The Food and Drug Administration (FDA) has issued warning letters to four homeopathic drug manufacturers due to serious concerns over the quality of the products produced by these companies.
FDA Commissioner Scott Gottlieb, MD, said “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.” King Bio recalled a number of drug products last year due to high levels of microbial contamination.
Homeopathic products are not approved by the FDA and could contain a wide range of ingredients which may cause irreparable harm if poorly manufactured. Since August 2018, >900 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.
The three other companies that received warning letters included Red Mountain Incorporated (for lacking quality oversight while manufacturing), Tec Laboratories (in part for releasing products marketed for children, without conducting testing to ensure they were free from objectionable levels of microbial contamination), and B. Jain Pharmaceuticals (FDA investigators observed insects in ingredients used to make its products).
In 2017, the FDA proposed a risk-based enforcement approach to homeopathic drug products to address the potential safety concerns these products could potentially pose to consumers. Based on the draft guidance, examples of products that would be subject to enforcement priorities may include those for infants and children with ingredients such as belladonna and nux vomica, in addition to those that are marketed for serious conditions such as cancer. “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 Gottlieb. He added that the agency is working on finalizing the draft guidance in the coming months.
For more information visit FDA.gov.