drug Manufactory, Tientsin, China 4. Product name: Dendrobium Moniliforme Night Sight Pills (Superior) Manufacturer: Tsinan People's Medicine Works, Tsinan, China 5. Product name: Grippe Tea and Pills Manufacturer: None identified. 6. Product name: Hui Chun Tan Manufacturer: United Pharmaceutical Manufactory, Kwang Chow, China 7. Product name: Huku Wan "Tiger Bone Pills" Manufacturer: Fu Sung Pharmaceutic Works, China 8. Product name: Jiguacao Wan Manufacturer: Yulin Drug Manufactory, Kwangsi, China 9. Product name: Lidan Tablets Manufacturer: Tsingtao Pharmaceutical Works, Tsingtao, China 10. Product name: Lidan Paishi Tablets Manufacturer: Qingdao Medicine Works, Qingdao, China 11. Product name: Lingzhi Co. Tablets Manufacturer: China National Chemicals I/E Corp., Kwang Chow Branch 12. Product name: Lychee Brand Chang Chow Pien Tze Huang Manufacturer: Changchow Pharmaceutical Factory, Fukien 13. Product name: Lycium-Rehmannia Pills Manufacturer: Lanzhou Fo Ci Pharmaceutical Factory, Lanzhou, China 14. Product name: Moschus fel Ursi Chufeng Toukuwan Manufacturer: China National Medicine and Health Products 1/E Corp., Guangxi Wu Chow Branch, China 15. Product name: Musk Fu Quat Chui Fong Pills Manufacturer: None indicated, Kwang Chow, China 16. Product name: Niu Huang Chang Ya Wan Manufacturer: Tianjin Drug Manufactory, Tianjin, China 17. Product name: Shu Kan Wan (Hepatico-Tonic Pills) Manufacturer: Lanchow Chinese Medicine Works, Qingdao Medicine Works, China 18. Product name: Sit Wo Tong "Ng Po Powder" Manufacturer: Sungib Industrial Center, Hong Kong 19. Product name: Specific Juk Tsyn Wan Manufacturer: Kwangchow United Manufactory of Chinese Medicine 20. Product name: Superior Fu Fang Jin Qian Chao Pill Manufacturer: China National Medicine and Health Products I/E Corp. Guangxi Branch, China 21. Product name: Superior Sore Throat Powder Spray Manufacturer: Fitshan Hang Chun Medicine Factory, Fitshan, China 22. Product name: Tong Shap Yee's Asthma Pills Manufacturer: Tong Shap Yee Medicine Company Ltd., Hong Kong 23. Product name: Wei Te Ling Manufacturer: Tsingtao Medicine Works, Tsingtao, China 24. Product name: Yang Hsin Ning Shen Wan Manufacturer: United Pharmaceutical Manufactory, Kwangchow, China 25. Product name: Yu Gong Hui Li Wan Manufacturer: China National Native Produce & Animal By-Products I/E Corp., China 26. Product name: Yunnan Produce Tienchi Pill Raw Manufacturer: Kunming Native Drug Factory, Yunnan, China ATTACHMENT C The following substances are being promoted in the United States through the mail by the Best Associates Co., Ltd., 11558 South St. #43, Cerritos CA 90701 as chinese medicines. Manufacturer/Shipper of the products is unknown. Ingredients are listed where known: QUIANLONG EMPEROR SPERM ESSENCE DRUG CLAIMS INGREDIENTS Recovery and maintenance Changbai Mountain of male sexual capability and Ginseng, Cornv, increase sexual desire. Cervipantotrichum, Penis Otarine, Penis Carvi, Herba Epimedii, and Gecko, etc. TA HUO LO TAN DRUG CLAIMS INGREDIENTS Improves vein and arteries Radix Silens, Radix relieving lower back pain, Ginseng, Honey, Radix shoulder ache, back pains, Angelicae, Sinesis, high blood pressure, etc., Rhizoma Coptidis and and is beneficial to blood Rhizoma Gastrodiae, etc. circulation, detoxification, and recovering from fatigue. CHEN LUNG HERBAL PILLS DRUG CLAIMS INGREDIENTS Effective in improving Radix ginseng, Cortex energy to the body. Cinnamomi, Radix Rehmannies, Rhizoma Gastrodiae, Ophiopogon and Herba Epimedii, etc. PIEN TZE HUANG DRUG CLAIMS INGREDIENTS Treatment for acute and Musk 3%, Cow Bezoar 5%, (chronic) hepatitis, Pupalia Geniculata 85%, prevention of and Snake Gall 7% cirrhosis, hangovers, and detoxification. YUN WU TEA DRUG CLAIMS INGREDIENTS Effective in relieving Unknown heartburn. SAN XIAO DIABETIC PILLS DRUG CLAIMS INGREDIENTS For diabetes, frequent Radix Ginseng, Honey, urination, nervous Pueraria Lobata, exhaustion, mental- Glycyrrhiza Uralensis, physical fatigue, eye Fructus Mume and sight failing, etc. Trichosanthes Kinlowii, etc. "851" DRUG CLAIMS INGREDIENTS Inhibits various cancer Various trace elements cells, prevents development essential to the body cancers, aging, prolongs such as silenium, life, reinforces immunity molybdenum, borosilicate and strengthens body strontium, soluble strength. proteins, amino acids, vitamins, polysaccharides, etc. PRODUCT NAME INDICATIONS Sunghwakiang Prevents impotence, Philteo Tablet aspermic and male hypogonadism. Helps to strengthen the bones, ligaments, limber and patella, and memory. Kang Wei Huan Jian Weak kidney and knees, Pills cold limbs, mental fatigue, anxiety, headache, asexuality, prospermia, impotence; promotes the normal growth of male genitals and maintains normal sexual function. Chinese Fu Wei Pill Unhealthy body, lack of blood or spirit, growing old, under grown, over working, neurasthenia, cannot sleep, loss of appetite