Due to significant violations of current good manufacturing practice (CGMP) regulations, the US Food and Drug Administration (FDA) on Monday sent warning letters to four manufacturers of homeopathic medicines in Florida, North Carolina, Oregon and India.
FDA highlighted how one company—Ashville, NC-based King Bio—"continues to concern us because of the low quality of their operation and the threat their products pose to consumers,” FDA Commissioner Scott Gottlieb said.
The warning letter for King Bio notes how during FDA’s inspection last July, test results “revealed inordinately high microbiological contamination.” And the company only recalled three contaminated lots after FDA contacted it regarding microbiological contamination. FDA also explained how King Bio’s manufacturing process is not validated, which is concerning because “some of your drugs are manufactured from Nux vomica
which contains strychnine, a highly toxic, well-studied poison that is used as a rodenticide.”
Another company, Oakland Park, FL-based Red Mountain, manufactures finished homeopathic drug products “containing ingredients with potentially toxic effects, including snake venom,” without an established Quality Unit, FDA said.
Albany, OR-based Tec Laboratories also received a warning letter after FDA found the firm “released multiple batches” of topical over the counter (OTC) and homeopathic drug products, labelled for use on children, “without conducting tests to ensure they were free from objectionable microorganisms.”
And Rajasthan, India-based B. Jain Pharmaceuticals Pvt. Ltd. received a warning letter after an FDA investigator “observed numerous flying insects” in a raw material storage room.
“In addition, various raw materials, some packaged in burlap sacks, were observed scattered across your quarantine room, and the ceiling in this room was stained with what appeared to be mold,” the warning letter says. The firm was placed on import alert in January.
FDA also raised issues with several of the companies’ misbranding issues, where unproven products were labeled as treatments for HIV, herpes, cancer and more.
“In addition to our concerns with contamination, some products labeled as homeopathic 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 labeled as homeopathic. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children,” FDA said.
FDA warns homeopathic firms