The U.S. Food and Drug Administration announced Tuesday that it would take action against four homeopathic companies that sell injectable products that are said to contain highly toxic substances, including lead, mercury, deadly nightshade, and strychnine.
These products – some are said to be injected directly into the bloodstream – are illegal and pose "serious risks to patient health," the FDA said in an announcement. The agency also published the warning letters it sent to all sellers on June 11th.
"These unapproved injectable drugs are particularly worrying because of their inherent inherent risk to patients," said Donald Ashley, director of the Office of Compliance at the FDA's Drug Evaluation and Research Center, in a statement. “These products continue to be of concern because they are labeled to contain potentially toxic ingredients that are intended for direct injection into the body. These warning letters reflect our ongoing commitment to patient safety. "
Homeopathy is a pseudoscience that contains the wrong assumption that "how heals how" – meaning that the substance can be used to treat this disease if taking a toxic substance causes symptoms similar to a disease. Homeopaths also believe that extreme dilutions of toxic substances increase their healing power. Therefore, many homeopathic products are so diluted that they no longer contain a single molecule of the ingredient – they are just water. Still, some homeopaths absurdly claim that water molecules have a “memory” for the ingredients they think are healing.
Since many homeopathic products are nothing more than water and fillers, they have often been ignored as harmless placebos. However, in recent years there has been an increasing number of cases of homeopathic products that have not been properly diluted or diluted with contaminated water containing disease-causing microbes. Many of the products were designed for children and toddlers.
For example, the FDA reported in 2016 that homeopathic tooth gels and tablets have been linked to the death of 10 babies. There have been reports of more than 400 other infants who were ill with the products and some had seizures. The products should contain highly diluted amounts of Belladonna, also known as deadly Nightshade, but FDA tests have shown increased and highly variable amounts of the toxic substance.
The cases make the idea of homeopathic products to be injected directly into the body much more worrying. When injected into the bloodstream, they can "bypass some of the body's key natural defenses against toxins, toxic ingredients, and dangerous organisms that can cause serious and life-threatening harm," the FDA wrote.
The four companies warned by the FDA are Hevert Pharmaceuticals LLC; MediNatura Inc .; 8046255 Canada Inc., doing business as Viatrexx; and World Health Advanced Technologies Ltd.
The companies sold a variety of products that are said to help treat a variety of conditions, such as muscle and joint pain, dwindling immune responses, and "nervous disorders" to tuberculosis, hepatitis B and C.
Many of the products are said to contain toxic substances, including Belladonna, Mercurius Solubilis (mercury) and Plumbum Aceticum (lead). Some are said to contain nux vomica, which, according to the FDA, contains strychnine, a powerful poison that is used to kill rodents.
In its letter to the company that operates as Viatrexx, the FDA found that an FDA inspection concluded that the company "has not established and followed appropriate written procedures to prevent microbiological contamination of drugs," which are said to be sterile, and which include validation covering all aseptic and sterilization processes. "
Companies have 15 days from receipt of the letters to correct the violations, or the agency may face legal action, including seizure and injunction.