and sex desire. Perfect Manhood Pill Impotence, nocturnal emission, lumbago, white hair & beard, frequent urine. Fuchingsong Shiaodu Itch due to skin/palm Chieyang Capsules ulcers, drug-allergic itch damp-heat type scrotum/crotch itch, papules and/or acne, chronic tinea and skin and skin ailments of all kinds. Niu Huang Ching Febrile illness, Hsin Wan dysphasia, delirium, vertigo, fever, annoyance, panic, excessive expectoration difficulty in the movement of one side of the body, facial nerve disorder, carpopedalis spasm. Pai Feng Wan Debility, anemia, colliquative sweating due to general weakness lumbar aching, atony of the legs, giddiness, abdominal pains, profuse leucorrhea, sudden discharge of blood, and weakness after child- birth. Changbai Mountain Anemia, rheumatism, Ginseng Capsules headaches, neurosis, mucous congestion, irregular blood pressure, cardiovascular troubles, ulcer, senility, weak eyesight, night blindness, diabetes, insomnia, sterility and poor physical state. Yen Chien Ning Cure for catarrhal inflammation of the upper respiratory tract, angina, tonsilitis, lymphadenitis, narisitis, ulcer, pneumonia and abscess, etc. Sea Horse Poor nourishment, Anemia, Genital Tonic Palpitation, Shortness of Pills breath, Lumbagoand pains in legs, poor memory and consumptive coughs. Yu Quan Thirst- Applicable in the treatment of Removing Pills diabetes such as yearning for drinking water so as to relieve one's thirst, eating a great deal and frequently passing urine which is turbid and also in the treatment of vague sight due to headache and dizziness. Ley Joong Pills Weak spleen and stomach, constant expectoration, cough at night, vomitting sensation, giddiness, and general weakness. Peking Royal Jelly Capsule. Loss of body-weight, fatigue, weakness in mental and physical energy, poor appetite, and falling off of hair. Liver diseases, degenerative conditions of the nervous systems, arthritis, rheumatism, anemia, peptic ulcer, and other ulcerative conditions of the gastrointestinal tract. Tiengi Tuzhung Reinforcing vital energy or Pills essence of the liver and kidney, strengthening the bones, reducing blood pressure. Tzep Ao Sanpien Pills Untimely senility, neurasthenia, sores wait and back, overburdens of the brain, anemia, dizziness, poor memory, involuntary perspiration, insomnia, pale faces, poor appetite, etc. Costrit Slimming Creme Contain many chinese plants, reduce belly wrinkles and make skin elastic Venus Men's Towel This is a health product for men. It can prolong erection and increase sensation, especially better for men suffering from premature ejaculation. Duzhong Jianyawan A neutriment for hepar and ren; clearing heat in hepar lowering blood pressure. Red Peach Hair Tonic This agent has an extraordinary effect on prevention of alopecia. Thin hair and bald head. It can also give good treatment for inborn patcy baldness. 101 Hair Tincture There is good nourishment for hair, it can prevent hair loss after diseases. Bald head and promote hair growth. China No. 1 China's No. 1 magical solution is an Tian Xian Liquid effective remedy for curing cancer, especially in the middle or late stage of illness. It is made with purely natural substances. The United Pharmaceutical Shou Wu Chih Tonic Manufactory of Kwangchow Product Codes may include: Kwangchow, PROC 54Y--99 The Peoples Republic of China 31P--08 MID: CNUNIPHAKWN 66V--99 FEI# 1000327427 HTS codes may also vary
Excerpt from Harvard Law School LEDA articleIt is evident from the preceding descriptions that these imported Chinese herbal medicines do not confirm either to the DSHEA or to the statutory provisions mandated by the Food, Drug and Cosmetic Act (FDCA) for the approval of new drugs. Yet they are easily available in herbal stores and pharmacies in Chinatown... It is unclear what is in these herbal medicines: as we have seen, some of the medicines have no ingredient lists, and even if they do, it is not certain that the medicines contain what they say they do. The range of ailments supposedly cured by these medicines is unfathomable -- it is difficult to imagine a cure for cerebral palsy or coronary heart disease coming in the shape of these medicines. Clearly some of these imported Chinese herbal medicines present a perfect opportunity for the FDA to “protect the unthinking from the unscrupulous.” It is worth noting that there is a strong contrast with this picture when one asks for Chinese herbal remedies in a general healthfood store [For example, Dr. Shen brand]. in the Cambridge Natural Foodstore, there were two or three shelves of Chinese herbal medicines ... manufactured in the United States which made no health claims but did list the ingredients. The contrast between the two sets of herbal medicines put in sharp relief the difference between compliant and completely non-compliant unregulated medications.
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