USFDA issues warning letter to Rajasthan based homeopathic firm and 3 others

New Delhi: The U.S. Food and Drug Administration (USFDA) recently posted warning letters to four companies producing homoeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency's serious concerns with the quality of drug products produced by King Bio.

"In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labelled as homoeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homoeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labelled as homoeopathic 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. One company that continues to concern us because of the low quality of their operation and the threat their products pose to consumers is King Bio. 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 FDA Commissioner Scott Gottlieb, M.D.

"Today we've also posted warnings letters to three other homoeopathic 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 labelled as homoeopathic that is 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 labelled as homoeopathic may not deliver any benefit and may have the potential to cause harm. That's why we've proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labelled as homoeopathic. 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 labelled 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," he added.

Products labelled as homoeopathic have not been approved by the FDA for any use and may not meet modern standards for safety, effectiveness and quality. Products labelled as homoeopathic 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. 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 warning letter to King Bio Inc. provides details of flaws in manufacturing operations and quality assurance systems found during a July 2018 FDA inspection of the facility. Beyond the violations found during the inspection, the FDA collected and tested samples of finished homoeopathic drug products; results revealed inordinately high microbiological contamination.

King Bio manufactures a range of products including those for children, adults and pets. Since August 2018, more than 900 potentially contaminated products manufactured by King Bio have been recalled, including those labelled 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.

The USFDA also posted warning letters to additional companies for products labelled as homoeopathic due to various quality and misbranding violations.

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


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

The FDA has taken similar actions this year, including a warning letter to Nutra Pharma Corp., Boca Raton, Fla.; as announced earlier this month, the FDA issued a warning letter regarding the company illegally marketing unapproved products labelled as homoeopathic with claims about their ability to treat addiction and chronic pain; the agency also alerted consumers to this health fraud scam. In February, the FDA issued a warning letter to Pure Source LLC, Doral, Fla. for distributing drugs made with contaminated raw materials.

In December 2017, the FDA proposed a risk-based enforcement approach that prioritizes enforcement and regulatory actions involving drug products labelled as homoeopathic and marketed without the required FDA approval that has the greatest potential to cause risk to patients. Given the concerns about the proliferation of potentially ineffective and harmful products labelled as homoeopathic, 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. We expect to finalize this guidance soon.

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