In 1982, physicians throughout the United States began receiving multiple mailings of a large softcover booklet called Biological Therapy with Homeopathic Remedies . 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 . In 1985, the Albuquerque Tribune reported that BHI had distributed nearly 200,000 of its booklets .
In response to this promotion, the U.S. Food and Drug Administration concluded that BHI was one of the most flagrant law violators among homeopathic marketers . Acting on this belief, the agency issued a regulatory letter  and banned the importation of BHI products that it considered unapproved new drugs. Despite these actions, however, BHI (now called Heel, Inc.) continued to violate the law and for many years has marketed more than a thousand products. This article traces the company’s history and states what I believe should be done to protect consumers.
Hans-Heinrich Reckeweg, MD (1905-1985), was a German physician who practiced homeopathy. The Heel Web site states that he founded Biologische Heilmittel Heel GmbH in Berlin 1936 and moved the company to its present location in Baden-Baden in 1953. Between 1936 and 1979, he developed 1,000 combination homeopathic remedies in Germany. In 1979, Reckeweg relocated to Albuquerque and created Biological Homeopathic Industries (BHI) and began manufacturing combination remedies in tablet form. In 1981 he founded Menaco Publishing Company, which published books and “journal” called “Biological Therapy” (now called the Journal of Biomedical Therapy). In 1997, the Albuquerque company was renamed Heel Inc, which now manufactures and distributes both BHI products and Heel products [5,6]. Heel products are primarily marketed to practitioners, whereas BHI products are primarily marketed to consumers,
According to Reckeweg:
Illness is the expression of self-healing. The afflicted organism attempts to regulate its functions through the body’s greater defense system by activating detoxification and excretion. Inflammation and fever are not necessarily “bad” signs but rather serve to detoxify and eliminate toxins. This occurs according to the chemical processes as defined and demonstrated in homotoxicology. Through this, the physician is provided a different perspective of illnesses as many puzzles are clarified and methods of treatment are re-established. Inflammation need not be suppressed by antibiotics and/or chemotherapy as this often provokes retoxification and therapeutical damage that should be avoided. By suppression the illness is propelled towards dangerous retoxic cellular phases that manifest themselves as chronic and/or lingering diseases. BHI homeopathic remedies stimulate the five systems that comprise the great corporal defense system as defined in homotoxicology .
Reckeweg further claimed that his methods worked by converting homotoxins into nontoxic substances that he called “homotoxons” .
The claims made for Heel-BHI products are available on several Web sites. Heel-BHI has a copy of its 210-page Routine Therapy guide for Heel products  and its 132-page Homeopathic Therapy guide for BHI products . Homotoxicology.net has posted Heel’s 669-page Biotherapeutic Index, which describes how to use products to treat more than 400 conditions . A 1993 edition of the book (pictured to the right), which was distributed at an osteopathic convention in 1998, was smaller but contained 12 pages on “neoplasia and neoplastic phases of disease.” (Neoplasm is a medical term for tumor.) These volumes contain the most brazen set of bogus therapeutic claims I have ever seen.
To illustrate the extent of the claims, I have posted the entry for Lyphomyosot® in the Biotherapeutic Index, which states that the product is useful for asthma, “blood purifying,” bronchitis, chronic gastritis, cystitis, dermatoses, diarrhea, eczema, flatulence, gallbladder disease, heel pain, herpes, kidney stones, liver disease, nasal polyps, rickets, swollen glands, tuberculosis, and several other problems.
Use By Practitioners
Practitioners can learn how to use Heel products through educational events sponsored by the company and/or its distributors. For many years, the Heel USA Web site listed more than 50 seminars, teleconferences, and Web-based programs each year. The seminar fee included a copy of Heel’s Practitioner’s Handbook. Some of the seminars were co-sponsored by Vibrant Health International Technologies, of Quebec, Canada, which also sold EAV devices. These devices are fancy galvanometers that measure skin resistance . They are not FDA-approved for diagnosis and cannot be legally marketed in interstate commerce as diagnostic devices. Many of the doctors who prescribe Heel products use such devices. In 2007, I got a glimpse into such use through a complaint from a man whose wife had consulted Jarir Nakouzi, M.D., a member of Heel’s speaker’s bureau. Nakouzi practices internal medicine and homeopathy in Bridgeport, Connecticut. His Web site described him as “an expert in oncology” , and the Vibrant Health Web site described him as “Heel International’s most accomplished oncology expert.”  He is not board certified but said he took a three-year fellowship in oncology after graduating from medical school in Italy. The patient had received standard treatment for breast cancer but was terminally ill. Nakouzi treated her for 12 weeks beginning in October 2002. The charges totaled more than $41,000, which included about $8,500 for worthless “bioresonance therapy” and “quadrant analysis and balancing” with an EAV device.
