By Beth Mole for Ars Technica
Homeopathic product maker King Bio has now expanded a recall to include all of its water-based human and animal treatments—a vast list including nearly 600 products. The expansion comes as the Food and Drug Administration (FDA) announced it found “high levels of microbial contamination” that appears to be recurring and has the potential to cause “life-threatening” infections.
The recall expansion is the second for King Bio, which first announced a recall of just three products in July. Last week, the company voluntarily expanded the recall to include 32 child and infant products. But the FDA wasn’t satisfied.
On Tuesday, the agency issued its own alert about King Bio’s products and offered a scathing perspective of the company’s manufacturing standards and business.
In the agency’s alert, FDA Commissioner Scott Gottlieb, M.D., was quoted as saying:
"We take product-quality issues seriously, and when we see substandard conditions during the course of our inspections—in this case conditions that are leading to high levels of microbial contamination with the potential to harm the public—we act swiftly to try to ensure the products are removed from circulation."
The alert went on to note that, in a recent FDA inspection of King Bio’s manufacturing facility, the agency discovered that “several” microbial contaminants had turned up in the company’s products, including the bacteria Burkholderia multivorans. This is an opportunistic pathogen that causes severe illnesses in people with compromised immune systems and is a rare but emerging cause of meningitis.
The FDA added that it also found evidence indicating “recurring microbial contamination associated with the water system used to manufacture drug products.”
After King Bio issued the first expanded recall on August 22, the FDA immediately notified the company that it needed to do more.
“The FDA contacted King Bio on August 23, 2018 and recommended the company again expand its recall to include all products that use water as an ingredient, including drug products for humans and animals,” the agency explained in the alert.
King Bio has now done that, recalling an exhaustive list of nearly 600 water-based products intended for use by adults, children, infants, and pets. The products are sold under the brand names Dr. King’s: Natural Medicine, Aquaflora, Natural Pet Pharmaceuticals, SafeCareRx, Natural Veterinary, and Safecare. Consumers can view the full lists here and here.
King Bio’s founder and president, naturopath Frank King, who goes by “Dr. King,” issued a statement on the company’s website about the expansion, explaining:
"While there have been no reports of illness or injury due to any of our products, we chose to issue the recall out of an abundance of caution…We are truly sorry for the inconvenience or concern our recall may have caused, but we felt this was the right thing to do to maintain your trust."
In an email to Ars, a King Bio representative declined to comment further on the issue, including requests for comment on the FDA’s concerns about manufacturing conditions or what the company was doing to correct the contamination issue.
The FDA, meanwhile, appears to want to make something of an example of King Bio. Last December, the agency said it would crack down on makers of homeopathic products, and the actions against King Bio seem to be part of that effort.
Dr. Gottlieb went on to say in the alert:
"In recent years, we’ve seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In addition to our concerns with contamination, some homeopathic products may not deliver any benefit and have the potential to cause harm. That’s why we’ve taken steps in the last year to advance a new regulatory approach to prioritize additional enforcement and regulatory actions against certain homeopathic products. We’re focused on products that have the greatest potential to cause risk to patients, including products for vulnerable populations like children. In the past year, we’ve also taken actions against homeopathic products that were making unproven drug claims."