Homeopathic Drug Products Focus of FDA Warning Letters

The FDA today posted warning letters directed at 4 companies producing homeopathic drug products, claiming significant violations of current good manufacturing practice (CGMP) regulations.

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits. We’re committed to continue taking appropriate actions when we believe patients are being put at risk by products that contain potentially harmful ingredients or have significant quality issues,” said FDA Commissioner Scott Gottlieb, MD, in a prepared statement.

The affected companies include King Bio Inc. of Asheville, NC. The FDA also warned the public in August 2018 about serious concerns with the quality of drug products produced by King Bio, which manufactures a range of products including those for children, adults and pets.

“Despite previous actions we’ve taken, our concerns remain. 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,” said Gottlieb. “Today we’ve also posted warnings letters to 3 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.”

According to Gottlieb, in addition to concerns about contamination, some products being made by these companies that are labeled as homeopathic do not deliver any benefit, yet may potentially be harmful. As a result, the agency has proposed a new regulatory approach to prioritizing additional enforcement and actions against certain products labeled as homeopathic.

Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labeled as Aquaflora, Canada, Dr. King’s Natural Medicine(s), Natural Pet, People’s Best and SafeCare. Other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories products.

In addition to King Bio, the FDA posted warning letters to the following companies for products labeled as homeopathic due to various quality and misbranding violations:

• Red Mountain Incorporated, Oakland Park, FL—A warning letter for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.
• Tec Laboratories Incorporated, Albany, OR—A warning letter for releasing products marketed for use with children, without conducting testing to ensure they were free from objectionable levels of microbial contamination. The company also did not adequately investigate test results that found high microorganism levels in its water system
• B. Jain Pharmaceuticals Pvt. Ltd., Rajasthan, India—A warning letter after FDA investigators observed insects in the facility and in ingredients used to make its products.

“We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children,” said Gottlieb “The actions we’ve taken recently, and over the course of the past year are further warning to all companies that these types of products must be manufactured and labeled appropriately. We’re working to finalize our draft guidance in the coming months to help ensure that products that reach consumers are not harmful to their health.”

The FDA has taken other similar actions this year, including a warning letter sent to Nutra Pharma Corp., Boca Raton, FL. In the letter, the agency claimed Nutra Pharma was illegally marketing unapproved products labeled as homeopathic with claims about their ability to treat addiction and chronic pain. The FDA also issued a warning letter to Pure Source LLC, Doral, FL for distributing drugs made with contaminated raw materials.

Products labeled as homeopathic have not been approved by the FDA for any use and may not 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. These products are often marketed as natural, safe and effective alternatives to approved prescription and nonprescription products and are widely available in the marketplace.

According to the FDA, these unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or may contain active ingredients that aren’t adequately tested or disclosed to patients.

Reference

FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards [news release]. Silver Spring, MD; April 1, 2019: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634885.htm. Accessed April 1, 2019.