FDA warns MediNatura against 'potentially toxic' homeopathic injectables for joint disease
The FDA has issued a warning letter to MediNatura Inc., ordering the company to cease illegal marketing of unapproved injectable homeopathic products that claim to treat “inflammatory and degenerative conditions of the musculoskeletal system” and relieve pain, swelling and joint stiffness.
“The FDA’s drug approval requirements are designed to protect patients by ensuring, among other things, that drugs are safe and effective for their intended uses,” Donald D. Ashley, JD, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a press release. “These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered.”
Ashley added that “these products are further concerning given that they are labeled to contain potentially toxic ingredients intended for injection directly into the body. These warning letters reflect our continued commitment to patient safety.”
In its letter, dated June 11, the FDA referenced several MediNatura products, including “Zeel Injection Solution,” “Traumeel Injection Solution,” “Engystol Injection Solution,” “Neuralgo Rheum Injection Solution,” “Lymphomyosot X Injection Solution” and “Spascupreel Injection Solution.” According to the FDA, these products are unapproved new and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.
In addition, the FDA warned that the products are concerning because they are labeled to contain ingredients such as “mercurius solubilis” (mercury) and “embryo totalis suis,” which could be toxic or otherwise harmful.
According to the FDA, claims made by MediNatura on its website include:
- Zeel Injection Solution: “... treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.”
- Traumeel Injection Solution: “... treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.”
- Engystol Injection Solution: “... support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.”
- Neuralgo-Rheum Injection Solution: “... treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.”
- Lymphomyosot X Injection Solution: “... improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymph nodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.”
- Spascupreel Injection Solution: “... relief of spasms of the smooth musculature of the gastrointestinal and urogenital tract as well as general muscle spasms.”
The MediNatura website also included several videos in its “Education” section that claimed its products could be indicated for tennis elbow, back pain, rotator cuff syndrome and fibromyalgia, according to the FDA’s letter.
“We recognize that ‘Zeel Injection Solution,’ ‘Traumeel Injection Solution,’ ‘Engystol Injection Solution,’ ‘Neuralgo Rheum Injection Solution,’ ‘Lymphomyosot X Injection Solution’ and ‘Spascupreel Injection Solution’ are labeled as homeopathic drugs with active ingredients measured in homeopathic strengths,” the warning letter stated. “[However,] Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act [21 U.S.C. 321(g)(1)] exempts homeopathic drugs from any of the requirements related to adulteration, misbranding or approval.”
The FDA has requested that MediNatura respond within 15 working days. The letter also states that failure to correct any violations could result in legal action against the company, including seizure and injunction.
Asked for comment, Cliff Clive, founder and CEO for MediNatura, told Healio Rheumatology that he is disappointed with the FDA’s actions and the company is in the process of developing their response.
“The FDA’s statements that the MediNatura injectable products present greater risk to consumers is without factual basis,” Clive said. “The MediNatura injectable products are labeled for use only under the care of licensed practitioners [and] are manufactured in [Good Manufacturing Practice]-compliant facilities to assure their quality and sterility.”
Disputing several of the claims made in the letter, Clive noted that rather than protecting patients, “the FDA’s actions threaten to remove valuable alternatives relied upon by medical practitioners in treating their patients.”
“These injections have been used legally by thousands of medical doctors for more than 30 years in the U.S., and in over 50 other countries for more than 60 years, with rigorous monitoring of adverse events,” Clive said. “As a result, there is a substantial amount of epidemiological data which shows that MediNatura’s injection products have a superb safety profile.”