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Government Enforcement Actions Related to Homeopathic or Alleged Homeopathic Products

FDA Warning Letters (56) Nearly all of these ordered the seller to stop claiming that products could effectively treat specific diseases of conditions. Some ordered the seller to stop claiming that products were vaccine equivalents. Some involved failure to use good manufacturing practices (GMP). A Nelson & Co / Najib Fayad (7/26/12): Arnica, Rhus Tox ABCO Laboratories / Allen Baron (6/19/12): IBU-RELIEF, Sexual Virility Max Aurora Health and Nutrition (Robert G. Thompson, M.D.12/01/16): Homeopathic product: Cold Sore Rescue B. Jain Pharmaceuticals Pvt. Ltd. / Kuldeep Jain {3/21/19): Ring Relief Ear Drops, Ring Relief Fast Dissolving Tablets Bill Gray Medical Corp / Bill Gray, M.D. (4/2/03): Dr. Gray’s Smallpox Shield Bio-Botanica Inc / Josephine Perricone (6/11/87): Nature’s Answer Homeopathic Herpes Cream Biological Homeopathic Industries (BHI / …

Disciplinary Actions against Homeopathic Medical Doctors

This article describes how several doctors have been disciplined by their state licensing boards for prescribing homeopathic medication instead of proven medical treatment. The links provide additional information about what happened. Warren Metzler, M.D. practiced what he called “constitutional homeopathy” in the 1980s and early 1990s. 1992, the New York State Board of Professional Medical Conduct charged him with mismanaging the care of four patients, one of whom died. All four had symptoms of serious diseases that required medical treatment and/or referral. Metzler testified that he used homeopathic remedies to “treat the entire person” rather than treating diseases. He also testified that illness is the result of a restricted spirit, there is no such thing as an incurable illness, and that it was not necessary to …

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FDA Officials Discuss Whether Homeopathic Drugs Should Be Marketable without a Prescription (1981)

July 10, 1981 Director Bureau of Drugs (HFO-l) Homeopathic Preparations Associate Commissioner for Regulatory Affairs (HFC1) This is in response to your request made at the July 6, 1981, meeting in your Office that the Bureau of Drugs delineate its position with respect to the domestic marketing of homeopathic drugs without the Rx legend. As you were informed by our Office of Compliance, since the passage of the Durham-Humphrey Amendment to the FD&C Act, the Agency has consistently stated that homeopathic preparations should be restricted to prescription sale and be labeled with the Rx legend. You were also advised that until now, no compliance program has been developed to regulate the marketing of homeopathic drugs due in large part to the relatively small volume of …

Heel-BHI: The World’s Most Outrageous Homeopathic Marketer

In 1982, physicians throughout the United States began receiving multiple mailings of a large softcover booklet called Biological Therapy with Homeopathic Remedies [1]. The booklet described what it called the practice of “homotoxicology” and offered 53 products intended for treating cancer, gallstones, glaucoma, kidney failure, multiple sclerosis, smallpox, syphilis, tuberculosis, and more than a hundred other diseases and conditions. The mailings came from Biological Homeopathic Industries (BHI), of Albuquerque, New Mexico, whose president, Dr. Hans-Heinrich Reckeweg, was said to have done “extensive research” since the late 1920s [1]. In 1985, the Albuquerque Tribune reported that BHI had distributed nearly 200,000 of its booklets [2]. In response to this promotion, the U.S. Food and Drug Administration concluded that BHI was one of the most flagrant law …

FDA Warns against Hyland’s Homeopathic Teething Tablets

Hyland’s Teething Tablets is a homeopathic product sold over-the-counter (OTC) in retail outlets for temporary relief of teething symptoms in children. In October 2010, the FDA warned consumers that this product may pose a risk to children and should not be used [1]. The FDA’s news release states: The tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has received reports of children …

Regulatory Actions against Katrina Tang

During 1990, FDA agents twice raided the Century Clinic, of Reno, Nevada (now called the Century Wellness Canter) and seized Dermatron devices and the medical records of 71 patients [1] The case was settled in 1993 with a consent agreement under which the clinic and its director, Katrina C. Tang, were prohibited from using EAV devices without either FDA approval or under an approved application for an investigational device exemption (INE) that would permit legitimate experimental use. The agreement also proivded for a $200,000 penalty for violation of the consent decree. After the agreement was signed, Biosource, which was not a party to it, obtained an investigational device exemption (IDE) by claiming that its Listen System devices would be used experimentally to see whether they …

Dermatron Devices Seized

SUBJECT: Denial of use of Dermatron and interference with desired medical treatment, Reno, Dist. Nev.; Civil No. N-91-041-HDM. PETITIONED 1-28-91 by Century Clinic, Reno, Nev., Yiwen Y. Tang, M.D., H.M.D., clinic medical director, Katrina C. Tang, H.M.D., clinic staff member, six named patients of the clinic, and an association of clinic patients, against HHS Secretary Louis W. Sullivan and FDA Commissioner David A. Kessler in a complaint for declaratory judgment and injunction: That the Dermatron was a galvanic skin response measurement device employed by thousands of physicians and that the Dermatron had been in commercial distribution prior to the enactment of the Medical Device Amendments on May 28, 1976, and accordingly had a “grandfather” status; that the Century Clinic and the other plaintiffs had their …