FDA Warning Letters Target Companies Selling Injectable Drugs As Homeopathic

Federal drug regulators have issued four warning letters to companies that sell injectable homeopathic drugs, indicating that the products pose a threat to consumers.

In a series of warning letters issued on June 16, the FDA cited four companies for using harmful ingredients and poor manufacturing processes for homeopathic products.

The warnings were issued to: Hervert Pharmaceuticals, LLC.; MediNatura, Inc.; 8046255 Canada, Inc., doing business as Viatrexx.; and World Health Advanced Technologies, Ltd., focusing on drugs manufactured by the companies that pose significant risks to patient health and violate federal law because they are unapproved drugs intended to treat serious conditions or diseases.

The companies were selling products injected directly into the body, often into the bloodstream, bypassing some of the body’s natural defenses against toxins, toxic ingredients, and dangerous organisms that can cause serious and life-threatening harm.

“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, in the press release.

The agency indicates these types of products can cause harm to consumers, and also cause consumers to stop or delay necessary medical treatment that has been proven to be safe and effective.

Homeopathic products 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.

They are often marketed as natural, safe and effective alternatives to approved prescription and non-prescription products and are widely available on the U.S. marketplace.

These types of products often lack premarket quality review for injectable drugs, which generally pose a greater risk to users than pills or other forms of medication. And the agency says some of these drugs in particular, were illegally marketed as treatments for diseases and conditions, which require FDA new drug approval.

For example, one of the drugs, Enercel is marketed by World Health as a treatment for serious diseases, like tuberculosis and hepatitis B and C.

In addition, many of the drugs were labeled to contain potentially toxic ingredients such as nux vomica, belladonna (deadly nightshade), mercurous solubilis (mercury), and plumber aceticum (lead). Nux vomica also contains strychnine which is a poison used to kill rodents.

These ingredients pose a risk of harm to consumers, especially when delivered directly into the body via injection, the FDA warns.

The letters are part of a recent effort by the FDA to address safe manufacturing guidelines for homeopathic products. Late last year, the FDA issued draft guidance focused on risk-based enforcement for homeopathic products, in an effort to provide more guidance on oversight of homeopathic products.

Consumers who have experienced side effects or problems related to quality of the homeopathic products including in the warnings, or any products related to the companies issued warnings, should report those problems to the FDA’s MedWatch Adverse Event Reporting program.