FDA Sends Warning To Homeopathic Drug Makers Over Poor Manufacturing Standards

Federal regulators indicate that certain homeopathic drug companies have engaged in poor manufacturing process, including which may result in a risk of bacterial contamination and unsafe ingredients in the products.

In a press release issued on April 1, the FDA announced that warning letters were recently sent to four companies, indicating they violated good manufacturing practice regulations and face regulatory actions, as well as additional enforcement.

The FDA sent the letters to King Bio Inc., of Asheville, North Carolina.; Red Mountain Inc., of Oakland Park, Florida; Tec Laboratories, of Albany, Oregon; and B. Jain Pharmaceuticals Pvt. Ltd., of Rajasthan, India.

In July 2018, the FDA inspected the King Bio facility and found numerous manufacturing violations. Samples from King Bio products tested positive for high levels of microbiological contamination and microbiological contamination was also found in the water system.

This inspection led to the recall of 900 King Bio products. However, despite the recall and repeated warnings to the company, King Bio continues to use unsafe manufacturing practices and produce poor quality products which may pose a threat to consumers, FDA inspectors warn.

“The warning letter we’re sending is a formal notice to King Bio outlining a number of ongoing, serious violations with their manufacturing operations that must be corrected,” FDA Commissioner Scott Gottlieb, said in the press release. “Today we’ve also posted warnings letters to three other homeopathic drug manufacturers for additional concerns we’ve observed – from the use of toxic substances like snake venom that has the potential to cause harm and does not have demonstrated benefit, to other firms whose products we’ve found to be contaminated. These actions build on similar steps we’ve taken over the past year, as we continue to see products labeled as homeopathic that are being marketed without approval for a wide array of diseases and conditions, from chronic pain to cancer. In addition to our concerns with contamination, some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm.”

Homeopathic Medicine Concerns

Homeopathy as a medical practice developed in the 1700s, and is based on the idea that a substance that may cause symptoms in a healthy person can be used to treat an illness in diluted amounts. Manufacturing and distribution began without FDA approval in the mid 1980s.

Homeopathic products are prepared from different sources, including plants, minerals, chemicals, and human and animal excretions and secretions. They are sold in pharmacies, in stores, and online.

It was a small market, until recently. Over the last decade the market has grown significantly to create a $3 billion industry.

However, as the industry has grown, the FDA has seen an increase in problems with safety and side effects.

Gottlieb warned that homeopathic products are being marketed for serious diseases and conditions, such as chronic pain and cancer. However, there is no evidence to indicate the products are effective to treat these conditions and using the products may pose a safety issue to consumers.

In addition to the warning letters, the agency also plans to implement a comprehensive enforcement process for products labeled as homeopathic and marketed without the FDA’s approval.

The agency urges consumers to report all side effects from homeopathic products to the FDA’s MedWatch Adverse Event Reporting Program.