In 2010, based on a review of this case, the Connecticut Department of Public Health charged him with failing to get adequate informed consent, failing to maintain adequate documentation, and using a bioresonance device as a diagnostic technique . In 2011, the complaint was settled with a consent order under which Nakouzi agreed to (a) pay $5,000, (b) stop using devices that measure skin resistance for diagnostic or treatment purposes, (c) stop making unsubstantiated claims that refrain from recommending, prescribing, or administering any alleged cancer treatment that lacks FDA approval or scientific support, and (d) serve probation for two years, during which at least 20 of his patient charts would be subject to random review by a supervisor acceptable to the Department .
FDA Enforcement Actions
In 1984, FDA officials concluded that BHI was one of the three most flagrant violators because they marketed products for very serious disease conditions . Soon afterward the agency warned Reckeweg that it was “unaware of any substantial scientific evidence which demonstrates that any of your marketed homeopathic drugs are generally recognized as safe and effective for their intended use” and that “continued marketing of these drugs is a serious violation of the Federal Food, Drug, and Cosmetic Act.”  A few months later, the Albuquerque Tribune stated that the company had stopped selling “anticancer, antivirus, artery, regeneration, and stroke pills” and would modify how it marketed the rest .
An FDA Enforcement Report indicates that in 1991 BHI recalled 1,055 bottles and 33,333 finished bulk tablets of BHI Infection Homeopathic Remedy Tablets because they were “subpotent.” 
Between October 1993 and September 1994, the FDA warned BHI to stop making claims that BHI Cold, which contained sulfur and pulsatilla, was effective against mumps, whooping cough, chronic respiratory diseases, herpes zoster, all viral infections, and measles. In addition, when combined with other BHI remedies, it had been illegally claimed to be effective against otitis, pleurisy, bronchitis or pneumonia, conjunctivitis, and tracheitis .
In January 2005, the FDA ordered Heel Inc. to stop making illegal claims for five products claimed to be effective in preventing or treating influenza . In 2010, the FDA and FTC jointly ordered Homeopathy for Health, of Moses Lake, Washington, to stop claiming that BHI Bronchitis, BHI Bronchitis for Children, BHI Flu Plus with Influenzinum, and Heel Gallium Heel were an effective anti-viral for respiratory flu, such as the then-current swine flu . The FDA also placed these products on its Fraudulent Products List .
In addition to warning letters, the FDA has issued import alerts to try to prevent most BHI products from being imported. Between October 1983 and April 1985, the agency made 10 detentions on grounds that the products were unapproved new drugs . The blockage includes all products labeled “sterile” or for injection. Since 1995, additional Heel products have been blocked because of illegal therapeutic claims and failure to abide by good manufacturing practices . There may have been other detentions, but I do not have access to such information.
Controversial Tax Break Proposal
In October 2003, the Bernalillo County (New Mexico) Commission approved a deal under which Heel could obtain an $8 million industrial revenue bond that would be repaid within 20 years. During the repayment period, it would not have to pay property taxes and certain gross-receipts taxes. Proponents argued that subsidies of this type help create jobs and are good for the local economy, but critics noted that some companies had left the state before such agreements have expired . I wondered whether the Commission knew or cared about the nature of Heel’s business. It turned out, however, that Heel decided not to use the bonds.
Heel Announces Withdrawal from the United States and Canada
In 2014, Heel announced that it would stop marketing within the United States and Canada after August 31, 2014. Its press release attributed the decision to two class-action suits that has caused a “substantial financial burden.” 
- One of the suits was filed by Robert A. Mason on behalf of consumers who had purchased Heel’s pain relief products, Traumeel and Zeel. The suit challenged claims the products (a) provide “natural” pain relief, (b) provide “on-the-spot” pain relief, (c) are “doctor recommended,” “used by doctors,” and “used by doctors worldwide,” and (d) are more effective than certain anti-inflammatory drugs. The suit also objected to claims that the products are proven clinically proven as effective, “when such clinical proof, if it even exists, consists either of biased studies performed by investigators compensated by Defendant or its parent or subsidiary corporations or studies that fall short of relevant agency advertising standards, facts which are not disclosed to consumers.”  In 2013, Heel entered into a settlement agreement under which, without admitting wrongdoing, it agreed to (a) stop claiming or implying that the products have been proven effective unless at least two independent, randomized, double-blind, placebo-controlled human clinical trials have demonstrated effectiveness, (b) indicates on its Web site how much the product ingredients have been diluted, and (c) pay $1 million into a settlement fund that will be used to reimburse buyers of the products—or, if funds remain after claims are paid, to a non-profit organization or organizations dedicated to informing consumers or advocating on their behalf about deceptive drug labeling concerns .
