Washington, D.C.--The U.S. Food and Drug Administration (FDA) sent four warning letters about violations of current good manufacturing practice (CGMP) regulations to companies that produce homeopathic drug products, including King Bio Inc., Red Mountain Inc., Tec Laboratories Inc. and B. Jain Pharmaceuticals Pvt. Ltd., according to a news release.
The release states these four companies are being warned about their homeopathic products because of their manufacturing safety, concerns with contamination, use of toxic substances, and mislabeling.
In the release, FDA noted that products labeled as homeopathic are not approved by the agency and might not meet safety, quality, or effectiveness standards. It also stated that homeopathic labeled products are often made from a range of substances that include plant ingredients, healthy or diseased animal or human sources, chemicals and minerals, and that some products might contain active ingredients that aren’t tested or disclosed to patients such as a previously warned substance, belladonna.
The release clarified the reasons behind each of the companies' warning letters:
- Red Mountain, in Oakland Park, FL, received a warning letter for improper manufacturing and the use of ingredients that can be potentially toxic, such as snake venom.
- Tec Laboratories, in Albany, OR, received a warning letter for releasing children’s products without proper testing to ensure that they did not have microbial contamination. They also did not test their water system, which was found to have high microorganism levels, according to the release.
- Jain Pharmaceuticals Pvt. Ltd., in Rajastha, India, received a warning letter for the insects in their facility, as well as ingredients used in their products.
- King Bio was issued a letter that includes details of violations in their manufacturing and quality assurance systems, and microbiological contamination found in test samples and water system. The letter states that the water system contained led, which led to a recall of more than 900 products. Some of those products recalled include Aquaflora Canada, Natural Pet, Dr. King’s Natural Medicine(s), SafeCare, and People’s Best. Other King Bio manufactured products that were recalled have different brand names associated with their distributing companies, such as Sprayology, Silver Star Brand, Beaumont Bio Med, HelloLife, and BioLyte Laboratories. King Bio's products have been subject to previous recalls, as reported by the FDA and by WholeFoods.
Outgoing FDA commissioner Scott Gottlieb said in the 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."
Gottlieb explained that these actions build on steps the agency has taken over the past year due to concerns with products labeled as homeopathic that are being marketed without approval for diseases and conditions, including chronic pain to cancer. "In addition to our concerns with contamination," Gottlieb said, "some products labeled as homeopathic may not deliver any benefit and may have the potential to cause harm."
FDA has proposed a new regulatory approach to prioritize additional enforcement and regulatory actions against certain products labeled as homeopathic, Gottlieb added. "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. 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.”
According to the release, other companies that have also received warning letters during the year include Nutra Pharma Corp. and Pure Source LLC.
The release states that in December 2017, the FDA proposed a risk-based enforcement approach that is meant to enforce and regulate actions for drug products that are labeled as homeopathic and marketed without FDA approval that cause the biggest risk to consumers. They also proposed taking additional enforcement and regulatory actions when needed to protect the public. FDA is expecting a finalization of this draft soon, according to the release.