Jun 18, 2020

The U.S. Food and Drug Administration has issued warning letters to four companies for selling unapproved injectable drug products labeled as homeopathic that can pose serious risks to patient health and violate federal law, as part of the agency’s efforts to protect Americans from potentially harmful products that are labeled as homeopathic.

The FDA is particularly concerned about unapproved injectable drug products labeled as homeopathic because they are injected directly into the body, often directly into the bloodstream and bypass some of the body’s key natural defenses against toxins, toxic ingredients and dangerous organisms that can cause serious and life-threatening harm. Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

“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. These unapproved injectable drugs are particularly concerning because they inherently present greater risks to patients because of how they are administered,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “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.”

No currently marketed drug products labeled as homeopathic have been approved by the FDA for any use and the agency cannot assure these drugs meet modern standards for safety, effectiveness and quality. Products labeled as homeopathic can be made from a wide range of substances, including ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals, and they can include known poisons or toxins. These drugs are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace. Additionally, the lack of premarket quality review is particularly concerning for injectable drugs, which generally pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.

The FDA issued the warning letters to Hervert Pharmaceuticals, LLC; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx; and World Health Advanced Technologies, Ltd. The products included in the warning letters are new drugs because they are not generally recognized as safe and effective for their labeled uses, and FDA has not approved these products. Some drugs, such as “Enercel,” marketed by World Health Advanced Technologies, Ltd., are intended for serious diseases such as tuberculosis and hepatitis B and C.

Many of the drugs were 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.

Drugs labeled as homeopathic may also cause significant and even irreparable harm if they are poorly manufactured. Viatrexx was also cited for substandard manufacturing practices for sterile drugs.

The foreign manufacturers of the injectable drugs sold by Hervert Pharmaceuticals, LLC; MediNatura New Mexico, Inc.; and Viatrexx were also placed on import alert 66-41 to stop these drugs from entering the U.S.

The FDA has taken steps to clarify for both consumers and industry how the potential safety risks of these products are assessed. On Oct. 24, 2019, the FDA withdrew Compliance Policy Guide (CPG) 400.400 “Conditions Under Which Homeopathic Drugs May be Marketed,” because it was inconsistent with the agency’s risk-based approach to regulatory and enforcement actions. The FDA also issued a revision of its draft guidance, titled Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry, for public comment. When finalized, this guidance will explain the categories of homeopathic drug products that we intend to prioritize under our risk-based enforcement approach. In the interim, before the draft guidance is finalized, the FDA intends to apply its general approach to prioritizing risk-based regulatory and enforcement action.