It’s hard to imagine, but the FDA had to issue warning letters to four homeopathic companies to stop selling products that contain lead, mercury, deadly nightshade, and strychnine. The FDA issued the warning letters to Hevert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The companies were selling injectable drug products labeled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurius solubilis (mercury), and plumbum aceticum (lead). For example, nux vomica contains strychnine, which is a highly toxic, well-studied poison that is used to kill rodents. The agency is concerned that these potentially toxic ingredients present additional risks of serious harm when delivered directly into the body, including directly into the bloodstream. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.
What are homeopathic drugs?
According to the National Institutes of Health (NIH), homeopathy, also known as homeopathic medicine, is a medical system that was developed more than 200 years ago. It’s based on the notion that a disease can be cured by a substance that produces similar symptoms in healthy people and that the lower the dose of the medication, the greater its effectiveness. Many homeopathic products are so diluted that no molecules of the original substance remain. Homeopathic products come from plants, minerals, or animals. Homeopathic products are often made as sugar pellets to be placed under the tongue but can come in other forms, such as ointments, gels, drops, creams, and tablets. Homeopathic products are regulated as drugs under the Federal Food, Drug and Cosmetic Act (FDCA). However, under current Agency policy, the FDA does not evaluate them for safety or effectiveness. The FDA allows homeopathic products that meet certain conditions to be marketed without agency preapproval. For example, homeopathic products must contain active ingredients that are listed in the Homeopathic Pharmacopeia of the United States (HPUS). In addition, the FDA requires that the label on the product, outer container, or accompanying leaflet include at least one major indication (i.e., medical problem to be treated), a list of ingredients, the number of times the active ingredient was diluted, and directions for use. If a homeopathic product claims to treat a serious disease such as cancer, it must be sold by prescription. Only products for minor health problems, like a cold or headache, that go away on their own, can be sold without a prescription.
Are they safe?
It’s important to remember that products labeled as homeopathic have not been reviewed by the FDA for safety or effectiveness. Therefore, these products can harm consumers who treat serious diseases or conditions with these types of products. Numerous products have been tested and recalled for incorrect, misleading information on the packaging, non-sterile production conditions, microbial contamination, containing deadly ingredients, and containing ingredients far in excess of the listed amounts. In 2017 Hyland’s homeopathic teething products were recalled after being linked to the deaths of 10 children. The FDA concluded the products had mislabeled the amounts of toxic belladonna (deadly nightshade) they contained.
No currently marketed drug products labeled as homeopathic have been approved by the FDA and the agency can not assure these drugs meet modern standards for safety, effectiveness, and/or quality. While they are marketed as natural and safe, there is ample proof that they often are not. There is no premarket review for safety and many contain known toxic ingredients. The FDA is currently finalizing their guidance as to the safety and use of homeopathic products.