The US Food and Drug Administration on Tuesday announced a crackdown on four homeopathic companies selling injectable products said to contain highly toxic substances, including lead, mercury, deadly nightshade, and strychnine.
These products—some meant 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 made public the warning letters it sent to each of the sellers, all dated June 11.
“These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”
Homeopathy is a pseudoscience that involves the erroneous belief that “like cures like”—meaning that if taking a toxic substance causes similar symptoms to a disease, the substance can be used to treat that disease. Homeopaths also believe that extreme dilutions of toxic substances increase their healing potency. As such, many homeopathic products are so diluted, they no longer contain a single molecule of the ingredient—they are just water. Still, some homeopaths absurdly claim that water molecules have “memory” of the ingredients they think are curative.
Because many homeopathic products are nothing more than water and fillers, they’ve often been disregarded as harmless placebos. But there have been a growing number of cases in recent years of homeopathic products that have been improperly diluted or diluted with contaminated water containing disease-causing microbes. Many of the products were intended for children and infants.
For instance, in 2016, the FDA reported that homeopathic teething gels and tablets had been linked to the deaths of 10 babies. There were reports of more than 400 other infants being sickened by the products, some suffering seizures. The products were supposed to have highly diluted amounts of belladonna, aka deadly nightshade, but FDA testing revealed elevated and wildly variable amounts of the toxic substance.
The cases make the idea of homeopathic products meant to be injected directly into the body far more worrisome. 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 companies sold a variety of products that claimed to help treat a hodgepodge of conditions from muscle and joint pain, waning immune responses, and “nervous disorders,” all the way to tuberculosis and hepatitis B and C.
Many of the products were said to contain toxic substances, including belladonna, mercurius solubilis (mercury), and plumbum aceticum (lead). Some were said to contain nux vomica, which the FDA noted contains strychnine, a potent poison used to kill rodents.
The FDA noted in its letter to the company doing business as Viatrexx that an FDA inspection concluded that the company had “failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.”
The companies have 15 days from the receipt of the letters to correct the violations or else the agency threatened to take legal actions, including seizure and injunction.