FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

Homeopathic vendors receive warning letters concerning major violations, including use of snake oil and contamination  

The Food and Drug Administration (FDA) yesterday sent warning letters to four businesses that develop and market “homeopathic drug products”  for a variety of illness  – from chronic pain to cancer – for committing violations of the agency’s good manufacturing practice (CGMP) regulations. These include products produced by King Bio, a company FDA said it had previously warned the public about regarding quality violations.

“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,” FDA said, noting that the homeopathic industry continues to spread its reach, nonetheless.  “… we need to continue to address, consistent with our current enforcement policies, situations where unapproved products labeled as homeopathic are being marketed for serious diseases and/or conditions where the products haven’t been shown to offer clinical benefits,” FDA said.   

FDA Commissioner Scott Gottlieb said in the announcement that the warning letter, or formal notice, that the agency sent to King Bio underscores numerous and serious violations with their manufacturing operations. Three other companies also received warnings letters for use of toxic substances including snake venom, which the agency says could not only be harmful but doesn’t demonstrate a benefit when consumed. Products from some of these companies were also 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,” Gottlieb said in the statement.  He said FDA is finalizing draft guidance, available later in the year. “We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. 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.

The statement explained that products labeled as homeopathic are not FDA-approved for any use and may not meet current standards for safety, effectiveness and quality, and often contain a variety of ingredients derived from plants, healthy or diseased animal or human sources, minerals and chemicals. Yet they are widely available for purchase and labeled natural, safe and effective alternatives to prescription and nonprescription products. “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, such as belladonna, which the agency has previously warned against,” the agency stated.

Following the July 2018 inspection, the FDA alerted consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to the high levels of microbial contamination identified at the manufacturing site. The company recalled all drug products made with water marketed for humans and animals.

FDA says 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. Additionally, other products manufactured by King Bio and distributed by other companies under different brand names were also recalled due to contamination. These include products sold under the brand names Sprayology, Silver Star Brand, HelloLife, Beaumont Bio Med and BioLyte Laboratories.

Other companies that received letters include:

· Red Mountain Incorporated, Oakland Park, Fla. —for lacking quality oversight while manufacturing homeopathic drug products containing ingredients with potentially toxic effects for consumers, including snake venom.

· Tec Laboratories Incorporated, Albany, Ore. —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 —FDA investigators observed insects in the facility and in ingredients used to make its products.

 In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labeled as homeopathic and marketed without the required FDA approval that have the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labeled as homeopathic, the FDA stated when it issued the draft guidance that it would consider taking additional enforcement and/or regulatory actions, consistent with its current compliance policies, in the interest of protecting the public.