- The other suit was filed by the Sandusky Wellness Center, of Sandusky, Ohio, on behalf of people who had received unsolicited faxes from Heel. The complaint, filed in 2012, charged that Hell had violated the federal Telephone Consumer Protection Act by sending out faxes without the recipients’ permission . Attached to the complaint was a copy of a fax in which Heel claimed that its Engystol product would “strengthen the natural immune response and boost defenses to better deal with viral infections such as influenza, cold sores and feverish conditions.” The case was settled with an agreement under which Heel made $6 million available to claimants, with a provision that if individual claims did not total at least $615,000, the difference between that number and the claims amount would be distributed to several charities. The plaintiff received a $15,000 award as class representative, and the plaintiff’s attorneys were awarded $2 million plus $170,000 for costs .
The Bottom Line
Heel-BHI has been marketing products with outrageous and illegal claims for more than 25 years. The vast majority are irrationally formulated and have not been scientifically tested. Using them instead of proven therapy is a waste of money and could lead to a delay in getting appropriate treatment. The FDA should take forceful action to rid the marketplace of these products. Since there is no logical reason to use the products, consumers should avoid practitioners who prescribe them.
- Biological Therapy with Homeopathic Remedies. Albuquerque, NM: Menaco Publishing Company, 1981, 1983.
- Uhlman M. FDA cracks down in city ‘homeopathic’ drug factory. Albuquerque Tribune March 14, 1985.
- Rados B. Riding the coattails of homeopathy’s revival. FDA Consumer 19(2):30-34, 1985.
- Michels D. Regulatory letter to Dr. Hans Heinrich Reckeweg, Dec 11, 1984.
- Story of Heel. Heel-BHI Web site, accessed March 14, 2007.
- Reckeweg HH. Foreword to Homeopathic Therapy: Physicians Reference. Albuquerque, NM: Heel, Inc., 1998.
- Reckeweg HH. Scientific basis of biological and homeopathic therapy. (Booklet) Baden-Baden: Aurelia Verlag, 1979.
- Routine Therapy: Practitioner’s Handbook of Homotoxicology, Second Edition. Albuquerque, NM: Heel, Inc., 2005.
- Homeopathic Therapy: Physicians Reference. Albuquerque, NM: Heel, Inc., 1998.
- Biotherapeutic Index, 5th revised English edition. Baden-Baden, Germany: Biologische Heilmittel GmbH, 2000, p 4.
- Barrett S. Quack “electrodiagnostic” devices. Quackwatch, Sept 5, 2007.
- Dr. Jarir Nakouzi, M.D. drjarirnakouzy.com, accessed Dec 3, 2007.
- Workshops. Vibrant Health International Technologies Web site, accessed Dec 3, 2007.
- Statement of charges. In re: Jarir Nakouzi, M.D. Petition No. 2007-0424-001-060, Nov 9, 2010.
- Consent order. In re: Jarir Nakouzi, M.D. Petition No. 2007-0424-001-060, Oct 1, 2011.
- Chastonay RJ. Request for limited inspection Re: Homeopathic Products. Memo, Oct 26, 1984
- FDA Enforcement Report, March 25, 1992, p 6.
- Health Fraud Actions, October 1993 – September 1994. Rockville, MD: FDA, 1994, p 3.
- Malarkey MA. Warning letter to Chris Rusnock. Jan 3, 2005
- Drugs detention for FY 84 to date. FDA computer printout. Oct 10, 1985.
- Details can be located by searching the FDA Web site for “Heel,” “BHI,” “Biologische Heilmittel” and “Heel GmbH.”
- Autor DM. Warning letter to Kathryn Jones, June 8, 2010.
- List of homeopathic drugs products from Brand Heel, Inc. FDA Web site Sept 22, 2010.
- Import alert #66-40. Detention without physical examination of drugs from firms which have not met drug GMPs. Revised Aug 17, 2007.
- Sanchez JW. Duke city company to get IRB. Albuquerque Tribune, Oct 14, 2003.
- Heel to focus on core markets. Heel press release, May 23, 2014.
- Complaint. Robert A. Mason v. Heel, Inc. U.S. District Court, Southern District of California Case No 3:12-cv-03056-GPC-KSC, filed, Dec 21, 2112.
- Class action settlement agreement. Robert A. Mason v. Heel, Inc. U.S. District Court, Southern District of California Case No 3:12-cv-03056-GPC-KSC, filed, Aug 14, 2013.
- Class action complaint. Sandusky Wellness Center LLC v. Heel, Inc., and John Does 1-10. U.S. District Court for the Northern District of Ohio. Case No 3:12-cv-01470-JZ, filed June 11, 2012.
- Final approval order and judgment of class wide settlement. Sandusky Wellness Center LLC v. Heel, Inc., and John Does 1-10. U.S. District Court for the Northern District of Ohio. Case No 3:12-cv-01470-JZ, filed April 25, 2014.
This article was revised on June 5, 2014.